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From: TSS ()
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
Date: January 18, 2006 at 1:37 pm PST


----- Original Message -----
From: "Terry S. Singeltary Sr."
To: "Bovine Spongiform Encephalopathy"
Sent: Wednesday, January 18, 2006 3:54 PM
Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN
THE USA


> ENFORCE -- January 18, 2006
>
> 06-03
>
>
>
> PRODUCT
> Human Tissue for Transplantation, Recall # B-0322-6
> a) Alloquent CC Allograft (8, 9 & 10 mm);
> b) Achilles Tendon;
> c) Cancellous Bone 4-10 mm (15 & 30 cc);
> d) Patella Tendon-Hemi;
> e) Iliac Crest Wedge (14-17mm, 11-13mm,
> <10mm, and 18+mm);
> f) Tibialis Tendon
> CODE
> a) Code: BS30-4008, BS30-4009, BS30-4010;
> b) Code: LATM;
> c) Code: LCISM & LCIPM;
> d) Code: LTTM;
> e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;
> f) Code: LTTM
> RECALLING FIRM/MANUFACTURER
> Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters dated
> October 12, and October 21, 2005.
> Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm
initiated
> recall is ongoing.
> REASON
> Human tissues, procured from donors without adequate donor eligibility
> determinations, were distributed.
> VOLUME OF PRODUCT IN COMMERCE
> 283 tissues
> DISTRIBUTION
> Nationwide and Turkey
>
> _______________________________
> PRODUCT
> PUROS Allograft Bone;
> Suspend Tutoplast Processed Fascia Lata,
> Recall # B-0375-6
> CODE
> a) U00000000045293 U00000000045294 U00000000045295 U00000000045296
> U00000000045297 U00000000045298 U00000000045299 U00000000045300
> U00000000045301 U00000000045302 U00000000045303 U00000000045368
> U00000000045369 U00000000045370 U00000000045371 U00000000045372
> U00000000045373 U00000000045374 U00000000045375 U00000000045425
> U00000000045426 U00000000045427 U00000000045428 U00000000045429
> U00000000045430 U00000000045532 U00000000045533 U00000000045534
> U00000000045535 U00000000045536 U00000000045537 U00000000045618
> U00000000045619 U00000000045620 U00000000045621 U00000000045622
> U00000000045623 U00000000045624 U00000000045625 U00000000045626
> U00000000045627 U00000000045628 U00000000045629 U00000000045630
> U00000000045680 U00000000045681 U00000000045682 U00000000045683
> U00000000045684 U00000000045685 U00000000045686 U00000000045821
> U00000000045822 U00000000045823 U00000000045846 U00000000045847
> U00000000045848 U00000000045849 U00000000045850 U00000000045851
> U00000000045852 U00000000045853 U00000000045854 U00000000045855
> U00000000045895 U00000000045896 U00000000045897 U00000000045898
> U00000000045899 U00000000045900 U00000000045901 U00000000045902
> U00000000045903 U00000000045904 U00000000045905 U00000000045931
> U00000000045932 U00000000045933 U00000000045934 U00000000045935
> U00000000045936 U00000000045937 U00000000045938 U00000000045939
> U00000000045945 U00000000045946 U00000000045947 U00000000045948
> U00000000045949 U00000000045950 U00000000045951 U00000000045952
> U00000000045962 U00000000045963 U00000000045964 U00000000045965
> U00000000045966 U00000000045967 U00000000045968 U00000000014542
> U00000000014210 U00000000014211 U00000000014212 U00000000014213
> U00000000014214 U00000000014215 U00000000014216 U00000000014217
> U00000000014218 U00000000014219 U00000000014220 U00000000014221
> U00000000014222 U00000000014223 U00000000014224 U00000000014225
> U00000000014226 U00000000014227 U00000000014228 U00000000014229
> U00000000014230 U00000000014231 U00000000014232 U00000000014233
> U00000000014234 U00000000014235 U00000000014236 U00000000014237
> U00000000014238 U00000000014239 U00000000014240 U00000000014241
> U00000000014242 U00000000014243 U00000000014294 U00000000014295
> U00000000014296 U00000000014297 U00000000014298 U00000000014299
> U00000000014300 U00000000014301 U00000000014302 U00000000014303
> U00000000014304 U00000000014305 U00000000014306 U00000000014307
> U00000000014308 U00000000014309 U00000000014310 U00000000014311
> U00000000014312 U00000000014313 U00000000014314 U00000000014315
> U00000000014316 U00000000014317 U00000000014318 U00000000014319
> U00000000014320 U00000000014321 U00000000014322 U00000000014323
> U00000000014324 U00000000014325 U00000000014326 U00000000014327
> U00000000014328 U00000000014329 U00000000014330 U00000000014331
> U00000000014332 U00000000014333 U00000000014334 U00000000014335
> U00000000014336 U00000000014337 U00000000014338 U00000000014339
> U00000000014340 U00000000014341 U00000000014342 U00000000014343
> U00000000014344 U00000000014345 U00000000014346 U00000000014347
> U00000000014348 U00000000014349 U00000000014350 U00000000014351
> U00000000014352 U00000000014354 U00000000014355 U00000000014356
> U00000000014357 U00000000014358 U00000000014359 U00000000014360
> U00000000014361 U00000000014362 U00000000014363 U00000000014364
> U00000000014365 U00000000014366 U00000000014367 U00000000014368
> U00000000014369 U00000000014370 U00000000014371 U00000000014372
> U00000000014373 U00000000014374 U00000000014375 U00000000014376
> U00000000014377 U00000000014378 U00000000014379 U00000000014380
> U00000000014381 U00000000014382 U00000000014383 U00000000014384
> U00000000014385 U00000000014386 U00000000014387 U00000000014388
> U00000000014389 U00000000014390 U00000000014391 U00000000014392
> U00000000014393 U00000000014394 U00000000014395 U00000000014396
> U00000000014397 U00000000014398 U00000000014399 U00000000014400
> U00000000014401 U00000000014402 U00000000014403 U00000000014404
> U00000000014405 U00000000014406 U00000000014407 U00000000014408
> U00000000014409 U00000000014410 U00000000014411 U00000000014412
> U00000000014413 U00000000014414 U00000000014415 U00000000014416
> U00000000014417 U00000000014418 U00000000014419 U00000000014420
> U00000000014421 U00000000014422 U00000000014423 U00000000014424
> U00000000014425 U00000000014426 U00000000014427 U00000000014428
> U00000000014429 U00000000014430 U00000000014431 U00000000014432
> U00000000014433 U00000000014434 U00000000014435 U00000000014436
> U00000000014437 U00000000014438 U00000000014439 U00000000014440
> U00000000014441 U00000000014442 U00000000014443 U00000000014444
> U00000000014445 U00000000014446 U00000000014447 U00000000014448
> U00000000014449 U00000000014450 U00000000014451 U00000000014452
> U00000000014453 U00000000014454 U00000000014460 U00000000014461
> U00000000014462 U00000000014463 U00000000014464 U00000000014465
> U00000000014466 U00000000014467 U00000000014468 U00000000014469
> U00000000014470 U00000000014471 U00000000014472 U00000000014473
> U00000000014474 U00000000014475 U00000000014477 U00000000014478
> U00000000014479 U00000000014480 U00000000014481 U00000000014482
> U00000000014483 U00000000014484 U00000000014485 U00000000014486
> U00000000014487 U00000000014488 U00000000014489 U00000000014490
> U00000000014491 U00000000014492 U00000000014493 U00000000014494
> U00000000014495 U00000000014496 U00000000014497 U00000000014498
> U00000000014499 U00000000014500 U00000000014501 U00000000014502
> U00000000014503 U00000000014504 U00000000014505 U00000000014506
> U00000000014507 U00000000014508 U00000000014509 U00000000014510
> U00000000014511 U00000000014512 U00000000014513 U00000000014514
> U00000000014515 U00000000014516 U00000000014517 U00000000014518
> U00000000014519 U00000000014520 U00000000014521 U00000000014522
> U00000000014523 U00000000014524 U00000000014525 U00000000014526
> U00000000014527 U00000000014528 U00000000014529 U00000000014530
> U00000000014531 U00000000014532 U00000000014533 U00000000014534
> U00000000014535 U00000000014536 U00000000014537 U00000000014538
> U00000000014539 U00000000014540 U00000000014541 U00000000014543
> U00000000014544 U00000000014545 U00000000014546 U00000000014547
> U00000000018019 U00000000042694 U00000000042695 U00000000042696
> U00000000042697 U00000000042698 U00000000042699 U00000000042700
> U00000000042701 U00000000042703 U00000000042704 U00000000042705
> U00000000042706 U00000000042707 U00000000042708 U00000000042709
> U00000000042710 U00000000042711 U00000000042712 U00000000042713
> U00000000042714 U00000000042715 U00000000042716 U00000000042717
> U00000000042718 U00000000042719 U00000000042720 U00000000042721
> U00000000042722 U00000000042723 U00000000042724 U00000000042725
> U00000000042726 U00000000042834 U00000000042835 U00000000042836
> U00000000042838 U00000000042839 U00000000042840 U00000000042841
> U00000000042842 U00000000042843 U00000000042844 U00000000042845
> U00000000042893 U00000000042894 U00000000042895 U00000000042896
> U00000000042897 U00000000042898 U00000000042899 U00000000042900
> U00000000042901 U00000000042902 U00000000042903 U00000000042904
> U00000000042905 U00000000042906 U00000000042907 U00000000042908
> U00000000042909 U00000000042910 U00000000042911 U00000000042912
> U00000000042913 U00000000042914 U00000000042915 U00000000042916
> U00000000042917 U00000000042918 U00000000042919 U00000000042920
> U00000000042954 U00000000042955 U00000000042956 U00000000042957
> U00000000042958 U00000000042959 U00000000042960 U00000000042961
> U00000000042962 U00000000042963 U00000000042964 U00000000042965
> U00000000042966 U00000000042967 U00000000042968 U00000000042969
> U00000000042970 U00000000042971 U00000000042972 U00000000042973
> U00000000042974 U00000000042975 U00000000042976 U00000000042977
> U00000000042978 U00000000042979 U00000000042980 U00000000042981
> U00000000042982 U00000000042983 U00000000042984 U00000000042985
> U00000000042986 U00000000042987 U00000000042988 U00000000042989
> U00000000042990 U00000000042991 U00000000042992 U00000000043018
> U00000000043019 U00000000043020 U00000000043021 U00000000043022
> U00000000043023 U00000000043024 U00000000043025 U00000000043026
> U00000000043027 U00000000043028 U00000000043029 U00000000043030
> U00000000043031 U00000000043032 U00000000043033 U00000000043034
> U00000000043035 U00000000043036 U00000000043037 U00000000043038
> U00000000043039 U00000000043040 U00000000043041 U00000000043042
> U00000000043043 U00000000043044 U00000000043045 U00000000043046
> U00000000043047 U00000000043048 U00000000043049 U00000000043050
> U00000000043145 U00000000043146 U00000000043147 U00000000043148
> U00000000043149 U00000000043150 U00000000043151 U00000000043152
> U00000000043153 U00000000043154 U00000000043155 U00000000043156
> U00000000043157 U00000000043158 U00000000043159 U00000000043160
> U00000000043161 U00000000043162 U00000000043163 U00000000043164
> U00000000043165 U00000000043166 U00000000043167 U00000000043168
> U00000000043169 U00000000043170 U00000000043171 U00000000043210
> U00000000043211 U00000000043212 U00000000043213 U00000000043214
> U00000000043215 U00000000043216 U00000000043217 U00000000043218
> U00000000043219 U00000000043220 U00000000043221 U00000000043222
> U00000000043223 U00000000043224 U00000000043225 U00000000043226
> U00000000043227 U00000000043228 U00000000043229 U00000000043230
> U00000000043231 U00000000043232 U00000000043233 U00000000043234
> U00000000043235 U00000000043236 U00000000043237 U00000000043238
> U00000000043239 U00000000043240 U00000000043241 U00000000043242
> U00000000043243 U00000000043268 U00000000043269 U00000000043270
> U00000000043271 U00000000043272 U00000000043273 U00000000043274
> U00000000043275 U00000000043276 U00000000043277 U00000000043278
> U00000000043279 U00000000043280 U00000000043281 U00000000043282
> U00000000043283 U00000000043284 U00000000043285 U00000000043286
> U00000000043287 U00000000043288 U00000000043289 U00000000043290
> U00000000043307 U00000000043308 U00000000043309 U00000000043310
> U00000000043311 U00000000043312 U00000000043313 U00000000043314
> U00000000043315 U00000000043316 U00000000043317 U00000000043318
> U00000000043319 U00000000043320 U00000000043321 U00000000043322
> U00000000043323 U00000000043324 U00000000043325 U00000000043326
> U00000000043327 U00000000043328 U00000000043329 U00000000043330
> U00000000043331 U00000000043332 U00000000043333 U00000000043334
> U00000000043335 U00000000043336 U00000000043337 U00000000043338
> U00000000043339 U00000000043342 U00000000043343 U00000000043344
> U00000000043345 U00000000043346 U00000000043347 U00000000043348
> U00000000043349 U00000000043350 U00000000043351 U00000000043352
> U00000000043353 U00000000043354 U00000000043355 U00000000043356
> U00000000043357 U00000000043358 U00000000043359 U00000000043360
> U00000000043361 U00000000043362 U00000000043363 U00000000043364
> U00000000043365 U00000000043366 U00000000043367 U00000000043368
> U00000000043369 U00000000043370 U00000000043371 U00000000043372
> U00000000043386 U00000000043387 U00000000043388 U00000000043389
> U00000000043390 U00000000043391 U00000000043392 U00000000043393
> U00000000043394 U00000000043395 U00000000043396 U00000000043397
> U00000000043398 U00000000043399 U00000000043400 U00000000043401
> U00000000043402 U00000000043403 U00000000043452 U00000000043453
> U00000000043454 U00000000043455 U00000000043456 U00000000043457
> U00000000043458 U00000000043459 U00000000043460 U00000000043461
> U00000000043462 U00000000043463 U00000000043464 U00000000043465
> U00000000043466 U00000000043467 U00000000043468 U00000000043469
> U00000000043490 U00000000043491 U00000000043492 U00000000043493
> U00000000043494 U00000000043495 U00000000043496 U00000000043497
> U00000000043498 U00000000043499 U00000000043500 U00000000043501
> U00000000043502 U00000000043503 U00000000043504 U00000000043505
> U00000000043506 U00000000043507 U00000000043508 U00000000043509
> U00000000043510 U00000000043582 U00000000043583 U00000000043584
> U00000000043585 U00000000043586 U00000000043587 U00000000043588
> U00000000043589 U00000000043590 U00000000043591 U00000000043592
> U00000000043593 U00000000043594 U00000000043595 U00000000043596
> U00000000043597 U00000000043598 U00000000043599 U00000000043600
> U00000000043601 U00000000043602 U00000000043603 U00000000043604
> U00000000043605 U00000000043606 U00000000043607 U00000000043608
> U00000000043609 U00000000043610 U00000000043611 U00000000043612
> U00000000043613 U00000000043614 U00000000043615 U00000000043616
> U00000000043617 U00000000043618 U00000000043619 U00000000043620
> U00000000043621 U00000000043622 U00000000043623 U00000000043653
> U00000000043654 U00000000043655 U00000000043656 U00000000043657
> U00000000043658 U00000000043659 U00000000043660 U00000000043661
> U00000000043662 U00000000043663 U00000000043664 U00000000043665
> U00000000043666 U00000000043667 U00000000043668 U00000000043669
> U00000000043670 U00000000043671 U00000000043672 U00000000043673
> U00000000043674 U00000000043675 U00000000043676 U00000000043677
> U00000000043678 U00000000043679 U00000000043680 U00000000043681
> U00000000043682 U00000000043683 U00000000043684 U00000000043685
> U00000000043686 U00000000043731 U00000000043732 U00000000043733
> U00000000043734 U00000000043735 U00000000043736 U00000000043737
> U00000000043738 U00000000043739 U00000000043740 U00000000043741
> U00000000043742 U00000000043743 U00000000043744 U00000000043745
> U00000000043746 U00000000043747 U00000000043748 U00000000043749
> U00000000043750 U00000000043751 U00000000043752 U00000000043753
> U00000000043754 U00000000043755 U00000000043756 U00000000043757
> U00000000043758 U00000000043759 U00000000043760 U00000000043761
> U00000000043762 U00000000043763 U00000000043764 U00000000043765
> U00000000043766 U00000000043767 U00000000043768 U00000000043769
> U00000000043770 U00000000043771 U00000000043782 U00000000043783
> U00000000043784 U00000000043785 U00000000043786 U00000000043787
> U00000000043788 U00000000043789 U00000000043790 U00000000043791
> U00000000043792 U00000000043793 U00000000043794 U00000000043795
> U00000000043796 U00000000043797 U00000000043798 U00000000043799
> U00000000043800 U00000000043801 U00000000043802 U00000000043803
> U00000000043804 U00000000043805 U00000000043806 U00000000043807
> U00000000043808 U00000000043809 U00000000043810 U00000000043811
> U00000000043812 U00000000043813 U00000000043834 U00000000043835
> U00000000043836 U00000000043837 U00000000043838 U00000000043839
> U00000000043840 U00000000043841 U00000000043842 U00000000043843
> U00000000043844 U00000000043845 U00000000043846 U00000000043847
> U00000000043848 U00000000043849 U00000000043850 U00000000043851
> U00000000043852 U00000000043853 U00000000043854 U00000000043855
> U00000000043856 U00000000043857 U00000000043858 U00000000043859
> U00000000043860 U00000000043861 U00000000043862 U00000000043863
> U00000000043864 U00000000043865 U00000000043866 U00000000043867
> U00000000043868 U00000000043869 U00000000043870 U00000000043871
> U00000000043872 U00000000043873 U00000000043874 U00000000043876
> U00000000043877 U00000000043878 U00000000043894 U00000000043895
> U00000000043896 U00000000043897 U00000000043898 U00000000043899
> U00000000043900 U00000000043901 U00000000043902 U00000000043903
> U00000000043904 U00000000043905 U00000000043906 U00000000043907
> U00000000043908 U00000000043909 U00000000043910 U00000000043911
> U00000000043920 U00000000043921 U00000000043922 U00000000043923
> U00000000043924 U00000000043925 U00000000043926 U00000000043927
> U00000000043928 U00000000043929 U00000000043930 U00000000043931
> U00000000043932 U00000000043933 U00000000043934 U00000000043935
> U00000000043936 U00000000043937 U00000000043938 U00000000043939
> U00000000043940 U00000000043941 U00000000043942 U00000000043943
> U00000000043944 U00000000043945 U00000000043946 U00000000043947
> U00000000043948 U00000000043949 U00000000043950 U00000000043951
> U00000000043952 U00000000043953 U00000000043954 U00000000043955
> U00000000043956 U00000000043957 U00000000043958 U00000000044036
> U00000000044037 U00000000044038 U00000000044039 U00000000044040
> U00000000044041 U00000000044042 U00000000044043 U00000000044044
> U00000000044045 U00000000044046 U00000000044047 U00000000044048
> U00000000044049 U00000000044050 U00000000044051 U00000000044052
> U00000000044053 U00000000044054 U00000000044055 U00000000044056
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> U00000000044171 U00000000044172 U00000000044173 U00000000044174
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> U00000000044183 U00000000044184 U00000000044185 U00000000044186
> U00000000044187 U00000000044188 U00000000044189 U00000000044190
> U00000000044191 U00000000044192 U00000000044193 U00000000044194
> U00000000044195 U00000000044196 U00000000044197 U00000000044198
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> U00000000044551 U00000000044552 U00000000044553 U00000000044567
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> U00000000044594 U00000000044595 U00000000044596 U00000000044597
> U00000000044598 U00000000044599 U00000000044600 U00000000044601
> U00000000044602 U00000000044614 U00000000044615 U00000000044616
> U00000000044617 U00000000044618 U00000000044619 U00000000044620
> U00000000044621 U00000000044622 U00000000044623 U00000000044624
> U00000000044625 U00000000044626 U00000000044644 U00000000044645
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> U00000000044650 U00000000044651 U00000000044652 U00000000044653
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> U00000000044681 U00000000044682 U00000000044683 U00000000044684
> U00000000044685 U00000000044686 U00000000044687 U00000000044712
> U00000000044713 U00000000044714 U00000000044715 U00000000044716
> U00000000044717 U00000000044718 U00000000044719 U00000000044720
> U00000000044721 U00000000044722 U00000000044723 U00000000044724
> U00000000044725 U00000000044726 U00000000044727 U00000000044728
> U00000000044729 U00000000044730 U00000000044731 U00000000044732
> U00000000044733 U00000000044734 U00000000044735 U00000000044736
> U00000000044737 U00000000044738 U00000000044739 U00000000044771
> U00000000044772 U00000000044773 U00000000044774 U00000000044775
> U00000000044776 U00000000044777 U00000000044778 U00000000044779
> U00000000044780 U00000000044781 U00000000044782 U00000000044783
> U00000000044784 U00000000044785 U00000000044786 U00000000044787
> U00000000044788 U00000000044789 U00000000044790 U00000000044791
> U00000000044792 U00000000044793 U00000000044794 U00000000044795
> U00000000044796 U00000000044797 U00000000044798 U00000000044799
> U00000000044800 U00000000044801 U00000000044802 U00000000044803
> U00000000044804 U00000000044805 U00000000044806 U00000000044807
> U00000000044808 U00000000044809 U00000000044810 U00000000044811
> U00000000044812 U00000000044813 U00000000044814 U00000000044815
> U00000000044816 U00000000044817 U00000000044818 U00000000044819
> U00000000044820 U00000000044821 U00000000044822 U00000000044823
> U00000000044824 U00000000044825 U00000000044826 U00000000044894
> U00000000044895 U00000000044896 U00000000044897 U00000000044898
> U00000000044899 U00000000044900 U00000000044901 U00000000044902
> U00000000044903 U00000000044904 U00000000044905 U00000000044906
> U00000000044907 U00000000044908 U00000000044909 U00000000044910
> U00000000044911 U00000000044912 U00000000044913 U00000000044914
> U00000000044915 U00000000044916 U00000000044917 U00000000044918
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> U00000000045864 U00000000045865 U00000000045866 U00000000045867
> U00000000045868 U00000000045869 U00000000045906 U00000000045907
> U00000000045908 U00000000045909 U00000000045910 U00000000045911
> U00000000045912 U00000000045913 U00000000045914 U00000000045915
> U00000000045916 U00000000045917 U00000000045918 U00000000045919
> U00000000045920 U00000000045921 U00000000045922 U00000000045940
> U00000000045941 U00000000045942 U00000000045943 U00000000045944
> U00000000045953 U00000000045954 U00000000045955 U00000000045956
> U00000000045957 U00000000045958 U00000000045959 U00000000045960
> U00000000045961 U00000000045969 U00000000045970 U00000000045971
> U00000000045972 U00000000045973 U00000000045974 U00000000045975
> U00000000045976 U00000000045977 U00000000045978 U00000000045979
> U00000000045980 U00000000045981 U00000000045982 U00000000045983
> U00000000045984 U00000000046043 U00000000046044 U00000000046051
> U00000000046052 U00000000046053 U00000000046054 U00000000046055
> U00000000046056 U00000000046057 U00000000083301 U00000000083302
> U00000000083310 U00000000083313 U00000000083317 U00000000083324
> U00000000083325 U00000000083326 U00000000083327 U00000000083331
> U00000000083336 U00000000083337 U00000000083338 U00000000083339
> U00000000083296 U00000000083300 U00000000083303 U00000000083304
> U00000000083305 U00000000083306 U00000000083307 U00000000083308
> U00000000083309 U00000000083311 U00000000083312 U00000000083314
> U00000000083315 U00000000083316 U00000000083318 U00000000083319
> U00000000083320 U00000000083321 U00000000083322 U00000000083323
> U00000000083328 U00000000083329 U00000000083330 U00000000083332
> U00000000083333 U00000000083334 U00000000083335 U00000000083297;
> b) BM03L11421A012031504 BM03L11821A012031504 BM04A11421A012041204
> BM03K10421A017031504 BM03K10421B017031504 BM03K10421C017031504
> BM03L11221A017020904 BM03L11421A017031504 BM03L11421B017031504
> BM03L12121A017031504 BM03L12221A017031504 BM04B10421A017051704
> BM03K10421A018031504 BM03K10421B018031504 BM03K11021A018031504
> BM03K11021B018031504 BM03K11021C018031504 BM03K11021D018031504
> BM03L10421A018020904 BM03L10421B018020904 BM03L11621A018031504
> BM03L11621B018031504 BM03L12121A018031504 BM03L12221A018031504
> BM04A11221A018041204 BM04A11321A018041204 BM04B10421A018051704
> BM03L11521A023020904 BM03L11521B023020904 BM03L11521D023020904
> BM03L11821A024031504 BM03L12321A024031504 BM04A11221A024041204
> BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904
> BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504
> BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904
> BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904
> BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904
>
> RECALLING FIRM/MANUFACTURER
>
> Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone,
facsimile
> and letter on October 14, 2005 and by letter dated October 24, 2005.
> Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm
> initiated recall is ongoing.
>
> REASON
>
> Human Tissues, procured from donors without adequate donor eligibility
> determinations, were distributed.
> VOLUME OF PRODUCT IN COMMERCE
> a) 5,676 allografts;
> b) 48 allografts
> DISTRIBUTION
> Nationwide, and Canada
>
>
> http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.html
>
>
> Recall of Human Tissue Products
>
> horizontal rule
>
> DATE RECALL INITIATED:
>
> October 14, 2005
>
> PRODUCT:
>
> Human Tissue For Transplantation
>
> MANUFACTURER:
>
> Regeneration Technologies, Inc
> Alachua, Florida
>
> REASON:
>
> Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of
> all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New
> Jersey) as a result of information regarding the accuracy of donor
screening
> documentation. RTI informed its consignees that a lack of assurance of
donor
> identity as well as the risk of infectious diseases also exists.
Consignees
> are asked to contact the manufacturer to arrange for product return.
>
> horizontal rule
>
> The information in this listing reflects CBER's best efforts to
communicate
> information that has been reported to FDA. Its accuracy and
> comprehensiveness cannot be guaranteed.
>
> Updated October 18, 2005
>
> http://www.fda.gov/cber/recalls/rtitis101405.htm
>
>
> FDA News
>
> FOR IMMEDIATE RELEASE
> P05-77
> October 26, 2005
>
> Media Inquiries:
> Julie Zawisza, 301-827-6242
> Consumer Inquiries:
> 888-INFO-FDA
>
> FDA Provides Information on Investigation into Human Tissue for
> Transplantation
>
> The Food and Drug Administration (FDA) is notifying the public of its
> investigation of human tissue recovered by Biomedical Tissue Services,
Ltd.
> (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue
may
> have been implanted into patients from early 2004 to September 2005. The
> tissue was recovered by BTS from human donors who may not have met FDA
donor
> eligibility requirements and who may not have been properly screened for
> certain infectious diseases. At this time, the implicated tissues from BTS
> include human bone, skin, and tendons. These products represent only a
small
> percentage of the overall U.S. tissue supply.
>
> While no adverse reactions related to these tissues have been reported to
> FDA at this time, because of the potential lack of proper screening of the
> tissue donors, some recipients of the tissues may be at increased risk of
> infections that could potentially be transmitted through tissues. FDA and
> the Centers for Disease Control and Prevention (CDC) believe the risks
from
> these tissues are low because the tissues were routinely processed using
> methods that help to reduce the risk of infectious disease; however, the
> actual infectious risk is unknown.
>
> FDA's requirements to determine donor eligibility include important steps
to
> ensure that donors do not harbor infections that could be transmitted to
> recipients. These steps include reviewing the donor's medical history and
> other factors, physically assessing the donor, and testing for relevant
> communicable diseases that may place the donor at an increased risk of
> infections that could then unintentionally be transmitted to recipients
> through the tissues.
>
> The following tissue processors received tissue from BTS:
>
> * LifeCell Corporation of Branchburg, NJ
> * Lost Mountain Tissue Bank of Kennesaw, GA
> * Blood and Tissue Center of Central Texas in Austin, TX
> * Tutogen Medical, Inc., of Alachua, FL
> * Regeneration Technologies, Inc., of Alachua, FL
>
> These firms already have voluntarily recalled all unused tissue remaining
in
> inventory and are working cooperatively with FDA to ensure that the
> implanting physicians whose patients may have received the products are
> properly notified. Physicians who implanted tissue from BTS should have
been
> contacted at this time by the receiving health care facility.
>
> FDA and CDC recommend that implanting physicians inform their patients
that
> they may have received tissue from a donor for whom an adequate donor
> eligibility determination was not performed. While the overall infectious
> risk is likely low, FDA and CDC recommend that physicians offer to provide
> patients access to appropriate infectious disease testing. The relevant
> communicable diseases for which a tissue donor is required to be tested
are
> HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C
> virus, and syphilis. Physicians who still have concerns or questions about
> the source of the tissue should contact the health care facility where the
> procedure was performed. FDA will continue its investigation into this
> matter and will issue further public health updates, as needed.
>
> Patients and physicians should report any infectious disease possibly
> related to a tissue transplant to the processing firms, who then should
> notify FDA. Patients and physicians who wish to notify FDA directly of
such
> infectious disease should report via FDA’s MedWatch reporting program at
> http://www.fda.gov/medwatch.
>
> Additional information is available on FDA’s web site at
> http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.
>
> ####
>
>
> http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
>
>
> Greetings,
>
> amazing isn't it, well disgusting really. the amazing part is the spin
they
> put on it;
>
> we go from this;
>
> REASON
> Human tissues, procured from donors without adequate donor eligibility
> determinations, were distributed.
>
> OR
>
> FDA and CDC recommend that implanting physicians inform their patients
that
> they may have received tissue from a donor for whom an adequate donor
> eligibility determination was not performed. ...
>
>
> TO the disgusting reality of the true allegations;
>
> > Authorities believe his body and those of hundreds of other people —
> > including famed British broadcaster Alistair Cooke — were secretly
carved
> up
> > in the back rooms of several funeral parlors citywide to remove bone,
skin
> > and tendons, without the required permission from their families.
> > Authorities allege the body parts were then sold for a profit.
> >
> > Worse, health officials fear some of the stolen body parts were
diseased,
> > and could infect patients who received them in skin grafts, dental
> implants
> > or other orthopedic procedures — a risk concealed by paperwork doctored
> with
> > forged signatures and false information.
>
>
> have not seen much about that at FDA/CDC site. it's been going on for some
> time though$
>
>
> CJD, they eye's have it, and they could be stealing them from your loved
one
>
>
> http://www.mad-cow.org/dec99_news.html#bbb
>
>
>
> TSS
>
>
> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Tuesday, December 27, 2005 8:39 PM
> Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN
> THE USA
>
>
> > ##################### Bovine Spongiform Encephalopathy
> #####################
> >
> > CJD WATCH MESSAGE BOARD
> > Anonymous
> > Re: Possible body parts theft ring uncovered (spreading TSEs
> > Tue Dec 27, 2005 20:34
> > 70.110.84.167
> >
> >
> > Update on Donor Screening
> > for TSEs
> > Melissa A. Greenwald, MD
> > Division of Human Tissues
> > Office of Cellular, Tissue and Gene Therapies
> > AATB 29th Annual Meeting
> > Hollywood, Florida
> > Council of Accredited Tissue Banks
> > Tuesday 20 September 2005
> > Today’s talk will focus on:
> > • What are Transmissible Spongiform
> > Encephalopathies (TSEs)?
> > • Background on CJD/vCJD Draft
> > Guidance
> > • Specific recommended deferral criteria
> > • Allow time for discussion and
> > questions
> > What are TSEs?
> > • Human Transmissible Spongiform
> > Encephalopathies (TSEs) include
> > Creutzfeldt Jakob Disease (CJD) and
> > variant Creutzfeldt Jakob Disease
> > (vCJD)
> > • CJD has been a known agent, but
> > vCJD has only been identified in the
> > recent past—is a human form of
> > Bovine Spongiform Encephalopathy
> > (BSE), known as “mad cow disease”
> > What are TSEs? (cont.)
> > • The TSE agent is a prion–a poorly
> > understood agent; is an abnormal
> > protein that causes a degenerative
> > disease of the central nervous
> > system (CNS) that is not curable and
> > invariably leads to the death of the
> > person with the disease
> > • The agent is very difficult to destroy
> > and would not be inactivated by
> > current tissue processing technology
> > What are TSEs? (cont.)
> > • Blood from some animals
> > experimentally infected with TSE
> > agents, including the BSE agent,
> > contains low levels of infectivity
> > • Several TSE agents, including BSE,
> > have been experimentally
> > transmitted by transfusion
> > • Agent for vCJD is ingested, so it is
> > likely that the agent has a bloodborne
> > phase in humans (the
> > specifics of the pathology in humans
> > is poorly understood)
> > What are TSEs? (cont.)
> > • There are no published studies
> > showing transmission of the BSE
> > agent via HCT/Ps; however
> > • vCJD agent is present in lymph
> > nodes and tonsils of infected
> > patients
> > • vCJD has been transmitted via blood
> > transfusion in the UK
> > • Transmission of CJD via cornea and
> > dura mater has already been
> > demonstrated in humans
> > What are TSEs? (cont.)
> > • Because of studies showing blood
> > infectivity of TSE agents, it is a
> > theoretical risk that HCT/Ps have the
> > potential to transmit TSEs
> > • Because of this theoretical risk, FDA
> > is concerned about the potential for
> > transmission of TSEs via HCT/Ps
> > and therefore considers TSEs a
> > RCDAD and requires donor
> > screening for these agents
> > CJD/vCJD draft guidance
> > • Deferral of tissue donors for risk
> > factors for “classic” (sporadic)
> > CJD—already recommended in the
> > 1997 guidance for industry
> > • The draft guidance for CJD/vCJD
> > incorporated those deferrals, and in
> > addition recommends deferrals for
> > risk factors for variant CJD—travel or
> > residence in BSE-affected countries
> > • The draft guidance published June
> > 2002
> > • There was a 6 month comment
> > CJD/vCJD draft guidance
> > • Draft guidance was modeled after the
> > guidance for industry for blood
> > donors, issued August 2001
> > • Recommends the same countries,
> > dates, and lengths of
> > travel/residence as does the
> > guidance for blood donors
> > • Permits an exception for the
> > collection and storage of
> > hematopoietic stem cells from
> > donors who live in or travel to a BSEaffected
> > country (for urgent medical
> > CJD/vCJD draft guidance
> > • Comments reviewed at CBER
> > • Final recommendations for
> > CJD/vCJD screening will be
> > incorporated into the final Donor
> > Eligibility guidance when published
> > • As of May 25, 2005 Transmissible
> > Spongiform Encephalopathy (CJD
> > and vCJD) is a relevant
> > communicable disease agent or
> > disease (RCDAD) and establishments
> > must screen for CJD/vCJD
> > CJD/vCJD draft guidance
> > • Specific deferral criteria in the draft
> > guidance are an indication of FDA’s
> > current thinking about how to
> > adequately and appropriately reduce
> > the risk of infectious disease
> > transmission by this agent
> > • Until a final guidance is issued,
> > establishments would not
> > necessarily have to “adopt” the
> > recommended deferral criteria but
> > the regulations do require some
> > screening for TSEs (including CJD
> > and vCJD)
> > CJD/vCJD draft guidance
> > • May use alternate screening criteria as long
> > as the screening criteria are at least as strict
> > as those recommended by FDA (i.e., are as
> > effective to adequately and appropriately
> > reduce the risk of infectious disease
> > transmission)
> > • No testing recommendations made—there
> > are no FDA approved tests for humans
> > CJD/vCJD Risks for Donor
> > Screening
> > • Persons who have been diagnosed
> > with vCJD or any other form of CJD
> > • Persons who have been diagnosed
> > with dementia or any degenerative or
> > demyelinating disease of the CNS or
> > other neurological disease of
> > unknown etiology [Possible that
> > FDA may make a distinction between
> > dementia and acute delirium (e.g.,
> > delirium caused by toxic/metabolic
> > disease or recent head trauma)]
> > Donor Screening (cont.)
> > • Persons who are at increased risk for CJD
> > – Receipt of human dura mater transplant
> > – Receipt of human pituitary-derived growth
> > hormone
> > – One or more blood relatives diagnosed with
> > CJD
> > • Persons who spent three months or more
> > cumulatively in the U.K. from the
> > beginning of 1980 through the end of 1996
> > Donor Screening (cont.)
> > • Persons who are current or former
> > U.S. military members, civilian
> > military employees, or dependents of
> > a military member or civilian
> > employee who resided at U.S.
> > military bases in Northern Europe for
> > 6 months or more from 1980 through
> > 1990, or elsewhere in Europe for 6
> > months or more from 1980 through
> > 1996
> > Donor Screening (cont.)
> > • Persons who lived cumulatively for 5
> > years or more in Europe between
> > 1980 and the present
> > • Persons who received any
> > transfusion of blood or blood
> > components in the U.K. between
> > 1980 and the present
> > • NOTE—If the person being
> > interviewed is not familiar with the
> > term CJD, you may take that as a
> > negative response
> > The UK
> > • For the guidance, the UK includes
> > – England
> > – Northern Ireland
> > – Scotland
> > – Wales
> > – Isle of Man
> > – Channel Islands
> > – Gibraltar
> > – the Falkland Islands.
> > Military Bases
> > • In Northern Europe includes
> > – Germany, UK, Belgium, Netherlands
> > – Deferral from 1980-1990
> > • In Southern Europe includes
> > – Greece, Turkey, Spain, Portugal, Italy
> > – Deferral from 1980-1996
> > Family History of CJD
> > • Would be ineligible UNLESS:
> > – the diagnosis of CJD was subsequently found
> > to be an incorrect diagnosis;
> > – the CJD was iatrogenic; or
> > – laboratory testing (gene sequencing) shows
> > that the donor does not have a mutation
> > associated with familial CJD
> > For further information
> > http://www.fda.gov/cber/gdlns/cjdvcjd0602
> > .htm
> > Melissa Greenwald
> > 301-827-2002
> > melissa.greenwald@fda.hhs.gov
> > Vox Sang. 89(2) pp. 63-70.
> >
> >
> > http://www.fda.gov/cber/summaries/aatb092005mg.pdf
> >
> >
> >
> > what does this week have in store for recipients of donor tissue;
> >
> >
> > PRODUCT
> > Acellular Dermal Matrix Skin Tissue, Recall # B-0276-6
> > CODE
> > Alloderm
> > B10084-002, B10084-007, B10084-009, B10084-012 thru 014, B10084-017 and
> 018,
> > B10084-023, B10084-025 thru 029, B10085-001 and 002, B10085-007 thru
012,
> > B10085-017, B10085-021 thru 025, B10088-001, B10088-006 thru 009,
> B10088-010
> > thru 021, B10088-025 thru 035, B10134-001 thru 004, B10134-010 and 011,
> > B10134-017 thru 026, B10192-007 and 008, B10192-012, B10192-016 and 017,
> > B10192-019, B10192-024 and 025, B10192-028 thru 035, B10222-001,
> B10222-005
> > and 006, B10222-014 and 015, B10222-017 thru 020, B10222-022 thru 024,
> > B10222-026, B10222-028, B10721-009 thru 012, B10721-016 thru 024,
> B10819-001
> > and 002, B10819-005 thru 007, B10819-009 thru 014, B10819-016 thru 018,
> > B10819-031 and 032, B10819-035, B10838-007, B10838-009, B10838-018 thru
> 023,
> > B10838-026 thru 028, B10850-001 thru 004, B10850-009 thru 016,
B11021-001
> > and 002, B11021-008 thru 011, B11022-016 and 017, B11024-011 thru 013,
> > B11024-015 thru 019, B11025-001, B11025-011 thru 016, B11025-019 thru
021,
> > B11026-001 thru 003, B11026-010 thru 012, B11026-015, B11026-017 thru
023,
> > B11052-003 and 004, B11052-012 and 013, B11052-015 and 016, B11054-013,
> > B11055-003 and 004, B11055-011 and 012, B11055-017, B11055-019 and 020,
> > B11061-002, B11061-015 thru 017, B11064-002 thru 004, B11064-013 thru
017,
> > B11064-020, B11064-022, B11065-001 and 002, B11065-004, B11065-006 and
> 007,
> > B11065-009, B11065-012 thru 018, B11079-004, B11079-013 and 014,
> B11079-016,
> > B11079-019, B11079-021 thru 024, B11079-029 thru 031, B11080-002,
> B11080-009
> > thru 011, B11080-016, B11080-021, B11083-019 thru 022, B11083-024 thru
> 027,
> > B11087-003 thru 005, B11087-007 thru 013, B11099-012 and 013, B11099-016
> > thru 026, B11103-003, B11103-008, B11103-011 thru 015, B11104-002 thru
> 005,
> > B11104-009, B11107-002 thru 004, B11107-011, B11107-014 thru 020,
> > B11107-025, B11115-003 and 004, B11115-012 and 013, B11115-018 thru 021,
> > B11115-025 and 026, B11120-019, B11120-021, B11127-008 thru 010,
> B11127-013
> > and 014, B11129-001, B11129-009 and 010, B11129-013 and 014, B11131-011
> thru
> > 013, B11131-015 thru 017, B11148-012, B11148-016 thru 023, B11156-009,
> > B11156-013 thru 017, B11163-002, B11163-015, B11163-017 thru 021,
> > B11180-001, B11180-004, B11180-009 thru 012, B11180-014 and 015,
> B11180-017,
> > B11181-001, B11181-003, B11181-009, B11181-011 thru 015, B11202-001 thru
> > 004, B11202-014 thru 016, B11202-021 and 022, B11213-001, B11213-003 and
> > 004, B11213-007, B11213-010 thru 014, B11213-022, B11217-010 thru 013,
> > B11217-015, B11239-003, B11239-006, B11239-015, B11239-023 and 024,
> > B11239-026, B11239-030, B11244-014, B11244-017, B11244-020, B11244-022,
> > B11247-001, B11247-016, B11247-018, B11247-021, B11262-016, B11266-014,
> > B11266-016, B11266-018 and 019, B11266-023, B11281-021, B11281-023,
> > B11282-015, B11282-019, B11286-013 and 014, B11296-010 thru 013,
> B11296-015,
> > B11324-027, B11324-030, B11327-014 and 015, B11349-009, B11350-012,
> > B11350-017, B11350-019, B11363-012, B11363-015, B11367-018 thru 020,
> > B11367-030 and 031, B11410-012 and 013, B11432-012, B11432-014,
B11468-013
> > and 014, B7406-001 thru 031, B7406-034 thru 037, B7406-045 thru 047,
> > B7406-050 thru 061, B7406-065 thru 067, B7406-069 thru 077, B7417-001
thru
> > 013, B7417-015 , B7417-019 thru 023, B7417-037 thru 042, B7417-044 thru
> 046,
> > B7417-048, B7417-050, B7417-054 thru 058, B7430-001 thru 014, B7430-018,
> > B7430-020, B7430-026 and 027, B7430-035 thru 037, B7430-039 thru 079,
> > B8410-012 thru 037, B8410-039 thru 052, B8411-002 and 003, B8411-007,
> > B8411-014 and 015, B8411-017 thru 056, B8414-001 thru 008, B8414-015
thru
> > 029, B8421-001, B8421-003, B8421-005 and 006, B8421-009, B8421-024 thru
> 048,
> > B8421-051 thru 058, B8422-001 thru 006, B8422-008, B8422-012, B8422-018
> thru
> > 028, B8422-030 thru 032, B8422-035 thru 039, B8422-043, B8422-045 thru
> 047,
> > B8422-050 and 052, B8422-054, B8424-001 thru 004, B8424-008, B8424-010,
> > B8424-014 thru 016, B8424-022 thru 032, B8424-034 and 035, B8424-037
thru
> > 044, B8425-010 thru 019, B8425-021 and 022, B8425-025 thru 027,
B8684-001
> > thru 005, B8684-007 and 008, B8684-010, B8684-016 thru 030, B8684-032,
> > B8684-034 and 035, B8684-037 thru 050, B8685-001 thru 003, B8685-011
thru
> > 042, B8695-002 and 003, B8695-005 thru 013, B8695-023 thru 061,
B8697-001,
> > B8697-006, B8697-014, B8697-017 and 018, B8697-020 and 021, B8697-037
thru
> > 039, B8697-041, B8697-043 thru 058, B8706-001 and 002, B8706-006 thru
009,
> > B8706-013, B8706-019 thru 023, B8706-025 thru 048, B8707-007 thru 014,
> > B8707-016 thru 019, B8708-008 thru 025, B8720-001, B8720-003 thru 005,
> > B8720-009, B8720-012, B8720-021 thru 025, B8720-027 thru 033, B8720-035
> and
> > 036, B8720-038 and 039, B8720-040 , B8720-042 thru 062, B8722-002,
> B8722-010
> > and 011, B8722-017 thru 025, B8722-027 thru 042, B8723-001, B8723-004
thru
> > 007, B8723-016, B8723-025 and 026, B8723-028 and 029, B8723-031 thru 33,
> > B8731-013 and 014, B8731-017, B8731-021 and 022, B8731-026 thru 045,
> > B8732-001, B8732-004 and 005, B8732-005, B8732-016 thru 024, B8732-026
> thru
> > 045, B8734-021 thru 023, B8734-027, B8734-029 thru 031, B8734-033,
> B8734-037
> > and 038, B8734-041, B8734-043 thru 053, B8734-055 thru 057, B9132-002
thru
> > 005, B9132-010, B9132-014 thru 029, B9228-007 thru 018, B9232-004,
> B9232-010
> > and 011, B9232-016 thru 023, B9243-001, B9243-003, B9243-005, B9243-011,
> > B9243-014, B9243-016, B9243-018 thru 027, B9245-001, B9245-009,
B9245-013
> > and 014, B9245-014, B9245-017, B9245-019 thru 028, B9284-001 thru 005,
> > B9284-007, B9284-011 thru 020, B9284-023 thru 026, B9284-029 thru 042,
> > B9285-001 and 002, B9285-004, B9285-012 and 013, B9285-016, B9285-019
thru
> > 027, B9285-029, B9322-002 thru 004, B9322-007, B9322-013 thru 022,
> B9322-024
> > thru 026, B9323-001, B9323-006 and 007, B9323-017, B9323-019 thru 030,
> > B9331-001, B9331-004 thru 007, B9331-017, B9331-020 thru 028, B9331-031
> thru
> > 042, B9333-001 thru 003, B9333-005 and 006, B9333-012, B9333-015 thru
020,
> > B9340-002 and 003, B9340-006 and 007, B9340-010 thru 012, B9340-014 thru
> > 022, B9491-001 thru 003, B9491-006, B9491-011 thru 013, B9491-017 thru
> 023,
> > B9509-001, B9509-012, B9509-018 thru 022, B9693-002, B9693-008 thru 015,
> > B9725-001, B9725-005 and 006, B9725-012 thru 031, B9725-033 thru 037,
> > B9765-002 and 003, B9765-005 thru 007, B9765-015, B9765-018 thru 022,
> > B9927-001 thru 004, B9927-007, B9927-009 thru 011, B9927-013 thru 029,
> > B9927-031 thru 033, C10602-016 thru 021
> > Repliform
> > B10084-019 and 020, B10084-022, B10084-024, B10134-016, B10192-013,
> > B10192-015, B10192-018, B10192-020 thru 023, B10819-027, B11120-008 thru
> 11,
> > B7406-044, B7406-048, B7406-064, B7406-078 thru 83, B7417-031 and 32,
> > B7430-038, B8414-014, B8421-020, B8421-022 and 23, B8422-042, B8424-036,
> > B8684-015, B8685-005 thru 8, B8697-040, B8697-042, B8706-024, B8723-019,
> > B8723-024, B8734-042, B9232-014 and 015, B9243-015, B9245-018, B9284-027
> and
> > 028, B9285-015, B9285-017 and 018, B9333-007 and 08, B9333-010 and 011,
> > B9509-015, B9725-007, B9765-008, C10602015
> > Graft Jacket
> > B10084-016, B10084-021, B10085-014 thru 016, B10088-023 and 024,
> B10134-013,
> > B10838-015, B11021-006, B11052-010, B11065-011, B11079-009, B11087-006,
> > B11131-008, B11148-009, B11163-016, B11163-008 and 009, B11181-010,
> > B11266-012, B7406-062, B7417-051 thru 053, B8421-049 and 050, B8422-041,
> > B8684-036, B8695-019, B8697-032, B8706-014, B8720-016, B8720-019,
> B8720-020,
> > B8720-034, B8720-037, B8732-025, B8732-013, B9243-013, B9245-015,
> B9245-016,
> > B9284-022, B9331-029 and 030, B9340-009, B9491-014, B9765-013, B9765-016
> > RECALLING FIRM/MANUFACTURER
> > LifeCell Corporation, Branchburg, NJ, by telephone and facsimile
> > transmission beginning September 30, 2005, and by follow-up letter dated
> > October 12, 2005. Firm initiated recall is ongoing.
> > REASON
> > Human Tissues, procured from donors without adequate donor eligibility
> > determinations, were distributed.
> > VOLUME OF PRODUCT IN COMMERCE
> > 1,652 allografts from 102 lots
> > DISTRIBUTION
> > Nationwide, Australia and Korea
> >
> > http://www.fda.gov/bbs/topics/enforce/2005/ENF00932.html
> >
> >
> > TSS
> >
> >
> >
> > ----- Original Message -----
> > From: "Terry S. Singeltary Sr."
> > To:
> > Sent: Saturday, December 24, 2005 9:57 AM
> > Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs
IN
> > THE USA
> >
> >
> > > ##################### Bovine Spongiform Encephalopathy
> > #####################
> > >
> > > Subject: Possible body parts theft ring uncovered (spreading TSEs from
> > > stolen body parts perfectly legal in Texas after 4 hours)
> > > Date: December 24, 2005 at 7:36 am PST
> > >
> > > Dec. 23, 2005, 11:44PM
> > > Possible body parts theft ring uncovered
> > > Skin and bones are alleged to have been sold secretly
> > >
> > > By TOM HAYS
> > > Associated Press
> > >
> > > NEW YORK - Michael Bruno's life had been uncomplicated: He was an
> > immigrant
> > > who worked hard, spoke his mind and succumbed to kidney cancer two
years
> > ago
> > > at 75.
> > >
> > > "Typical Italian cab driver," recalled his son, Vito. "He had an
opinion
> > > about everything."
> > >
> > > It's only after death that his story became ghoulish.
> > >
> > > Authorities believe his body and those of hundreds of other people —
> > > including famed British broadcaster Alistair Cooke — were secretly
> carved
> > up
> > > in the back rooms of several funeral parlors citywide to remove bone,
> skin
> > > and tendons, without the required permission from their families.
> > > Authorities allege the body parts were then sold for a profit.
> > >
> > > Worse, health officials fear some of the stolen body parts were
> diseased,
> > > and could infect patients who received them in skin grafts, dental
> > implants
> > > or other orthopedic procedures — a risk concealed by paperwork
doctored
> > with
> > > forged signatures and false information.
> > >
> > > "It's not just disrespectful to my father," said Vito Bruno, who has
> sued
> > > one of the funeral homes. "It's an absolutely hideous crime against
> other
> > > people."
> > >
> > > In the Cooke case, authorities confirmed this week that investigators
> > > contacted the late broadcaster's family after finding paperwork
> indicating
> > > his bones had been removed and sold by a Fort Lee, N.J., tissue bank,
> > > Biomedical Tissue Services, before he was cremated. Cooke, best known
as
> > the
> > > host of PBS's Masterpiece Theatre, died from cancer last year at 95 in
> > > Manhattan.
> > >
> > > Violation of FDA rules
> > > The family insists it never signed off on the procedure, and that
> someone
> > > had falsified documents by changing his cause of death to heart
attack,
> > and
> > > by lowering his age to 85. Harvesting bones from cancer patients
> violates
> > > rules by the Food and Drug Administration.
> > >
> > > A state grand jury in Brooklyn has been hearing evidence against at
> least
> > a
> > > half dozen funeral homes in the borough and against Biomedical Tissue
> > > Services. Authorities allege that they illegally profited by
conspiring
> to
> > > sell stolen body parts, and say indictments could be handed up early
> next
> > > year.
> > >
> > > The scandal's reach extends beyond the New York City area. In the
fall,
> > the
> > > FDA ordered a recall of products produced by tissue processors in
Texas,
> > New
> > > Jersey, Florida and Georgia, all customers of Biomedical Tissue
> Services.
> > >
> > > Health officials advised physicians that patients who were implanted
> with
> > > the tissue should be tested for HIV, hepatitis and other infectious
> > > diseases. The officials said they believed the health hazards were
> > minimal,
> > > and no infections have been reported since the FDA warning.
> > >
> > > But past cases have demonstrated dire risks. In 2001, a Minnesota man
> died
> > > after a knee surgery from an infection traced to cartilage from an
> > infected
> > > donor. A year later, health officials in Oregon announced that several
> > > patients were infected with hepatitis C after receiving donated organs
> and
> > > tissue from a single corpse.
> > >
> > > Authorities say the Brooklyn case stems from a deal struck between a
> > dentist
> > > who started Biomedical Tissue Services, Michael Mastromarino, 42, of
> Fort
> > > Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator
> from
> > > Staten Island.
> > >
> > > Alleged harvesting scheme
> > > Investigators suspect Nicelli helped secure access to tissue and bones
> > from
> > > funeral directors for $500 to $1,000 a body. Mastromarino allegedly
> would
> > > remove the body parts, then ship them to processors paying thousands
of
> > > dollars per order.
> > >
> > > Attorneys for Nicelli and Mastromarino did not respond to numerous
phone
> > > messages left by the Associated Press, but have previously denied that
> > their
> > > clients did anything wrong. A phone number listed for Biomedical
Tissue
> > > Services was disconnected.
> > >
> > >
> > > http://www.chron.com/disp/story.mpl/nation/3545690.html
> > >
> > >
> > > Dec. 23, 2005, 11:05AM
> > > Authorities Probe Theft of Body Parts
> > >
> > > By TOM HAYS Associated Press Writer
> > > © 2005 The Associated Press
> > >
> > > NEW YORK — Authorities are investigating allegations that hundreds of
> > bodies
> > > were illegally carved up in funeral homes around New York City and
sold
> > for
> > > parts without the permission of the families of the deceased.
> > >
> > > Corpses _ including that of famed British broadcaster Alistair Cooke _
> > were
> > > used to harvest human bone, skin and tendons which were then sold for
a
> > > profit, authorities allege.
> > >
> > > Worse, health officials fear some of the stolen body parts were
> diseased,
> > > and could infect patients who received them in skin grafts, dental
> > implants
> > > or other orthopedic procedures _ a risk concealed by paperwork
doctored
> > with
> > > forged signatures and false information.
> > >
> > > "It's not just disrespectful to my father," said Vito Bruno, who has
> sued
> > > one of the funeral homes after his father Michael's corpse was
> desecrated.
> > > "It's an absolutely hideous crime against other people."
> > >
> > > In the Cooke case, authorities confirmed this week that investigators
> > > contacted the late broadcaster's family after finding paperwork
> indicating
> > > his bones had been removed and sold by a Fort Lee, N.J., tissue bank,
> > > Biomedical Tissue Services, before he was cremated. Cooke, best known
as
> > the
> > > host of "Masterpiece Theatre," died from cancer last year at 95 in
> > > Manhattan.
> > >
> > > The family insists it never signed off on the procedure, and that
> someone
> > > had falsified documents by changing his cause of death to heart
attack,
> > and
> > > by lowering his age to 85. Harvesting bones from cancer patients
> violates
> > > rules by the Food and Drug Administration.
> > >
> > > A daughter, Susan Cooke Kittredge, said the family was "shocked and
> > > saddened" by the news.
> > >
> > > "That people in need would have received his body parts, considering
his
> > age
> > > and the fact he was ill when he died, is appalling to the family, as
is
> > that
> > > his remains were violated," she said.
> > >
> > > The probe _ first reported by the Daily News in October _ has
generated
> > > other gruesome stories. In one instance, the corpse of a Queens
> > grandmother
> > > that investigators exhumed last month had nearly all the bones removed
> > below
> > > the waist and replaced with PCV pipes.
> > >
> > > A grand jury in Brooklyn has been hearing evidence against at least a
> half
> > > dozen funeral homes in the borough and against Biomedical Tissue
> Services
> > > that they illegally profited by conspiring to sell stolen body parts.
> > > Authorities say indictments could be handed up early next year.
> > >
> > > The brewing scandal's reach extends far beyond the New York City area.
> > >
> > > In the fall, the FDA ordered a recall of products produced by tissue
> > > processors in New Jersey, Florida, Georgia and Texas, all customers of
> > > Biomedical Tissue Services. Since the announcement, authorities in
> Canada
> > > have determined that about 300 potentially tainted products were
> imported
> > > there, and used for dental surgery on at least two patients.
> > >
> > > Health officials advised physicians that patients who were implanted
> with
> > > the tissue should be tested for HIV, hepatitis and other infectious
> > > diseases. The officials said they believed the health hazards were
> > minimal,
> > > and no infections have been reported since the FDA warning.
> > >
> > > But past cases have demonstrated dire risks.
> > >
> > > In 2001, a Minnesota man died after a knee surgery from an infection
> > caused
> > > by a bacterium traced to cartilage from an infected donor. A year
later,
> > > health officials in Oregon announced that several patients were
infected
> > > with hepatitis C after receiving donated organs and tissue from a
single
> > > corpse.
> > >
> > > Authorities say the Brooklyn case stems from a deal struck between a
> > dentist
> > > who started Biomedical Tissue Services, Michael Mastromarino, 42, of
> Fort
> > > Lee, and Joseph Nicelli, 49, an embalmer and funeral parlor operator
> from
> > > Staten Island.
> > >
> > > Investigators suspect Nicelli helped secure access to tissue and bones
> > from
> > > funeral directors for $500 to $1,000 a body. Mastromarino allegedly
> would
> > > remove the body parts, then ship them to processors paying thousands
of
> > > dollars per order.
> > >
> > > Attorneys for both Nicelli and Mastromarino did not respond to
numerous
> > > phone messages left by The Associated Press. A phone number listed for
> > > Biomedical Tissue Services was disconnected.
> > >
> > > The Brooklyn case demonstrates the potential pitfalls of allowing
> funeral
> > > homes and tissue banks to do business without stricter oversight, said
> > Annie
> > > Cheney, author of the upcoming book, "Body Brokers: Inside America's
> > > Underground Trade in Human Remains."
> > >
> > > "The fact that these people were supposedly able to get away with this
> for
> > > so long is shocking," she said.
> > >
> > >
> > > http://www.chron.com/disp/story.mpl/ap/nation/3544706.html
> > >
> > >
> > > Dec. 23, 2005, 10:35AM
> > > Allegations of body part sales investigated
> > >
> > > Associated Press
> > >
> > > NEW YORK — Authorities are investigating allegations that the body of
> > > British broadcaster Alistair Cooke — among hundreds of others — was
> > > illegally carved up in the back room of a funeral home and sold so its
> > parts
> > > could be used in transplants.
> > >
> > > Officials confirmed this week that investigators found paperwork
> > indicating
> > > Cooke's bones had been removed and sold by Biomedical Tissue Services,
a
> > > Fort Lee, N.J., tissue bank, before he was cremated.
> > >
> > > Cooke, longtime host of PBS' "Masterpiece Theatre" and known around
the
> > > world for his "Letter From America" shows on the BBC, died from cancer
> > last
> > > year at age 95 in New York.
> > >
> > > His family said it never agreed to the bone removal and that someone
> > > falsified documents by changing Cooke's cause of death to heart attack
> and
> > > by lowering his age to 85.
> > >
> > > A day after his death, Cooke's bones were allegedly sold for about
> $7,000
> > to
> > > two transplant companies. The family was supplied with what they were
> told
> > > were his ashes, and scattered them in Central Park.
> > >
> > > A daughter, Susan Cooke Kittredge, said the family was "shocked and
> > > saddened" by the news.
> > >
> > > "That people in need would have received his body parts, considering
his
> > age
> > > and the fact he was ill when he died, is appalling to the family, as
is
> > that
> > > his remains were violated," she said.
> > >
> > > A phone number listed for Biomedical Tissue Services was disconnected.
> > >
> > >
> > > http://www.chron.com/disp/story.mpl/nation/3544620.html
> > >
> > >
> > > TSS
> > >
> > >
> > > ----- Original Message -----
> > > From: "Terry S. Singeltary Sr."
> > > To:
> > > Sent: Tuesday, December 20, 2005 4:25 PM
> > > Subject: Re: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN
TSEs
> IN
> > > THE USA
> > >
> > >
> > > > ##################### Bovine Spongiform Encephalopathy
> > > #####################
> > > >
> > > > Subject: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad
> cow
> > > > disease i.e. CJD and other dangerous pathogens
> > > > Date: December 20, 2005 at 2:05 pm PST
> > > >
> > > >
> > > > Greetings BSE-L et al;
> > > >
> > > >
> > > > well, the 'dear unlucky john recipient' letters are in the mail,
while
> > > these
> > > > company's are laughing all the way to the bank. ...TSS
> > > >
> > > >
> > > > Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow
> disease
> > > i.e.
> > > > CJD and other dangerous pathogens
> > > >
> > > >
> > > >
> > > > Body snatchers tied to allograft firms?
> > > > Alleged New York-area ring investigated for selling parts to corpse
> > tissue
> > > > harvesters.
> > > > October 7, 2005: 2:54 PM EDT
> > > > By Aaron Smith, CNN/Money staff writer
> > > >
> > > >
> > > >
> > > >
> > > > NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey
> company
> > > that
> > > > harvests body parts from corpses are being investigated for their
> > alleged
> > > > roles in a body snatching ring that sold parts to companies
> specializing
> > > in
> > > > medical grafts, sources close to the investigation said Friday.
> > > >
> > > > The Brooklyn district attorney's office declined to comment on the
> > > > investigation. But sources close to the investigation acknowledged
> that
> > it
> > > > has been going on for about one and a half years, focusing on
Michael
> > > > Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J.,
who
> > > > allegedly harvested body parts illegally from the Daniel George
> funeral
> > > home
> > > > in Brooklyn.
> > > >
> > > > The firms that bought the allegedly black-market tissue have not
been
> > > > accused of any wrongdoing. Human tissue is usually obtained from
> > > non-profit
> > > > tissue banks. In the U.S., it's illegal to buy and sell human
tissue.
> > > >
> > > > Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down
> > $0.66
> > > > to $7.28, Research), a company in Alachua, Fla., said her company
has
> > > > severed all ties with Biomedical Tissue Services, their former
source
> > for
> > > > some of the body parts used to make medical grafts, or allografts.
> > > >
> > > > "We had previously terminated the relationship with Biomedical
Tissue
> > > > Services and we are cooperating with the appropriate authorities on
> this
> > > > issue," said Crites-Wacker, who declined to say when the termination
> > took
> > > > place.
> > > >
> > > > Crites-Wacker also said that her company's BioCleanse process, in
> which
> > > > bones and tendons are sterilized through a melange of chemicals,
> > > temperature
> > > > and pressure, ensures that its products are safe.
> > > >
> > > > Two other allograft companies have been identified as customers of
> > > > Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33,
> > > Research),
> > > > of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06,
> > > Research)
> > > > of West Paterson, N.J.
> > > >
> > > > LifeCell Corp. had issued a Friday statement saying it had
voluntarily
> > > > recalled some human tissue products after questions were raised
about
> > > > Biomedical Tissue Services.
> > > >
> > > > "Specifically, the company recalled all lots of product that were
> > produced
> > > > using tissue from Biomedical Tissue Services (BTS)," LifeCell said
in
> a
> > > > release.
> > > >
> > > > LifeCell, which markets products made from human tissues that are
used
> > in
> > > > surgical procedures, said it recalled certain AlloDerm, Repliform
and
> > > > GraftJacket products on Sept. 30.
> > > >
> > > > LifeCell's stock price slid about 5 percent this morning, and a
Piper
> > > > Jaffray analyst attributed the slump to a New York Daily News story
> that
> > > > first reported on the investigation.
> > > >
> > > > "We believe this morning's weakness in LifeCell's shares is related
to
> a
> > > > news article that alleges LifeCell inadvertently received tissue
from
> an
> > > > illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a
> > > written
> > > > report.
> > > >
> > > > LifeCell said in the statement all other tissues supplied by
> Biomedical
> > > > Tissue Services remain "on hold until the discrepancies in the donor
> > > > documentation can be resolved."
> > > >
> > > > Denhoy said that LifeCell did not appear to do anything illegal and
> that
> > > > "LifeCell itself was the victim of fraud," referring to allegations
> that
> > > > Biomedical Tissue Services forged death certificates and family
> consent
> > > > forms.
> > > >
> > > > Denhoy said that LifeCell receives tissue from 30 sources, "so the
> loss
> > of
> > > > one will likely not impact the underlying business," though
increased
> > > > regulatory scrutiny could drive down the stock price.
> > > >
> > > > "While LifeCell and the other tissue companies appear to have done
> > nothing
> > > > wrong, this event could increase regulatory and media scrutiny of
the
> > > > business," said Denhoy, who rates the company market perform. "We
> > recently
> > > > downgraded LifeCell shares on competitive concerns and today's
> > revelations
> > > > may pressure the stock further."
> > > >
> > > > Eric Franz, the attorney representing funeral home owners Debora
> Johnson
> > > and
> > > > Robert Nelms, said his clients "did not participate in any criminal
> > > conduct
> > > > whatsoever."
> > > >
> > > > Attempts to reach Mastromarino and his company Biomedical Tissue
> > Services
> > > > were unsuccessful. The Daily News reported that Mastromarino
declined
> to
> > > > comment.
> > > >
> > > > Regeneration Technologies produces heart valves, bone and tendon
> > implants
> > > > and bone paste, which is used to plug holes. LifeCell specializes in
> > > > AlloDerm, a "dermal matrix" made from human skin that is used in
> grafts.
> > > > Tutogen focuses on bone and dental implants.
> > > >
> > > > --from staff and wire reports
> > > >
> > > >
> > > >
> > > >
> > > >
> >
http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest
> > > >
> > > >
> > > > FDA News
> > > > FOR IMMEDIATE RELEASE
> > > > P05-77
> > > > October 26, 2005
> > > > Media Inquiries:
> > > > Julie Zawisza, 301-827-6242
> > > > Consumer Inquiries:
> > > > 888-INFO-FDA
> > > >
> > > >
> > > >
> > > > FDA Provides Information on Investigation into Human Tissue for
> > > > Transplantation
> > > > The Food and Drug Administration (FDA) is notifying the public of
its
> > > > investigation of human tissue recovered by Biomedical Tissue
Services,
> > > Ltd.
> > > > (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this
> tissue
> > > may
> > > > have been implanted into patients from early 2004 to September 2005.
> The
> > > > tissue was recovered by BTS from human donors who may not have met
FDA
> > > donor
> > > > eligibility requirements and who may not have been properly screened
> for
> > > > certain infectious diseases. At this time, the implicated tissues
from
> > BTS
> > > > include human bone, skin, and tendons. These products represent only
a
> > > small
> > > > percentage of the overall U.S. tissue supply.
> > > >
> > > > While no adverse reactions related to these tissues have been
reported
> > to
> > > > FDA at this time, because of the potential lack of proper screening
of
> > the
> > > > tissue donors, some recipients of the tissues may be at increased
risk
> > of
> > > > infections that could potentially be transmitted through tissues.
FDA
> > and
> > > > the Centers for Disease Control and Prevention (CDC) believe the
risks
> > > from
> > > > these tissues are low because the tissues were routinely processed
> using
> > > > methods that help to reduce the risk of infectious disease; however,
> the
> > > > actual infectious risk is unknown.
> > > >
> > > > FDA's requirements to determine donor eligibility include important
> > steps
> > > to
> > > > ensure that donors do not harbor infections that could be
transmitted
> to
> > > > recipients. These steps include reviewing the donor's medical
history
> > and
> > > > other factors, physically assessing the donor, and testing for
> relevant
> > > > communicable diseases that may place the donor at an increased risk
of
> > > > infections that could then unintentionally be transmitted to
> recipients
> > > > through the tissues.
> > > >
> > > > The following tissue processors received tissue from BTS:
> > > >
> > > > LifeCell Corporation of Branchburg, NJ
> > > > Lost Mountain Tissue Bank of Kennesaw, GA
> > > > Blood and Tissue Center of Central Texas in Austin, TX
> > > > Tutogen Medical, Inc., of Alachua, FL
> > > > Regeneration Technologies, Inc., of Alachua, FL
> > > > These firms already have voluntarily recalled all unused tissue
> > remaining
> > > in
> > > > inventory and are working cooperatively with FDA to ensure that the
> > > > implanting physicians whose patients may have received the products
> are
> > > > properly notified. Physicians who implanted tissue from BTS should
> have
> > > been
> > > > contacted at this time by the receiving health care facility.
> > > >
> > > > FDA and CDC recommend that implanting physicians inform their
patients
> > > that
> > > > they may have received tissue from a donor for whom an adequate
donor
> > > > eligibility determination was not performed. While the overall
> > infectious
> > > > risk is likely low, FDA and CDC recommend that physicians offer to
> > provide
> > > > patients access to appropriate infectious disease testing. The
> relevant
> > > > communicable diseases for which a tissue donor is required to be
> tested
> > > are
> > > > HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus,
> hepatitis
> > C
> > > > virus, and syphilis. Physicians who still have concerns or questions
> > about
> > > > the source of the tissue should contact the health care facility
where
> > the
> > > > procedure was performed. FDA will continue its investigation into
this
> > > > matter and will issue further public health updates, as needed.
> > > >
> > > > Patients and physicians should report any infectious disease
possibly
> > > > related to a tissue transplant to the processing firms, who then
> should
> > > > notify FDA. Patients and physicians who wish to notify FDA directly
of
> > > such
> > > > infectious disease should report via FDA’s MedWatch reporting
program
> at
> > > > http://www.fda.gov/medwatch.
> > > >
> > > >
> > > > http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
> > > >
> > > >
> > > >
> > > > Recall of Human Tissue
> > > >
> > > >
> > > > DATE RECALL INITIATED:
> > > >
> > > > October 13, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > Human Tissue for Transplantation
> > > >
> > > > MANUFACTURER:
> > > >
> > > > Biomedical Tissue Services, Ltd
> > > > Fort Lee, New Jersey
> > > >
> > > > REASON:
> > > >
> > > > Biomedical Tissue Services (BTS) was recently made aware that there
is
> > the
> > > > possibility that tissue has been procured from donors without proper
> > > > medical/social histories. BTS is performing a voluntary recall of
any
> > > unused
> > > > tissue from its consignees.
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > >
> > > > Updated October 18, 2005
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls/btstis101305.htm
> > > >
> > > >
> > > >
> > > >
> > > > Tutogen Medical Tissue Recall
> > > >
> > > > Frequently Asked Questions and Answers
> > > >
> > > > Q: What prompted this recall?
> > > >
> > > > A: Tutogen was unable to verify donor consent for certain tissue
> > provided
> > > by
> > > > one of its recovery agency suppliers (BioMedical Tissue Services of
> Fort
> > > > Lee, NJ). Tutogen, along with several other tissue processing
> companies,
> > > > received allograft material from BioMedical Tissue Services. One of
> > these
> > > > other processing companies notified Tutogen that they were having
> > > difficulty
> > > > in reaching persons taking the consent information or next of kin
for
> > > > BioMedical tissue donors. Upon receiving this notification, Tutogen
> > > > immediately initiated a review and investigation of all donor
consents
> > > > received from BioMedical Tissue Services. Tutogen also experienced
> > > problems
> > > > in contacting consent takers, witnesses and next of kin shown on the
> > > > documentation provided by BioMedical Tissue Services. We further
> > attempted
> > > > to contact Dr. Michael Mastromarino, CEO and Executive Director of
> > > > BioMedical Tissue Services, to assist in this matter, but without
> > success.
> > > > Although Tutogen does not believe that there are any safety concerns
> > > related
> > > > to this tissue, the company elected to initiate a voluntary recall
of
> > > > products incorporating the BioMedical tissues, on ethical grounds.
> > > >
> > > > Q: What tissue products are being recalled?
> > > >
> > > > A: Specific serial/lot numbers of Tutogen’s Puros® Allograft
> Cancellous
> > > > Particles (marketed by Zimmer Dental) and a small quantity of
> Tutoplast®
> > > > Fascia Lata (marketed by Mentor Corporation and Innovative Opthalmic
> > > > Products, Inc.) are involved in this recall.
> > > >
> > > > Q: How much allograft tissue did BioMedical Tissue Services provide
to
> > > > Tutogen?
> > > >
> > > > A: The quantity of tissue received from BioMedical represents a
small
> > > > fraction (about 2%) of all tissue processed by Tutogen.
> > > >
> > > > Q: What did Tutogen do to notify customers of the recall?
> > > >
> > > > A: Upon completion of its donor documentation investigation, Tutogen
> > > > notified the FDA of our intent to initiate a voluntary recall. We
> > > > immediately identified all BioMedical tissue, from raw material
stock
> > > > through finished goods and field distribution, and quarantined all
> > > material
> > > > within our control. Customer shipment information was assembled and
a
> > > recall
> > > > letter was prepared and approved by the FDA. Initially, Tutogen
> alerted
> > > all
> > > > customers of record via telephone, describing the reason for the
> recall,
> > > > providing serial numbers of product shipped to them and indicating
the
> > > > process for the return and replacement of affected product.
> > > >
> > > > Simultaneously, copies of the recall letter and distribution
> information
> > > for
> > > > the affected product was sent to each customer by facsimile. This
same
> > > > information was then provided to customer accounts by certified
mail.
> At
> > > the
> > > > request of the FDA, Tutogen sent a recall follow-up letter to
affected
> > > > customers, including FDA mandated language regarding patient
> > notification
> > > > and access to disease testing.
> > > >
> > > > An additional letter was prepared and mailed to those customers that
> had
> > > not
> > > > received any of the products manufactured using BioMedical tissue
and
> > were
> > > > not affected by the voluntary recall. In the interim, the company
> > prepared
> > > > and issued a press release concerning this recall and participated
in
> > > > numerous conference calls, throughout the U.S. and Canada, with
> surgeon
> > > > groups, industry organizations (such as the American Association of
> > Tissue
> > > > Banks) and professional associations (such as the American
Association
> > of
> > > > Oral and Maxillofacial Surgeons and the American Academy of
> > > Periodontology).
> > > >
> > > > These prior communications were supplemented by a scientific
> > dissertation
> > > > mail-out that described the Tutogen Tutoplast® process, which
> > subsequently
> > > > led to the preparation of a technical monograph detailing this
process
> > and
> > > > its qualification history. The monograph may be accessed on this
> website
> > > by
> > > > selecting the link entitled, "The Tutoplast® Process: A Review of
> > > Efficacy".
> > > >
> > > > Q: How can I tell whether I received any of the affected product?
> > > >
> > > > A: All customers of record, that received products manufactured
> > utilizing
> > > > tissue provided by BioMedical, were notified and should have
received
> an
> > > > individualized list of all product serial numbers shipped to them.
> > > Affected
> > > > product may also be quickly identified by visually checking the
> > > > alpha-numeric designator beneath the product barcode label (see
> samples,
> > > > shown below).
> > > >
> > > > The affected product alpha-numeric code begins with the letters "BM"
> or
> > > > "BT".
> > > >
> > > > Q: How should I go about returning affected product that may remain
in
> > my
> > > > inventory stock?
> > > >
> > > > A: Once any affected product has been identified, place it in a
> shipping
> > > > container and mark the outside of the container with "BMRECALL".
> Address
> > > the
> > > > package to:
> > > >
> > > > Tutogen Medical
> > > >
> > > > 13709 Progress Boulevard
> > > >
> > > > South Wing
> > > >
> > > > Alachua, FL 32615
> > > >
> > > > Biomedical Tissue Services
> > > >
> > > > Biotissue Recovery Services
> > > >
> > > > Call UPS at (800) PICK UPS and request a package pick-up. Forward
the
> > > > package to Tutogen, via UPS ground, using account number Y6X706.
This
> > > > shipping account number is reserved for the return of recalled items
> and
> > > is
> > > > for one-way service to Tutogen, from U.S. accounts. Only product
> > affected
> > > by
> > > > this recall will be accepted for return.
> > > >
> > > > Canadian customers should contact Zimmer Dental Corporation Customer
> > > Service
> > > > at (800) 265-0968 or (905) 567-2073 for return instructions.
> > > >
> > > > Q: What is the risk to patients that have already received recalled
> > > > implants?
> > > >
> > > > A: The FDA and CDC have indicated that they believe the overall risk
> of
> > > > disease transmission by these products is low, but unknown. Because
> > > Tutogen’
> > > > s Tutoplast® tissue preservation and sterilization process is
> extremely
> > > > rigorous and has passed significant challenge testing, we believe
that
> > all
> > > > tissue distributed by Tutogen, including that from BioMedical Tissue
> > > > Services, is safe and effective for its intended use. In addition,
> > > > comprehensive physical examination and serology testing is routinely
> > > > performed on all donors processed by Tutogen.
> > > >
> > > > Q: What types of evaluations are performed on donors processed by
> > Tutogen
> > > > Medical?
> > > >
> > > > A: Consent for donation, along with a detailed medical/social
history,
> > is
> > > > obtained from each donor or their next of kin by hospital, medical
> > > examiner,
> > > > funeral home or recovery agency personnel. The recovery team
> identifies
> > > the
> > > > donor and conducts a detailed physical evaluation of the body. This
> > > > examination incorporates an extensive assessment checklist for
> > > > characteristics that would disqualify a donor from further
> consideration
> > > and
> > > > addresses tissue appearance and condition during the retrieval
> process.
> > > The
> > > > recovery team also collects a donor blood sample and forwards it to
a
> > > > third-party CLIA certified laboratory for disease testing, using FDA
> > > > approved test methodology. The serology test results, along with the
> > > > previously mentioned donor documentation, is examined by Tutogen’s
> > Quality
> > > > Assurance Department and a staff Medical Director (a licensed
> > physician).
> > > > Only after these thorough reviews are completed and release is
granted
> > by
> > > > the Medical Director, is donor tissue allowed to enter the
Tutoplast®
> > > > process.
> > > >
> > > > Q: What testing is done on the donor serology sample?
> > > >
> > > > A: Tutogen requires that the following serology testing be performed
> and
> > > > found to be "negative" or "non-reactive", prior to accepting any
donor
> > > > tissue for processing:
> > > >
> > > > Hepatitis B surface antigen (HBsAg)
> > > >
> > > > Hepatitis B core antibody (HBcAb – IgG +IgM)
> > > >
> > > > Hepatitis C Virus antibody (HCV Ab)
> > > >
> > > > Hepatitis B and C Nucleic Acid Testing (HBV and HCV NAT)
> > > >
> > > > Human Immunodeficiency Virus I and II antibodies (HIV I and II Ab)
> > > >
> > > > HIV I – p24
> > > >
> > > > Human T-Lymphotropic Virus I and II (HTLV I and II Ab)
> > > >
> > > > Syphilis – Rapid Plasma Reagin (RPR/STS)
> > > >
> > > > Q: Who will pay for the cost of disease testing for my patients?
> > > >
> > > > A: Although Tutogen does not feel that the products manufactured
using
> > > > BioMedical tissue pose a safety concern, out of respect for your
> > patients’
> > > > welfare and as a service to you, Tutogen has elected to bear the
cost
> of
> > > the
> > > > appropriate infectious disease testing.
> > > >
> > > > Q: What process has Tutogen put in place to accomplish the disease
> > > testing"?
> > > >
> > > > A: We have made arrangements with ViroMed Laboratories (division of
> > > > LabCorp), a respected, CLIA and FDA certified organization, to
conduct
> > > this
> > > > testing. Should you choose to inform those patients who received the
> > > > affected implants, we suggest that you offer them the opportunity to
> be
> > > > tested for the specified infectious diseases. Additionally, we
> recommend
> > > > that you maintain a record of notification for each patient, which
> would
> > > > indicate their acceptance or rejection of the testing offered and be
> > > > signed/dated by that individual. For those patients that elect to
> > undergo
> > > > testing, both U.S. and Canadian customers should follow the process
> > > > delineated, below.
> > > >
> > > >
> > > > 1. Provide Tutogen Medical with the name and mailing address of the
> > > patient.
> > > > Only patients that received implants utilizing tissue provided by
> > > BioMedical
> > > > Tissue Services are eligible for this pre-paid testing. This
> information
> > > > will be verified in our Tissue Utilization Record (TUR) database, or
> you
> > > may
> > > > provide documentation confirming the patient’s implant, if no TUR
was
> > > > previously forwarded to Tutogen.
> > > >
> > > >
> > > > 2. Let the patient know that a test kit will be sent to him or her
by
> > > > ViroMed Laboratories within the next few days and will include
> > > instructions
> > > > on how to proceed.
> > > >
> > > >
> > > > 3. Instruct the patient to set up an appointment with and take the
> test
> > > kit
> > > > to their Primary Care physician. Alternatively, the patient may
elect
> to
> > > > visit a LabCorp service center as indicated in item # 7, below.
> > > >
> > > >
> > > > 4. Following the instructions provided with the kit, the Primary
Care
> > > > physician or professional healthcare office staff member should
obtain
> a
> > > > blood sample from the patient and forward it to ViroMed Laboratories
> in
> > > the
> > > > postage-paid mailer that will be included in the kit.
> > > >
> > > >
> > > > 5. ViroMed Laboratories will perform the appropriate disease testing
> and
> > > > forward the results to the patient’s Primary Care physician. If a
> > > > confirmatory test is necessary, ViroMed Laboratories will
> automatically
> > > > perform this additional testing and include those results in the
final
> > > test
> > > > report.
> > > >
> > > >
> > > > 6. Upon receipt of the ViroMed data, the Primary Care physician
should
> > > > contact the patient and discuss the final results of the testing
with
> > him
> > > or
> > > > her.
> > > >
> > > >
> > > > 7. In the event that your patient does not have a Primary Care
> > physician,
> > > he
> > > > or she may go to a "walk-in" clinic to have a blood sample taken or
to
> > be
> > > > referred to a LabCorp service
> > > >
> > > >
> > > > center near them and have this blood sample drawn and forwarded to
> > ViroMed
> > > > Laboratories for testing. The attending physician may call ViroMed
> > Client
> > > > Services, at (800) 582-0077, to arrange for a test kit or to obtain
> > > > instructions for handling the sample. These patients must have their
> > > > eligibility verified by Tutogen. LabCorp or ViroMed will provide all
> > > > associated test kit supplies. A list of service center locations is
> > > > available on the LabCorp website (www.labcorp.com ) under the
"Patient
> > > > Service Center Locator" link.
> > > >
> > > > If you have a patient that has already presented for infectious
> disease
> > > > testing, a reimbursement request for costs not covered by the
> individual
> > ’s
> > > > insurance carrier can be made by forwarding the invoice, showing the
> net
> > > > responsibility of the patient, or a receipt, marked "Paid" to:
> > > >
> > > > Tutogen Medical, Inc.
> > > >
> > > > Accounts Payable
> > > >
> > > > 13709 Progress Blvd., Box 19
> > > >
> > > > Alachua, FL 32615
> > > >
> > > > The invoice should clearly show the name and address of the facility
> > > > performing the disease testing and be annotated with the name of the
> > > patient
> > > > ’s dentist/oral surgeon and practice name, as well as the
identifier,
> > > > "BMRECALL".
> > > >
> > > > Q: What testing will be performed on each patient’s blood sample?
> > > >
> > > > A: The recommended testing is for HIV I and II, Hepatitis B virus,
> > > Hepatitis
> > > > C virus and syphilis. All test results will remain confidential,
> between
> > > > patient and doctor.
> > > >
> > > > Q: Is Tutogen still receiving tissue from BioMedical Tissue
Services?
> > > >
> > > > A: No. Upon initiating the voluntary recall, Tutogen suspended the
> > > > acceptance of any tissues from BioMedical Tissue Services and has
> > > officially
> > > > terminated its relationship with them.
> > > >
> > > > Q: How can a situation such as this be prevented in the future?
> > > >
> > > > A: At this point, there is no simple answer to this question.
Tutogen
> > > > adhered to all of its standard screening, inspection and processing
> > > > procedures and there was no deviation or departure from its quality
> > > > assurance systems. All processing companies rely on the FDA
registered
> > and
> > > > state licensed recovery agencies to comply with established
> regulations
> > > and
> > > > industry guidelines. Tutogen is currently evaluating a number of
> > potential
> > > > additional safeguards, but no mechanisms have been identified that
> would
> > > > provide a foolproof solution. In addition, we are working very
closely
> > > with
> > > > the Food and Drug Administration and American Association of Tissue
> > Banks
> > > to
> > > > devise workable options that might preclude recurrence.
> > > >
> > > >
> > > > http://www.tutogen.com/recallQandA.pdf
> > > >
> > > >
> > > > Recall of Human Tissue Products
> > > >
> > > >
> > > > DATE RECALL INITIATED:
> > > >
> > > > October 14, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > Human Tissue For Transplantation
> > > >
> > > > MANUFACTURER:
> > > >
> > > > Regeneration Technologies, Inc
> > > > Alachua, Florida
> > > >
> > > > REASON:
> > > >
> > > > Regeneration Technologies, Inc. (RTI) is conducting a voluntary
recall
> > of
> > > > all tissue received from BioMedical Tissue Services (BTS; Ft. Lee,
New
> > > > Jersey) as a result of information regarding the accuracy of donor
> > > screening
> > > > documentation. RTI informed its consignees that a lack of assurance
of
> > > donor
> > > > identity as well as the risk of infectious diseases also exists.
> > > Consignees
> > > > are asked to contact the manufacturer to arrange for product return.
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > >
> > > > Updated October 18, 2005
> > > >
> > > >
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls/rtitis101405.htm
> > > >
> > > >
> > > > FDA News
> > > > FOR IMMEDIATE RELEASE
> > > > P05-77
> > > > October 26, 2005
> > > > Media Inquiries:
> > > > Julie Zawisza, 301-827-6242
> > > > Consumer Inquiries:
> > > > 888-INFO-FDA
> > > >
> > > >
> > > >
> > > > FDA Provides Information on Investigation into Human Tissue for
> > > > Transplantation
> > > > The Food and Drug Administration (FDA) is notifying the public of
its
> > > > investigation of human tissue recovered by Biomedical Tissue
Services,
> > > Ltd.
> > > > (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this
> tissue
> > > may
> > > > have been implanted into patients from early 2004 to September 2005.
> The
> > > > tissue was recovered by BTS from human donors who may not have met
FDA
> > > donor
> > > > eligibility requirements and who may not have been properly screened
> for
> > > > certain infectious diseases. At this time, the implicated tissues
from
> > BTS
> > > > include human bone, skin, and tendons. These products represent only
a
> > > small
> > > > percentage of the overall U.S. tissue supply.
> > > >
> > > > While no adverse reactions related to these tissues have been
reported
> > to
> > > > FDA at this time, because of the potential lack of proper screening
of
> > the
> > > > tissue donors, some recipients of the tissues may be at increased
risk
> > of
> > > > infections that could potentially be transmitted through tissues.
FDA
> > and
> > > > the Centers for Disease Control and Prevention (CDC) believe the
risks
> > > from
> > > > these tissues are low because the tissues were routinely processed
> using
> > > > methods that help to reduce the risk of infectious disease; however,
> the
> > > > actual infectious risk is unknown.
> > > >
> > > > FDA's requirements to determine donor eligibility include important
> > steps
> > > to
> > > > ensure that donors do not harbor infections that could be
transmitted
> to
> > > > recipients. These steps include reviewing the donor's medical
history
> > and
> > > > other factors, physically assessing the donor, and testing for
> relevant
> > > > communicable diseases that may place the donor at an increased risk
of
> > > > infections that could then unintentionally be transmitted to
> recipients
> > > > through the tissues.
> > > >
> > > > The following tissue processors received tissue from BTS:
> > > >
> > > > LifeCell Corporation of Branchburg, NJ
> > > > Lost Mountain Tissue Bank of Kennesaw, GA
> > > > Blood and Tissue Center of Central Texas in Austin, TX
> > > > Tutogen Medical, Inc., of Alachua, FL
> > > > Regeneration Technologies, Inc., of Alachua, FL
> > > > These firms already have voluntarily recalled all unused tissue
> > remaining
> > > in
> > > > inventory and are working cooperatively with FDA to ensure that the
> > > > implanting physicians whose patients may have received the products
> are
> > > > properly notified. Physicians who implanted tissue from BTS should
> have
> > > been
> > > > contacted at this time by the receiving health care facility.
> > > >
> > > > FDA and CDC recommend that implanting physicians inform their
patients
> > > that
> > > > they may have received tissue from a donor for whom an adequate
donor
> > > > eligibility determination was not performed. While the overall
> > infectious
> > > > risk is likely low, FDA and CDC recommend that physicians offer to
> > provide
> > > > patients access to appropriate infectious disease testing. The
> relevant
> > > > communicable diseases for which a tissue donor is required to be
> tested
> > > are
> > > > HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus,
> hepatitis
> > C
> > > > virus, and syphilis. Physicians who still have concerns or questions
> > about
> > > > the source of the tissue should contact the health care facility
where
> > the
> > > > procedure was performed. FDA will continue its investigation into
this
> > > > matter and will issue further public health updates, as needed.
> > > >
> > > > Patients and physicians should report any infectious disease
possibly
> > > > related to a tissue transplant to the processing firms, who then
> should
> > > > notify FDA. Patients and physicians who wish to notify FDA directly
of
> > > such
> > > > infectious disease should report via FDA’s MedWatch reporting
program
> at
> > > > http://www.fda.gov/medwatch.
> > > >
> > > > Additional information is available on FDA’s web site at
> > > > http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.
> > > >
> > > > ####
> > > >
> > > >
> > > > http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
> > > >
> > > >
> > > > Recall of Human Tissue Products
> > > >
> > > >
> > > > DATE RECALL INITIATED:
> > > >
> > > > October 11, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > Human Tissue for Transplantation
> > > >
> > > > MANUFACTURER:
> > > >
> > > > The Blood and Tissue Center of Central Texas
> > > > Austin, Texas
> > > >
> > > > REASON:
> > > >
> > > > Central Texas Regional Blood and Tissue Center is voluntarily
> recalling
> > > > tissue products as the firm is unable to confirm information
provided
> by
> > > > BioMedical Tissue Services (BTS; Ft. Lee, New Jersey). Consignees
are
> > > asked
> > > > to contact the manufacturer to arrange for product return.
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > >
> > > > Updated October 18, 2005
> > > >
> > > >
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls/blotis101105.htm
> > > >
> > > >
> > > > Recall of Human Tissue Products
> > > >
> > > >
> > > > DATE RECALL INITIATED:
> > > >
> > > > October 12, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > Human Tissue for Transplantation
> > > >
> > > > MANUFACTURER:
> > > >
> > > > Tutogen Medical, Inc.
> > > > Alachua, Florida
> > > >
> > > > REASON:
> > > >
> > > > Tutogen Medical is conducting a voluntary recall of all materials
that
> > > were
> > > > manufactured utilizing BioMedical Tissue Services (BTS; Ft. Lee, New
> > > Jersey)
> > > > donor tissue. This action is being taken because Tutogen is unable
to
> > > > satisfactorily confirm that donor eligibility had been properly
> obtained
> > > by
> > > > BTS. Tutogen informed its consignees that there is a lack of
assurance
> > > that
> > > > appropriate donor identification, donor screening, and medical
history
> > > data
> > > > collection was performed and, therefore, a risk of infectious
disease
> > > > exists. Consignees are asked to contact the manufacturer to arrange
> for
> > > > product return.
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > >
> > > > Updated October 18, 2005
> > > >
> > > >
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls/tutotis101205.htm
> > > >
> > > >
> > > > Withdrawal of Human Tissue Products
> > > >
> > > >
> > > > DATE WITHDRAWAL INITIATED:
> > > >
> > > > October 10, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > Human Tissue for Transplantation
> > > >
> > > > MANUFACTURER:
> > > >
> > > > Lost Mountain Tissue Bank
> > > > Kennesaw, Georgia
> > > >
> > > > REASON:
> > > >
> > > > Lost Mountain Tissue Bank, Inc. (LMTB) has initiated consignee
> > > notifications
> > > > for all tissue products processed and/or distributed from donors
> > procured
> > > in
> > > > the New York area by Biomedical Tissue Services (BTS; Ft. Lee, New
> > > Jersey).
> > > > LMTB was informed of some discrepant and possibly fraudulent
> information
> > > in
> > > > donor documentation. LMTB is notifying all relevant hospitals and
> > medical
> > > > professionals of the market withdrawal of all tissue products
> beginning
> > > with
> > > > the letters “GL” or “T” in the tissue identification number (ID#).
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > >
> > > > Updated October 18, 2005
> > > >
> > > >
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls.htm
> > > >
> > > >
> > > > DATE RECALL INITIATED:
> > > >
> > > > September 30, 2005
> > > >
> > > > PRODUCT:
> > > >
> > > > AlloDerm, Repliform, and GraftJacket
> > > >
> > > > MANUFACTURER:
> > > >
> > > > LifeCell Corporation
> > > > Branchburg, New Jersey
> > > >
> > > > REASON:
> > > >
> > > > LifeCell Corporation initiated a voluntary recall of certain
AlloDerm,
> > > > Repliform, and GraftJacket product from the marketplace on September
> 30,
> > > > 2005. The recall was prompted when internal quality processes raised
> > > > questions about the donor documentation received from one tissue
> > recovery
> > > > organization. Specifically, the company recalled all lots of product
> > that
> > > > were produced using tissue from Biomedical Tissue Services (BTS).
Life
> > > Cell
> > > > promptly notified the FDA and all relevant hospitals and medical
> > > > professionals. All other BTS inventory remains on hold until the
> > > > discrepancies in the donor documentation can be resolved. LifeCell
> works
> > > > with more than 40 other tissue recovery organizations that are not
> > > affected
> > > > by this recall.
> > > >
> > > >
> > > > The information in this listing reflects CBER's best efforts to
> > > communicate
> > > > information that has been reported to FDA. Its accuracy and
> > > > comprehensiveness cannot be guaranteed.
> > > >
> > > >
> > > >
> > > > Updated October 12, 2005
> > > >
> > > >
> > > >
> > > >
> > > > http://www.fda.gov/cber/recalls/tislife093005.htm
> > > >
> > > >
> > > > Compliance Program
> > > > Inspection of Human Cells, Tissues, and Cellular and Tissue-Based
> > Products
> > > > (HCT/Ps)
> > > > 7341.002
> > > >
> > > >
> > > > http://www.fda.gov/cber/cpg/7341002tis.htm
> > > >
> > > >
> > > >
> > > >
> > > > TSS
> > > >
> > > >
> > > >
> > > > ----- Original Message -----
> > > > From: "Terry S. Singeltary Sr."
> > > > To:
> > > > Sent: Thursday, October 27, 2005 9:55 AM
> > > > Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs
IN
> > THE
> > > > USA
> > > >
> > > >
> > > > ##################### Bovine Spongiform Encephalopathy
> > > #####################
> > > >
> > > > From: TSS ()
> > > > Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs
IN
> > THE
> > > > USA
> > > > Date: October 27, 2005 at 8:40 am PST
> > > >
> > > > WASHINGTON
> > > > FDA investigating human tissue sales
> > > > WASHINGTON - The Food and Drug Administration said Wednesday that it
> is
> > > > investigating a New Jersey-based company that sold human tissue to
> > > > processors for eventual implantation into people, because it may not
> > have
> > > > been properly screened for infections. The New York Daily News
> reported
> > > > earlier this month that the district attorney's office in Brooklyn,
> > N.Y.,
> > > is
> > > > investigating the company, Biomedical Tissue Services of Fort Lee,
> N.J.,
> > > on
> > > > allegations that the company illegally bought body parts from
funeral
> > > homes
> > > > to sell to tissue processors. An FDA spokeswoman would not comment
on
> > > those
> > > > allegations. The tissues include human bones, skin and tendons and
> > > > constitute only a small portion of the U.S. tissue supply, the FDA
> said.
> > > > They were implanted between early 2004 and September 2005. The Blood
> and
> > > > Tissue Center of Central Texas in Austin received some.
> > > >
> > > > http://www.chron.com/cs/CDA/ssistory.mpl/nation/3419112
> > > >
> > > >
> > > > FOR IMMEDIATE RELEASE
> > > > P05-77
> > > > October 26, 2005
> > > > Media Inquiries:
> > > > Julie Zawisza, 301-827-6242
> > > > Consumer Inquiries:
> > > > 888-INFO-FDA
> > > >
> > > >
> > > > FDA Provides Information on Investigation into Human Tissue for
> > > > Transplantation
> > > > The Food and Drug Administration (FDA) is notifying the public of
its
> > > > investigation of human tissue recovered by Biomedical Tissue
Services,
> > > Ltd.
> > > > (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this
> tissue
> > > may
> > > > have been implanted into patients from early 2004 to September 2005.
> The
> > > > tissue was recovered by BTS from human donors who may not have met
FDA
> > > donor
> > > > eligibility requirements and who may not have been properly screened
> for
> > > > certain infectious diseases. At this time, the implicated tissues
from
> > BTS
> > > > include human bone, skin, and tendons. These products represent only
a
> > > small
> > > > percentage of the overall U.S. tissue supply.
> > > >
> > > > While no adverse reactions related to these tissues have been
reported
> > to
> > > > FDA at this time, because of the potential lack of proper screening
of
> > the
> > > > tissue donors, some recipients of the tissues may be at increased
risk
> > of
> > > > infections that could potentially be transmitted through tissues.
FDA
> > and
> > > > the Centers for Disease Control and Prevention (CDC) believe the
risks
> > > from
> > > > these tissues are low because the tissues were routinely processed
> using
> > > > methods that help to reduce the risk of infectious disease; however,
> the
> > > > actual infectious risk is unknown.
> > > >
> > > > FDA's requirements to determine donor eligibility include important
> > steps
> > > to
> > > > ensure that donors do not harbor infections that could be
transmitted
> to
> > > > recipients. These steps include reviewing the donor's medical
history
> > and
> > > > other factors, physically assessing the donor, and testing for
> relevant
> > > > communicable diseases that may place the donor at an increased risk
of
> > > > infections that could then unintentionally be transmitted to
> recipients
> > > > through the tissues.
> > > >
> > > > The following tissue processors received tissue from BTS:
> > > >
> > > > LifeCell Corporation of Branchburg, NJ
> > > > Lost Mountain Tissue Bank of Kennesaw, GA
> > > > Blood and Tissue Center of Central Texas in Austin, TX
> > > > Tutogen Medical, Inc., of Alachua, FL
> > > > Regeneration Technologies, Inc., of Alachua, FL
> > > > These firms already have voluntarily recalled all unused tissue
> > remaining
> > > in
> > > > inventory and are working cooperatively with FDA to ensure that the
> > > > implanting physicians whose patients may have received the products
> are
> > > > properly notified. Physicians who implanted tissue from BTS should
> have
> > > been
> > > > contacted at this time by the receiving health care facility.
> > > >
> > > > FDA and CDC recommend that implanting physicians inform their
patients
> > > that
> > > > they may have received tissue from a donor for whom an adequate
donor
> > > > eligibility determination was not performed. While the overall
> > infectious
> > > > risk is likely low, FDA and CDC recommend that physicians offer to
> > provide
> > > > patients access to appropriate infectious disease testing. The
> relevant
> > > > communicable diseases for which a tissue donor is required to be
> tested
> > > are
> > > > HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus,
> hepatitis
> > C
> > > > virus, and syphilis. Physicians who still have concerns or questions
> > about
> > > > the source of the tissue should contact the health care facility
where
> > the
> > > > procedure was performed. FDA will continue its investigation into
this
> > > > matter and will issue further public health updates, as needed.
> > > >
> > > > Patients and physicians should report any infectious disease
possibly
> > > > related to a tissue transplant to the processing firms, who then
> should
> > > > notify FDA. Patients and physicians who wish to notify FDA directly
of
> > > such
> > > > infectious disease should report via FDA’s MedWatch reporting
program
> at
> > > > http://www.fda.gov/medwatch.
> > > >
> > > > Additional information is available on FDA’s web site at
> > > > http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.
> > > >
> > > > ####
> > > >
> > > >
> > > > http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
> > > >
> > > >
> > > > a bit of history;
> > > >
> > > >
> > > > The Eyes have it/CJD * and they could be stealing them from YOUR
loved
> > > > one, hence the spread of CJD (aka MADCOW DISEASE) will spread...
> > > >
> > > >
> > > > ############ Creutzfeldt-Jakob Disease
> > > > #############
> > > >
> > > > Greetings list members, I was impressed that someone is listening,
> > > > considering the timing of when I broke the story in Nov. and this
was
> > > > posted in Dec., what a coincidence. Thanks for listening. I find it
> > > > rather frightening of the fact sporadic CJD as well as vCJD can
> > > >
> > > > transmit infectivity this way. Makes me wonder about blood?
> > > > Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA
> > > >
> > > > Vol. 282 No. 23, December 15, 1999
> > > > Preventing Prion Transmission in Corneal Transplants
> > > >
> > > >
> > > > http://www.vegsource.com/talk/madcow/messages/7242.html
> > > >
> > > >
> > > > Cadaver corneal transplants -- without family permission
> > > >
> > > > Houston, Texas channel 11 news 28 Nov 99
> > > > Reported by Terry S. Singeltary Sr. son of CJD victim
> > > >
> > > > http://mad-cow.org/~tom/dec99_news.html#bbb
> > > >
> > > >
> > > > VOL. 282 No. 23, December 15, 1999
> > > >
> > > > Preventing Prion Transmission in Corneal Transplants
> > > >
> > > > To the Editor: We agree with the Council on Scientific Affairs'
> > > > recommendation that "physicians become knowledgeable about BSE
[bovine
> > > > spongiform encephalopathy] so they can appropriately advise their
> > patients
> > > > about routes and rates of BSE transmission."1 Unfortunately, there
is
> > only
> > > > passing mention of prion transmission by corneal transplantation,
> which
> > is
> > > > performed on 40,000 to 50,000 patients each year in the United
> States.2
> > In
> > > > addition to the 1974 US case,3 2 additional cases of probable and
> > possible
> > > > transmission, respectively, have been reported in Germany and
Japan,3
> > but
> > > > the major new concern relative to prion transmission via corneas
> > occurred
> > > > recently in Great Britain. In February 1997, the corneal transplant
> and
> > > > sclera from a 53-year-old woman who had died of presumed metastatic
> lung
> > > > cancer were transplanted to 3 recipients.4 In November 1997, the
> donor's
> > > > brain revealed sporadic Creutzfeldt-Jakob disease (CJD), confirmed
by
> > the
> > > > United Kingdom CJD Surveillance Unit.4 . . . [Full Text of this
> Article]
> > > >
> > > >
> > > >
> > >
> >
>
http://jama.ama-assn.org/cgi/content/extract/282/23/2211?maxtoshow=&HITS=10&
> > > >
> > >
> >
>
hits=10&RESULTFORMAT=&fulltext=CJD+EYE&searchid=1130425573446_2695&stored_se
> > > > arch=&FIRSTINDEX=0&journalcode=jama
> > > >
> > > >
> > > > http://www.vegsource.com/talk/madcow/messages/7643.html
> > > >
> > > >
> > > > http://www.vegsource.com/talk/madcow/messages/7708.html
> > > >
> > > >
> > > > VVOL
> > > >
> > > > http://mad-cow.org/~tom/dec99_news.html#bbb
> > > >
> > > >
> > > > Testimony of Bess Believeaux, Lions Eye Bank of Central Texas
> > > > (Submission to the Jan. 18/19 meeting of the TSE Advisory Committee)
> > > >
> > > >
> > > > http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_16.pdf
> > > >
> > > >
> > > > TSS Submission to the same Committee;
> > > >
> > > >
> > > > http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
> > > >
> > > >
> > > > Tissue Banks International (TBI), Gerald J Cole
> > > >
> > > >
> > > > http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf
> > > >
> > > >
> > > > re-use contact lenses
> > > >
> > > >
> > > > http://www.vegsource.com/talk/madcow/messages/7691.html
> > > >
> > > >
> > > > TSS
> > > >
> > > >
> > > > Link: Reported by Terry S. Singeltary Sr. son of CJD victim 28 Nov
99
> > THE
> > > > EYES HAVE IT, CJD...
>
> http://www.mad-cow.org/dec99_news.html#bbb
>
>
> > > >
> > > >
> > > > #################### https://lists.aegee.org/bse-l.html
> > > ####################
> > > >
> > > > #################### https://lists.aegee.org/bse-l.html
> > > ####################
> > >
> > > #################### https://lists.aegee.org/bse-l.html
> > ####################
> > >
> >
> > #################### https://lists.aegee.org/bse-l.html
> ####################
> >
>




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