JANUARY 2006
WEEK ENDING JANUARY 7
PRODUCT Red Blood Cells
CODE
Unit numbers: 6863817, 6863820
RECALLING
FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ,
REASON
Blood products, which tested initially reactive
for an infectious disease were repeat tested in duplicate on an invalidated test
run, and were not retested on a subsequent run, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ
PRODUCT Source Plasma
CODE
Unit numbers: 01630992, 01628135, 01616422,
01613384, 01608991, 01606386, 01620975
RECALLING
FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Service, LP, Van
Nuys, CA
Manufacturer: ZLB Plasma Services, Columbia, SC.
REASON
Blood products that tested negative for
antibodies to the human immunodeficiency virus (anti-HIV-1/2), but were
collected from a donor that subsequently tested positive for anti-HIV-1/2, were
not properly quarantined, and were distributed.
VOLUME OF PRODUCT IN
COMMERCE 7 units
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Unit number: 7030260750
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., San Antonio, TX
REASON Blood product, which was collected from a donor who was
deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Source Plasma
CODE
Unit numbers: 0150012788 and
0150013147
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Kalamazoo, MI
REASON
Blood products, collected from an ineligible donor
who had been permanently deferred due to exchanging sex for money, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION Spain
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
c) Red Blood Cells, Leukocytes Reduced,
Irradiated
d) Platelets
e) Platelets, Leukocytes
Reduced,
f) Fresh Frozen Plasma
CODE
a) Unit number: 17KK08653;
b) Unit numbers: 17KM49180,
17FR15101, 17GM42739, 17KQ43514, 17KQ38249;
c) Unit number:
17KM42040;
d) Unit numbers: 17KK08653, 17KP52866;
e) Unit numbers:
17GM42739, 17KM42040, 17KQ43514, 17KQ38249, 17Q31127, 17KM49180;
f) Unit
numbers: 17KM49180, 17KQ38249
RECALLING FIRM/MANUFACTURER American
National Red Cross, North Central Region, Saint Paul, MN
REASON Blood products,
which tested negative for the antibody to the human immunodeficiency virus, but
were collected from a donor who previously tested reactive for the antibody,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 17
units
DISTRIBUTION MN, MA, SD, IA, and MO
PRODUCT Platelets
CODE
Unit number: 2109787
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Recovered Plasma
CODE
a) Unit number: 06FR39967;
b) Unit numbers:
06FR37676, 06FR39967
RECALLING FIRM/MANUFACTURER American National
Red Cross, Southern California Region, Pomona, California
REASON Blood
products, collected from a donor who was at increased risk of variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CA and Switzerland
PRODUCT
a) Red Blood Cells
b)
Platelets
CODE a) and
b) Unit numbers: 6723768
RECALLING FIRM/MANUFACTURER LifeShare
Community Blood Services, Elyria, OH
REASON Blood products, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Red Blood Cells
CODE
Unit number: 0120622
RECALLING
FIRM/MANUFACTURER LifeShare Community Blood Services, Elyria, OH
REASON
Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells
c)
Platelets
CODE a) and
b) Unit numbers: 0603349
RECALLING FIRM/MANUFACTURER LifeShare
Community Blood Services, Elyria, OH
REASON Blood products, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
007GE24478
RECALLING FIRM/MANUFACTURER American National Red Cross,
Arizona Region, Tucson, AZ
REASON Red Cells,
collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AZ
PRODUCT Red Blood Cells (Apheresis)
CODE
Unit number:
FL20909
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON
Red Cells, lacking appropriate quality control
documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 157407254
-- split unit
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock Center, Lubbock, TX
REASON Platelets, possible contaminated with
microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
216646
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY
REASON Red Cells, possibly contaminated with
microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
0649979
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, for which there was no documentation of weld
acceptability for the sterile docking of the filter, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 0653551,
0659554
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood products, for which there was no
documentation of weld acceptability for the sterile docking of the filter, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 0650067,
0657598, 0650086, 0659625, 0654485
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood
products, for which there was no documentation of weld acceptability for the
sterile docking of the filter, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5 units
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells For
Further Manufacture
b) Recovered Plasma,
CODE
a) Unit number: 17KP52866;
b) Unit numbers:
17FR15101, 17KM42040, 17KQ43514, 17KK08653, 17Q31127, 17GM42739,
17KP52866
RECALLING FIRM/MANUFACTURER American National Red
Cross, North Central Region, Saint Paul, MN
REASON Blood products, which
tested negative for the antibody to the human immunodeficiency virus, but were
collected from a donor who previously tested reactive for the antibody, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION CA, and France
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 07GJ13519,
07GJ13526, 07FH33976, 07FN47847
RECALLING
FIRM/MANUFACTURER American National Red Cross, Arizona Region, Tucson, AZ
REASON
Red Cells, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION AZ and CA
WEEK ENDING JANUARY 14
PRODUCT
a) Red Blood Cells
b)
Platelets
CODE a) and
b) Unit number: 0119589
RECALLING FIRM/MANUFACTURER LifeShare
Community Blood Services, Elyria, OH
REASON Blood products, associated
with a unit of Fresh Frozen Plasma that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit number:
21KL69575;
b) Unit numbers: 21KP55627 (split unit), 21KP53522,
21KP51485
RECALLING FIRM/MANUFACTURER American National Red Cross,
Pacific Northwest Region, Portland, OR
REASON Blood products, collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION OR
WEEK ENDING JANUARY 21
PRODUCT
Human Tissue for
Transplantation
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
Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ.
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,
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
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U00000000043581 U00000000043720 U00000000043721 U00000000043722 U00000000043723
U00000000043724 U00000000043725 U00000000043726 U00000000043727 U00000000043728
U00000000043729 U00000000043730 U00000000043772 U00000000043773 U00000000043774
U00000000043775 U00000000043776 U00000000043777 U00000000043778 U00000000043779
U00000000043780 U00000000043781 U00000000043879 U00000000043880 U00000000043881
U00000000043882 U00000000043883 U00000000043884 U00000000043885 U00000000043886
U00000000043887 U00000000043888 U00000000043889 U00000000043890 U00000000043891
U00000000043892 U00000000043893 U00000000044013 U00000000044014 U00000000044015
U00000000044016 U00000000044017 U00000000044018 U00000000044019 U00000000044020
U00000000044021 U00000000044022 U00000000044023 U00000000044024 U00000000044025
U00000000044026 U00000000044027 U00000000044028 U00000000044029 U00000000044030
U00000000044031 U00000000044032 U00000000044033 U00000000044034 U00000000044035
U00000000045167 U00000000045168 U00000000045169 U00000000045170 U00000000045171
U00000000045172 U00000000045173 U00000000045178 U00000000045179 U00000000045180
U00000000045181 U00000000045278 U00000000045279 U00000000045280 U00000000045281
U00000000045282 U00000000045283 U00000000045284 U00000000045285 U00000000045286
U00000000045287 U00000000045288 U00000000045289 U00000000045290 U00000000045291
U00000000045292 U00000000045358 U00000000045359 U00000000045360 U00000000045361
U00000000045362 U00000000045363 U00000000045364 U00000000045365 U00000000045366
U00000000045367 U00000000045856 U00000000045857 U00000000045858 U00000000045859
U00000000045860 U00000000045861 U00000000045862 U00000000045863 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
Responsible Firm: Biomedical Tissue Services, Ltd., Fort
Lee, NJ.
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
PRODUCT Plasma, Frozen
CODE Unit number: 03KK29245
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Source Plasma
CODE
Unit numbers: 0150062399, 0150062621, 0150063028,
0150063270, 0150063839, and 0150066870
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., Kalamazoo, MI
REASON Blood products, which were collected from a donor
who had engaged in multiple high risk behavior activities, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION Spain
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers:
12KJ15689, 12KJ12263 (split unit), 12KJ12604 (split unit), 12KJ12971 (split
unit), 12KJ13665 (split unit), 12KJ13997 (split unit), 12KJ14353 (split unit),
12KJ14705, 12KJ15362, 12KJ16047 (split unit)
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 17
units
DISTRIBUTION AL, GA, NC, and SC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
03KK29476, 03KK28606, 03KK27395, 03KK26550
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood products, collected from a donor who had
lived in an area designated as endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA
PRODUCT Red Blood Cells
CODE
Unit number: T18289
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Traverse City, MI
REASON
Blood products, collected from an ineligible donor
due to a history of surgery and travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI and Switzerland
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes
Reduced,
c) Red Blood Cells, Leukocytes Reduced, Irradiated,
d) Fresh Frozen Plasma,
CODE
a) Unit number: 03LN26561;
b) Unit numbers: 03LN26555,
03LN26556, 03LN26558, 03LN26559, 03LN26562, 03LN26563, 03LN26564,
03LN26565, 03LN26566, 03LN26567;
c) Unit number: 03LN26568
d) Unit
numbers: 03LN26558, 03LN26562, 03LN26563, 03LN26564,
03LN26566
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood products,
in which the sample tubes for viral marker testing were not maintained at an
appropriate temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 17 units
DISTRIBUTION GA
PRODUCT Cryoprecipitated AHF
CODE
Unit numbers: 411295, 413945,
419940
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, OH
REASON Blood products, which were not refrozen
within one hour of preparation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 03GW32329,
03GW31195, 03GW30161
RECALLING FIRM/MANUFACTURER American National
Red Cross, Southern Region, Atlanta, GA
REASON Blood products, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT Recovered Plasma
CODE
Unit number: 03GH60796
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood product, collected from an ineligible donor
due to a history of Multiple Sclerosis, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
03LS21901, 03LS21903, 03LS21904, 03LS21905, 03LS21908, 03LS21907, 03LS21909,
03LS21910, 03LS21911, 03LS21912
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood products, prepared from units of Whole Blood
that exceeded the manufacturer’s specification for volume, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION GA, and SC
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
2186850
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Lexington, KY
REASON Platelets, which were possibly contaminated with
coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit number:
12F45910;
b) Unit number: 12W00161 (Parts 1 &
2), 12W01634
RECALLING FIRM/MANUFACTURER American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood products, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NC and SC
PRODUCT Red Blood Cells
CODE
Unit number: 6969679
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ
REASON
Blood product, associated with a unit of Fresh
Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
CODE
Unit number: 6734380
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ
REASON
Blood product, associated with a unit of Fresh
Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
CODE
Unit number: 6973284
RECALLING
FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ
REASON
Blood product, associated with a unit of Fresh
Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cell,
Leukocytes Reduced, Irradiated
b) Platelets, Irradiated
CODE a) and b) Unit number:
R172781
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget
Sound Blood Center and Program, Seattle, WA
Manufacturer: Puget Sound Blood Center and Program, Everett, WA.
REASON
Blood products, collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION WA
PRODUCT Red Blood Cells
CODE
Unit number: M164785
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and
Program, Seattle, WA
Manufacturer:
Puget Sound Blood Center and Program, Bellevue, WA. .
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Source Plasma
CODE
Unit numbers: 96476468, 96446409, 96442524,
96434659, 96427767, 96422007, 96406779, 96401330, 96396780, 96390481, 96386026,
96380253, 96375051, 96369227, 96362051, 96356395, 96350935, 96345382, 96341711,
96335260, 96327234, 96324493, 96315804, 96312490, 96305614, 96302835, 96290743,
96281314, 96278093
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc.,
Gresham, OR
REASON Blood products, collected from a donor who was
previously deferred for high-risk behavior, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 29 units
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Unit numbers: 66183792, 66168348, 66156048,
66149699, 66145295, 66137788, 66134992, 66128816, 66123408, 66119388, 66096412,
66093220, 66083832, 66079835, 66074014, 66069362, 66058069, 66047902, 66041665,
66030096, 66025320, 66020530, 66015161, 66010432, 65995426, 65990452, 65985830,
65981511, 65972922, 65964897, 65958094, 65950012, 65943915, 65930724, 65927618,
65921944, 65916995, 65911228, 66054894
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Gresham, OR
REASON Blood
products, collected from a donor who was previously deferred for high-risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 39
units
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Unit numbers: 81466702, 81459483, 81445448,
81439959, 81422128, 81410118, 81357802, 81353163, 81345878, 81340149, 81326952,
81322374, 66157533, 66144755, 66131274, 66127932, 66121442, 66117469, 66112969,
66106678, 66103509, 66079019, 66076100, 66058274, 66053101
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Gresham, OR
REASON Blood products,
collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 25
units
DISTRIBUTION CA
PRODUCT Source Plasma
CODE
Unit numbers: 11801535, 83991813, 83988547,
83982477, 83980756, 83908316, 83905391, 83902703, 83900075, 83897450, 83895159,
83891267, 83889448, 83885846, 83884566, 83880315, 83868740, 83864896, 83858949,
83857218, 83853241, 83847738, 83846083, 83841897, 83839795, 83835476, 83829185,
83827709, 83822933, 83821325, 83816857, 83812798, 83796487, 83792557, 83790867,
83786402, 83781322, 83778124, 83774867, 83771798, 83768644, 83765988, 83763144,
83759994, 83756856, 83753381, 83750250, 83747175, 83743863, 83741104, 83737725,
83731129, 83723513, 65460283, 65458006, 65452868, 65449752, 65445846, 65443286,
65440063, 65437537, 65434437, 65420621, 65419496, 65414361, 65409947, 65407134,
65402191, 65400593, 65395912, 65394069, 65389324, 65387740, 65383629, 65379288,
65374955, 65370858, 65366929, 65364895, 65359167, 65277805, 65274934, 65271544,
65268100, 65261286, 65254394, 65247617, 65245903, 65241356, 65238790, 65233764,
65230534, 65226797, 65223413, 65220139, 65215968, 65208625, 65206577, 65201947,
52554841, 52551765, 52548765, 52545795, 52542367, 52538711, 52535772, 52532917,
52529573, 52526213, 52521522, 52520297
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Spokane, WA
REASON Blood
products, collected from a donor who was previously deferred for high-risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 111
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
E165768
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and
Program, Seattle, WA
REASON Blood product, collected from an unsuitable
donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells
CODE
Unit number: F150894
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center and Program, Seattle, WA
REASON
Blood
product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
FG74677
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank,
Heartland Blood Center, Aurora, IL
REASON Blood product, collected from
an unsuitable donor based on travel to an area considered endemic for malaria,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit number: 4101212
RECALLING
FIRM/MANUFACTURER Northwest Florida Blood Center, Inc., Pensacola, FL
REASON
Blood products, collected from an unsuitable donor
due to a history of travel to an area considered at increased risk of exposure
to variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
84Q78767
RECALLING FIRM/MANUFACTURER American National Red Cross,
Northern California Region, Oakland, CA
REASON Blood product, collected from
an ineligible donor due to a history of Multiple Sclerosis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: Y68733,
Y68736, Y68731
RECALLING FIRM/MANUFACTURER Blood Bank of San
Bernardino and Riverside Counties, San Bernardino, CA
REASON Blood products,
labeled with an incorrect expiration date, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
17KR79235
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN
REASON Blood product, collected from
a donor who reported travel to an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Source Plasma
CODE
Unit number: 05DILB9885
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., DeKalb, IL
REASON Blood product, not properly quarantined after the
receipt of post donation information related to a recent tattoo, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 6532971
(split unit)
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc.,
Lakeland, FL
REASON Platelets, which were possibly contaminated with
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Platelets, Leukocytes
Reduced
CODE Unit number:
17KS13595
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN
REASON Blood product, corresponding to a unit
of red cells that was possibly contaminated with gram positive cocci, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
26924-2828
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort
Smith, AR
REASON Blood product, collected from a donor who did not
have a complete medical history interview, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Source Plasma
CODE
Unit numbers: 05HPAA3351, 05HPAA3148, 05HPAA2986,
05HPAA2765, 05HPAA2584, 05HPAA2206, 05HPAA1946, 05HPAA1772, SH041111, SH040835,
SH040652, SH039894, SH039691, SH039395, SH040441, SH038942, SH038756, SH038520,
SH038305, SH038008, SH037795, SH037400, SH036818, SH036618
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services, L.P., Harrisburg, PA
REASON
Blood products, collected from a donor for whom
post donation information was provided regarding multiple high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION NY, PA, and France
PRODUCT
a) Platelets, Leukocytes
Reduced,
b) Plasma, Frozen
CODE a) and b) Unit number: 17KV37011
RECALLING
FIRM/MANUFACTURER American National Red Cross, North Central Region, St.
Paul, MN
REASON Blood products, corresponding to a unit of red
cells that was possibly contaminated with Staphylococcus species and implicated
in an adverse transfusion reaction, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MA and MN
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
4906429
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc.,
Orlando, FL
REASON Platelets, which were possibly contaminated with
Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis
CODE
Unit number: 4079180 (split
unit)
RECALLING FIRM/MANUFACTURER Northwest Florida Blood Center,
Inc., Pensacola, FL
REASON Platelets, which were possibly contaminated with
Group B Streptococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
1310505
RECALLING FIRM/MANUFACTURER LifeShare Community Blood
Service, Elyria, OH
REASON Blood product, associated with a unit of Platelets
that was possibly contaminated with coagulase negative Staphylococcus, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
042M15772, 042M15773, 042M15774, 042M15775, 042F61251, 042FG13941, 042FG13942,
042FG13943, 042FG13944, 042FG13945, 042FG13946, 042FX40820, 42FX40822,
042FX40823, 042GC13986, 042GC13987, 042GC13988, 042FX40821
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern
Ohio Region
REASON Blood products, which may have had a
post-filtration hematocrit of greater than 80%, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION OH
PRODUCT Recovered Plasma
CODE
Unit number: T18289
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Traverse City, MI
REASON
Blood products, collected from an ineligible donor
due to a history of surgery and travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
2102131
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY
REASON Blood product, manufactured without the entire
quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Platelets
CODE
Unit number: 431060
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Platelets, which may not have been stored under
continuous agitation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Platelets
CODE
Unit numbers: 0479158, 0479161,
0479164
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Platelets, which may not have been
stored under continuous agitation and controlled temperature, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
03LX21668, 03LS17957
RECALLING FIRM/MANUFACTURER American National
Red Cross, Southern Region, Atlanta, GA
REASON Blood products, which had a
post-filtration hematocrit of greater than 80%, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
03FQ23600, 03FQ23825, 03GG91527, 03GW27967, 03KY15784, 03LG19809
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON
Blood products, which had a post-filtration
hematocrit of greater than 80%, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced
b) Platelets Pheresis,
Leukocytes Reduced
CODE a) and b) Unit
number: 2184221
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Blood products, which were possibly contaminated
with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION KY
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 2170531
(Parts A & B)
RECALLING FIRM/MANUFACTURER Central Kentucky
Blood Center, Lexington, KY
REASON Blood products, which were possibly
contaminated with Propionibacterium acnes, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit
numbers: 22KG87846 (Parts 1 & 2)
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON Blood products, which may have been contaminated
with Bacillus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION PA
\PRODUCT
a) Red Blood Cells,
Pheresis,
\b) Platelets Pheresis, Leukocytes Reduced
CODE a) and b) Unit number:
E27890
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank,
Inc., Rockford, IL
REASON Blood products, which were possibly contaminated
with Staphylococcus auricularis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION IL and NY
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 03LQ19421
(part 1) and 03LQ19855 (part 1)
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Southern Region, Atlanta, GA
REASON Blood products, stored at an incorrect
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Fresh Frozen Plasma
CODE
Unit number: L28502
RECALLING
FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Tacoma, WA
REASON
Blood product, collected from an ineligible donor
due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
40GR77399
RECALLING FIRM/MANUFACTURER American National Red Cross,
Heart of America, Peoria, IL
REASON Blood
product, collected from a donor that did not answer one of the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers:
26729-8539 (split unit), 26729-8538 (split unit)
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR
REASON Blood
products, which failed to meet the minimum specification for red blood cell
recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION AR
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
8707608
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc.,
Orlando, FL
REASON Blood product, which was not properly quarantined
after the receipt of post donation information related to a recent human tissue
transplant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Recovered Plasma
CODE
Unit number: 2297968
RECALLING
FIRM/MANUFACTURER Inland Northwest Blood Center, Spokane, WA
REASON
Blood product, collected from a donor for whom
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria
WEEK ENDING JANUARY 28
PRODUCT Platelet Pheresis
Leukocytes Reduced
CODE Unit number: 9341120
RECALLING FIRM/MANUFACTURER New York Blood Center Inc., New York, NY.
REASON
Blood product, with platelet
yield below the specified minimum requirement, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY
PRODUCT Platelet Pheresis
Leukocytes Reduced
CODE Unit numbers: 04FP76149
Part 1, 04FP76149 Part 2
RECALLING FIRM/MANUFACTURER The American
National Red Cross, New England Region, Dedham, MA
REASON Blood products, possible contaminated with Bordetella holmseii, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION MA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number: 71X176072
(Part 3)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Gainesville, FL
REASON Blood product, which yielded a platelet count
that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
6462085
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc.,
Orlando, FL
REASON Blood product, which yielded a platelet count that
was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit numbers: 3928969
(Parts B & C)
RECALLING FIRM/MANUFACTURER Florida's Blood
Centers, Inc., Orlando, FL
REASON Blood products, which yielded a
platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Source Plasma
CODE
Unit numbers: LF262809, LF262583, LF254714, LF253848,
LF246294, LF245766
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services, L.P., Lakeland, FL
REASON Blood products, collected from a donor
who provided post donation information regarding multiple high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION NC
PRODUCT Platelets, Leukocytes
Reduced
CODE Unit number:
17FG33974
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN
REASON Blood product, associated
with an air-contaminated red cell unit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MN
PRODUCT Red Blood Cells
CODE
Unit number: GN24831
RECALLING
FIRM/MANUFACTURER American National Red Cross, Northern California
Region, Oakland, CA
REASON Blood product, collected from an ineligible donor
due to a history of rheumatoid arthritis and use of the medications Methotrexate
and Plaquenil, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells
CODE
Unit number: B311422
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center,
Seattle, WA
Manufacturer: Puget
Sound Blood Center, Bellevue, WA.
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells
CODE
Unit number: E168494
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center,
Seattle, WA
Manufacturer: Puget
Sound Blood Center, Seattle, WA.
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells
Leukocytes Reduced, Recall # B-0518-6
CODE Unit number:
2141795
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center
Inc., Lexington, KY
REASON Blood product, collected from a donor who visited
a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 03E39789
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood product, collected from a donor
who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood Cells
Leukocytes
CODE Unit numbers: 6960593,
6957583
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TN and MS
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
6919182
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 280987
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 574766
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, collected from a donor who had a
tattoo applied within twelve months of donating, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells
Leukocyte Reduced,
b) Recovered Plasma
CODE a) and b) unit number: 12GN74153
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood products, collected from a donor with a
history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA and NC
PRODUCT Red Blood Cells
CODE
Unit numbers: 785862 and 838711
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which tested negative for the
antibody to hepatitis B core antigen (anti-HBc) but were collected from a donor
who tested repeatedly reactive for anti-HBc on two separate occasions, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
R36391
RECALLING FIRM/MANUFACTURER South Bend Medical Foundation,
Inc., South Bend, IN
REASON Blood product, which was collected from a donor in
which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT
a) Red Blood Cells
b) Cryoprecipitated
AHF
c) Plasma,
Cryoprecipitate Reduced,
d) Platelets
e) Fresh Frozen Plasma
CODE
a) b)
and c) Unit number: KJ49752;
d) and e) Unit number: FS50178
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood
products, collected from a donor who provided post donation information
regarding multiple high-risk behaviors, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 units
DISTRIBUTION OH and PA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated
CODE Unit number:
04G72553
RECALLING FIRM/MANUFACTURER American National Red Cross,
New England Region, Dedham, MA
REASON Blood product, which was
incorrectly labeled as having been irradiated, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
30659-2677
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected from a donor
for which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION ND
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
Y83281
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and
Riverside Counties, San Bernardino, CA
REASON Blood product, collected in a
manner that may compromise the sterility of the product, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
23148-7953
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Billings, MT.
REASON
Blood products, collected from a donor
for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WY
PRODUCT Red Blood Cells
CODE
Unit number: 4426304
RECALLING
FIRM/MANUFACTURER Florida's Blood Center, Inc., St. Petersburg, FL
REASON
Blood product, collected from a donor who may have
been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Red blood Cells
Leukocytes Reduced,
b) Cryoprecipitated AHF, Pooled,
CODE a) and b) Unit number: 16GR13839
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Central Ohio Region, Columbus, OH
REASON Blood products, collected from a donor
with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH and MD
PRODUCT Platelet Pheresis
Leukocyte Reduced Irradiated
CODE Unit number:
16KF49020
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Central Ohio Region, Columbus, OH
REASON Blood product, labeled as leukoreduced but not
tested for white blood cell (WBC) count as required, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells (Apheresis) Leukocytes
Reduced
CODE Unit
number: 16KQ00310
RECALLING FIRM/MANUFACTURER The American National
Red Cross, Central Ohio Region, Columbus, OH
REASON Blood product, with an
unacceptably low red cell recovery rate, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
084FT43562
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern California Region, Oakland, CA
REASON Blood product,
which may have been manufactured from a unit of whole blood more than eight
hours after collection, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Recovered Plasma
CODE
Unit number: 23148-7953
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood
Systems, Inc., Billings, MT.
REASON Blood products, collected from a donor for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT Whole Blood
CODE
Unit number: 84K22028
RECALLING
FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross,
Northern California Region, Oakland, CA
Manufacturer: The American National Red Cross, San Jose, CA.
REASON
Blood product, collected in an
expired collection bag, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA