OCTOBER 2002
WEEK ENDING OCTOBER 5, 2002
PRODUCT
Source Plasma.
CODE Unit G48509-076.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los
Angeles, CA.
Manufacturer: Alpha Therapeutic Corporation, Fayetteville, NC.
REASON Blood product, collected under conditions in which sterility may have
been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen; d) Recovered Plasma.
CODE a) Units 1396250, 1396251, 1396252, 1396253, 1396254, 1396255, 1396256,
1396258, 1396260, 1396261, 1396262, 1396263, 1396264, 1396266, 1396267,
1396268, 1396269, 1396270, 1396272, 1396273, 1396274, 1396275, 1396276,
1396277, 1396278, 1396279, 1396280, 1396281, 1396282, 1396283, 1396286,
1396287, 1396288, 1396289, 1396290, 1396291, 1396295, 1396296, 1396297,
1396299, 1396300, 1396301, 5108316, 5108317, 5108318, 5108319, 5108320,
5108321, 5108322, 5108323, 5108324, 5108325, 5108326, 5108327, 5108328,
5108329, 5108330, 5108331, 5108332, 5108333, 5108334, 5108335, 5108336,
5108337, 5108338, 5108339, 5108340, 5108341, 5108342, 5108343, 5108344,
5108345, 5108346, 5108347, 5108348, 5108349, 5108350, 5108351, 5108352,
5108354, 5108355, 5108356, 5108357, 5108358, 5108359, 5108360, 5108361,
5108362, 5108363, 5108364, 5108365, 5108366, 5108367, 5108368;
b) Units 5108320, 5108323, 5108324, 5108326, 5108328, 5108331, 5108336,
5108340, 5108342, 5108344, 5108348, 5108363, 5108365;
c) Units 5108316, 5108317, 5108319, 5108320, 5108321, 5108324, 5108326,
5108328, 5108329, 5108330, 5108331, 5108332, 5108333, 5108335, 5108336,
5108338, 5108340, 5108342, 5108344, 5108345, 5108347, 5108348, 5108349,
5108350, 5108351, 5108352, 5108354, 5108355, 5108357, 5108359, 5108361,
5108362, 5108363, 5108364, 5108365, 5108366, 5108367, 5108368, 5108334;
d) Units 1396250, 1396251, 1396252, 1396253, 1396254, 1396255, 1396256,
1396258, 1396259, 1396260, 1396261, 1396262, 1396263, 1396264, 1396266,
1396267, 1396268, 1396269, 1396270, 1396272, 1396273, 1396274, 1396275,
1396276, 1396277, 1396278, 1396279, 1396280, 1396281, 1396282, 1396283,
1396285, 1396286, 1396288, 1396289, 1396290, 1396291, 1396295, 1396296,
1396297, 1396299, 1396300, 1396301, 5108323, 5108339, 5108343, 5108346,
5108360.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX
REASON
Blood products, incorrectly tested for antibody to the human immunodeficiency
virus (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 94 units; b) 13 units; c) 39 units; d) 48
units.
DISTRIBUTION TX, IL, FL and NY.
PRODUCT
a) Red Blood Cells; b) Platelets; c)
Fresh Frozen Plasma;
CODE a) and c) Unit 22LY41039, 22LW28926, 22LJ25952, 22FQ25666; b) Units
22LJ25952, 22FQ25666.
RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON
Blood products, collected from a donor who provided post donation information
regarding having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION PA and NJ.
PRODUCT
a) Red Blood Cells; b) Red Blood Cells Leukocytes Removed; c) Fresh Frozen
Plasma; d) Plasma; e) Cryoprecipitated AHF;
f) Recovered Plasma
CODE
a) and c) Unit 30GG94854; b) Units 30GH75705, 30GN42595, 30GN33180, 30GW08370,
and 30GH61013; d) unit 30GN42595; e)
units 30GH75707, 30GN42595, 30GN33180, and 30GW08370; f) units 30GH75705,
30GN37242, 30GN33180, 30GW08370, 30GH61013.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern
Pennsylvania Region, Ashley, PA
REASON
Blood products, which were collected from a donor who had taken the medication
Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION PA, NY, MA and Switzerland.
PRODUCT
Source Plasma.
CODE Unit 71FPBBXM.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose arm preparation was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
Source Plasma.
CODE Unit (1 unit) 71 96D669.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose arm preparation was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
Source Plasma
CODE
Unit 71 FPCBYT.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose arm preparation was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma.
CODE Unit 71 FPCBQF.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, which was not tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma
CODE Units 71 96D210, 71 96D173, 71 96D005, 71 96C982.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Switzerland.
PRODUCT
Source Plasma.
CODE Units 71 FPBGFR, 71 FPBGCR, 71 FPBGBB, 71 FPBFYC, 71 FPBFXB.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION Germany.
PRODUCT
Source Plasma
CODE Unit 71 FPBMVS.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose arm preparation was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Corneas.
CODE Tissue numbers 02-0968 OD and 02-0968 OS.
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA
REASON
Human tissue for transplantation, that tested repeatedly reactive for
antibodies to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Japan.
PRODUCT
Source Plasma
CODE Unit numbers 71FPCGQJ, 71FPCGCF, 71FPCFYF, 71FPCFSH, 71FPCFMV, 71FPCFJS,
71FPCFBY, 71FPCDLT, 71FPCDFX, 71FPCCZG, 71FPCCNN, 71FPCCJH, 71FPCCCB, 71FPCBWZ,
71FPCBLZ, 71FPCBJK, 7196G664, and 7197F760.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, that tested negative for viral markers, but were
collected from a donor who disclosed a risk factor for increased incidence of
infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION IL, NC, MA and Germany.
PRODUCT
Source Plasma.
CODE Unit numbers 71FPBHKR, 71FPBHHQ, 71FPBHFL, 71FPBHCZ, 71FPBHBR, 71FPBGZC,
71FPBGVJ, 71FPBGRK, 71FPBGPJ, 71FPBGMT, 71FPBGKY, 71FPBGJM, 71FPBGCW, 71FPBGCC,
71FPBFYP, 71FPBFXH, 71FPBFVW, 71FPBFVC, 7196J034, 7196J080, 7196J211, 7196J291,
7196J344, 7196J356, 7196J457, 7196J493, 7196J505, 7196J884, 7196J966, 7196J536,
7196J549, 7196J580, 7196J596, 7196J638, 7196J650, 7196J676, 7196J690, 7186J724,
7196J741, 7196J777, 7196J791, 7196J825, 7196J838, 7196J875, 7196J912, 7196J934,
7196J983, 7196K012, 7196K026, 7196K052, 7196K069, 7196K101, 7196K114, 71FPBFLV,
71FPBFMX, 71FPBFPP, 71FPBFQH, and 71FPBFRV.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA2.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 58 units.
DISTRIBUTION IL, NC, Switzerland and Germany.
PRODUCT
Source Plasma.
CODE Unit numbers G51468-178, G51263-178, G50939-178, G50755-178, G50203-178,
G49124-178, G48693-178, G48493-178, G42443-178, G41953-178, G41752-178,
G40158-178, G39770-178, G39555-178, G38986-178, G37271-178, G37066-178,
G36700-178, G36486-178, G36109-178, G35738-178, G35284-178, G34529-178,
G34243-178, G34028-178, G33719-178, G33426-178, G32971-178, G32778-178,
G31798-178, G31529-178, G31236-178, G30955-178, G30663-178, G30394-178,
G30162-178, G29817-178, G28736-178, G28636-178, G27783-178, G27449-178,
G27265-178, G26655-178, G26846-178, G26104-178, G25947-178, G25592-178,
G25422-178, G25055-178, G24834-178, G24493-178, G24359-178, G23904-178,
G23744-178, G23392-178, G23214-178, G22852-178, G22659-178, G21514-178,
G21394-178, G21011-178, G20842-178, N-06491-178, and N-06476-178.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Melrose Park, IL.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 64 units.
DISTRIBUTION CA.
PRODUCT
Source Plasma.
CODE Unit numbers DDCLYK-A, DDCLST-A, DDCLMS-A, DDCLHT-A, DDCKRN-A, DDCKNH-A,
DDCKDG-A, DDCJZQ-A, DDBMCG-A, DDBLRD-A, DDBLNC-A, DDBLGT-A, DDBKZX-A, DDBKSQ-A,
DDBKNF-A, DDBKGY-A, DDBKCX-A, DDBJVL-A, DDBJRZ-A, DDBJMC-A, DDBJKB-A, DDBDYG-A,
DDBDVC-A, DDBDNW-A, and DDBDLG-A.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Melrose Park, IL.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to illegal drug use, weredistributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells
CODE Unit number KC06511.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood product, collected from a donor that did not have a hematocrit or
hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 10732-0373, 10732-0396, and 10732-0411.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
REASON Blood products, that were not tested for pH or platelet count as
required by the firm's standard operating procedures (SOPs), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AZ.
PRODUCT
Platelets Pheresis
CODE Unit number 07FP14357.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region,
Tucson, AZ
REASON Platelets with an elevated platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT
Platelets, Leukoreduced.
CODE Unit 22LJ49273.
RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON Blood product, which was not properly quarantined after the donor of the
product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
Source Plasma.
CODE Unit number 71FPBMQM.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose health history screening was
not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma
CODE Unit number 71FPBMNZ.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose health history screening was
not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma.
CODE Unit number 71FPCCHJ.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose health history screening was
not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma.
CODE Unit number 71FPBMWB.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose health history screening was
not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma
CODE Unit number G-92240-046.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA.
REASON Blood product, collected from a donor whose arm inspection was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 10728-7559 and 10728-4792.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
REASON Blood products possibly exposed to unacceptable shipping temperatures
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 10729-7307; 10729-7318; 10729-7319; 10729-7343; 10730-1518;
10730-1991; 10730-1992; 10730-2512; 10730-3037; 10730-3336; 10730-3338;
10730-3451; 10730-3925; 10730-3931; 10730-4959; 10730-5556.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
REASON Blood products possibly exposed to unacceptable shipping temperatures
were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION AZ.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit number 10731-5872.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
REASON Blood product, collected from a donor whose body temperature was
improperly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated; b) Platelets Pheresis,
Irradiated.
CODE a) Unit numbers 07FV09363, 07FN23715, and 07FF94964; b) Unit number
20R13450.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region,
Tucson, AZ.
REASON Blood products that were subjected to irradiation twice were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AZ.
WEEK ENDING OCTOBER 12
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 50P29342, 50P29820, 50P29948, 50P30179, 50P30259, 50P30887,
50P31046, and 50P31571.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie
Region, Toledo, OH.
REASON Platelets Pheresis with an elevated platelet count based on volume of
product collected were distributed.
VOLUME
OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION OH.
PRODUCT
Source Plasma.
CODE Unit 71 FPBGCJ.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, collected from a donor whose arm preparation was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
WEEK ENDING OCTOBER 19
PRODUCT
Source Plasma.
CODE Unit 7196K098.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, which was not tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT
Source Plasma.
CODE Units 71FPCGCY, 71FPCFXZ, 71FPCFQN.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Germany.
PRODUCT
BD Vacutainer_ Safety-Lok_ Blood Collection Sets (Catalogue # 367285, 367286,
367287, 367292, 367294, 367281, 367282, 367283, 367284).
CODE Lot Numbers / Expiration Dates:
|
367285
/ Exp. |
367286
/ Exp. |
367287
/ Exp. |
367292
/ Exp. |
|
1183719
/ N/A |
1221539
/ 7-31-03 |
1248553
/ N/A |
1176295
/ N/A |
|
1232277
/ N/A |
1221540
/ 7-31-03 |
1248554
/ N/A |
1176296
/ N/A |
|
1239672
/ N/A |
1221541
/ 7-31-03 |
1290075
/ N/A |
1285296
/ N/A |
|
1270421
/ N/A |
|
1290104
/ N/A |
1305516
/ N/A |
|
1274247
/ N/A |
|
1306048
/ N/A |
1305517
/ N/A |
|
1276950
/ N/A |
|
1306049
/ N/A |
1305518
/ N/A |
|
1345631
/ N/A |
|
|
1305520
/ N/A |
|
1345630
/ N/A |
|
|
1335325
/ N/A |
|
1355543
/ N/A |
|
|
1335326
/ N/A |
|
2029705
/ N/A |
|
|
1345615
/ N/A |
|
2029706
/ N/A |
|
|
1345616
/ N/A |
|
367294
/ Exp. |
|
1276911
/ N/A |
|
1276912
/ N/A |
|
1276930
/ N/A |
|
2018702
/ N/A |
|
367281
/ Exp. |
367282
/ Exp. |
367283
/ Exp. |
367284
/ Exp. |
|
1183717
/ N/A |
1232273
/ 7-31-03 |
1180459
/ N/A |
1296195
/ 10-31-03 |
|
1194894
/ N/A |
1232274
/ 7-31-03 |
1180461
/ N/A |
1296196
/ 10-31-03 |
|
1194895
/ N/A |
1232275
/ 7-31-03 |
1180462
/ N/A |
1314804
/ 10-31-03 |
|
1194896
/ N/A |
1248561
/ 8-31-03 |
1183718
/ N/A |
1314805
/ 10-31-03 |
|
1194897
/ N/A |
1248562
/ 8-31-03 |
1184758
/ N/A |
|
|
1200830
/ N/A |
1256695
/ 8-31-03 |
1208215
/ N/A |
|
|
1200833
/ N/A |
1248557
/ 8-31-03 |
1214297
/ N/A |
|
|
1200834
/ N/A |
1248558
/ 8-31-03 |
1214298
/ N/A |
|
|
1200835
/ N/A |
1248559
/ 8-31-03 |
1214299
/ N/A |
|
|
1296172
/ N/A |
1248560
/ 8-31-03 |
1214300
/ N/A |
|
|
1296173
/ N/A |
1257958
/ 8-31-03 |
1214301
/ N/A |
|
|
1305502
/ N/A |
1257960
/ 8-31-03 |
1221528
/ N/A |
|
|
1305513
/ N/A |
1281016
/ 9-30-03 |
1221529
/ N/A |
|
|
1357273
/ N/A |
1281017
/ 9-30-03 |
1221530
/ N/A |
|
|
|
1281018
/ 9-30-03 |
1239647
/ N/A |
|
|
|
1285259
/ 9-30-03 |
1239649
/ N/A |
|
|
|
1285260
/ 9-30-03 |
1239651
/ N/A |
|
|
|
1285262
/ 9-30-03 |
1270443
/ N/A |
|
|
|
1305498/
10-31-03 |
1316010
/ N/A |
|
|
|
1305499/
10-31-03 |
1316011
/ N/A |
|
|
|
1305501/
10-31-03 |
1316012
/ N/A |
|
|
|
1320189
/ 10-31-03 |
1316013
/ N/A |
|
|
|
|
1316014
/ N/A |
|
|
|
|
1316015
/ N/A |
|
|
|
|
1335321
/ N/A |
|
|
|
|
1335322
/ N/A |
|
|
|
|
1335323
/ N/A |
|
|
|
|
1335324
/ N/A |
|
|
|
|
1345632
/ N/A |
|
|
|
|
1345633
/ N/A |
|
|
|
|
2008015
/ N/A |
|
|
|
|
2008016
/ N/A |
|
|
|
|
2008017
/ N/A |
|
|
|
|
2008018
/ N/A |
|
|
|
|
2008019
/ N/A |
|
|
|
|
2008021
/ N/A |
|
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co.,
Franklin Lakes, NJ.
Manufacturer: Becton Dickinson Vacutainer Systems, Sumter, SC.
REASON Vacutainer_ Brand Safety-Lok_ Blood Collection Sets that have caused
blood leakage during phlebotomy, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION Nationwide.
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated.
CODE Unit 10727-9256.
RECALLING FIRM/MANUFACTURER United Blood Services, Scottsdale, AZ.
REASON Blood product, for which documentation of irradiation was incomplete,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE a) and b) Unit LL12679.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
Source Plasma.
CODE Unit 71FPCBQP.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood product, that lacked assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
Source Plasma.
CODE Units 71 FPCGQB, 71 FPCGJR, 71 FPCGDT.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, collected from a donor who had not completed the
CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Germany.
PRODUCT
Source Plasma
CODE Units 71 FPCGNJ and 71 FPCGHR.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC.
REASON Blood products, collected from a donor who had not completed the
CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Germany.
PRODUCT
Recovered Plasma.
CODE Unit 03GN40759.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA.
REASON Blood products, collected from a donor who had lived in Western Europe
for greater than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Recovered Plasma.
CODE Unit 03K18869.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA.
REASON Blood product, collected from a donor who had lived in Western Europe
for greater than 6 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit 03GK70297.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA
REASON
Blood products, collected from a donor who had lived in Western Europe for
greater than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets, Leukocytes Reduced; c)
Fresh Frozen Plasma.
CODE a); b) and c) Unit 16LH54794.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio
Region, Columbus, OH
REASON
Blood products, collected from an unsuitable donor due to high risk behavior
found to increase the risk of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced; b) Platelets Pheresis, Leukocytes
Reduced.
CODE a) Units 03LV06498 (parts 1 and 2), 03LV06503 - part 2, 03LV06512-part 2,
03LV06516-part 1, 03LV06520-part 1, 03LV06524-part 1, 03LV06527-part 1,
03LV06529-part 1, 03LV06535-parts 1 and 2, 03LV06537-parts 1 and 2. b) Units
03LV06503 - part 1, 03LV06508, 03LV06510,
03LV06518 - parts 1 and 2, 03LV06524 - part 2, 03LV06530, 03LV06541, 03LV06543.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA.
REASON Blood products, labeled as Leukocytes Reduced, but did not meet the
requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 13 units; b) 9 units.
DISTRIBUTION GA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma
CODE a) and b) Unit 07FL04787.
RECALLING FIRM/MANUFACTURER American National Red Cross, Arizona Region,
Tucson, AZ
REASON
Blood products, collected from a donor whose eligibility to donate was not
adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT
Platelets
CODE Unit 1890459.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY.
REASON Platelets, collected from a donor that had ingested aspirin in the
previous 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 42FY32369.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio
Region, Cleveland, OH
REASON
Blood products, collected from a donor who reported travel to an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT
Source Plasma
CODE Unit FDGKPM.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis-Bio Services, Inc.,
Knoxville, TN.
Manufacturer: Aventis Bio-Services, Inc., Canton, OH.
REASON Source Plasma, collected in a manner that lacked assurance of sterility,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT
Source Plasma
CODE Unit 73115878.
RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services, L.P.,
Deerfield, IL.
Manufacturer: BioLife Plasma Services, L.P., Newport, KY.
REASON Source Plasma, collected from a donor who did not answer a medical
history question concerning behavior known to increase risk of infection with
the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Units 40GK35778, 40GF41090, 40GR56470, 40GR57799, 40GC65117, 40GS63295,
40GC68591.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Heart of America
Region, Peoria, IL
REASON
Blood products, collected from a donor who was using Tazorac for psoriasis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL and CA, AK and AL.
PRODUCT
Source Plasma
CODE G-49190-178, G-48945-178, G-47790-178, G-47485-178, G-47258-178,
G-46994-178, G-46416-178, G-46320-178, G-45821-178, G-45467-148, G-45188-178,
G-44777-178, N-08747-178, N-08714-178, G-16389-178, G-16227-178, N-06132-178,
N-06120-178, G-15307-178, G-15234-178, G-14876-178, G-14731-178, G-14416-178,
G-14240-178, G-13916-178, G-13744-178, G-13304-178, G-13000-178, G-12833-178,
G-12518-178, G-12360-178, G-12047-178, G-11896-178, G-11540-178, G-11431-178,
G-11081-178, G-10837-178, G-10578-178, G-10185-178, G-09361-178, G-09215-178,
G-08854-178, G-08687-178, G-08352-178, G-08189-178, G-07816-178, G-07636-178,
G-07260-178, G-07109-178, G-06780-178, G-06603-178, G-06215-178, G-06042-178,
G-05684-178, G-05537-178, G-05191-178, G-05005-178, FT90022327, FT90022144,
FT90020708, FT90020511, FT90019498, FT90019374, FT90019005, FT90016806,
FT90015282, FT90007542, G-49467-178, G-49695-178, G-61585-178, G-62340-178,
G-63025-178, G-63189-178, DDBBHW, DDBBKV, DDBBQR, DDBBWH, DDBBYZ, DDBCFD,
DDBCHH, DDBCMW, DDBCQP, DDBCWC, DDBDCM, DDBPGY.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Melrose Park, IL.
REASON Source Plasma, collected from a donor who tested positive for syphilis,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 85 units.
DISTRIBUTION IL, CA and GA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 10722-2754 and 10727-0732.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
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 AZ.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number 10728-2634.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
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 AZ.
PRODUCT Source Plasma
CODE Unit numbers 9WX430, 9WX442, 9WX470, 9WX491, 9WX530, 9WX540, 9WX576, FLBVJT,
FLBVKN, FLBWDF, FLBWHD, FLBWJY, FLCMMF, FLCMRR, and FLCNCX.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Waco, TX.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells
CODE Unit number 3852037.
RECALLING FIRM/MANUFACTURER Department of the Army, Walter Reed Army Medical
Center Blood Bank, Washington, D.C
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 NM.
PRODUCT
Red Blood Cells
CODE Unit number C07821.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
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 VA.
PRODUCT
a) Red Blood Cells; b) Platelets Irradiated.
CODE a) and b) Unit number M72291.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
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 VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit number 29FV52085.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic
Region, Norfolk, VA
REASON
Blood product, collected from an unsuitable donor based on living in an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number 53FJ77232.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake
and Potomac Region, Baltimore, MD
REASON
Blood product, collected from an unsuitable donor based on living in an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Maryland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Fresh Frozen Plasma.
CODE a) and b) Unit number 53GQ93875.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake
and Potomac Region, Baltimore, MD
REASON
Blood products, collected from an unsuitable donor due to medication with the
drug Purinethol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 8719675 and 8744908.
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX.
REASON Blood products, that tested negative for the antibody to hepatitis B
core antigen (anti-HBc), but were collected from a donor that had been
previously deferred for reactive testing for anti-HBc, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE Units 40FP10666, 40P76999, 40P76998, 40P76973, 40P76981.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by letter dated
June 20, 2002.
REASON Blood products, that lacked assurance of proper temperatures during
shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION GA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit 11GK52088.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA.
REASON Blood products, collected from a donor who was taking Propecia, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT
Whole Blood, Autologous.
CODE Units 03KL106500, 03KL10608, 03KL10616, 03KL10617.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA.
REASON Blood products, which were collected in expired collection bags, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION GA and MD.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b )Recovered Plasma.
CODE a) and b) Unit 42FM34325.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio
Region, Cleveland, OH
REASON
Blood products, collected from a donor whose arm inspection was not documented,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and CA.
PRODUCT
Source Plasma
CODE Unit 53-DDJBTY-0.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Melrose Park, IL.
REASON Source Plasma, collected from a donor whose arm inspection was not
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 10730-1553, 10730-1570, 10730-4427, 10730-4434, 10730-4437,
10730-4439, 10730-5852, 10730-6371, 10730-7753, and 10730-7761.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
REASON Blood products possibly exposed to unacceptable shipping temperatures
were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION AZ.
PRODUCT
Red Blood Cells
CODE Unit number 4814468.
RECALLING FIRM/MANUFACTURER Department of the Navy, National Naval Medical
Center Blood Bank, Bethesda, MD
REASON
Blood product, that did not have the additive solution included, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Saudi Arabia.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 35GY19459 and 35GC11150.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian
Region, Roanoke, VA
REASON
Blood products that were possibly out of controlled storage for more than 30
minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT
Platelets Pheresis.
CODE Unit number 35P35968 (distributed as two split products).
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian
Region, Roanoke, VA
REASON
Blood products, possibly exposed to unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit 10728-8173.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ.
REASON Blood product, collected from an ineligible donor who had recently had
surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
WEEK ENDING OCTOBER 26
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Units 53J75427, 53J75439, 53J75444, 53J75447, 53J75461, 53J75470.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac
Region, Baltimore, MD
REASON
Blood products, collected from a donor who hematocrit was incorrectly
calculated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MD and Washington DC.
PRODUCT
Source Plasma.
CODE Unit numbers 0480788024, 0480793262, and 0480802262.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc. (formerly Nabi), Tempe, AZ
REASON
Blood products, collected from an unsuitable donor due to previous positive
testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC and the United Kingdom.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Unit number 29GV47981.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic
Region, Norfolk, VA
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 MD.
PRODUCT
a) Red Blood Cells. Leukocytes Reduced; b) Recovered Plasma.
CODE a) and b) Unit number 29GP69957.
RECALLING FIRM/MANUFACTURER The American National Red Cross,Mid-Atlantic
Region, Norfolk, VA
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to a risk factor for increased incidence of infection
with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma.
CODE a) and b) Unit number 29KF15448.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic
Region, Norfolk, VA
REASON
Blood products, collected from an ineligible donor due to medication with the
drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA and CA.
PRODUCT
Red Blood Cells.
CODE Unit number FS02399.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA.
REASON Blood product, collected from a donor whose body temperature was not
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Red Blood Cells.
CODE Unit number KW41496.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA.
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 CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Red Blood Cells, Autologous; c) Red
Blood Cells, Leukocytes Reduced, Irradiated;
d) Platelets, Leukocytes Reduced; e) Fresh Frozen Plasma; f) Recovered Plasma,
Leukocytes Reduced.
CODE a) Units J05850, J05852, J05853,
J05854, J05855, J05856, J05859, J05860, J05861, R43824, R43826, R43827, R43828,
R43829, R43830, R43833, R43835, R43836, R43838, R43839, R43840, R43841, R43842,
R43843, R43844;
b) Unit R43831;
c) Unit R43834;
d) Unit J05850, J05852, J05853, J05854, J05855, J05856, J05859, J05860, R43824,
R43826, R43827, R43828, R43829, R43830, R43832, R43833, R43835, R43836, R43838,
R43839, R43840, R43841, R43842, R43843, R43844;
e) Units J05859, R43836, R43843, R43833, R43830;
f) Units J05850, J05852, J05853, J05854, J05855, J05856, J05860, J05861,
R43824, R43826, R43827, R43828, R43829, R43832, R43834, R43835, R43838, R43839,
R43840, R43841, R43842, R43844.
RECALLING FIRM/MANUFACTURER Coastal Bend Blood Center, Corpus Christi, TXete.
REASON Blood products, which were incorrectly tested for the HIV-1 p24 antigen,
were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 25 units; b) 1 unit; c) 1 unit; d) 25 units;
e) 5 units; f) 22 units.
DISTRIBUTION TX and CA.