NOVEMBER 2001
WEEK ENDING NOVEMBER 3
PRODUCT AND CODE: Red Blood Cells,
Deglycerolized, Unit 0535732
REASON: Blood product, deglycerolized with an expired
reagent, was distributed.
MANUFACTURER/RECALLING FIRM: Hoxworth Blood Center,
Cincinnati, Ohio
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Source Leukocytes, Unit
06GW41751; Recovered Plasma, Unit 06GW41751, 06LC56047
REASON: Blood products collected from a donor with a
history of having tested positive for hepatitis B core antigen (anti-HBc) were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, Los
Angeles, CA
DISTRIBUTION: CA and Switzerland
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Units 13FH86285, 13FH86291, 13FH86292, 13FH96293, 13FH86297,
13FN67432.
Platelets,
Units 13FH86285, 13FH86291, 13FH86292, 13FH96293, 13FH86297, 13FN67432
Recovered
Plasma, Units 13FH96293 and 13FN67432
REASON: A unit of pooled Platelets, Leukoreduced, which
was implicated in a transfusion reaction, found to be contaminated with
Staphylococcus epidermidis.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Detroit, Michigan
DISTRIBUTION: MI and CA
QUANTITY: 14 units
PRODUCT AND CODE: Red Blood Cells, Units
36260-7641 and 36261-7605
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Ventura, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Units
GJ65879 and GJ62497
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Tri-Counties Blood Bank,
Santa Barbara, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Platelets Pheresis, Unit
07FP10490
REASON: Platelets with an elevated platelet count were
distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Tucson, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Irradiated, Unit 03GG73910
REASON: Blood product, which was stored at unacceptable
temperatures, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Atlanta, GA
DISTRIBUTION: GA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, Units 36262-1187 and 36262-1191
REASON: Blood products that were out of controlled storage
for more than 30 minutes were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Ventura, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Pheresis,
Unit GJ80527 ; Red Blood Cells, Pheresis, Leukocytes Reduced, Unit GJ80563
REASON: Blood products, collected on an apheresis machine
where there was no documentation of evaluation of the filter assemblies as
required, were distributed.
MANUFACTURER/RECALLING FIRM: Tri-Counties Blood Bank,
Santa Barbara, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Pheresis,
Units GJ72711, GJ73965, and GK15229
REASON: Blood products, collected on an apheresis machine where
there was no documentation of evaluation of the filter assemblies as required,
were distributed.
MANUFACTURER/RECALLING FIRM: Tri-Counties Blood Bank,
Santa Barbara, CA
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 3 units
PRODUCT AND CODE: Corneas, Tissue
Identification Numbers 01-0789,01-0790
REASON: Corneas, collected from a donor who tested
repeatedly reactive for the HIV p24 antigen, with no HIV 1/2 DNA detected by
PCR, were distributed.
MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Central
Texas, Austin, TX
DISTRIBUTION: Texas and Mexico
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma, Units
27868874, 29774487, 29777525, 28280514, 28283027, 28285854
REASON: Blood products, collected from a donor with a
history of intravenous drug use, were distributed.
MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center,
Dallas, TX
DISTRIBUTION: CA
QUANTITY: 6 units
PRODUCT AND CODE: Source Plasma, Unit Q5E446
REASON: Blood product that tested negative for HBsAg, but
was not quarantined after the donor subsequently tested RR for HBsAg, was
distributed.
MANUFACTURER/RECALLING FIRM: Alabama Plasma, Inc.,
Birmingham, AL
DISTRIBUTION: NC
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Leukocytes Reduced,
Unit 7475165
REASON: Blood product, which was labeled as leukoreduced,
but failed the quality control specification for white blood cell count, was
distributed.
MANUFACTURER: New York Blood Center,
Melville, NY
RECALLED BY: New York Blood Center (Center West), New
York, NY
DISTRIBUTION: New York
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma for
Manufacturing Use Only, Unit 00LWIB4967
REASON: Blood product, collected from a donor who engaged in
multiple high-risk behaviors, was distributed.
MANUFACTURER: Community Bio-Resources,
Inc., Onalaska, WI
RECALLED BY: Community Bio-Resources, Inc., Hoover, Al
DISTRIBUTION: Austria
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma for
Manufacturing Use Only, Units 00LWIB5087, 00LWIB5564
REASON: Blood products, collected from a donor who engaged
in high-risk behavior, were distributed.
MANUFACTURER: Community Bio-Resources,
Inc., Onalaska, WI
RECALLED BY: Community Bio-Resources, Inc., Hoover, Al
DISTRIBUTION: Austria
QUANTITY: 2 units
PRODUCT AND CODE: Counterfeit Neupogen
(Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single
use vials per carton; 24 cartons distributed Lot Number P000890, Expiration
date 12/02
REASON: Counterfeit Neupogen was distributed.
RECALLING FIRM: Albers Medical, Inc., Kansas
City, MO
DISTRIBUTION: TN and NJ
QUANTITY: 240 vials
PRODUCT AND CODE: Counterfeit Neupogen
(Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use
vials per carton; 18 cartons distributed, Lot Number P000890, Expiration Date
12/02
REASON: Counterfeit Neupogen was distributed.
RECALLING FIRM: H.D. Smith Drug Company,
Carlstadt, NJ
DISTRIBUTION: NY and NJ
QUANTITY: 180 vials
PRODUCT AND CODE: Counterfeit Neupogen
(Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single
use vials per carton, 117 vials
Lot
Number P000890, Expiration Date 12/02
Lot
Number P000948, Expiration Date 03/03
Lot
Number P000992, Expiration Date 06/03
REASON: Counterfeit Neupogen was distributed.
RECALLING
FIRM: Drug Max, Pittsburgh, PA
DISTRIBUTION: CA, DC, FL, GA, MI, NJ, NY
PA, TX and WA
QUANTITY: 117 vials
PRODUCT AND CODE: Counterfeit Neupogen
(Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single
use vials per carton, 287 cartons, Lot Number P000890, Expiration Date
12/02
REASON: Counterfeit Neupogen was distributed.
RECALLING
FIRM: TW Medical Veterinary Supply, Leander, TX
DISTRIBUTION: MO, PA and FL
QUANTITY: 2,870 vials
PRODUCT AND CODE: Counterfeit Neupogen
(Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single
use vials per carton, 17 boxes distributed
Lot
Number P000890, Expiration Date 12/02
Lot
Number P000992, Expiration Date 06/03
REASON: Counterfeit Neupogen was distributed.
RECALLING FIRM: Top Source, Bartlett, TN
DISTRIBUTION: NY, NM, VA, CA and NJ
QUANTITY: 17 vials
PRODUCT AND CODE: Platelets, Units 30 34322,
30 34323
REASON: Blood products, which had unacceptable platelet
counts, were distributed.
MANUFACTURER/RECALLING FIRM: The Community Blood Center,
Inc., Appleton, WI
DISTRIBUTION: WI
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Unit
C70268; Recovered Plasma, Unit C70268
REASON: Blood products, collected from a donor who had
surgery within 48 hours of donation, were distributed.
MANUFACTURER/RECALLING FIRM: Virginia Blood Services,
Richmond, VA
DISTRIBUTION: VA and Switzerland
QUANTITY: 2 units
PRODUCT AND CODE: Albuminar-5 Albumin (Human)
U.S.P. 5%; 250 mL vials, containing 12.5 grams and 25.0 grams of albumin in
normal saline, 210,270 vials distributed
Lot
numbers: W34710, W35010, W35110,
W35210, W41311, W41411, W41411B, W41511, W41611, W41711, W41811, W41911,
W42111, W42211, W42311, W42411, W42511, W42611, W42712, W42812, W42912, W43012,
W43112, W43312, W43412, W43512, W43612, W43712, W43912, W44012, W44212, W44312,
W44412, W44612, W44712, W44812, W44912, W45012, W45112, W45212, W45312, W45412,
W45512,
W45712,
W45812, W45912, W46112, W46412, X700601, X700701, X701001, X701101, X702602,
X702702, X704602, X704702, X704902, X705002, X705202, X705302, X705402,
X707203, X707303, X707503, X707703, X707803, X708604
Albuminar-5
Albumin (Human) U.S.P. 5%; 500 mL vials containing 12.5 grams and 25.0 grams of
albumin in normal saline, 100,699 vials distributed Lot numbers W34209, W34309,
W34409, W34509, W35310, W35410, W35510, W35610, W35710, W35810, W35910, W36010,
W36110, W36210, W36310, W36410, W36510, W36610, W36710, W36810, W37010, W37110,
W37210, W37310, W37410, W37510, W37610, W37710, W37810, W37910, W38010, W38110,
W38210, W38310, W38410, W38510, W38610, W38711, W38811, W38911, W39011, W39111,
W39211,
W39311, W39411, W39711, W39811, W39911, W40011, W40111, W40211, W40311, W40611,
W40811, W41011, X700001, X700201, X700401, X701501, X701601, X701901, X708203,
X708403
REASON: Sterility of the products may have been compromised
due to the potential for holes in the stopper septum.
MANUFACTURER:
Aventis Behring L.L.C., Bradley, IL
RECALLED BY: Aventis Behring L.L.C., King of Prussia, PA
DISTRIBUTION: Nationwide
QUANTITY: 210,270 vials; 100,699 vials
PRODUCT AND CODE: Platelets, Pheresis (34
units), unit numbers 09FP11944, 09FP12385, 09FP12782, 09FP13357, 09FP13811, 09FP13964,
09FP14398, 09FP14862, 09FP15311, 09FP16156, 09FP16478, 09FP17790, 09FP18451,
09FP19246, 09P58687-1, 09P58687-2, 09P59321, 09P61935, 09P63484, 09P64721-1,
09P64721-2, 09P65136-1, 09P65136-2, 09P67413-1, 09P67413-2, 09P69358-1,
09P69358-2, 09P69772-2, 09P70157-1,
09P70157-2,
09P70651-1, 09P70651-2, 09P70704-1, and 09P70704-2
REASON: Blood products, labeled with incorrect human
leukocyte antigen (HLA) type, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Omaha, NE
DISTRIBUTION: CA, AR, OR, NE, IA
QUANTITY: 34 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, Unit number 0736672
REASON: Blood product, collected from a donor that tested
positive for the Fya blood group antigen, but was labeled Fya negative, was
distributed.
MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of
Minnesota, Minneapolis, MN
DISTRIBUTION: MN
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis,
Leukocytes Reduced, unit numbers 0796321 and 0805277
REASON: Blood products with an increased platelet count that
were not tested for pH as required were distributed.
MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of
Minnesota, Minneapolis, MN
DISTRIBUTION: MN
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, unit number 10706-7964; Recovered Plasma, unit number 10706-7964
REASON: Blood products, collected from a donor whose health
history screening was inadequately performed, were distributed.
MANUFACTURER: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ and VA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, Unit number 50LG41701
REASON: Blood product, collected from an unsuitable donor
based on living in an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Toledo, OH
DISTRIBUTION: OH
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis, unit
number 7445418
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford,
TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes Reduced,
unit number 12M05709
REASON: Blood product, collected from an unsuitable donor
based on living in an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Charlotte, NC
DISTRIBUTION: NC
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, unit number 12L58954
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Charlotte, NC
DISTRIBUTION: NC
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells (8 units),
unit numbers 21GS06356, 21Y58308, 21Y56749, 21Y55436, 21Y54094, 21Y52852,
21Y48696, and 21Y47492; Red Blood Cells, Leukocytes Reduced (7 units), unit
numbers 21Y63240, 21Y62050, 21GS09211, 21KQ04129, 21KQ02382, 21Y59615, and
21Y51171; Cryoprecipitated AHF (13 units), unit numbers 21Y63240, 21Y62050,
21GS09211, 21KQ04129, 21GS06356, 21Y59615, 21Y58308, 21Y56749, 21Y55436, 21Y54094,
21Y52852, 21Y48696, and 21Y47492; Plasma (1 unit), unit number 21Y54094
REASON: Blood products, collected from an ineligible donor
due to a history of medication with the drug Acyclovir (Zovirax), were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Salem, OR
RECALLED BY: The American National Red Cross, Portland, OR
DISTRIBUTION: AZ, CA, NJ, OR, TX, UT and
WA
QUANTITY: 29 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced (1 unit), unit number 42FX94172
Platelets,
Leukocytes Reduced (2 units), unit numbers 42FX94172 and 42S57347
Fresh
Frozen Plasma (1 unit), unit number 42FX94172
REASON: Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from a donor that
previously tested repeatedly reactive for anti-HCV, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Cleveland, OH
DISTRIBUTION: OH
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes Reduced
(1 unit), unit number GK54195
Recovered
Plasma (1 unit), unit number GK54195
REASON: Blood products, collected from an ineligible donor
due to medication with the drug Methotrexate, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells (1 unit),
unit number GL62814; Recovered Plasma (1 unit), unit number GL62814
REASON: Blood products, collected from an ineligible donor
due to a history of intravenous (IV) drug use, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced (1 unit), unit number FK32661
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Healthcare Provider
Services, Inc., Providence, RI
DISTRIBUTION: RI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes,
Reduced (2 units), Unit numbers 10627-0013 and 10633-3833
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells (1 unit),
Unit number 10601-4607;Red Blood Cells, Leukocytes, Reduced (2 units), Unit
numbers
10626-7938
and 10630-7134; Platelets (1 unit), unit number 10601-4607
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced (1 unit), unit number 10624-8100
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Scottsdale, AZ
DISTRIBUTION: AZ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, unit numbers 4590376, 4716138, 6538799, and 6805488
REASON: Blood products were distributed with an elevated
white blood cell count.
MANUFACTURER/RECALLING FIRM: Central Indiana Regional
Blood Center, Indianapolis, IN
DISTRIBUTION: IN
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, Unit number 0788895
REASON: Blood product, that was incorrectly leukoreduced by
filtration twice, was distributed.
MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of
Minnesota, Minneapolis, MN
DISTRIBUTION: MN
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis (4
units), Unit numbers 04W757514, 04W757575, 04W757599, and 04W757587
REASON: Unlicensed blood products were distributed
interstate.
MANUFACTURER/RECALLING FIRM: Civitan Regional Blood
Center, Inc., Gainesville, FL
DISTRIBUTION: AL
QUANTITY: 4 units
PRODUCT Corneas
CODE Tissue Id. 2001-07-3073, 2001-07-3074.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland
Lions Eye Banks, Columbia, MO
Procuring
Firm: Missouri Lions Eye Bank, Springfield, MO.
REASON Corneas, that were collected from a donor who tested
repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-
HBc),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK and KS
PRODUCT Source Plasma for Manufacturing Use Only
CODE Units 00LWIB8896, 00LWIB9820, 00LWIC1337,
00LWIC1965.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community
Bio-Resources, Inc., Hoover, AL
Manufacturer:
Community Bio-Resources, Inc., Onalaska, WI.
REASON Blood products, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Austria.
PRODUCT a) Red Blood Cells, b) Platelets,c) Cryoprecipitate
AHF, Pooled
CODE a) Unit 0546061; b) Unit 0546061; c) Unit 0546061.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, Ohio
REASON Blood product, collected from a donor with a history
of having tested positive for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Platelets; c) Liquid Plasma;
d) Cryoprecipitate; e) Recovered Plasma
CODE a) Units 42FP84273, 42FY46000, 42T10971, 42S58036,
42G36643, 42J35244, 42M64574;
b)
Units 42FP84273, 42S58036, 42J35244, 42M64574;
c)
Unit 42S58036;
d)
Unit 42G36643;
e)
Units 42FP84273, 42FY46000, 42T10971, 42G36643, 42J35244.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Cleveland, Ohio
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION OH and CA.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit F126584.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center
& Program, Seattle, WA
REASON Blood product, which may not have been irradiated,
was labeled as irradiated.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WA.
PRODUCT Source Plasma
CODE Units (30
units) 22428325, 19957913, 19956015, 20360887, 19669069, 14506215, 15346261,
14457166, 16636767, 16633810,
17640268,
17637268, 16314344, 16312838, 16311589, 16090507, 16088092, 16087088, YP86391,
YP82372, YP82202, YP81909, YP81597,
YP80442,
YP80011, YP79895, YP78111, YP75686, YP75568, YP75347.
RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN
Manufacturer:
Interstate Blood Bank, Inc., Milwaukee, WI
REASON Blood products, collected from a donor who had
engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION CA and IL.
PRODUCT Source Plasma
CODE Units 23098244, 23092600.
RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN
Manufacturer: Interstate Blood Bank, Inc., Madison, WI.
REASON Blood products, collected from a donor who had body
piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE 99SWIA5743, 99SWIA5935, 99SWIA6175, 99SWIA6364.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL
Manufacturer:
Community Bio-Resources, Inc., Sheboygan, WI.
REASON Blood products, collected from a donor who had a
Rubella immunization, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MN.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma
CODE a) Units 21KR09340, 21KR06567; b) Units 21KR09340,
21KR06567.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, collected from a donor taking the
drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION GA and OR.
PRODUCT a) Red Blood Cells, Leukoreduced, b) Platelets
CODE a) Unit 13GV13930; b) Unit 13GV13930.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood products, collected from a donor who reported
having lived in a country designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells;b) Platelets Irradiated; c)
Recovered Plasma
CODE a) Unit number 3037667; b) Unit number 3037667; c)
Unit number 3037667.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Dayton, OH
REASON Blood products, collected from an ineligible donor
due to medication with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH and Switzerland.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered
Plasma
CODE a) Unit numbers 06FH85173 and 06FH84102; b) Unit
number 06FH85173; c) Unit number 06FH84102.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Los
Angeles, CA
Manufacturer:
American Red Cross Blood Services, Southern California Region, Fullerton, CA
REASON Blood products, collected from an ineligible donor
due to medication with the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit number 1926993; b) Unit number 1926993.
RECALLING FIRM/MANUFACTURER Central Indiana Regional
Blood Center, Inc., Indianapolis, IN
REASON Blood products, collected from a donor whose health
history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and Switzerland.
PRODUCT Red Blood Cells
CODE Unit number 24GK22146.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Louisville, KY
REASON Blood product, labeled with the incorrect red blood
cell antigen typing information, 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 FM20503; b) Unit number FM20503.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., Providence, RI
REASON Blood products, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were
collected
from a donor that previously tested repeatedly reactive for anti-HIV-2, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION RI and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 12GH99665.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood product, that tested negative for antibodies
to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was
collected
from a donor that previously tested repeatedly reactive for anti-HIV-1/2, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 01KK67047.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, West Henrietta, NY
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 NY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 03GF64030.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Atlanta, GA
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 GA.
PRODUCT Recovered Plasma
CODE Unit 06GR47936.
RECALLING FIRM/MANUFACTURER American Red Cross, Los
Angeles, CA
REASON Blood product, collected from a donor with a history
of having tested positive for hepatitis B surface antigen (HbsAg), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Unit 03K23318.
RECALLING FIRM/MANUFACTURER American Red Cross ,
Atlanta, GA
REASON Blood product, which was labeled as leukoreduced,
but failed the quality control specification for white blood cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Platelet, Pheresis, Leukoreduced
CODE Unit 03F11943.
RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta,
GA
REASON Blood product, which was labeled as leukoreduced,
but that failed the quality control specification for white blood cell
count,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Platelet, Pheresis, Irradiated (Split unit)
CODE Unit 20R12321.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Tucson, AZ
REASON Blood products, which were not quarantined after
receiving information concerning a post nation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Cornea
CODE Unit C-01-172-OD.
RECALLING FIRM/MANUFACTURER Lions Eye and Tissue Bank, Inc.
(lions of District 22-C), Seabrook, Maryland
REASON Cornea, collected from a donor who tested repeat
reactive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT Fresh Frozen Plasma (3 Quad Packs)
CODE Unit 8798943.
RECALLING FIRM/MANUFACTURER Community Blood Centers of
South Florida, Lauderhill, Florida
REASON Blood products, collected from a donor taking the
drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Platelets
CODE Unit 8858283.
RECALLING FIRM/MANUFACTURER Community Blood Centers of
South Florida, Lauderhill, Florida
REASON Blood product, collected from a donor with a history
of ear piercing within the past 12 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Red Blood
Cells, Leukocytes Reduced Irradiated,
CODE a) Unit numbers 18FW16936 and 18FR44026; b) Unit
number 18FX23598.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Lansing, MI
REASON Blood products, collected from an unsuitable donor
based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.
PRODUCT Platelets Pheresis
CODE Unit number 28FP04506
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Atlanta, GA
Manufacturer:
American Red Cross Blood Services, Daytona Beach, FL
REASON Blood product, that tested positive for Cytomegalovirus
(CMV), but was labeled negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT a) Red Blood
Cells, Leukocytes Reduced; b) Plasma
CODE a) Unit number 38LC14725; b) Unit number 38LC14725.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Fort Wayne, IN
REASON Blood products, that tested negative for the
antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but
were
collected
from a donor that previously tested repeatedly reactive for anti-HIV-1/2, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and NY.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit number 10623-0447.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood product, collected from an ineligible donor
due to a medical history of polycythemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE 18FJ43400.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Lansing, MI
REASON Blood product, that was incorrectly leukoreduced,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells, Leukoreduced ; b) Platelets
CODE Unit 01W81928; Unit 01W81928.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, West Henrietta, NY
REASON Blood products, which were mislabeled as CMV
antibody negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DIS