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.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Platelets; d) Recovered Plasma
CODE a) Units L18895, L18879; b) Unit L25171; c) Unit
L18879; d) Unit L18895.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, collected from donors whose donor
history was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION IL and Switzerland.
PRODUCT Source Plasma
CODE Units (20 units) G-86935-118, G-86833-118,
G-86182-118, G-85518-118, G-85325-118, G-85129-118, G-84955-118, N-22054-118,
N-
22029-118,
G-87732-118, G-87484-118, G-87343-118, G-88101-118, G-87895-118, G-86555-118,
G-86455-118, G-89151-118, G-89008-118,
G-88430-118,
G-88289-118.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles,
CA,
Manufacturer:
Alpha Therapeutic Corporation, Louisville, KY.
REASON Blood products, which tested negative for all
required viral marker testes, but were collected from a donor who had been
deferred due to an unknown reactive lab result, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION CA, NC, Germany and Spain.
PRODUCT Source Plasma
CODE G-56850-178, G-56733-178, G-56403-178,
G-56104-178, G-55854-178, G-55505-178,
G-55345-178, G-54976-178, G-54853-178, G-54463-178, G-54323-178, G-53970-178,
G-53805-178, G-53434-178, G-53263-178, G-52951-178, G-52755-178, G-52412-178,
G-52231-178, G-51900-178, G-51734-178, G-51375-178, G-51202-178, G-50844-178,
G-50668-178, G-50344-178, G-50159-178, G-49852-178, G-49511-178, G-49315-178,
G-47141-178, G-46792-178, G-46626-178, G-46244-178, G-46077-178, G-45717-178,
G-45570-178, G-45262-178, G-45043-178, G-44664-178, G-44489-178, G-44131-178,
G-43941-178, G-43578-178, G-43403-178, G-43055-178, G-42940-178, G-42552-178,
G-42376-178, G-42003-178, G-41813-178, G-41406-178, G-41218-178, G-40592-178,
G-40426-178, G-40017-178, G-39883-178, G-36018-178, N-08077-178, N-08046-178.
RECALLING FIRM/MANUFACTURER Seramed Bio Center/Melrose
Park, Melrose Park, IL
REASON Blood products, which tested negative for all
required tests, but were collected from a donor who had previously been
deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells
CODE Unit 13FN62230.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood product, collected from a donor taking the
drug Arava, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Source Plasma
CODE Units
449004, 449223, 449472.
RECALLING FIRM/MANUFACTURER Centeon (Aventis)
Bio-Services, Inc., Little Rock, AR
REASON Blood products, collected from a donor with a
history of having tested positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Germany.
PRODUCT Red Blood Cells
CODE Unit number S84027.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, 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 Red Blood Cells
CODE Unit Y62482.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, 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; b) Red Blood Cells, Leukocytes
Reduced
CODE a) Unit number S94694; b) Unit number S91538.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
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 CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers 2302873, 2303388, and 2303510
(distributed as two split units).
RECALLING FIRM/MANUFACTURER LifeShare, Inc., 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 4 units.
DISTRIBUTION OH.
PRODUCT Cryoprecipitated AHF
CODE Unit numbers 1784941, 1750496, 1789656, 1785016,
1753225, 1786413, 1757077, 1791911, 1784507, and 1795364.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Inc., Lexington, KY
REASON Blood products, which were thawed and labeled with
the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION KY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 084FT33620.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Oakland, CA
REASON Blood product, labeled with the incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes
CODE Reduced, Units 10623-7690 and
10633-6050.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer:
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 8338045.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks,
Inc., West Palm Beach, FL
REASON Blood product, collected from an ineligible donor
due to medication with the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Platelet Pheresis
CODE Unit 6651906 (part 1).
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood
Bank, Sarasota, FL
REASON Blood product, which did not meet acceptable
platelet yields, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Red Blood Cells
CODE Unit FM37567.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., Providence, RI
REASON Blood product, which was collected from a donor
whose hemoglobin result was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT Red Blood Cells
CODE Unit FJ83066.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., Providence, RI
REASON Blood product, which was collected from a donor
whose hemoglobin result was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Fresh Frozen Plasma; d) Recovered Plasma
CODE a) Units L22326, L21241; b) Units L22735, L28611; c)
Units L21241, L22735; d) Units L28611, L22326.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, collected from a donor whose arm
inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION IL and Switzerland.
PRODUCT Platelets Pheresis
CODE Unit numbers 8837250, 8837252, 8837247.
RECALLING FIRM/MANUFACTURER Community Blood Centers of
South Florida, Inc., Lauderhill, FL
REASON Unlicensed blood PRODUCTs were distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TN.
PRODUCT Source Plasma
CODE 99SWIA6837, 99SWIA7074, 99SWIA7302.
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 3 units.
DISTRIBUTION MN.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 3038862.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Inc., Appleton, WI
REASON Blood product, leukoreduced by filtration greater
than five days past the time of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit numbers 50C14091 and 50C14281.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Toledo, OH
REASON Blood products, labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukoreduced, Irradiated
CODE Units 5343971, 7520291.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
Texas
REASON Blood products, which were out of controlled storage
for more than thirty minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukoreduced, Irradiated
CODE Units 50LH21552, 50LH21554.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Toledo, OH
REASON Blood products, which were labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Fresh Frozen Plasma
CODE Unit 38FE72836.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Fort Wayne, IN
REASON Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Red Blood Cells, Leukocytes Reduced Washed
CODE 03LR61195, 03GR54968, 03FJ63453, 03R14614, 03G10178,
03FQ16784, 03GK56226, 03L17515, 03S07957, 03FJ63332, 03FR47438, 03GJ67133,
03LL13888, 03GL52824, 03FQ16679, 03GH48291, 03V17818, 03GL54004, 03FR46726,
03GF64091, and 03FJ62453.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Atlanta, GA
REASON Blood products, that were below the minimum
specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION GA.
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma
CODE a) Units 42FT85123, 42G21060; b) Unit 42T85123; c)
Units 42FT85123, 42G21060.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Cleveland, OH
REASON Blood products, collected from a donor with a
history of Idiopathic Thrombocytopenic Purpura, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OH and MI.
PRODUCT a) Red Blood Cells, Leukoreduced; b)
Cryoprecipitated AHF; c) Recovered Plasma
CODE a) Unit 10626-5833; b) Unit 10626-5833; c) Unit
10626-5833.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
United Blood Services, Scottsdale, AZ
85252
REASON Blood products, collected from a donor who received
a bone graft within a year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AZ.
PRODUCT Platelets Pheresis
CODE Unit number 8894571.
RECALLING FIRM/MANUFACTURER Community Blood Centers of
South Florida, Inc., Lauderhill, FL
REASON Unlicensed blood PRODUCT was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Red Blood Cells
CODE Unit 04Q071515.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Gainesville, FL
REASON Blood product, which was collected from a donor who had
received a tissue transplant (surgery) within one year of donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Source Plasma
CODE Units 15796929, 15795687, 15793966, 15793058,
15791238, 14560217, 14558429, 14557422, 1455756, 14554513, 14552557, 14551802,
15469496, and 15468758.
RECALLING FIRM/MANUFACTURER Sera-Tec Biologicals, North
Brunswick, NJ
REASON Blood products, which were collected from a donor
who was taking the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit YA-114266.
RECALLING FIRM/MANUFACTURER Pyramid Biological
Corporation, Van Nuys, CA.
REASON Blood product, which was collected from a donor who
was not properly screened, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ
WEEK
ENDING NOVEMBER 24
PRODUCT Automated Blood Bank Analyzer
CODE ABS2000.
RECALLING FIRM/ MANFACTURER Immucor, Inc., Norcross,
Georgia
REASON Incorrect test results for ABO or Rh led to
incorrect interpretation for patient specimens, and could have resulted in the
issuance of an incompatible unit of blood.
PRODUCT 83 units
DISTRIBUTION Nationwide and Canada, Germany, Hong Kong,
Italy, Japan, Netherlands, Philippines, Portugal, Spain and Taiwan
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) Units 13FS73291, 13FS70715; b) Units 13FS73291,
13FS70715.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
PRODUCT 4 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced
CODE a) 21KR12623; b) 21KH47459
RECALLING FIRM/ MANFACTURER American Red Cross,
Portland, OR
REASON Blood products, collected from donors who reported
travel to an area designated as endemic for malaria, were distributed.
PRODUCT 2 units.
DISTRIBUTION DC and CA.
PRODUCT Counterfeit Neupogen (Filgrastim)
CODE 10/1.0 ml. single use vials per carton, Lot Number
P000890, Expiration Date 12/02.
RECALLING FIRM Grapevine Trading Company,
Springboro, OH
REASON Counterfeit Neupogen was distributed.
PRODUCT 30 vials.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Platelets, Pheresis; c)
Cryoprecipitated AHF; d) Fresh Frozen Plasma; e) Platelets Units
CODE a) Units 6356321, 6439274, 6605731; b) Units
8279884, 8331857, 8361895, 6691551; c) Unit
6356321; d) Units 6439274, 6605731;
e)
Units 6356321, 8501617 (split unit), 6439274, 6605731, 8425030 (split unit).
RECALLING FIRM/ MANFACTURER Community Blood Centers of
South Florida, Inc. Lauderhill, FL
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus, but were collected from a donor
who previously tested repeatedly reactive for the HIV antibody, were
distributed.
PRODUCT 17 units.
DISTRIBUTION FL, NC, NY, IL.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets; c)
Fresh Frozen Plasma
CODE a) Unit 13GL03314; b) Unit 13GL03314; c) Unit
13GL03314.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood products, collected from a donor who had a
tattoo within twelve months of donation, were distributed.
PRODUCT 3 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets
CODE a) Unit 13FM64909; b) Unit 13FM64909.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood products, collected from a donor who reported
having lived in an area designated as
endemic for malaria, were distributed.
PRODUCT 2 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced
CODE a) Unit 13LS50510; b) Unit 13LS49830.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Detroit, MI
REASON Blood products, collected from a donor who reported
having lived in an area designated as
endemic for malaria, were distributed.
PRODUCT 2 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Recovered Plasma
CODE a) Unit 10612-3125; b) Unit 10622-3951; c) Units
10612-3125, 10622-3951.
RECALLING FIRM/ MANFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ.
REASON Blood products, collected from a donor with a
history of Hepatitis A, were distributed.
PRODUCT 4 units.
DISTRIBUTION AZ and Switzerland.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) Unit L54929; b) Unit L54929.
RECALLING FIRM/ MANFACTURER Virginia Blood Services,
Richmond, VA
REASON Blood products, collected from an unsuitable donor,
were distributed.
PRODUCT 2 units
DISTRIBUTION VA.
PRODUCT a) Capture-R Ready-Screen (Pooled Cells) Test Wells,
Lot CW021 and N42, expiration 16 Mar 01; packaged as part of test kit lots 07613, 07614, 05559 or 05561.
b)
Capture-R Ready-Screen (I and II), Lots X2701, X2801, expiration date 16 Mar
01; lot X29,expiration 30 Mar 01;
packaged as part of test kit
lots
05567, 05568, 07607, 07608, 09661 or 09662.
c)
Capture-R Ready-Screen (4), Lot G0101, expiration 16 Mar 01; lot G02 expiration
30 Mar 01; Lot G03, expiration 13 Apr 01; packaged as a stand alone or part of
test kit lots, 09672, 09673, 09674, 09675, 11732, 11733, 11734 or 11735.
d)
Capture-R Ready-ID, Lot ID48, expiration 16 Mar 01; Lot ID49, expiration 30 Mar
01; packaged as part of test kits lots 0558 , 07616,
07622
or 09671.
CODE a) Lot CW021 and N42, expiration 16 Mar 01; packaged
as part of test kit lots 07613, 07614, 05559 or 05561.
b)
Lots X2701, X2801, expiration date 16 Mar 01; lot X29, expiration 30 Mar
01; packaged as part of test kit lots
05567, 05568, 07607, 07608,
09661
or 09662.
c)
Lot G0101, expiration 16 Mar 01; lot G02 expiration 30 Mar 01; Lot G03,
expiration 13 Apr 01; packaged as a stand alone or part of test kit
lots,
09672, 09673, 09674, 09675, 11732, 11733, 11734 or 11735.
d)
Lot ID48, expiration 16 Mar 01; Lot ID49, expiration 30 Mar 01; packaged as
part of test kits lots 0558, 07616, 07622 or 09671.
RECALLING FIRM/ MANFACTURER Immucor, Norcross, GA
REASON Use of the products may result in the failure to
detect some examples of Anti-Fya
PRODUCT 7,226 units
DISTRIBUTION Nationwide and in Australia, Belgium, Canada,
Denmark, England, Germany, Hong Kong, Hungary, Ireland, Italy, Japan,
Netherlands, Philippines, Portugal, Spain, Sweden, and Taiwan.
PRODUCT Platelets
CODE Units 07FF91308, 07FF91318, 07FF94474, 07FF82968,
07FF88679, 07FF84052, 07FF84050, 07FF87930, 07FF88249, 07FE02475, 07FF89971.
RECALLING FIRM/ MANFACTURER American National Red Cross,
Tucson, AZ
REASON Platelets, which were prepared from whole blood
units collected from donors who had taken aspirin within thirty-six hours of
donation, were distributed.
PRODUCT 11 units
DISTRIBUTION AZ, CA, and OK.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets; c)
Plasma Unit; d) Fresh Frozen Plasma
CODE a) Units 03GS47981, 03GV21077; b) Unit 03GV21077; c)
Unit 03GS47981; d) Unit 03GS47981.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Atlanta, GA
REASON Blood products, collected from a donor who had
sexual contact with an individual who had lived in an HIV Group O risk area,
were distributed.
PRODUCT 5 units
DISTRIBUTION GA and CA.
PRODUCT Platelets, Irradiated
CODE Unit 03LM95493
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, Atlanta, GA
REASON Blood product, corresponding to a unit of clotted
Red Blood Cells, was distributed.
PRODUCT 1 unit
DISTRIBUTION GA.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Unit R35403; b) Unit R35403
RECALLING FIRM/ MANFACTURER San Diego Blood Bank, San
Diego, CA
REASON Blood products, collected from a donor who took the
drug Proscar, were distributed.
PRODUCT 2 units
DISTRIBUTION CA and VA.
PRODUCT Pulmonary Artery
CODE Serial Number 6105688.
RECALLING FIRM/ MANFACTURER CryoLife, Inc., Kennesaw, GA
REASON Tissue for transplant was collected from a donor who
had not been properly evaluated.
PRODUCT 1 unit
DISTRIBUTION CA.
PRODUCT Pulmonary Hemi-Artery
CODE Serial Numbers 3988325, 3988333.
RECALLING FIRM/ MANFACTURER CryoLife, Inc., Kennesaw, GA
REASON Tissue for transplant which was collected from a
donor who had not been properly evaluated.
PRODUCT 2 unit
DISTRIBUTION CA and NY.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit C41140.
RECALLING FIRM/ MANFACTURER South Bend Medical
Foundation, Inc., South Bend, IN
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
PRODUCT 1 unit.
DISTRIBUTION IN.
PRODUCT Recovered Plasma
CODE Unit 3036738.
RECALLING FIRM/ MANFACTURER Central Florida Blood Bank,
Inc., Orlando, FL
REASON Blood product, untested for viral markers, was
distributed.
PRODUCT 1 unit.
DISTRIBUTION FL.
PRODUCT Red Blood Cells
CODE Unit 1906438.
RECALLING FIRM/ MANFACTURER Central Florida Blood Bank,
Inc., Orlando, FL
REASON Blood product, that tested repeatedly reactive for
the antibody to hepatitis B core antigen (anti-HBc), was distributed.
PRODUCT 1 unit.
DISTRIBUTION FL.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets; c)
Recovered Plasma
CODE a) Unit 01KX48736; b) Unit 01KX48736; c) Unit
01KX48736.
RECALLING FIRM/ MANFACTURER American Red Cross Blood
Services, West Henrietta, NY
REASON Blood products, collected from an unsuitable donor,
were distributed.
PRODUCT 3 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukoreduced
CODE Units 3035579, 4052218, 8605491.
RECALLING FIRM/ MANFACTURER Community Blood Center,
Inc., Appleton, WI
REASON Red Blood Cells, leukoreduced by filtration greater
than five days past the time of collection, were distributed.
PRODUCT 3 units.
DISTRIBUTION MI.
PRODUCT
Red Blood Cells, Leukoreduced
CODE Units 8052552, 8052554.
RECALLING FIRM/ MANFACTURER Community Blood Center,
Inc., Appleton, WI
REASON Red Blood Cells, leukoreduced by filtration greater
than five days past the time of collection, were distributed.
PRODUCT 2 units.
DISTRIBUTION MI.
PRODUCT Source Plasma
CODE Units (103 units) 0510144339, 0510145354,
0510145384, 0510145390, 0510145392, 0510145396, 0510145467, 0510145489,
0510145505, 0510145506, 0510145514, 0510145530, 0510145551, 0510145586,
0510145587, 0510143731, 0510143903, 0510144354, 0510144546, 0510145219,
0510145274, 0510145307, 0510145377, 0510145391, 0510145426, 0510145439,
0510145445, 0510145453, 0510145455, 0510145458, 0510145498, 0510145591,
0510145592, 0510145595, 0510145596, 0510145597, 0510145598, 0510145599,
0510145600, 0510144688, 0510144689, 0510144724, 0510144730, 0510144737,
0510144741, 0510144742, 0510144782, 0510144784, 0510144787, 0510144910,
0510144983, 0510145006, 0510145041, 0510145043, 0510145454, 0510145475,
0510145478, 0510145520, 0510145558, 0510145567, 0510145568, 0510145583,
0510145593, 0510142816,
0510142853,
0510143200, 0510143501, 0510143722, 0510143968, 0510143988, 0510144212,
0510144355, 0510138923, 0510139630, 0510141105, 0510142993, 0510143558,
0510143582, 0510143619, 0510143632, 0510143704, 0510143728, 0510144076,
0510144108, 0510144124, 0510144138, 0510144622, 0510144739, 0510144883,
0510144893, 0510144905, 0510144988, 0510145252, 0510145305, 0510145509,
0510145512, 0510143949, 0510144054, 0510144455, 0510141666, 0510140258,
0510140388, 0510145253.
RECALLING FIRM/ MANFACTURER Recalling Firm: Nabi, Boca
Raton, FL Manufacturer: Nabi Biomedical
Center, Nashville, TN.
REASON Blood products, which were stored at unacceptable
temperatures, were distributed.
PRODUCT 103 units.
DISTRIBUTION NY and NC.
PRODUCT Collagenase Santyl Ointment
CODE 15 grams and 30 grams, Lots (3 lots) 0000074200,
0000074201, 0000071342.
RECALLING FIRM/ MANFACTURER Advance Biofactures
Corporation, Lynbrook, NY
REASON Products, that were found to have exceeded the
potency specification, were distributed.
PRODUCT 3 lots (43,416 tubes).
DISTRIBUTION FL.
PRODUCT Engerix-B, Hepatitis B Vaccine
CODE 20 mcg/ml, Lot ENG33824A.
RECALLING FIRM/ MANFACTURERRecalling Firm: Warehouse
Distributor, Bindley Western Drug Company, Westbrook, ME
Manufacturer:
Glaxo SmithKline Beecham, Rixensart, Belgium.
REASON Vaccines that were stored under unacceptable
temperatures were distributed.
PRODUCT 970 units
DISTRIBUTION ME, NY, VT, MA, RI, NY.
PRODUCT Ortho Summit Processor, Model # 135028
CODE All serial numbers
RECALLING FIRM/ MANFACTURER Ortho Clinical Diagnostics,
Raritan, NJ
REASON The instrument failed to notify users of double row
washing and/or lack of row washing of microwell plates, and failed to display
an error message for an invalid test.
PRODUCT 114 instruments
DISTRIBUTION Nationwide.