JULY 2001
WEEK ENDING JULY 7
PRODUCT AND CODE: Red Blood Cells, unit
4056710; Platelets, unit 4056710
REASON: Blood products, collected from a donor with
Crohn’s disease, were distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center,
Dayton, OH
DISTRIBUTION: OH
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells
Leukoreduced, unit 12GR03564
REASON: Blood product, which was collected from a donor
with active post-poliomyelitis muscular atrophy, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Carolinas Region, Charlotte, NC
DISTRIBUTION: NC
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
1727888.
REASON: Blood products, collected from a donor with a
history of Hodgkin’s Disease, were distributed.
MANUFACTURER/RECALLING FIRM: Central Indiana Regional
Blood Center, Indianapolis, Indiana
DISTRIBUTION: IN and Switzerland
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 04R64529
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, New England Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells (2 units),
unit number 04GJ02418 (split unit)
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, New England Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
number 04FC79460
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, New England Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 53H77398
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, Greater Chesapeake and Potomac Region, Baltimore, MD
DISTRIBUTION: MD
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 29GX12243
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, Mid-Atlantic Region, Norfolk, VA
DISTRIBUTION: NC
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 29FW40076
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, Mid-Atlantic Region, Norfolk, VA
DISTRIBUTION: VA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 49GN04187
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, Southwest Region, Ponca City, OK
DISTRIBUTION: OK
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, units
12FQ48437, 12FP34499, 12FP34084, and 12FR52236; Fresh Frozen Plasma, unit
12FP34084;
Cryoprecipitated
AHF, unit 12FQ48437; Recovered Plasma, units 12FQ48437, 12FP34499, 12FQ44113,
and 12FR52236
REASON: Blood products, which were collected from a donor
with a history of Behcet’s Syndrome, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross,
Charlotte, NC
DISTRIBUTION: NC and Switzerland
QUANTITY: 10 units
PRODUCT AND CODE: Red Blood Cells, units
1233721, 1242026, 1246035, 1256941; Platelets, units 1233721, 1246035; Plasma,
unit 1242026
Fresh
Frozen Plasma, unit 1246035; Red Blood Cells, Leukocytes Reduced, unit 1274972;
Recovered Plasma, unit 1256941
REASON: Blood products, collected from an unsuitable donor
due to previously testing positive for HIV, were distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Kansas City, MO
DISTRIBUTION: MO, KS, CA
QUANTITY: 10 units
PRODUCT AND CODE: Red Blood Cells (6 units),
unit numbers 2201304, 8071111, 5032285, 5025214, 5016026, and 5005762
Platelets
(2 units), unit numbers 2201304 and 5032285
Cryoprecipitated
AHF (2 units), unit numbers 8071111 and 5025214
Fresh
Frozen Plasma (3 units), unit numbers 2201304, 5016026, and 5005762
Plasma,
Cryoprecipitate Removed (1unit), unit number 8071111
Recovered
Plasma (2 units), unit numbers 5032285 and 5025214
REASON: Blood products, that tested negative for
hepatitis, but were collected from an unsuitable donor based on previous
reactive hepatitis testing, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH
DISTRIBUTION: OH, FL,TN
QUANTITY: 16 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, units 0344150, 0345460, 0347722, 0347726, 0347733, 0347738
REASON: Blood products, which were labeled as leukoreduced
but did not undergo leukoreduction, were distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Kansas City, MO
DISTRIBUTION: KA
QUANTITY: 6 units
PRODUCT AND CODE: Platelets Pheresis,
Leukocytes Reduced (2 units), unit number 0079513 (split unit - 2 aliquots
distributed)
Platelets
Pheresis, Leukocytes Reduced Irradiated (3 units), unit numbers 0079516 (split
unit - 1 aliquot distributed) and 0079518
(split
unit - 2 aliquots distributed)
REASON: Blood products, that were labeled leukoreduced but
were not tested to determine the white blood cell count as required in the
firm's standard operating procedures, were distributed.
MANUFACTURER/RECALLING FIRM: Michigan Community Blood
Center, Grand Valley Blood Program, Grand Rapids, MI
DISTRIBUTION: MI
QUANTITY 5 units
PRODUCT AND CODE: Platelet, Pheresis,
Leukoreduced , unit 3872596
REASON: Blood product, with a low platelet count, was
distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, Texas
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 3809631; Cryoprecipitated AHF, unit number 3809631; Plasma,
Cryoprecipitate Removed, unit number 3809631
REASON: Blood products, collected from a donor who should
have been deferred due to use of the medication Arthrotec, were distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, Texas
DISTRIBUTION: TX
QUANTITY: 3 units
PRODUCT AND CODE: Red Blood Cells, unit
numbers 42W06650 and 42M97944; Red Blood Cells, Leukocytes Reduced, unit number
42FH96660; Platelets, unit number 42FH96660
REASON: Blood products, that tested negative for antibody
to hepatitis B core antigen (anti-HBc), but were collected from a donor that
previously tested repeatedly reactive for anti-HBc on more than one occasion,
were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Northern Ohio Region, Cleveland, OH
DISTRIBUTION: OH
QUANTITY: 4 units.
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 18GG34166
REASON: Blood product, that tested negative for antibody
to hepatitis B core antigen (anti-HBc), but was collected from a donor that
previously tested repeatedly reactive for anti-HBc on more than one occasion,
was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Great Lakes Region, Lansing, MI
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukocytes
Reduced, unit numbers 18FX26150 and 18FX26162
Platelets,
unit numbers 18FX26150, 18FX26158, 18FX26161, and 18FX26162
REASON: Blood products, collected from donors whose donor
suitability determinations were inadequately performed, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Great Lakes Region, Lansing, MI.
DISTRIBUTION: MI and MN
QUANTITY: 6
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 13GQ40747; Platelets, unit number 13GQ40747
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
DISTRIBUTION: MI
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, unit number
C24942
REASON: Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL
DISTRIBUTION: IL
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells (4 units),
unit numbers 3879151 and 3758915 (split units); Platelets Pheresis (1 unit),
unit number 3850090
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: TX
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, unit
number S60865; Platelets, unit number S60865
REASON: Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM: Michigan Community Blood
Center, Grand Valley Blood Program, Grand Rapids,MI
DISTRIBUTION: MI
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Reduced, unit number 3824411; Platelets, unit number 3824411; Source
Leukocytes, unit number 3824411; Recovered Plasma, unit number 3824411
REASON: Blood products, collected from an unsuitable donor
due to a history of residing in the United Kingdom for more than 6 months, were
distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: TX, NJ and NY
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, units
6241118, 6144105 ; Recovered
Plasma, units 6241118, 6144105
REASON: Blood products, collected from a donor with a
history of having tested positive for anti-HCV, were distributed.
MANUFACTURER: Michigan Community Blood
Center, Saginaw Valley Blood Program, Saginaw, Michigan
RECALLED BY: Michigan Community Blood Center, Grand
Valley Blood Program, Grand Rapids, Michigan
DISTRIBUTION: MI and Switzerland
QUANTITY: 4 units
PRODUCT AND CODE: Source Plasma, units
0420888166, 0420888436, 0420890211, 420890474, 0420891296, 0420891501,
0420892022, 0420892407, 0420893055, 0420893454
REASON: Blood products, collected from a donor who engaged
in high-risk behavior, were distributed.
MANUFACTURER: North American Biologicals,
Inc., Lansing, MI
RECALLED BY: North American Biologicals, Inc., Boca
Raton, FL
DISTRIBUTION: NC
QUANTITY: 10
PRODUCT AND CODE: Red Blood Cells, units 5068746,
5021652, 5006567, 4917781, 4865822, 4809574, 4750536; Platelets, units 5068746, 4089574; Plasma, unit 5021652;
Cryoprecipitate, units 5021652, 5006567;
Recovered Plasma, units 5068746, 4917781, 4089574, 4750536
REASON: Blood products, collected from a donor with a
history of hepatitis, were distributed.
MANUFACTURER/RECALLING FIRM: Carter BloodCare, Dallas, TX
DISTRIBUTION: TX
QUANTITY: 16 units
PRODUCT AND CODE: Hormodendrum
cladosporioides, lot 202032000
REASON: Allergenic extract, which failed initial bulk
sterility testing, was distributed.
MANUFACTURER/RECALLING FIRM: Allergy Laboratories, Inc.,
Oklahoma City, OK
DISTRIBUTION: OK
QUANTITY: 1 lot
PRODUCT AND CODE: Red Blood Cells, unit
18FT32301
REASON: Blood product, which was determined to have a
hematocrit value greater than 80%, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, Great
Lakes Region, Lansing, MI
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells Units 38L44237, 38FE33563, 38FE33278,
38K59003, 38E70908, 38K59036, 38E70946, 38E77059, 38FE35349, 38FE33509,
38FE32769, 38L43220.
Red
blood cells, Leukoreduced, Unit 38FC36671
Platelets,
Units 38FC36671, 38E70946
Fresh
Frozen Plasma, Units 38E70946, 38FE32769
Recovered
Plasma, Units 38L44550, 38FE33563, 38K59003, 38K59036,38L43220
REASON: Blood products, collected from donors who were not
asked the question regarding the use of the drug Propecia, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Fort Wayne, IN
DISTRIBUTION: CA, IN, MI, NY, OH and Switzerland
QUANTITY: 22 units
PRODUCT AND CODE: Whole Blood (1 unit), unit
number 0276103; Red Blood Cells (4 units), unit numbers 0249088, 2145854, 4102609,
and 4112519; Red Blood Cells, Leukocytes Reduced (4 units), unit numbers
0269990, 2166487, 0306783, and 2178914; Platelets (3 units), unit numbers
0249088, 2145854, and 4102609; Cryoprecipitated AHF (1 unit), unit number
2178914; Plasma (1 unit), unit number 2178914; Fresh Frozen Plasma (4 units),
unit numbers 0249088, 2145854, 4102609, and 0269990
REASON: Blood products 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-1, were
distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Kansas City, MO
DISTRIBUTION: MO, KS, NE
QUANTITY: 18 units
PRODUCT AND CODE: Recovered Plasma for use in
Manufacturing Injectable products, unit 1727888
REASON: Blood product, collected from a donor with a
history of Hodgkin’s Disease, were distributed.
MANUFACTURER/RECALLING FIRM: Central Indiana Regional
Blood Center, Inc., Indianapolis, IN
DISTRIBUTION: Switzerland
QUANTITY: 1 unit
PRODUCT AND CODE: Limulus Amebocyte Lysate
(LAL) Reagent Water, lot numbers 8L5410 and 9L3690
REASON: LAL Reagent Water, that may cause inhibition of
the LAL assay, was distributed.
MANUFACTURER/RECALLING FIRM: BioWhittaker, Inc.,
Walkersville, MD
DISTRIBUTION: Nationwide and Mexico, Brazil, South
Africa, Italy, Belgium, Sweden, Canada, and Pakistan
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, unit 01KX48677
REASON: Blood product, prepared from a unit of Whole Blood
with an extended collection time, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, New York-Penn Region, West Henrietta, NY
DISTRIBUTION: NY
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
53FL89870
REASON: Blood product, which was determined to have a
hematocrit value greater than 80%, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD
DISTRIBUTION: MD
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
number 13FY56324
REASON: Blood product, incorrectly tested for the Kell
antigen, was distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
DISTRIBUTION: MI
QUANTITY: 1 unit.
PRODUCT AND CODE: Red Blood Cells, unit
numbers 38FC69047 and 38FC69035
REASON: Blood products, labeled with a volume that was
below the firm’s minimum specification, were distributed.
MANUFACTURER/RECALLING FIRM: The American National Red
Cross, Indiana-Ohio Region, Fort Wayne, IN
DISTRIBUTION: IN
QUANTITY: 2 units
PRODUCT AND CODE: American Elm Allergenic
Extract, lot B710241A; White Ash Allergenic Extract, lot B712022A
REASON: Allergenic extracts, which were labeled with incorrect
expiration dates, were distributed.
MANUFACTURER/RECALLING FIRM: Allergy Laboratories of
Ohio, Inc., Columbus, OH
DISTRIBUTION: MD
QUANTITY: 2 lots
WEEK ENDING JULY 14
PRODUCT AND CODE: Red Blood Cells, Units
38FC51064, 38FC49042, 38FC45179, 38FC41705, 38FC37268, 38FC28609, 38FC26219,
38FC24456, 38FC22309, 38FC11373, 38FC09302, 38FC05504, 38FF55345, 38FC20100,
38FC15758, and 38FC13668.
Platelets,
Units 38FC51064, 38FC28609, 38FC24456, 38FC22309, 38FC11373, 38FC09302,
38FC05504, 38FC03172, 38FF55345, 38FC15758, and
38FC37268
Cryoprecipitate,
Units 38FC05504, 38FC03172, and 38FC13668.
Fresh
Frozen Plasma, Units 38FC51064, 38FC49042, 38FC37268, 38FC28609,
38FC26219, 38FC22309, 38FC11373,
38FF55345 and 38FC15758.
Recovered
Plasma, Units 38FC45179, 38FC41705, 38FC24456, 38FC09302, 38FC05504, 38FC03172,
38FC20100 and 38FC13668
REASON: Blood products, collected from a donor whose
family member answered the donor screening questions for them, were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Fort Wayne, IN
DISTRIBUTION: CA, IN, NY, and Switzerland
QUANTITY: 46
PRODUCT AND CODE: Source Plasma, Unit
19888736
REASON: Blood product, with a two times elevated ALT
level, was distributed for further manufacture.
MANUFACTURER/RECALLING FIRM: Sera-Tec Biologicals
Limited Partnership, Denton, Texas
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Unit
3808353
REASON: Blood product that was not quarantined after
receiving information concerning a post donation illness was distributed.
MANUFACTURER/RECALLING FIRM: Oklahoma Blood Institute,
Sylvan N. Goldman Institute, Oklahoma City, OK
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells Units
L04250, L02615, M84346, T52350, T033222,T031302, T028101, T025140, T012049,
T007397
Platelets,
Pheresis, Units T038725, T035305, T034495
Platelets
Units T031302, T012049, T007397
Fresh
Frozen Plasma Units L04250 (divided into 4 aliquots), L02615,T52350
REASON: Blood components were not tested for antibodies,
due to a computer software error, were distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas City, Topeka, KS
DISTRIBUTION: KA, CA, MO, AL
QUANTITY: 22 units
WEEK ENDING JULY 21
PRODUCT
AND CODE: Red Blood Cells, Leukocytes Reduced, units 50LG42192, 50LG42209
REASON: Blood products, collected from a donor whose arm had not been
adequately prepared prior to venipuncture, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Western Lake
Erie Region, Toledo, OH
DISTRIBUTION: OH
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit G02018; Platelets, units S30085,
G02018, G01613, G01828
REASON: Blood products, which were mislabeled as CMV antibody negative, were
distributed.
MANUFACTURER/RECALLING FIRM: Michigan Community Blood Center, Grand Valley
Blood Program, Grand Rapids, MI
DISTRIBUTION: MI and NY
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, unit 13GX30166; Platelets, unit 13GX30166;
Recovered Plasma, unit 13GX30166
REASON: Blood products, collected from a donor who was at increased risk for
new variant Creutzfeld Jakob Disease (nvCJD), were distributed
MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southeastern
Region, Detroit, MI
DISTRIBUTION: MI
QUANTITY: 3 units
PRODUCT AND CODE: Source Plasma, unit LP-32757
REASON: Blood product, collected from a donor who had a tatto within twelve
months of donation, was distributed
MANUFACTURER: Pyramid Biological Corporation, Las Vegas, NV
RECALL BY: Pyramid Biological Corporation, Van Nuys, CA
DISTRIBUTION: Germany
QUANTITY: 1 unit
WEEK ENDING JULY 28
PRODUCT AND CODE: Red Blood Cells,
units 2204298, 2204299; Recovered
Plasma, units 2204298, 2204299
REASON: Blood products, collected from donors with a
history of hepatitis or yellow jaundice due to mononucleosis, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria, OH
DISTRIBUTION: OH and FL
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells,
units 2121539, 2220589, 2150878,
2150958, 2121608; Platelets, Pheresis Leukoreduced, unit 2301361; Fresh Frozen Plasma, units 2150958, 2121608; Plasma, Cryo-reduced,
unit 2220589; Cryoprecipitated AHF,
units 2220589, 2150878
REASON: Blood products, collected from donors who were not
properly screened for high risk behaviors, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria, OH
DISTRIBUTION: OH and MD
QUANTITY: 11 units
PRODUCT AND CODE: Red Blood Cells, Leukocyte
Reduced, unit 0320837
REASON: Blood product, collected from a donor who had
self-administered the donor health history questions, was distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas, Kansas City, MO
DISTRIBUTION: KA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
units 42FX02312, 42FX02316, 42FX02319,
42FX02322, 42FX02324, 42FX02327, 42FX02328
REASON: Blood products, collected from a donor whose arm
preparation had not been appropriately performed prior to venipuncture, were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
DISTRIBUTION: OH
QUANTITY: 7 units
PRODUCT AND CODE: Red Blood Cells, unit 42K28860; Platelets, unit 42K28860
REASON: Blood products, collected from a donor who
reported having lived in an area designated as endemic for malaria, were
distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
DISTRIBUTION: OH
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, Pheresis, unit
42KP03951
REASON: Blood product, which had a low platelet count, was
distributed in interstate commerce.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Platelets, Pheresis,
Leukocyte Reduced, units 6931581,
6931561
REASON: Blood products, which did not meet the
specifications of a leukoreduced product, were distributed labeled as
leukroreduced.
MANUFACTURER/RECALLING FIRM: Central Indiana Regional
Blood Center, Inc., Indianapolis, IN
DISTRIBUTION: IN
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma, unit 38657702
REASON: Blood products, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed.
MANUFACTURER/RECALLING FIRM: Nabi Biomedical Center,
Corpus Christi, TX
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Corneas, OBO102017 (Left and Right)
REASON: Corneas that were collected from a donor who
tested repeatedly reactive for HBsAg, by another tissue procurement
organization, were distributed.
MANUFACTURER/RECALLING FIRM: Medical Eye Bank Maryland,
Baltimore, MD
DISTRIBUTION: MD and Washington, D.C.
QUANTITY: 1 set of corneas (left and right)
PRODUCT AND CODE: Red Blood Cells, units
04LE18901, 04G00238; Platelets, units 04LE18901, 04G00238; Fresh Frozen Plasma,
unit 04G00238; Recovered Plasma, unit 04LE18901
REASON: Blood products, collected from a donor taking the
drug Methotrexate, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, New
England Region, Dedham, MA
DISTRIBUTION: MA and VT
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 04KW85761
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross, New England
Region, Dedham, MA
DISTRIBUTION: MA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 01LH38531
REASON: Blood product, collected in a manner that
compromises the sterility of the unit, was distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, New York-Penn Region, West Henrietta, NY
DISTRIBUTION: NY
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, units
13FN46669, 13FL94655, 13FC01819; Red Blood Cells, Leukoreduced, units
13FJ51632, 13FG84442, 13FG84438
REASON: Blood products, corresponding to a unit of pooled
Platelets, that were implicated in a transfusion reaction, and found to be
contaminated with Staphylococcus, Coagulase negative, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Southeastern Region, Detroit, MI
DISTRIBUTION: MI
QUANTITY: 6 units
PRODUCT AND CODE: Red Blood Cells
Leukoreduced, unit 3821485
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: TX
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, units
KY74075, KQ88274 ; Recovered Plasma, units KY74075, KQ88274
REASON: Blood products, collected from a donor who had a
tattoo within twelve months of donation, were distributed.
MANUFACTURER Blood Centers of the Pacific, Peninsula South
Bay Center, Burlingame CA
RECALLED BY: Blood Centers of the Pacific, San
Francisco, CA
DISTRIBUTION: CA and Switzerland
QUANTITY: 4 units
PRODUCT AND CODE: Source Leukocytes, unit
3941253
REASON: Blood product, collected from a donor whose
suitability was not adequately determined, was distributed.
MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood
Center, Houston, TX
DISTRIBUTION: NJ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
38K83158; Platelets, unit 38K83158
REASON: Blood products, collected from a donor with
Erythropoietic Porphyria, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Fort Wayne, IN
DISTRIBUTION: IN
QUANTITY: 2 units
PRODUCT AND CODE: Source Plasma, units
28284512, 29963829
REASON: Blood products, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, were distributed.
MANUFACTURER/RECALLING FIRM: Nabi Biomedical Center,
Dallas, TX
DISTRIBUTION: CA
QUANTITY: 2 units
PRODUCT AND CODE: Red Blood Cells, unit
93-63862
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
92-59080
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
94-45725; Red Blood Cells, Irradiated, unit 90-11400; Platelets, unit 94-45725
Recovered
Plasma, units 94-45725, 90-11400
REASON: Blood products, collected from a donor who was
born in and traveled to an area considered to be high risk for anti-HIV-1/2,
Group O, were distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: KY, TN and CA
QUANTITY: 5 units
PRODUCT AND CODE: Red Blood Cells, Unit
93-56453
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 94-67515
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, unit 94-68398
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Medic Regional Blood
Center, Knoxville, TN
DISTRIBUTION: TN
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
6886092
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER/RECALLING FIRM: Blood Center of New
Jersey, Inc., East Orange, NJ
DISTRIBUTION: NJ
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, unit
19233-4761
REASON: Blood product, collected from a donor who reported
travel to an area designated as endemic for malaria, was distributed.
MANUFACTURER:
United Blood Services, Reno, NV
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, units
K45135, K42713, K34902, K31603; Platelets, unit K45135; Fresh Frozen Plasma,
units K42713, K34902; Frozen Plasma, unit K31603; Cryoprecipitate, unit K31603;
Recovered Plasma, unit K45135
REASON: Blood products, collected from a donor who
provided post donation information involving having engaged in high risk behaviors,
were distributed.
MANUFACTURER/RECALLING FIRM: Blood Centers of the
Pacific, Burlingame CA
RECALLED BY: Blood Centers of the Pacific, San
Francisco, CA
DISTRIBUTION: CA
QUANTITY: 10 units
PRODUCT AND CODE: Recovered Plasma, units 13FL94655,
13FC01819, 13FJ51632, 13FG84442, 13FG84438
REASON: Blood products, corresponding to a unit of pooled
Platelets, that were implicated in a transfusion reaction, and found to be
contaminated with Staphylococcus, Coagulase negative, were distributed.
MANUFACTURER/RECALLING FIRM: American Red Cross Blood
Services, Southeastern Region, Detroit, MI
DISTRIBUTION: MI
QUANTITY: 5
PRODUCT AND CODE: Red Blood Cells,
Leukoreduced, Irradiated, units
FR24643, FR24495, FR24580, FR24683, FR24592
REASON: Blood products, labeled with extended expiration
dates, were distributed.
MANUFACTURER/RECALLING FIRM: Delta Blood Bank,
Stockton, CA
DISTRIBUTION: CA
QUANTITY: 5 units
PRODUCT AND CODE: Platelets, units 2121560,
2111901, 2206052, 2221502
REASON: Blood products, prepared from four units of Whole
Blood with extended collection times, were distributed.
MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria,
OH 44035
DISTRIBUTION: OH
QUANTITY: 4 units
PRODUCT AND CODE: Red Blood Cells, unit
1284980
REASON: Blood product, labeled with an extended expiration
date, was distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas, Kansas City, MO
DISTRIBUTION: MO
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells,
Leukocytes Removed, unit 0340082
REASON: Blood product, labeled with an extended expiration
date, was distributed.
MANUFACTURER/RECALLING FIRM: Community Blood Center of
Greater Kansas, Kansas City, MO
DISTRIBUTION: MO
QUANTITY: 1 unit
PRODUCT AND CODE: Red Blood Cells, Leukoreduced,
units 12449-4200, 12450-3676
REASON: Blood products, which may not meet the parameter
for red blood cell recovery, were distributed.
MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,
Albuquerque, NM,
RECALLED BY: Blood Systems, Inc., Scottsdale, AZ
DISTRIBUTION: TX and NM
QUANTITY: 2 units
PRODUCT AND CODE: Platelets, unit G00613
REASON: Blood product, prepared from a unit of Whole Blood
with an extended collection time, was distributed.
MANUFACTURER/RECALLING FIRM: Michigan Community Blood
Center, Grand Valley Blood Program, Grand Rapids, MI
DISTRIBUTION: MI
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit
LA-48255
REASON: Blood product, collected from a donor whose arm
inspection and skin disease status had not been documented, was distributed.
MANUFACTURER:
Pyramid Biological Corporation, Van Nuys, CA.
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit
LP-27408
REASON: Blood product, collected from a donor whose arm
inspection and skin disease status had not been documented, was distributed.
MANUFACTURER:
Pyramid Biological Corporation, Las Vegas, NV
DISTRIBUTION: NJ
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit
G-53655-165
REASON: Blood product, collected from a donor whose arm
inspection and skin disease status had not been documented, was distributed.
MANUFACTURER:
Pyramid Biological Corporation, Las Vegas, NV
DISTRIBUTION: CA
QUANTITY: 1 unit
PRODUCT AND CODE: Source Plasma, unit
LP-25981
REASON: Blood product, collected from a donor whose health
history screening was inadequately performed, was distributed.
MANUFACTURER: Pyramid Biological Corporation, Las Vegas,
NV
RECALLED BY: Pyramid Biological Corporation, Van Nuys,
CA
DISTRIBUTION: Austria
QUANTITY