SEPTEMBER 2007
WEEK ENDING SEPTEMBER 1
PRODUCT Red
Blood Cells
CODE Unit:
3955300
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, collected from
an unsuitable donor based on residence in an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Source Plasma
CODE
Units: 04PWID9915,
04PWIE0397
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services LP, Deerfield, IL
REASON Blood products, which were not properly
quarantined after receiving post donation information regarding a history of
incarceration, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION CA
PRODUCT
a)
Cryoprecipitated AHF,;
b) Platelets,
c) Fresh Frozen Plasma,
d) Plasma Frozen
Cryoprecipitate Reduced,
e) Platelets Leukocytes Reduced,
CODE
a) Units 032KC11962, 032KE26911,
032KE26985, 032KE78325, 032KF73185, 032KF77699,
032KF83791, 032KM32682, 032KQ48678, 032KQ48783,
032KQ50697, 032KQ56596, 032KT12914, 032KT12996, 032KT14572, 032KT14697, and 032KV07140;
b) Units 032GL61122,
032GL73918, 032GL76657, 032KC10116, 032KE15609,
032KE21519, 032KE22564, 032KE25346, 032KE27198, 032KE27443, 032KE32317, 032KE39118, 032KE40592, 032KE43732, 032KE53792,
032KF74382, 032KF76327, 032KF76601, 032KF77445,
032KF82337, 032KF85277, 032KJ46307, 032KJ57813,
032KJ67668, 032KJ67831, 032KJ69578, 032KJ71946, 032KJ73026,
032KJ75425, 032KJ77686, 032KL06520, 032KM20236,
032KM20352, 032KM28047, 032KQ48748, 032KQ50535,
032KQ51773, 032KQ55703, 032KQ56511, 032KQ60117,
032KQ64710, 032KQ76385, 032KQ95412, 032KQ96168,
032KS00644, 032KS01086, 032KY13829, 032KY14115, 032KY18487, and 032LF39881;
c) Units 032FE99895, 032FT08805,
032GK89412, 032GL63693, 032GL73918, 032GL76657,
032GL76868, 032GR28938, 032KC10116, 032KC10818, 032KC16110, 032KC28957, 032KC31594, 032KC31933, 032KE14154,
032KE15609, 032KE21519, 032KE22564, 032KE27443,
032KE32317, 032KE53792, 032KE57103, 032KE59063,
032KE59786, 032KE61466, 032KE67785, 032KE67806, 032KE72484, 032KF76327, 032KF76601, 032KF77445, 032KF84816, 032KF85161,
032KJ57813, 032KJ67668, 032KJ67831, 032KJ69321,
032KJ69578, 032KJ71946, 032KJ75207, 032KJ75425,
032KJ77686, 032KJ91002, 032KJ99567, 032KL06520, 032KM35063, 032KN07217, 032KN07394, 032KN10156, 032KQ46626, 032KQ55703,
032KQ60117, 032KQ64710, 032KQ95412, 032KR14369,
032KS00644, 032KS01086, 032KT20885, 032KT26788,
032KY14115, 032KY17968, 032KY17979, 032KY18487,
032LF39881, 032LL96570, and 032LX27605;
d) Units 032KF77699, 032KT12914, and
032KT12996;
e) Units 032KC31594, 032KE59063, 032KE59786, 032KE67785,
032KE72432, 032KE72484, 032KN07217, 032KN10048,
032KN10156, 032KN10391, 032KN21593, 032KT09585,
032KT10862, 032KT26788, 032KV01617, and
032KV08233
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI
REASON Blood products, which were manufactured
from a whole blood unit in which an associated blood component contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 152
units
DISTRIBUTION GA, WI, AL, ID, NC, IL, OH, MA, MI,
IA, CA, PR, MN, and
NY
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 04H65631
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, New England
Region, Dedham, MA.
REASON Blood
product, which was manufactured from a whole blood unit in which an associated
blood component was hemolyzed, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Recovered
Plasma
CODE Unit:
1877603
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, collected from a donor
who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Fresh
Frozen Plasma
CODE Units: 7195822 and
7191732
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product,
collected from a donor who was at increased risk for variant Creutzfeldt-Jakob
Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION FL
PRODUCT
a)
Platelets Pheresis Leukocytes Reduced,
b) Platelets
Pheresis Leukocytes Reduced Irradiated,
c) Platelets
Pheresis Leukocytes Reduced Washed,
CODE
a) Units: 032FT09303, 032FT09304,
032FT09308, 032FT09313, 032FT09314, 032FT09317,
032FT09317, 032FT09320, 032FT09331, 032FT09339,
032FT09342, 032FT09343, 02FT09344, 032FT09345, 032FT09347,
032FT09348, 032FT09350, 032FT09351, 032FT09352,
032FT09355, 032FT09357, 032FT09358, 032FT09360,
032FT09365, 032FT09367, 032FT09368, 032FT090369, 032FT09373, 032FT09374,032FT09375, 032FT09384, 032FT09388,
032FT09390, 032FT09396, 032FT09399, 032FT09401,
032FT09415, 032FT09418, 032FT09448, 032FT09448,
032FT09454, 032FT09476, 032FT09496, 032FT09511, 032FT09537,
032FT09537, 032FT09540, 032FT09540, 032FT09568,
032FT09579, 032FT09580, 032FT09585, 032FT09586,
032FT09586, 032FT09587, 032FT09597, 032FT10405, 032FT10410, 032FT10417, 032FT10426, 032FT10433, 032FT10444,
032FT10446, 032FT10463, 032FT10466, 032FT10466,
032FT10467, 032FT10467, 032FT10471, 032FT10478,
032FT10478, 032FT10479, 032FT10485, 032FT10486, 032FT10510,
032FT10512, 032FT10512, 032FT10530, 032FT10530,
032FT10531, 032FT10532, 032FT10545, 032FT10547,
032FT10553, 032FT10553, 032FT10559, 032FT10559, 032FT10565, 032FT10584, 032FT10589, 032FT10600, 032FT10602,
032FT10602, 032FT10610, 032FT10610, 032FT10619,
032FT10625, 032FT10627, 032FT10637, 032FT10637,
032FT10640, 032FT10640, 032FT10642, 032FT10654, 032FT10654, 032FT10655, 032FT10657, 032FT10659, 032FT10678, 032FT10679,
032FT10684, 032FT10686, 032FT10687, 032FT10702,
032FT10716, 032FT10717, 032FT10722, 032FT10722,
032FT10728, 032FT10734, 032KM38194, 032KM38195, 032KM38196, 032KM38197, 032KM38197, 032KM38211, 032KM38212,
032KM38252, 032KM38252, 032KM38271, 032KM38271,
032KM38272, 032KM38319, 032KM38320, 032KM38334,
032KM38356, 032KM38359, 032KM38406, 032KM38406,
032KM38416, 032KM38441, 032KM38442, 032KM38443,
032KM38443, 032KM38455, 032KM38474, 032KM38475, 032KM38480, 032KM38480, 032KM38497, 032KM38501, 032KM38508,
032KM38518, 032KM38520, 032KM38522, 032KM38531,
032KM38534, 032KM38569, 032KM38572, 032KM38593,
032KM38594, 032KM38595, 032KM38595, 032KM38596,
032KM38596, and 032KM38599;
b) Units: 032FT09325,
032FT09332, 032FT09349, 032FT09370, 032FT09424,
032FT09456, 032FT09457, 032FT09507, 032FT10405, 032FT10528, 032FT10558, 032FT10593, 032FT10717, 032FT10738,
032KM38571, and 032KM38571;
c) Units: 032FT09305,
032FT10482, 032KM38500, and 032KM38535
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Madison, WI
REASON
Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 186 units
DISTRIBUTION IL
and WI
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced
CODE Units: 6142999 (Part A) and 6142999 (Part
B)
RECALLING FIRM/MANUFACTURER Central Texas Regional
Blood & Tissue Center, Austin, TX
REASON Blood products,
which did not meet acceptable product specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Units: 6167049, 6167041,
6167045, 6167011, 6167029, 6167032, 6167036, 3240287, 3240337, 6167034, 3240360,
3240362, 1721443, 3240351, 3240334, 3240340, 3240365, 3240342, 3240364, 6167008,
1721441, 3240281, 3240330, 3240286, 3240356, 3240289, 3240336, 3240333, 3240349,
and 6167007
RECALLING FIRM/MANUFACTURER Central Texas
Regional Blood and Tissue Center, Austin, TX
REASON Blood
products, which were not manufactured in accordance with standard operating
procedures (SOP), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 30 units
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced
CODE Units: 3837230 (split
unit)
RECALLING FIRM/MANUFACTURER Central Indiana
Regional Blood Center, Inc., Indianapolis, IN
REASON Platelets, HLA incompatible with the
designated recipient but labeled HLA compatible, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Source
Plasma,
CODE Units: I72030362,
I72056790, I72041212, I72056969, I72053241, I72035673, I72026220, I72035677, and
I72050808
RECALLING FIRM/MANUFACTURER International
BioResources, Llc, Fort Worth, TX
REASON Blood products, collected from donors
who did not have a complete medical history interview, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION NC
PRODUCT Source Plasma
CODE
Units: I72043020,
I72035266, 364004672, I72052454, I72043647, I72052144, I72052434, 364004621,
I72047356, I72054961, I72041195, 364001990, I72034585, 364001842, I72053858,
I72036569, 364003764, 364003693, 364004896, 364000177, I72055055, I72058575,
I72056802, I72039771, I72058884, I72050211, I72044745, and
I72056290
RECALLING FIRM/MANUFACTURER International
BioResources, Llc., Fort Worth, TX
REASON Blood products, collected from
donors who did not have a complete medical history interview, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 28
units
DISTRIBUTION NC
WEEK ENDING SEPTEMBER 8
PRODUCT Fresh
Frozen Plasma
CODE Unit:
9040539
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, collected from a donor
who received rabies vaccine, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Fresh
Frozen Plasma
CODE Unit:
03M72705
RECALLING FIRM/MANUFACTURER Mayo Clinic
Rochester Division of Transfusion Medicine, Rochester, MN
REASON
Blood
product, collected from a donor who received a body piercing within 12 months of
donating, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Recovered
Plasma
CODE Unit:
3952910
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, which was collected from
an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease
(vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
Recovered Plasma
CODE Unit:
4853593
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL, by facsimile on March 7, 2006.
REASON
Blood product, which was collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1unit
DISTRIBUTION AL
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Unit: 9876918 (split
product)
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Units: 53LT93418, 53LT93424, and
53LT93436
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD
REASON
Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION MD
and
DC
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Units: 53LT92257 (split
unit)
RECALLING FIRM/MANUFACTURER American National Red
Cross-Greater Chesapeake and Potomac Region, Baltimore, MD
REASON
Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MD
PRODUCT
a)
Cryoprecipitated AHF,
b) Plasma Cryoprecipitate Reduced,
CODE
a) and b) Unit:
J58617
RECALLING FIRM/MANUFACTURER Virginia Blood
Service, Inc., Richmond, VA
REASON Blood product, which was
manufactured from a whole blood unit in which an associated blood component
contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION VA and
NC
PRODUCT
Cryoprecipitated AHF,
CODE Unit:
H58881
RECALLING FIRM/MANUFACTURER Virginia Blood
Service, Inc., Richmond, VA
REASON Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: J32626
RECALLING
FIRM/MANUFACTURER Virginia Blood Service, Inc., Richmond, VA
REASON
Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Units: 5609059 and
5609099
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood products, which did not
meet acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT
Red
Blood Cells Leukocytes Reduced Irradiated
CODE Unit: 4320311 (split
product)
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ
REASON Blood products, which were collected
from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Units: 5617247, 3776422, and
5571330
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood products, which were
collected
from a donor who had traveled to areas considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION LA
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Unit: 7119005 (split
product)
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: 4320230
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON
Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
Fresh
Frozen Plasma
CODE Unit:
7212391
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, collected from a
therapeutic donor and not labeled to indicate the type of donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Unit: 71X307875
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT
Red
Blood Cells Leukocytes Reduced,
CODE Unit: 7792066
RECALLING
FIRM/MANUFACTURER Coral Blood Services, Inc., Scarborough, ME
REASON
Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
CODE a) and b) Unit:
5612960
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood product, which was improperly
tested for syphilis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION LA
WEEK ENDING SEPTEMBER 15
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 163869885
RECALLING
FIRM/MANUFACTURER Blood Systems Inc, Scottsdale, AZ
REASON
Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 157397539
RECALLING
FIRM/MANUFACTURER Blood Systems Inc, Lubbock Center, Lubbock, TX
REASON
Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Units: 157403764 and
150157219
RECALLING FIRM/MANUFACTURER Blood Systems Inc,
Lubbock Center, Lubbock, TX
REASON Blood
product, which was collected from a donor who had traveled to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 163863693
RECALLING
FIRM/MANUFACTURER Blood Systems Inc, Scottsdale, AZ
REASON
Blood product, which was collected from
a donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT
a)
Red Blood Cells
b) Platelets
c)
Fresh Frozen Plasma
CODE a), b), and
c) 04LE69672
RECALLING FIRM/MANUFACTURER ARC Blood
Services, New England Region, Dedham, MA
REASON Blood product, which
tested negative for the antibody to the human immunodeficiency virus (anti-HIV)
but was collected from a donor who previously tested positive for anti-HIV, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MA and
ME
PRODUCT
a)
Red Blood Cells
b) Fresh Frozen Plasma
CODE a) and b) Unit:
04LE66272
RECALLING FIRM/MANUFACTURER ARC Blood Services,
New England Region, Dedham, MA
REASON Blood product, which tested negative for
the antibody to the human immunodeficiency virus (anti-HIV) but was collected
from a donor who previously tested positive for anti-HIV, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Source Plasma
CODE
Unit:
04SMNB1663
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services LP, Deerfield, IL
REASON Blood product, which was not quarantined
after receiving information regarding a post-donation illness, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Austria
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells,
CODE
a) and b) Unit:
1036920
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood products, collected from a donor
for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT Source Plasma
CODE
Units: 03PWIF6155,
03PWIF6897, 03PWIF7706, 03PWIF8221, 03PWIF8997, 03PWIF9479
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services LP, Deerfield, IL
REASON
Blood products, collected from a donor
who received an MMR immunization, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 6
units
DISTRIBUTION CA
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit: 9974212
RECALLING
FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced
CODE Units: 112532254 (parts 1 &
2)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. dba
United Blood Services, El Paso, TX
REASON Blood products, collected in a manner
that may compromise the sterility of the products, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX and
NM
PRODUCT Platelets
CODE
Unit:
FN03349
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA
REASON Blood product, associated with a unit of
Red Blood Cells that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Units: 150156060, 150159311,
150159974
RECALLING FIRM/MANUFACTURER Blood Systems, Inc
- Lubbock Center, Lubbock, TX
REASON Blood products, which tested
negative for hepatitis, but were collected from a donor with a history of
Hepatitis A, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION TX
PRODUCT Platelets
CODE
Unit: N60150
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids, MI
REASON
Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT
a)
Red Blood Cells
b) Cryoprecipitated AHF
c) Plasma Cryoprecipitate Reduced
CODE
a), b), and c) Units:
3485683
RECALLING FIRM/MANUFACTURER Lifesource, Glenview,
Chicago, IL
REASON Blood product, which was collected from
a donor with a history of multiple high risk behaviors, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IL
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 5619083
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA,
REASON
Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Cryoprecipitated
AHF,
CODE Unit:
KE84243
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA
REASON Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 242457339
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON
Blood product, which was collected in a
manner that may have compromised the sterility of the collection system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SD
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated
CODE Units: 2126749 (split
unit)
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ
REASON Blood products, which were collected
from a donor who had traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Platelets
CODE
Unit:
1129542
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 4506920
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Source Plasma
CODE
Units: 0010071827,
0010073024, 0010073061, 0010073110, 0010073324, 0010071744, 0010073926,
0010073426, 0010074009, 0010074158, 0010074295, 0010074594, 0010075158,
0010075438, 0010075459, 0010075614, 0010075619, 0010075862, 0010075896,
0010076106, 0010076452, 0010076455, 0010076461, 0010076679,
0010076809
RECALLING FIRM/MANUFACTURER Biomat USA, Inc.,
Allentown, PA,
REASON Blood products, collected from a donor
who did not have a complete medical history interview, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 25
units
DISTRIBUTION Spain
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 22LJ99237
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey,
Philadelphia, PA
REASON Blood product, which was incorrectly
labeled as to red cell antigen type, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT
a)
Cryoprecipitated AHF,
b) Plasma Cryoprecipitate Reduced,
Recall # B-1458-07;
c) Fresh Frozen Plasma,
CODE
a) 032KC37300, 032KC37301, 032KC37302,
032KC37303, 032KC37304, 032KC37305, 032KC37306,
032KC37307, 032KC37309, 032KC37310, 032KC37311,
032KC37312, 032KC37313, 032KC37314, 032KC37315,
032KC37316, 032KC37317, 032KC37318, 032KC37321, 032KC37322, 032KC37324, 032KC37325, 032KC37326, 032KC37328,
032KC37329, 032KC37330, 032KC37361, 032KC37362,
032KC37363, 032KC37364, 032KC37365, 032KC37366,
032KC37367, 032KT27641, 032KT27642, 032KT27644,
032KT27663, 032KT27664, 032KT27667, 032KT27668,
032KT27672, 032KT27673, 032KT27674, 032KT27676, 032KT27678, 032KT27679, 032KT27680, 032KT27683, 032KT27684,
032KT27685, 032KT27687, 032KT27688, 032KT27689,
032KT27690, 032KT27691, 032KT27694, 032KT27696,
032KY21510, 032KY21511, 032KY21512, 032KY21513,
032KY21516, 032KY21517, 032KY21519, 032KY21537,
032KY21554, 032KY21557, 032KY21558;
b) 032KC37357, 032KT27623, 032KT27684,
032KT27691, 032KY21511, 032KY21547;
c) Unit:
032KN22773
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Madison, WI
REASON Blood products,
which were incorrectly labeled with an extended expiration date, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 75
units
DISTRIBUTION WI
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Red Blood Cells
Leukocytes Reduced Irradiated
CODE
a)
Units: 032FC57431, 032FC57495, 032FC57499, 032FC57502, 032FC57503, 032FC57504, 032FC57632, 032FC57633, 032FC57638,
032FC57641, 032FC57653, 032FC57655, 032FC58010,
032FC58285, 032FC58464, 032FC58476, 032FC58921,
032FC59065, 032FC59067, 032FC59131, 032FC59135, 032FC59138, 032FC59378, 032FC59526, 032FC59657, 032FC59670, 032FC59676,
032FC59883, 032FC59887, 032FC59888, 032FC59890,
032FC59895, 032FC59899, 032FC60269, 032FJ20894,
032FJ20901, 032FJ21423, 032FJ21429, 032FJ21758, 032FJ22548, 032FJ22692, 032FJ22718, 032FJ22859, 032FJ23003, 032FJ23548,
032FJ25022, 032FJ25203,
032FJ25219, 032FJ25531, 032FJ25666, 032GC08497, 032GC08600, 032GC08607, 032GC08609, 032GC08923, 032GC08924, 032GC08930,
032GC08935, 032GC08941, 032GC09887, 032GC10336,
032GC10337, 032GC10685, 032GC12140, 032GC12675,
032GC12676, 032GC12677, 032GC12680, 032GC12681, 032GC12683, 032GC12720, 032GC12968, 032GE56073, 032GE56212, 032GE56306,
032GE56309, 032GE56314, 032GE56328, 032GE56677,
032GE56691, 032GE57729, 032GE57733, 032GE57743,
032GE57885, 032GE58032, 032GE58248, 032GF65144, 032GF65925, 032GF66352, 032GF67365, 032GF68305, 032GF68310,
032GM15678, 032GM15776, 032GM15795, 032GM15798,
032GM16039, 032GM16040, 032GM16752, 032GM16756, 032GM16760, 032GM16786, 032GM16884, 032GM16887, 032GM16888,
032GM16983, 032GM16985, 032GM16995, 032GR82668,
032GR82888, 032GR82900, 032GR82908, 032GR84166,
032GR84183, 032GR84186, 032GR84324, 032GR84601, 032GR84770,
032GR84771, 032GR84962, 032GR85076, 032GR85586,
032GR89325, 032GR89380, 032GR89612, 032GR89613,
032GR89617, 032GR89619, 032GR90495, 032GR90527, 032GR90528, 032KC37680, 032KC38136, 032KC38138, 032KC39579,
032KC39588, 032KC39722, 032KC39723, 032KC39728,
032KC39730, 032KC39759, 032KC40505, 032KC40506,
032KC40823, 032KC40830, 032KC40836, 032KC40838, 032KC40842, 032KC40843, 032KC41387, 032KC41495, 032KC41505, 032KC41528,
032KC41529, 032KC41530, 032KC41531, 032KE80078,
032KE80111, 032KE82018, 032KE82312, 032KE82374,
032KE82989, 032KE83006, 032KE83012, 032KE83259, 032KE83285, 032KE85830, 032KE85831, 032KE85832, 032KE85843, 032KE85953,
032KE85956, 032KE86785, 032KE87191, 032KE87192,
032KE87416, 032KE87471, 032KL13873, 032KN25769,
032KN25772, 032KN25775, 032KN25786, 032KN27677, 032KN27679, 032KN27680, 032KN27684, 032KN27685, 032KN27716, 032KN28079,
032KN28085, 032KN28138, 032KN28139, 032KN28141,
032KN28148, 032KN28542, 032KN28544, 032KN29030,
032KR16128, 032KR17057, 032KR17995, 032KR17997, 032KR17999, 032KR18000, 032KR18115, 032KR18426, 032KR18427, 032KR18429,
032KR18431, 032KR18506, 032KR19967, 032KR19969,
032KR19972, 032KR20177, 032KR20185, 032KR20224,
032KR20226, 032KR20241, 032KR20334, 032KR20337, 032KR20345, 032KR20347, 032KR20350, 032KR20359,032KR20360, 032KR20362,
032KR20424, 032KS04710, 032KS04711, 032KS04720,
032KS04741, 032KS05044, 032KS05137, 032KS05140,
032KS05142, 032KS05144, 032KS05145, 032KS05182, 032KS05185, 032KS05187, 032KS05268, 032KS05837, 032KS05842, 032KS05954,
032KT28273, 032KT28275, 032KT28280, 032KT28342,
032KT28343, 032KT28345, 032KT29614, 032KT29618,
032KT29631, 032KT29632, 032KT29840, 032KT29860, 032KT29876, 032KT29900, 032KT29902, 032KT29904, 032KT29911, 032KT30087,
032KT30090, 032KT30114, 032KT30121, 032KT30210,
032KT30234, 032KT30237, 032KT30349, 032KT31242,
032KT31259, 032KT31681, 032KT31688, 032KT32203, 032KT32329, 032KT32369, 032KT32376, 032KT32388, 032KT32415, 032KT32830,
032KT32845, 032KT32876, 032KT33022, 032KT33826,
032KT36190, 032KT36192, 032KT36193, 032KT36218,
032KT37008, 032KT37029, 032KT37420, 032KT38560, 032KT38561, 032KT38562, 032KT38568, 032KV10643, 032KV11843, 032KV13082,
032KV13103, 032KV13542, 032KV13618, 032KV13619,
032KV13623, 032KV13630, 032KV13873, 032KV13876,
032KV13877, 032KV13879, 032KV13881, 032KV13905, 032KV13911, 032KV13919, 032KZ00288, 032KZ00619, 032KZ00647, 032KZ00990,
032KZ00992, 032KZ00995, 032KZ01000, 032KZ01008,
032LE09742, 032LE09744, 032LF57613, 032LF57924,
032LF57928, 032LF58085, 032LF58088, 032LF58200, 032LF58201, 032LF58202, 032LF58204, 032LF58692, 032LF58713, 032LF58714,
032LF58715, 032LF58716, 032LF58737, 032LF58902,
032LF58997, 032LF59001, 032LF59668, 032LF59670,
032LF59676, 032LF59685, 032LF59757, 032LF59759, 032LF59937, 032LF59959, 032LF60012, 032LF60277, 032LF60283, 032LF60287,
032LF60289, 032LF60292, 032LF60571, 032LF60573,
032LG08327, 032LG08669, 032LG08964, 032LG09049,
032LG09121, 032LJ11842, 032LJ12066, 032LJ12071, 032LJ12073, 032LJ12075, 032LJ12079, 032LJ12113, 032LJ12126, 032LJ12275,
032LJ12602, 032LJ12874, 032LV26335, 032LW16104,
032LX37772, 032LX38637, 032LX38674, 032LX38676,
032LX38689, 032LX38706, 032LX38722, 032LX38829, 032LX39764, 032LX42218, 032LX42219, 032LX42358, 032LX43294, 032LX43297,
032LX43304 032LX43363, 032LX43831, 032LX43868,
032LX43921;
b) Units: 032FC58463, 032FC59784, 032FJ25213, 032GC08507,
032GC08597, 032GC08606, 032GC09144, 032GC09994,
032GC10696, 032GC11632, 032GC11641, 032GC12986,
032GF65137, 032GM16091, 032GM16754, 032GR85581, 032GR85597, 032KC38135, 032KC39295, 032KC39428, 032KC41504,
032KE80254, 032KE83260, 032KE87190, 032KL14771,
032KL14788, 032KL14856, 032KN25779, 032KN28084,
032KR17055, 032KR17996, 032KR18436, 032KS05821, 032KT30065, 032KT30075, 032KT30201, 032KT30209, 032KT31136, 032KT31143,
032KT33646, 032KT33654, 032KT33829, 032KT33839,
032KT37007, 032KV10639, 032KV11216, 032KZ00294,
032KZ00630, 032LF58521, 032LF58723, 032LF59802, 032LF59925, 032LJ12112, 032LJ12430, 032LX37162, 032LX38827, 032LX40706,
032LX43801
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI
REASON Blood products,
which failed to meet the minimum specification for hematocrit and red blood cell
recovery, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 450 units
DISTRIBUTION WI, IL, MA,
and
PA
PRODUCT Fresh
Frozen Plasma
CODE Unit:
4632058
RECALLING FIRM/MANUFACTURER Anne Arundel Medical
Center Blood Bank, Annapolis, MD
REASON Blood product, which
was not manufactured in accordance to current Good Manufacturing Practices, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Fresh
Frozen Plasma
CODE Unit:
4632215
RECALLING FIRM/MANUFACTURER Anne Arundel Medical
Center Blood Bank, Annapolis, MD
REASON Blood product, which
was not manufactured in accordance to current Good Manufacturing Practices, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
WEEK ENDING SEPTEMBER 22
PRODUCT
a) Red
Blood Cells, Leukocytes Reduced
b) Cryoprecipitated AHF
c) Plasma, Cryoprecipitate
Reduced
d) Recovered Plasma
CODE
a) Unit: 4041220;
b) Units: 5600008,
7110721;
c) Unit: 5600008;
d) Units: 7110721, 3771359,
9704332
RECALLING FIRM/MANUFACTURER
Recalling Firm:
LifeShare Blood Centers, Shreveport, LA
REASON Blood products, collected from a donor
considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD)
due to family history, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 7 units
DISTRIBUTION LA and
Switzerland
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit:
029GW50990
RECALLING FIRM/MANUFACTURER American National
Red Cross Mid Atlantic Region, Norfolk, VA
REASON Blood product, collected in a manner
that may have compromised the sterility of the collection system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Red Blood
Cells
CODE Unit:
8743786
RECALLING FIRM/MANUFACTURER Union Memorial
Hospital Bb, Baltimore, MD
REASON Blood product, which was collected
from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit:
5825350
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood product, which was
collected from a donor in which donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated
CODE Unit: FR67264
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, with incomplete
documentation of the irradiation process, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT
a)
Platelets Pheresis Leukocytes Reduced
b) Platelets
Pheresis Leukocytes Reduced Irradiated
CODE
a) and b) Units:
1162662
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit:
306594711
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected using an
abbreviated screening process for which the donor was not eligible, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION ND and Switzerland
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit:
306583787
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected using an
abbreviated screening process for which the donor was not eligible, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red
Blood Cells, Leukocytes Reduced
b) Red Blood Cells (Apheresis), Leukocytes
Reduced
CODE
a) Unit: 306579512;
b) Units: 306574366
(split product)
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Blood Systems, Inc., Scottsdale, AZ
REASON Blood products, collected from donors
using an abbreviated screening process for which they were not eligible, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL and ND
PRODUCT Platelets
Pooled Leukocytes Reduced Irradiated
CODE Unit: KR13977
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, labeled “leukoreduced”,
but which had not undergone leukoreduction, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: FT10681
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, collected from a donor
who was taking the drug Proscar, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Platelets
Pheresis Leukocytes Reduced
CODE Unit: 71X43758-9
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: LS95174
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: KC11880
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, collected from a donor
who reported having malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Fresh Frozen Plasma
CODE
a) and b) Unit:
J08210
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Inc., Richmond, VA
REASON Blood products, collected from a donor
considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC and
VA
PRODUCT Fresh
Frozen Plasma (Apheresis)
CODE Unit:
4326915
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shewsbury, NJ
REASON Blood product, collected from a donor
considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: 306599502
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product,
collected from a donor who reported living in a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION ND
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: LV00505
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, which was not evaluated
by the firm when returned due to possible hemolysis, was
re-distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT
a)
Red Blood Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit: J25560;
b) Unit:
J43395
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Inc., Richmond, VA
REASON Blood products, collected from donors
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION VA and
Switzerland
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Unit: 4916582
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood product, labeled as leukoreduced, but which did not meet the requirements for a leukoreduced
product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a)
Red Blood Cells
b) Platelets Irradiated
c) Fresh Frozen Plasma
CODE
a) and c) Units: R69417,
K91427;
b) Unit: R69417
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA
REASON
Blood products, collected from a donor
with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5
components
DISTRIBUTION VA
PRODUCT
a)
Cryoprecipitated AHF, Pooled
b) Recovered Plasma
CODE
a) Unit: 9990686;
b) Unit:
4787531
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood products, collected from a donor
who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL and
Austria
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE
a) and b) Units:
306559951, 306599000
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood products, collected from an
ineligible donor due to a history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NV, SD, and
Switzerland
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Red Blood Cells (Apheresis) Leukocytes
Reduced
CODE
a) Units: 119937644, 119937656, 119937659,
119939859, and 119939869;
b) Units: 119937647 (1), 119937647 (2), 119937652
(1), 119937652 (2), 119939853 (1), 119939853 (2), 119939806, 119939835,
119939840 (1), and 119939840 (2)
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, El
Paso, TX
REASON Blood products, collected from donors
who did not have complete medical history interviews, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION TX, NM and
Switzerland
PRODUCT
a)
Red Blood Cells
b) Fresh Frozen Plasma
CODE
a) Units: 0234948, 0162873;
b) Unit:
0162873
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood products, collected from an
ineligible donor due to a reported history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MN
PRODUCT
Red Blood
Cells Leukocytes Reduced
CODE Unit:
53GR77550
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD,
REASON
Blood product, collected from donors
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
component
DISTRIBUTION MD and
CA
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: 71P248874
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
Platelets
Pheresis Leukocytes Reduced
CODE Unit: FK28979
RECALLING
FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL
REASON
Blood product, possibly contaminated
with air, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT
Red
Blood Cells Leukocytes Reduced
CODE Unit: 2873632
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood product,
tested for viral markers using a sample that was possibly diluted, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a)
Fresh Frozen Plasma
b) Recovered Plasma
CODE
a) Unit: 4935838;
b) Units: 4890038,
4881091, 4798285, 4789450, 4753329 and 1422239
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood products, which were collected
from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7
units
DISTRIBUTION FL and Austria
PRODUCT Recovered
Plasma
CODE Unit:
306594711
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected using an
abbreviated screening process for which the donor was not eligible, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION ND and
Switzerland
PRODUCT Recovered
Plasma
CODE Unit:
306583787
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected using an
abbreviated screening process, for which the donor was not eligible, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Recovered
Plasma
CODE Unit:
306579512
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON
Blood product, collected from donor
using an abbreviated screening process for which they was not eligible, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Recovered
Plasma
CODE Unit:
5795028
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood product, stored at an elevated
temperature, was distributed
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT Red Blood
Cells Leukocytes Reduced Irradiated
CODE Unit: 306564803
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc.,
Fargo, ND.
REASON Blood product, documented as being out
of controlled storage for more than 30 minutes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION ND
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Red Blood Cells
Leukocytes Reduced Irradiated
CODE
a)
Unit: 163867610;
b) Unit: 163867612
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood Systems, Inc./dba
United Blood Services, Meridian, MS.
REASON Blood products, collected using a scale
that had unacceptable quality control results documented, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Recovered Plasma
CODE
a) and b) Unit:
4031171
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood products, collected from
a donor whose arm inspection was not documented, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA and
Switzerland
PRODUCT Recovered
Plasma
CODE Units: J25560,
J43395
RECALLING FIRM/MANUFACTURER Virginia Blood
Services, Inc., Richmond, VA
REASON Blood products, collected from donors
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION VA and
Switzerland
PRODUCT Recovered
Plasma
CODE Units: 119937644,
119937656, 119939826, 119939851, 119939875, 119939859, and
119939869
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., dba United Blood Services, El Paso, TX
REASON Blood
products, collected from donors who did not have complete medical history
interviews, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 7 units
DISTRIBUTION TX, NM and
Switzerland
PRODUCT Recovered
Plasma
CODE Unit:
53GR77550
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD
REASON
Blood product, collected from donors
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
component
DISTRIBUTION MD and
CA
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 36FT06715
RECALLING
FIRM/MANUFACTURER American National Red Cross, Columbia, SC
REASON
Blood product,
collected from a donor who was at risk for Leishmaniasis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
WEEK ENDING SEPTEMBER 29
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells, Leukoreduced,
c) Red Blood Cells,
Leukoreduced, Irradiated,
d) Recovered Plasma,
CODE
a) Units: 53FE76367 53FE76370 53GF47139
53GF46948 53FE76400 53GF47913 53GF46312 53FE76466
53FE76881 53GF46550 53GF47233 53GF47940 53GF47830
53GF47602 53FE76512 53FE76526 53GF47524 53GF47526
53GF47277 53GF46308 53GF46106 53FC18397 53GF45926 53GF46327 53GF46329 53FE76369 53GF46094 53GF46109 53GF47907
53FE76866 53FE76767 53FE76511 53GF47527 53GF47532
53FE76390 53GF47272 53GF47235 53GF46476 53GF46309
53GF46315 53GF45791 53GF47136 53GF47107 53GL18307
53GF47903 53FE76472 53GF46759 53FC18393 53FE76879
53FE76501 53FE76477 53GF47297 53FE76355 53GF47238
53GF47242 53FE76078 53GF46792 53GF46307 53GF46102 53GF46584 53GF47834 53FE76489 53FE76475 53GF47369 53GF47302
53GF47113 53GF47810 53FE76409 53FE76337 53FE76362
53GF46702 53GF46762 53GF46784 53GF47263 53FE76817
53GF46306 53FE76334 53GF47245 53GF47718 53FE76378
53GF46581 53GF46588 53GF46576 53FC18383 53GF46283
53GF46131 53GF46134 53GF46138 53GF46124 53GF46129;
b) Units: 53FE76390
53FE76866 53GF47473 53GF47825 53FE76526 53GF47238
53FE76859 53GF47602 53FE76406 53FE76413 53GF47824
53GF47532 53FE76335 53FE76339 53FE76902 53FE76851 53FE76510 53FE76512 53FE76360 53GF47233 53GF47834 53GF47527
53FE76370 53GF47526 53GF47465 53FE76403 53GL18330
53GF47893 53GF47895 53GF47898 53GF47901 53FE76881
53FE76809 53FE76799 53FE76806 53FE76805 53GF47617
53FE76511 53GL18310 53FE76879 53FE76507 53FE76519
53FE76516 53FE76341 53GL18307 53GF47949 53FE76334
53GF47971 53GF47966 53GF47471 53GF47363 53GF47372 53GF47830 53GF47467 53FE76362 53FE76367 53GF47378 53GF47992
53GF47988 53GF47978 53GF47974 53GF47965 53GL18311
53GL18335 53GF47933 53GF47935 53GF47938 53GF47907
53FE76861 53FE76868 53FE76870 53GF47625 53FE76501
53FE76475 53FE76410 53GF47524 53GL18325 53GF47453
53GF47470 53GF47903 53GF47913 53FE76801 53FE76817
53FE76808 53GF47718 53FE76489 53FE76337 53FE76909 53GF47625 53GF47593 53GF47364 53GF47629 53GF47620 53GF47627
53FE76378 53FE76386 53GL18337 53GL18306 53GF47810
53FE76477 53FE76767 53FE76472 53FE76409 53FE76355
53FE76369 53FE76365 53GF47622 53GF47993 53GF47997
53FE76769 53FE76486 53GF47599 53GF47940 53FE76468
53FE76757 53FE76474 53GF47604 53GF47606 53FE76400
53FE76470 53GF47995 53GF47586 53FE76984 53FE76752 53Y99491 53GF47589 53GF47914 53GF47591;
c) Unit:
53FE76753;
d) Units: 53FE76174 53FE76192 53FE76194 53FE76198 53FE76199
53FE76219 53FE76230 53FE76232 53FE76237 53FE76239 53FE76241 53FE76243 53FE76244
53FE76752 53FE76753 53FE76757 53FE76769 53FE76799 53FE76801 53FE76805 53FE76806
53FE76808 53FE76809 53FE76842 53FE76851 53FE76859 53FE76861 53FE76868 53FE76870
53FE76902 53FE76908 53FC18337 53FC18352 53FC18354 53FC18355 53FC18358 53FC18360
53FC18361 53FC18369 53FC18392 53FC18395 53FE76332 53FE76335 53FE76341 53FE76202
53GF47078 53GF47081 53GF47083 53GF47085 53GF47087 53GF47068 53GF47144 53GF47146
53GF47453 53GF47465 53GF47467 53GF47470 53GF47471 53GF47473 53GF47586 53GF47589
53GF47591 53GF47593 53GF47599 53GF47604 53GF47606 53GF46975 53FE76174 53FE76192
53FE76194 53FE76198 53FE76199 53FE76219 53FE76230 53FE76232 53FE76237 53FE76239
53FE76241 53FE76243 53FE76244 53GF45980 53GF45982 53GF46114 53GF46116 53GF46118
53GF46123 53GF46689 53GF46930 53GF46933 53GF46935 53GF46938 53GF46941 53GF46944
53GF46973 53GF47273 53GF47274 53GF47279 53GF47364 53GF47372 53GF47378 53GF45919
53GF45922 53GF45925 53GF45999 53GF46000 53GF46004 53GF46005 53GF46010 53GF46011
53GF46012 53GF46060 53GF46062 53GF46064 53GF46317 53GF46324 53GF46333 53GF46395
53GF46398 53GF46401 53GF46403 53GF46419 53GF46422 53GF46814 53GF46819 53GF46820
53GF46825 53GF46829 53GF46833 53GF46835 53GF46842 53GF46846 53GF46849 53GF46852
53GF47006 53GF47007 53GF47009 53GF47010 53GF47020 53GF47022 53GF47040 53GF47041
53GF47043 53GF47045 53GF47047 53GF46546 53GF46553 53GF46555 53GF46557 53GF46559
53GF46586 53GF46590 53GF46594 53GF46710 53GF46712 53GF46714 53GF46715 53GF46751
53GF46754 53GF46757 53GF46763 53GF46767 53GF46770 53GF46783 53GF46786 53GF46791
53FE76360 53FE76365 53FE76375 53FE76386 53FE76392 53FE76403 53FE76406 53FE76410
53FE76413 53FE76468 53FE76470 53FE76474 53FE76507 53FE76510 53FE76514 53FE76516
53FE76519 53GF45759 53GF45778 53GF45782 53GF45788 53GF45793 53GF46424 53GF46428
53GF46429 53GF46432 53GF46450 53GF46465 53GF46467 53GF46468 53GF46470 53GF46472
53GF46481 53GF46491 53GF46494 53GF46500 53GF46514 53GF46515 53GF46519 53GF46522
53GF46524 53GF46528 53GF46530 53FE76910 53FE76912 53FE76914 53GF47258 53GF47301
53GF47824 53GF47825 53GF47898 53GF47617 53GF47620 53GF47622 53GF47625 53GF47627
53GF47629
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD,
REASON
Blood donor records were not completed
and the blood collected from the donors and shipped to consignees increased the
health risk to recipients.
VOLUME OF PRODUCT IN
COMMERCE 441 components
DISTRIBUTION MD, VA,
D.C., CA and Switzerland
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 163843652,
163831997
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems Inc, Scottsdale, AZ
Manufacturer: Blood Systems
Inc/dba United Blood Services, Meridian,
MS.
REASON Platelets,
mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Red
Blood Cells
CODE Unit:
FW73341
RECALLING FIRM/MANUFACTURER Blood Center of
Wisconsin, Inc., Milwaukee, WI
REASON Blood product, for which viral
marker testing was incomplete, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Platelets
Pheresis, Leukocytes Reduced, Irradiated
CODE Unit: 53GK42471
RECALLING
FIRM/MANUFACTURER American National Red Cross-Greater Chesapeake
& Potomac Region, Baltimore, MD
REASON Blood product,
associated with a platelet unit that was possibly contaminated with coagulase
negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets
Pheresis, Leukocytes Reduced, Irradiated,
CODE Unit: 4320139
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON
Platelets, which were possibly
contaminated with Propionibacterium acnes, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 71X383024
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with an unacceptable
platelet count, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit: 71X439522
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a)
Platelets Pheresis Leukocytes Reduced Irradiated,
b)
Platelets Pheresis Leukocytes Reduced,
CODE
a) Units: 03FK27860 (1 & 2), 03FK27864,
03FK27882, 03FK27897, 03FK27902, 03FK27930 (1 & 2),
03FK27972, 03FK27975, 03FK27981, 03FK27992 (1 & 2),
03FK28000 (1 & 2), 03FK28001 (1 & 2), 03FK28011, 03FK28027,
03FK28042;
b) Units: 03FK27864, 03FK27867, 03FK27875 (1 & 2), 03FK27882,
03FK27890, 03FK27893, 03FK27897, 03FK27902,
03FK27910, 03FK27915, 03FK27922, 03FK27924, 03FK27937 (1
& 2), 03FK27941, 03FK27947, 03FK27957 (1 & 2),
03FK27959 (1 & 2), 03FK27962, 03FK27968, 03FK27972, 03FK27975, 03FK27981, 03FK27988, 03FK28005 (1 & 2), 93FK28013,
03FK28017 (1 & 2), 03FK28020 (1 & 2), 03FK28021,
03F28032 (1 & 2), 03FK28033 (1 & 2), 03FK28036,
03FK28037, 03FK28043
RECALLING FIRM/MANUFACTURER American
National Red Cross, Atlanta, GA
REASON Blood products, labeled as
leukoreduced, but which did not meet the criteria for leukoreduced products,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 62
units
DISTRIBUTION GA
PRODUCT Source Plasma
CODE
Units: LU0093233,
LU0095425, LU0110653
RECALLING FIRM/MANUFACTURER DCI
Biologicals Lubbock, LLC, Lubbock, TX
REASON Blood products,
collected from a donor who provided post donation information regarding multiple
high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION NC
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced,
b) Platelets,
Leukocytes Reduced,
c) Fresh Frozen Plasma,
CODE a), b) and c) Unit:
032KE89305
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Madison, WI
REASON Blood products,
which tested negative for the antibody to Hepatitis C virus (anti-HCV), but were
collected from a donor who previously tested positive for anti-HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION IL
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 5794152
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA
REASON
Blood products, which tested
negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2),
but were collected from a donor who was previously deferred for testing repeat
reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA and
Switzerland
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1196786
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with a unit of
Platelets that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 247491246
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc.,
Scottsdale, AZ,
Manufacturer: Blood
Systems, Inc., Rapid City, SD.
REASON Blood product, which had an unacceptable platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SD
PRODUCT Platelets,
CODE
Unit:
1116726
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with a red
cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MN and
Switzerland
PRODUCT Red
Blood Cells
CODE Unit:
1055793
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Pau, MN
REASON Blood
products, which tested negative for the antibody to the human immunodeficiency
virus (anti-HIV-1/2), but were collected from a donor who was previously
deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN and
Switzerland
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 247480870
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Rapid City, SD
REASON
Blood product, collected from a donor
who did not have a complete medical history interview, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AZ and Switzerland
PRODUCT Cryoprecipitated
AHF,
CODE Units: 040GV51818,
040GV51830, 040GW63644, 040GW63694, 040GW63706, 040LF11195, 040LF11211,
040LF11221, 040LF11276, 040LT22357
RECALLING
FIRM/MANUFACTURER American National Red Cross Heart of America
Region, Peoria, IL
REASON Blood products, which were not frozen
within the required one hour following manufacture, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION IL
PRODUCT Source
Plasma,
CODE Units: LP037521,
LP037537, LZ014098, LZ014334
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank Inc.,
Memphis, TN
Manufacturer: Interstate
Blood Bank Inc Mo, Saint Louis, MO.
REASON Blood products, which tested negative
for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were
collected from a donor that subsequently tested positive for anti-HIV-1/2, were
not properly quarantined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION CA and
Austria
PRODUCT Recovered
Plasma
CODE Unit:
5795028
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood product, stored at an elevated
temperature, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red
Blood Cells, Leukocytes, Reduced, Irradiated, Washed, CODE Unit: FQ66331 (Part
4)
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
REASON Blood product, which may have been
exposed to unacceptable temperature during shipment, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Red
Blood Cells,
CODE Unit:
W70584
RECALLING FIRM/MANUFACTURER Michigan Community
Blood Centers, Saginaw, MI
REASON Blood product, which was not labeled
for an unexpected antibody, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Recovered
Plasma
CODE Unit:
5794152
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Alexandria, LA
REASON Blood products, which tested negative
for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were
collected from a donor who was previously deferred for testing repeat reactive
for the antibody, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA and
Switzerland
PRODUCT Source Plasma
CODE
Unit:
386015730
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Waukegan, IL,
REASON Blood product, collected from a donor
for whom there was no documentation on the donor record of an arm inspection or
general appearance of the donor, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red
Blood Cells Pheresis, Leukocytes Reduced,
CODE Unit: FC2012231 (Parts A &
B)
RECALLING FIRM/MANUFACTURER Community Blood Council of
New Jersey, Inc., Trenton, NJ
REASON Blood products, collected
using an expired blood collection set, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Units: K68754, K73490
RECALLING
FIRM/MANUFACTURER Regional Health, Resource Center, Urbana, IL
REASON
Blood products, which were out of
controlled storage for more than 30 minutes during leukoreduction, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Unit: 123772091
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ
Manufacturer: Blood System, Inc.,
Albuquerque, New Mexico.
REASON Blood product, labeled with an extended
expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AZ
PRODUCT Recovered
Plasma,
CODE UNIT:
1055793
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Pau, MN,
REASON Blood
products, which tested negative for the antibody to the human immunodeficiency
virus (anti-HIV-1/2), but were collected from a donor who was previously
deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN and
Switzerland
PRODUCT Recovered
Plasma
CODE Unit:
247480870
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Rapid City, SD
REASON Blood product,
collected from a donor who did not have a complete medical history interview,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AZ and Switzerland
PRODUCT
a)
Red Blood Cells Pheresis, Leukocytes Reduced,
b) Red
Blood Cells, Leukocytes Reduced,
CODE
a) Units: 129385216 (Parts 1 & 2) and
129388802;
b) Units: 129378337, 129382089, 129382313, 129382320,
129383462,129384765, 129384762, 129384758,
129384300
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood System, Inc., Albuquerque, NM.
REASON
Blood products, which may have
been exposed to unacceptable storage temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION AZ and NM