MARCH 2008
WEEK ENDING MARCH 1
PRODUCT Source
Plasma,
CODE Units: HRFMGK, HRFLYG, HRFKZY, HRFKNH,
HRFJQD, HRFJHG, HRFRKH, HRFQZM, HRFQNZ, HRFPXR, HRFPVY, HRFNLF,
and HRFNFJ
RECALLING FIRM/MANUFACTURER ZLB Plasma,
Lawton, OK,
REASON Blood products, collected from a donor
whose scheduled physical exam was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION IL and
Germany
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Red Blood Cells Leukocytes Reduced Irradiated,
CODE
a) 04GF60953;
b)
04GF63137
RECALLING FIRM/MANUFACTURER ARC Blood Services,
New England Region, Dedham, MA
REASON Blood products, collected from
an unsuitable donor based on residing in an area considered endemic for malaria,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MA and
ME
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
72C101429
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers Inc.,
Huntsville, AL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
72C179417
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers Inc.,
Huntsville AL,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X342275
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc - Birmingham
Region, Birmingham, AL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 71Z879418,
71Z879431
RECALLING FIRM/MANUFACTURER Lifesouth Community
Blood Centers Inc - Birmingham Region, Birmingham AL,
REASON
Blood
products, which were leukoreduced greater than 72 hours after collection, were
distributed
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit; 163926420 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER Blood Systems Inc/dba
United Blood Services, Meridian, MS,
REASON Blood products,
which were possibly contaminated with Corynebacterium species, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 208476427 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER Blood Systems Inc,
Lafayette, LA
REASON Blood products, which were possibly
contaminated with Corynebacterium species, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION LA.
TX
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: S92458
RECALLING
FIRM/MANUFACTURER Central Illinois Community Blood Center,
Springfield, IL
REASON Blood product, which was labeled as
leukoreduced, but was not tested to verify the White Blood Cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 71T412891; 71T602674; 71T423997;
71T67963X; 71T006932; 71T012441; 71T215938; 71T003536
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood products, which were not
manufactured in accordance to the manufacturer's instructions for leukocyte
reduction, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8
units
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 71X640499,
72C433762
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Dunwoody, GA,
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 GA
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Platelets,
CODE
a) Units: 5802640,
5756352, 5778260, and 5801777;
b) Units: 5802640, 5801777, 5744015, and
5756352
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX,
REASON Blood products, were
manufactured from units of Whole Blood that was unsuitable, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
components
DISTRIBUTION TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 71T813625 and
71T814799
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Gainesville, F
REASON Blood products,
which were not manufactured in accordance to the manufacturer's instructions for
leukocyte reduction, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Red Blood Cells Leukocytes Reduced,
;
c)
Red Blood Cells Leukocytes Reduced Irradiated,
d) Whole
Blood CPD,
e) Red Blood Cells,
CODE
a) Units: 200405292
(Parts 1 & 2), 200405527 (Parts 1 & 2), 200405531 (Parts 1 & 2),
200405540 (Parts 1 & 2), 200405545 (Parts 1 & 2),
200405550 (Parts 1 & 2),
200407714 (Parts 1 & 2),
200407748 (Parts 1 & 2), 200407749 (Parts 1 & 2),
200407754 (Parts 1 & 2), 200409595 (Parts 1 & 2),
200409597 (Parts 1 & 2),
200411397 (Part 1),
200414857 (Parts 1 & 2), 200414868 (Parts 1 & 2), 200415214
(Parts 1 & 2), 200415447 (Parts 1 & 2), 200415454
(Parts 1 & 2), 200415458 (Parts 1
& 2), 200415459
(Parts 1 & 2), 200415469 (Parts 1 & 2), 200415591 (Parts 1 & 2),
200416853 (Parts 1 & 2), 200416858 (Parts 1 & 2),
200416861 (Parts 1 & 2),
200418284 (Parts 1 & 2),
200421535 (Parts 1 & 2), 200421751 (Parts 1 & 2),
200421761 (Parts 1 & 2), 200425566 (Parts 1 & 2), 208478162 (Parts 1
& 2),
208478165 (Parts 1 & 2), 208478166 (Parts 1
& 2), 200419609 (Part 2);
b) Units: 200405282, 200405283, 200405287,
200405291, 200405295, 200405528,
200405537, 200405539,
200405543, 200405548, 200405549, 200405551, 200405556,
200405559, 200407683, 200407684, 200407690, 200407693, 200407695, 200407696,
200407709, 200407710, 200407712, 200407720, 200407722,
200407746, 200407747,
200407751, 200407755, 200407756,
200407760, 200407762, 200407763, 200411395,
200414727,
200414856, 200414858, 200414860, 200414861, 200414862, 200414863,
200414864, 200414865, 200414866, 200414867, 200414872,
200414873, 200414875,
200415206, 200415208, 200415209,
200415219, 200415230, 200415236, 200415240,
200415241,
200415243, 200415251, 200415253, 200415390, 200415449, 200415452,
200415455, 200415460, 200415463, 200415464, 200415471,
200415473, 200415475,
200415501, 200415507,
200415508, 200415513, 200415515, 200415517, 200415522,
200415524, 200415527, 200415530, 200415533, 200415563, 200415566, 200415571,
200415573, 200415579, 200415586, 200415589, 200415594,
200415595, 200415598,
200416855, 200416864, 200416866,
200416867, 200418206, 200418279, 200418280,
200418281,
200418285, 200418286, 200418287, 200418288, 200418289, 200419606,
200419610, 200419612, 200421205, 200421209, 200421211,
200421213, 200421219,
200421221, 200421223, 200421224,
200421225, 200421478, 200421480, 200421530,
200421533,
200421539, 200421540, 200421543, 200421544, 200421545, 200421754,
200421755, 200421766, 200421769, 200421781, 200421785,
200421787, 200421788,
200421790, 208478161, 208478164,
208478167, 208478172, 200405286, 200405293,
200407764,
200415250, 200415518, 200416857, 200421778;
c) Unit: 208478169;
d) Unit:
200405294;
e) Units: 200405284, 200405288
RECALLING
FIRM/MANUFACTURER Blood Systems Inc, Lafayette, LA,
REASON
Blood products, for which the sterility
may have been compromised, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 214 units
DISTRIBUTION LA, NC,
NJ
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
71R218865
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers Inc - East Alabama Region, Opelika, AL
REASON
Blood product, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red Blood Cells Apheresis Leukocytes Reduced,
CODE
Unit: 5978523
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX,
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red Blood
Cells Apheresis Leukocytes Reduced,
CODE Unit: 5917374 (Parts A &
B)
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX,
REASON Blood products, collected from a donor
who provided post donation information concerning a previous positive test for
the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 2150346,
2151439
RECALLING FIRM/MANUFACTURER Bergen Community
Regional Blood Center, Paramus, NJ
REASON Blood products, with a low
platelet count, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NJ,
NY
PRODUCT
a) Red
Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Plasma Frozen,
d) Red Blood
Cells Leukocytes Reduced Irradiated,
CODE
a) Units: 04G89928; 04E05730;
b) Units:
04L89860; 04LQ74775; 04G90614; 04LC40536; 04KT95900;
c) Units: 04G90614;
04J91124;
d) Unit: 04J91124;
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region,
Dedham, MA,
REASON Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION MA, NY, NH, ME, VT,
CA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C04768X
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C249239
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated,
b) Platelets Pheresis Leukocytes Reduced,
CODE
a) Units: 004P63177 Part1; 004P63177 Part
2;
b) Units: 004GP66536 Part 1; 004GP66536 Part 2
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region,
Dedham, MA
REASON Blood products, which did not meet the
acceptable product specifications for release, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION VT, MA, NY
PRODUCT Red Blood
Cells Leukocytes Reduced,
CODE Units:
163929653, 163925600
RECALLING FIRM/MANUFACTURER Blood
Systems Inc/dba United Blood Services, Meridian, MS
REASON
Blood
products, which were incorrectly tested for Lewis-b red cell antigen, but were
labeled as negative for Lewis-b antigen, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 71R510796
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Huntsville, AL
REASON Blood product, which was not returned to
controlled storage within eight hours following collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Fresh Frozen Plasma,
CODE
a)
71R631686, 71R639414, 71R639426
b) 71R639414
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Huntsville, AL
REASON Blood products, which were not returned
to controlled storage within eight hours following collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION AL
PRODUCT Platelet Pheresis Leukocytes Reduced,
CODE
Unit: 8107459
RECALLING
FIRM/MANUFACTURER LifeShare Community Blood Services,
Elyria, OH
REASON Platelets, which were not stored under
continuous agitation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 027KF16549
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood product, collected from
donors with unacceptable hematocrit determinations, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit: 5979392;
b) Unit:
5942576
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX,
REASON Blood products, which may have
been exposed to unacceptable storage temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Platelets,
Pheresis, Leukocytes Reduced,
CODE Units: 1543032
(split)
RECALLING FIRM/MANUFACTURER Indiana Blood Center,
Indianapolis, IN,
REASON Blood
products, with incomplete anti-HTLV testing, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Red Blood Cells,
CODE
Unit: 72C156963
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, Fl
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 Nationwide
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated,
CODE
Unit: 71R973858
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Birmingham Region, Birmingham, AL
REASON Blood product,
labeled with an extended expiration date, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood Cells,
CODE
Unit: 168878688
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood
Services, Meridian MS,
Manufacturer: Blood
Systems Inc/dba United Blood Services, Hattiesburg, MS.
REASON
Blood product, which may have reached an
unacceptable temperature during shipment, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit #: 5988171
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON
Blood product, incorrectly labeled as to
red cell antigen type, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Source Plasma,
CODE
Units: 04PWIG0150,
04PWIG0725
RECALLING FIRM/MANUFACTURER
Recalling Firm:
BioLife Plasma Services LP, Deerfield, IL,
Manufacturer: Biolife Plasma Services, Stevens Point, WI.
REASON
Blood products, which were not
quarantined subsequent to receiving information regarding a post donation
illness, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Recovered Plasma,
CODE
Units: 04G89928; 04L89860; 04LQ74775;
04E05730; 04LC40536; 04KT95900
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region,
Dedham, MA
REASON Blood products, which were collected
from a donor in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION MA, NY, NH, ME, VT, CA
WEEK ENDING MARCH 8
PRODUCT Cryoprecipitated AHF Irradiated,
CODE
Units: 0365414; 0378815; 0378830; 0398735;
0366520; 0365427; 0401026; 0378828
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Cryoprecipitated AHF units, not
processed and re-frozen within one hour, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8
units
DISTRIBUTION LA
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 033GF86054
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT,
REASON
Blood product, collected from
a donor whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CT
PRODUCT Platelets,
CODE
Unit:
0390365
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA,
REASON Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 7086250(1) and
7086250(2)
RECALLING FIRM/MANUFACTURER South Texas Blood
& Tissue Center, San Antonio, TX,
REASON Blood products,
which were collected from a donor who traveled to malarial endemic areas, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Source Plasma,
CODE
Unit:
386026885
RECALLING FIRM/MANUFACTURER Talecris Plasma
Resources, Inc., Waukegan, IL,
REASON Blood product,
which tested negative for Hepatitis B, but was collected from a donor who
subsequently tested positive for Hepatitis B surface antigen (HbsAg), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 2710000
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX,
REASON Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE1
unit
DISTRIBUTION TX
PRODUCT Recovered
Plasma,
CODE Unit:
033GF86054
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Farmington, CT
REASON Blood product, collected from a donor whose suitability to donate was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE
Units: 033GC04426 Part1, 033GC04426 Part2;
033GX00978 Part1; 033GX00978 Part2; 033GX00984 Part1; 033GX00984 Part2;
033GX01030 Part1; 033GX01030 Part2
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT,
REASON
Blood products, prepared without the
appropriate amount of additive solution (ADSOL), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION NY, MA,
CT
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 0357016
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON
Blood product, which was out of controlled storage for more than 30 minutes
during leukoreduction, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated,
CODE
Units: I3015681, I3011999
RECALLING FIRM/MANUFACTURER Community Blood Center of
Greater Kansas City, Kansas City, MO
REASON Blood products,
which were labeled with incorrect expiration dates, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MO
WEEK ENDING MARCH 15
PRODUCT Red Blood
Cells (Apheresis),
CODE Units:
12KY21430, 12LQ24674
RECALLING FIRM/MANUFACTURER American
Red Cross Carolinas Blood Services Region, Charlotte, NC
REASON
Blood products, with an unacceptable
total hemoglobin level, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 2131008
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON Blood product, which was possibly contaminated
with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 04H71598
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham,
MA,
REASON Blood product, collected from a
donor for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Source Plasma
CODE
Units
386022324, 386020192, 386020056, 386019792, 386019627, 386019290, 386018979,
386017604, 386018464, 386017426, 386017166, 386016869, 386016545, 386016355,
386016039, 386009877
RECALLING FIRM/MANUFACTURER Talecris
Plasma Resources, Inc., Waukegan, IL,
REASON Blood products,
which were collected from a donor who was deferred due to risk factors
associated with variant Creutzfeldt-Jakob disease (vCJD) travel, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 16
units
DISTRIBUTION NC
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X162682
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Birmingham Region, Birmingham, AL
REASON Blood product, for
which the documentation of irradiation was incomplete, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 163934931
RECALLING
FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services,
Meridian, MS,
REASON Blood product, which was possibly
contaminated with Propionibacterium species, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells,
CODE
Unit: 71V108080
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody,
GA,
REASON Blood product, associated with a Fresh Frozen
Plasma unit that contained a clot, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71C544881
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C215027
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Brooksville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72C244662
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 72E039393
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers,
Inc.,Dunwoody, GA,
Manufacturer: LifeSouth
Community Blood Centers, Inc., Inverness, FL
REASON Blood product, with a low platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells
(Apheresis),
CODE Unit: 72C022229
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, which did not meet the
minimum requirement for Red Blood Cell volume, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Platelets, ;
b) Fresh Frozen Plasma,
c) Red Blood Cells Leukocytes Reduced,
CODE
a), b), and c) Unit:
2305939
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood products,
which were not quarantined after receiving post donation information concerning
high-risk behavior, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION FL,
SC
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 4250074
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood product, collected from a donor
who traveled to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
CODE
Unit: 72C14050X
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL
REASON Blood product, collected in a manner
that may have compromised the sterility of the unit, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 9940038 (Part
C)
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers,
Inc., Orlando, FL
REASON Blood product, collected in a manner
that may have compromised the sterility of the unit, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 7093003 (split unit); and 7093060
(split unit)
RECALLING FIRM/MANUFACTURER South Texas
Blood & Tissue Center, San Antonio, TX,
REASON Blood products,
which did not meet acceptable product specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION AR and
TX
PRODUCT
a) Red
Blood Cells Leukocytes Reduced,
b) Recovered Plasma
(Liquid),
c) Cryoprecipitated AHF, Pooled,
CODE
a) and b) Unit: 2687783;
c) Unit:
6002251
RECALLING FIRM/MANUFACTURER South Texas Blood
& Tissue Center, San Antonio, TX,
REASON Blood products,
which were collected from a donor with a history of high risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX and
Switzerland
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 2625829
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, 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 Platelets Pheresis Leukocytes Reduced,
CODE
Units: 1678435 (part 1); 1678435 (part 2);
and 1678435 (part 3)
RECALLING FIRM/MANUFACTURER Blood
Center of New Jersey, East Orange, NJ,
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION NJ
PRODUCT Fresh Frozen Plasma
(Apheresis),
CODE Units: 3006006 and
3005285
RECALLING FIRM/MANUFACTURER South Texas Blood
& Tissue Center, San Antonio, TX, b
REASON Blood products,
which were collected from an unsuitable donor based on risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 2729997
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, 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 Source
Plasma,
CODE Units: 0500115443 and
0500115022
RECALLING FIRM/MANUFACTURER Biomat USA, Inc.,
Arlington, TX,
REASON Blood products, which were collected from a donor
who had received a body piercing within 12 months of the donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION Barcelona,
Spain
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: V85292
RECALLING
FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Units: 71X505277 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Huntsville, AL,
REASON Platelets, associated with a
platelet unit that was returned due to the absence of swirling, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Recovered Plasma,
CODE
Unit: 04H71598
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA
REASON
Blood product, collected from a
donor for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA and
MA
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Units: 49GW22415, 49KG10236, 49KG10238,
and 49KQ10742
RECALLING FIRM/MANUFACTURER American
National Red Cross SW Region – HT, Tulsa, OK
REASON Blood
products, which were not leukoreduced within the appropriate time period after
collection, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION OK and
TX
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 9971595
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood product, for which the quality
control testing was incomplete, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pooled Leukocytes Reduced,
CODE
Platelet Pool 72Z543766 (containing units
72C493691, 72C00775X, 72C121219, 72C121220),
Platelet Pool 72Z543778
(containing units 72C007816, 72C145647, 72C493709,
72C121244)
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers, Inc., Gainesville, F
REASON Platelets,
which were pooled using expired blood bags, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 2691645
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX,
REASON Blood product, which was incorrectly labeled with
an extended expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE Unit: 2753503 (double
unit)
RECALLING FIRM/MANUFACTURER South Texas Blood &
Tissue Center, San Antonio, TX,
REASON Blood products, which were
collected from a donor who had undergone corneal transplant surgery, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 6733888
RECALLING
FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ,
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 NJ
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b)
Units: 71R694243
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers Inc., Birmingham Region, Birmingham, AL,
REASON Blood products, which were untested for the human
immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the Nucleic Acid
Test (NAT), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 29GS67268
RECALLING
FIRM/MANUFACTURER American National Red Cross Mid Atlantic, Norfolk,
VA,
REASON Blood product,
which tested positive for the Jk(a) red cell antigen, but was labeled as Jk(a-),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 29GP89121, 29GV66758,
29GZ35669,29GZ35671, 29GZ35675, 29GZ35683, 29GV66765, 29GV66773, 29GZ35667,
29GZ35668, 29GZ35677
RECALLING FIRM/MANUFACTURER American
National Red Cross Mid Atlantic, Norfolk, VA,
REASON Blood products, which may have been shipped under
unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 11 units
DISTRIBUTION VA and NC
WEEK ENDING MARCH 22
PRODUCT Red Blood
Cells Leukocytes Reduced,
CODE Lot
numbers: 0330797; 0363693; 0278933; 0283597; 0269498;
0366966
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood products, leukoreduced after the
required post collection time limit, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 units
DISTRIBUTION LA
and MS
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Lot: 49GK12784
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT, Tulsa,
OK
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 OK
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen Plasma,
d) Recovered
Plasma,
CODE
a) and b) Units: 8781502,
5575898;
c) Unit: 8781502;
d) Unit: 5575898
RECALLING
FIRM/MANUFACTURER Lifesource, Glenview, IL,
REASON
Blood products, collected from a donor
who provided post donation information regarding multiple high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION IL and
Switzerland
PRODUCT Bone Talus, Part Code: 32647002 and Bone, Right ankle set/distal
tibia talus, Part Code: 32747002,
CODE Units: 070160001 and
070160-002,003
RECALLING FIRM/MANUFACTURER AlloSource,
Inc., Centennial, CO,
REASON Human tissue, recovered from an
ineligible donor, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA and
WI
PRODUCT Platelets,
CODE
Units:
V39628; V39417; V40927
RECALLING FIRM/MANUFACTURER Blood
Assurance Inc., Chattanooga, TN,
REASON Platelets, processed at an
incorrect centrifuge setting, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION TN and
GA
PRODUCT Corneal tissue for transplant,
CODE
Lots: 04-2015, 04-2016, 05-2031, 05-2032,
05-2185, 05-2186 06-2661, 06-2662
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Georgia Eye Bank,
Atlanta, GA,
Manufacturer: Emory Clinic, Decatur, GA.
REASON
Human tissues from donors, tested using
diagnostic test kits rather than FDA licensed or cleared screening tests for
hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core
antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8 corneas
DISTRIBUTION GA and
TN
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced, CODE Lot: 3822688
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON
Blood product, leukoreduced after the required post collection time limit,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Skin (Posterior Leg),
CODE
Lot: 20060013
RECALLING
FIRM/MANUFACTURER Transplant Services Center UT Southwestern Medical
Center, Dallas, TX
REASON Skin allografts, with a positive fungus
culture, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 12
allografts
DISTRIBUTION IL
PRODUCT Cornea,
CODE
Lot:
20060014
RECALLING FIRM/MANUFACTURER Transplant Services
Center UT Southwestern Medical Center, Dallas, TX
REASON Human
cornes, positive for Staphylococcus aureus, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
cornea
DISTRIBUTION TX
PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Module v6.0.1 and
v6.0.2,
CODE Sunquest Blood Bank and
Blood Donor version 6.0.1 distributed with Sunquest Laboratory version 6.1
(Specific Build 6.1.0.0131) and version 6.2 (Specific Build 6.2.0.0114 and
6.2.0.0119) and Blood Donor version 6.0.2 distributed with Sunquest Laboratory
version 6.3 (Specific Build 6.3.0082 and 6.3.0086)
RECALLING
FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,
REASON
Software, with a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 129 clients
had the affected code
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) OC Fem Hemi Condyle,
b) Femur Distal
Right,
c) Bone-Tendon-Bone,
d)
Posterior Tibialis,
e) Achilles Tendon w/ Calc,
f) Anterior
Tibialis, ;
g) C/C Chips 1.7-10mm
30 cc,
h) Canc crushed .1-4mm 30cc,
i) Dowel 13mm (diam),
CODE
a) Serial numbers 002641371002 and
002641371001;
b) Serial number 002641371003;
c) Serial numbers
002641370011a, 002461379913a, 002641370014a;
d) Serial numbers 002641370018a
and002641370017a;
e) Serial numbers: 002645170007a and 002645170008a;
f)
Serial number 002641370020a and 002641370019a;
g) Serial numbers:
002641370046a, 002641370047a, 002641370048a, 002641370049a;
h) Serial
numbers: 002641370027a, 002641370028a, 002641370029a, 002641370030a;
i)
Serial numbers: 002641370037a and 002641370038a
RECALLING
FIRM/MANUFACTURER Musculoskeletal Transplant Foundation, Edison, NJ,
REASON
Tissue allografts associated with a
pre-processing culture positive for group D Enterococcus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 22
units
DISTRIBUTION NJ, LA, CA, UT, AZ, MS, CT, AR and
Mexico
PRODUCT Skin Non-Meshed (Burn Unit), Part Code: 5101-9B,
CODE Lot: 0945110101
RECALLING
FIRM/MANUFACTURER AlloSource, Inc., Centennial, CO,
REASON
Human tissue distributed from a donor whose eligibility was
questionable.
VOLUME OF PRODUCT IN COMMERCE 1
allograft
DISTRIBUTION OH
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Lot: 4847391
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON
Blood product, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Platelets,
b) Red Blood Cells Leukocytes
Reduced, 8
CODE a) and b) Lot:
4255835
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL,
REASON Blood products, collected from a
donor who traveled to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Cornea,
CODE
Lot:
07130OD; 07130OS
RECALLING FIRM/MANUFACTURER Upstate NY
Transplant Service, Inc., Buffalo, NY,
REASON Tissue products, collected
from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
corneas
DISTRIBUTION CA
PRODUCT Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1
and 6.0.2,
CODE Blood Bank and Blood
Donor version 6.0.1 distributed with Sunquest Laboratory version 6.1 and version
6.2; Blood Bank and Blood Donor, version 6.0.2 distributed with Sunquest
Laboratory version 6.3
RECALLING
FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ
REASON
Software, with a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 283 clients
had the affected product
DISTRIBUTION Nationwide and
Internationally
PRODUCT Source Plasma,
CODE
Units: 7030429377,
7030428939, 7030427655, 7030426403, 7030423635, 7030422804, 7030422335,
7030420964, 7030419541, 7030417731, 7030417258, 7030416356, 7030415581,
7030414958, 7030414185, 7030412758, 7030411271, 7030406334, 7030404839,
7030404613, 7030402827, 7030402140, 7030401020, 7030400171, 7030399555,
7030398309, 7030397581, 7030396915, 7030395681, 7030394873, 7030394541,
7030393726, 7030393317, 7030389143, 7030388834, 7030388109, 7030387708,
7030386993, 7030386631, 7030384670, 7030381972, 7030381429, 7030380993,
7030380436, 7030375833, 7030373473, 7030373230
RECALLING
FIRM/MANUFACTURER ZLB Plasma Services, San Antonio, TX,
REASON
Blood products, collected from a donor
who received piercings within one year of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 47
units
DISTRIBUTION NC
PRODUCT Plasma,
CODE
Unit:
027LQ34799
RECALLING FIRM/MANUFACTURER ARC Greater
Alleghenies, Johnstown, PA,
REASON Blood product, which was collected in a collection system that may have a
potential defect which could compromise the sterility of the closed system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Cryoprecipitated
AHF,
CODE Unit: 027KJ34268
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA,
REASON
Blood product,
which was collected in a collection system that may have a potential defect
which could compromise the sterility of the closed system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WV
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 027LH33676
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood product,
which was collected in a collection system that may have a potential defect
which could compromise the sterility of the closed system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Cryoprecipitated
AHF,
CODE Unit: 027KN09716
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood product,
which was collected in a collection system that may have a potential defect
which could compromise the sterility of the closed system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WV
PRODUCT
a) Red
Blood Cells Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) and b) Lot:
2300711
RECALLING FIRM/MANUFACTURER Florida’s Blood
Centers, Inc., Orlando, FL
REASON Blood product, which was not
quarantined after receiving information regarding a post-donation illness, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Source Plasma,
CODE
Units: 4170039868,
4170039493
RECALLING FIRM/MANUFACTURER ZLB Plasma, Tulsa,
OK,
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 Germany
PRODUCT Source Plasma,
CODE
Units: 364000434, 364009385, 364009829,
364013968
RECALLING FIRM/MANUFACTURER International
BioResources, LLC, Fort Worth, TX
REASON Blood products,
collected from a donor for whom donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NC