MAY 2006
WEEK ENDING MAY 6
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced
CODE Unit numbers: 10291-1549
(2 units)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, collected in an apheresis
collection kit that may have exceeded the acceptable time period for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ
PRODUCT Recovered Plasma
CODE
Unit number: 36FF00603
RECALLING
FIRM/MANUFACTURER American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood product, which tested negative for
hepatitis, but was collected from an ineligible donor due to a subsequent
disclosure of previous positive hepatitis testing, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Irradiated
CODE Unit numbers: 71L17340,
71L31791, 71L02593, 71L19122
RECALLING FIRM/MANUFACTURER Shands
Hospital Blood Bank, Gainesville, FL
REASON Blood products, possibly
labeled with an incorrect expiration date, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells
b) Platelets,
Irradiated
c) Fresh
Frozen Plasma
CODE a), b) and c) Unit numbers:
03GG53725
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood products, which tested negative
for hepatitis, but were collected from an ineligible donor due to a subsequent
disclosure of previous positive hepatitis testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA
PRODUCT Human Cornea
CODE
Tissue: 060005100
RECALLING
FIRM/MANUFACTURER Oklahoma Lions Eye Bank, Oklahoma City, OK,
REASON
Human tissue for
transplantation, that tested negative for hepatitis prior to distribution, but
was subsequently found to test repeatedly reactive for antibodies to hepatitis B
core antigen (anti-HBc) by a different facility, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION OK
PRODUCT Recovered Plasma
CODE
Unit number:
36LF16951
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC
REASON Blood product, which tested
negative for hepatitis, but was collected from an ineligible donor due to a
subsequent disclosure of previous positive hepatitis testing, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
b) Recovered
Plasma
CODE
a) Unit numbers: GK37669, GL16655;
b) Unit
numbers: GK37669, GL25220, GL16655
RECALLING
FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties,
San Bernardino, CA
REASON Blood products, collected from
a donor who provided post donation information regarding multiple high-risk
behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CA and Switzerland
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
12L81544
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood product, collected from
a donor who visited a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Red Blood Cells
CODE
Unit number: B305494
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Source Plasma
CODE
Unit number: 46874412
RECALLING
FIRM/MANUFACTURER Plasma Biological Services, Inc., Asheville, NC
REASON
Blood product, which tested negative for the
antibody to hepatitis C virus (anti-HCV), but was collected from a donor who
subsequently tested positive for anti-HCV, was not properly quarantined and was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
b) Fresh Frozen
Plasma
CODE
a) Unit numbers: 0840885, 0846107, 2000682, 0857377,
0859456;
b) Unit numbers: 0855151, 0854373
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc, Greenville, SC
REASON
Blood products, associated with units that were
found to contain clots, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 7 units
DISTRIBUTION MA, NC and SC
PRODUCT
a) Red Blood Cells
Leukocytes Reduced
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 36LK31608
RECALLING
FIRM/MANUFACTURER The American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood products,
collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION SC
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
003KF16604
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Atlanta, GA, 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 GA
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 108LJ33027
(2 units), and 108LJ33030 (3 units)
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Columbia, SC.
REASON
Blood products, which may have been
exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 5 units
DISTRIBUTION SC
PRODUCT Red Blood Cells
Pheresis,
Leukocytes Reduced
CODE Unit numbers: 11340-5471
(2 units), 11341-5953 (2 units), 11342-4559 (2 units)
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, El
Paso, TX
REASON Blood products, for which documentation of an
abnormal alarm during apheresis collection was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION TX
PRODUCT Source Plasma
CODE
Unit numbers: CS041715, CS042430, CS042921, CS043871,
CS046408, CS046925, CS047544, CS048148, CS048777, CS049308, CS041876, CS042782,
CS043711, CS045910, CS046631, CS047358, CS047929, CS048534, CS049048, CS049594
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P.,
Columbia, SC
REASON Blood products, collected from an ineligible donor
due to swollen tonsils, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 20 units
DISTRIBUTION NC
PRODUCT Red Blood Cells for
manufacture of non-injectables,
CODE Unit
number: GL25220
RECALLING FIRM/MANUFACTURER Blood Bank of San
Bernardino and Riverside Counties, San Bernardino, CA,
REASON Blood product,
collected from a donor who provided post donation information regarding multiple
high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets Pheresis,
CODE
a) Unit numbers: 38C32265, 38W41246;
b) Unit
numbers: 38FX01925 (split product), 38FX02036 (split product), 38FX02088,
38FX02132
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Indiana-Ohio Region, Fort Wayne, IN
REASON Blood products, collected from a donor at risk for
leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION IN and KY
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Unit numbers: 11341-8544
(2 units)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., dba
United Blood Services, El Paso, TX,
REASON Blood products, for which
documentation of an abnormal alarm during apheresis collection was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
1029-1464
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood product, which may have been collected in an
expired collection bag, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AZ
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
03GR66009
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Atlanta, GA, REASON Blood product,
which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT
a) Whole Blood
b) Red Blood Cells,
c) Red Blood Cells
Leukocytes Reduced,
CODE
a) Unit number:
12LP23592;
b) Unit numbers: Cells, units 12LP23591, 12LP23599, and
12FH85723;
c) Unit numbers: 12FX58888, 12X92241, 12X92204, 12FX58918,
12KM61344,
12KM61404, 12FX58976, 12X92248, 12LF90779, 12FV03748, 12FH85713,
12KM61339, 12KM61358, 12KM61367, 12FX58859, 12FK35068, 12M07148, and
12LF90817
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Durham, NC,
REASON Blood
products, which may have been stored at unacceptable temperatures, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 22
units
DISTRIBUTION NC and SC
WEEK ENDING MAY 13
PRODUCT
Irradiated Cancellous
Bone & Marrow, 0.25, 0.5, 1.0 and 2.0 gram vials,
CODE
Lot # 03049, 1.0 gram, Vial numbers: 1 thru 51
Lot
# 03051, 0.25 gram, Vial numbers 1 thru 205
Lot # 04091, 0.25 gram, Vial
numbers 1 thru 393
Lot # 04102, 0.5 gram, Vial numbers 1 thru 44
Lot #
04103, 1.0 gram, Vial numbers 1 thru 47
Lot # 04104, 1.0 gram, Vial numbers 1
thru 44
Lot # 04109, 1.0 gram, Vial numbers 1 thru 60
Lot # 04113, 2.0
gram, Vial numbers 1 thru 23
Lot # 04120, 1.0 gram, Vial numbers 1 thru
31
Lot # 04123, 2.0 gram, Vial numbers 1 thru 23
Lot # 04124, 0.5 gram,
Vial numbers 1 thru 70
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Rocky Mountain Tissue Bank, Aurora, CO
Manufacturer: BioMedical Tissue Services,
Ltd., Fort Lee, NJ,
REASON Human
tissues, procured from donors without adequate donor eligibility determinations,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 991
vials
DISTRIBUTION Nationwide
PRODUCT Source Plasma,
CODE
Unit number: 46874405
RECALLING
FIRM/MANUFACTURER Plasma Biological Services, Inc., Asheville, NC
REASON
Blood product, with an elevated ALT result, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number:
12M36018
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Source Plasma
CODE
Unit numbers: N36747097, N36788097, G85618097,
G85964097, G86543097, G88293097, G88630097, G90047097, G90377097, G91542097,
G92158097, G92485097, G93136097, G94053097, G94402097, and G98161097
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, San
Diego, CA
REASON Blood products, which were collected from a donor who
engaged in multiple high risk behavior activities, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 16
units
DISTRIBUTION NC and Spain
PRODUCT
a) Red Blood Cells
Leukocytes Reduced Irradiated, 6;
b) Plasma Frozen,
CODE a) and b) Unit number: 16GR21277
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Columbus, OH
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 2
units
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells
Leukocytes Reduced
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 1173839
RECALLING
FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH
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 2
units
DISTRIBUTION OH
PRODUCT
a)
Red Blood Cells Leukocytes Reduced
b) Platelets
Leukocytes Reduced
CODE a) and b) Unit number:
1153953
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
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 OH
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 1095505,
1103417, and 1076168
RECALLING FIRM/MANUFACTURER Hoxworth Blood
Center, Cincinnati, OH
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION OH
PRODUCT Fresh Frozen Plasma,
CODE
Unit numbers: K75730 and
K76608
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Community Blood Center of Carolinas, Charlotte, NC.
REASON Blood products,
which were manufactured from associated blood components that exhibited clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells
Leukocytes Reduced
b) Cryoprecipitated AHF,
c) Recovered Plasma,
CODE a), b), and c)
Unit number: 50V03694
RECALLING FIRM/MANUFACTURER American Red
Cross Blood Services, Toledo, OH, REASON Blood products, which were collected from a donor who had
tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION OH, TX, and Switzerland
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit number: 13GN03072
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI,
REASON
Blood products,
which were collected from a donor who had received a tattoo within twelve months
of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI and CA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE a) and b) Unit number:
13FX28625
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Detroit, MI, 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 MI
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit numbers: 2163570
(Parts A and B)
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Inc., Lexington, KY
REASON Blood products, which were possibly
contaminated with Propionibacterium acnes, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY
PRODUCT
a) Fresh Frozen Plasma,
b) Plasma,
Cryoreduced,
CODE
a) Unit number: 0217920;
b) Unit number:
0872029
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc.,
Greenville, SC
REASON Blood products, associated with units that were
found to contain clots, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NC, and SC
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated
CODE Unit
numbers: 09FC06820, 09FC06822, 13X07559, and 13X08008
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan
Region, Detroit, MI,
REASON Blood products,
which were incorrectly irradiated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced6;
b) Platelets,
c) Fresh Frozen Plasma,
d) Recovered Plasma,
CODE
a) Unit numbers: 36GQ20986, 36R66115;
b) and c)
Unit number: 36GQ20986;
d) Unit number: 36R66115
RECALLING
FIRM/MANUFACTURER American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood products,
collected from an ineligible donor due to a history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CA, PR, and SC
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced,
b) Platelets Pheresis,
Leukocytes Reduced,
CODE a) and b) Unit number:
2730423
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Ventura, CA
REASON
Blood products, which were possibly contaminated
with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit number:
33FP51310
RECALLING FIRM/MANUFACTURER American National Red Cross,
Connecticut Region, Farmington, CT
REASON Platelets, possibly contaminated with Bacillus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells
Pheresis, Leukocytes Reduced
b) Platelets Pheresis,
Leukocytes Reduced,
CODE a) and b) Unit number:
12LT52911
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood products, collected from a donor with a low
body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Recovered Plasma,
CODE
Unit number: 12M36018
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
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
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Recovered Plasma,
CODE
a) Unit numbers: 12LF05089, 12LF05090, 12LF05091, 12LF05092,
12LF05093,
12LF05094, 12LF05095, 12LF05096, 12LF05098, 12LF05099,
12LF05100;
b) Unit numbers: 12LF05089, 12LF05090, 12LF05091, 12LF05092,
12LF05093,
12LF05094, 12LF05095, 12LF05096, 12LF05098, 12LF05099,
12LF05100
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood products,
manufactured from units of Whole Blood which may have reached an unacceptable
temperature during shipment, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 22 units
DISTRIBUTION CA, GA, and NC
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
CODE
a) Unit numbers:
10048-3902, 10048-3898, 10048-3901;
b) Unit numbers: 10048-3902,
10048-3901
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Platelets, which reached
an unacceptable temperature during shipment, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 5 units
DISTRIBUTION AZ
PRODUCT Source Plasma,
CODE
Unit numbers: F-20641-014, F-23223-014,
F-24710-014
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, National City, CA, REASON Blood products, collected from a donor
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION Sweden
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
3100117
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Indianapolis, IN.
REASON Blood product, which did not have a
white blood cell count performed, but was labeled as leukocyte reduced, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT
a) Platelets Leukocytes
Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit number: 13GV67457
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI, REASON
Blood products, which were
collected in a manner in which the collection time was not appropriately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI and AZ
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit numbers: 13GL29724,
13GL29727, 13GL29728, 13GL29729, 13GL29730, 13GL29731, 13GL29732 and 13GL29735
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Detroit, MI, REASON Blood products,
which were manufactured from whole blood units that may have been exposed to
unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8 units
DISTRIBUTION MI
PRODUCT Source Plasma
CODE
Unit numbers: 0360045037, 0360045238, 0360046299,
0360046529
RECALLING FIRM/MANUFACTURER Biomat USA, Inc. South Bend, IN
REASON
Blood products, collected from a donor who was
previously deferred for unacceptable test results, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION Spain
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number:
1134047
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Blood product, collected from an ineligible donor
due to a history of Thrombotic Thrombocytopenic Purpura (TTP), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
WEEK ENDING MAY 20
PRODUCT
Carticel (Autologous
Cultured Chondrocytes),
CODE Lot # CC17694-21
Expiration: December 22, 2005
RECALLING FIRM/MANUFACTURER Genzyme
Biosurgery, Cambridge, MA
REASON Carticel, possibly contaminated with
Novosphingobium capsulatum, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 lot
DISTRIBUTION MA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) 06GV75980 and 06GP03112
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood products,
which were collected from a donor who had engaged in multiple high risk behavior
activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
36KH13005
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Columbia, SC
REASON
Blood product, which did not meet
acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit: 17KY79877
RECALLING
FIRM/MANUFACTURER The American National Red Cross, North Central Region,
St. Paul, MN
REASON Blood products, collected from a donor
whose medical history screening regarding high risk behavior was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT Platelets
CODE
Unit: M82162
RECALLING
FIRM/MANUFACTURER Anderson Area Medical Center Blood Bank, Anderson, SC
REASON Blood product, possibly contaminated with Serratia
liquifasciens, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 71M763674
RECALLING
FIRM/MANUFACTURER Life South Community Blood Center, Dunwoody, GA,
REASON Blood product, associated with a red blood cell product
that failed filtration, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
GW00365
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI, REASON Platelets, which were possibly contaminated with
Micrococcus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION WI
PRODUCT Source Plasma,
CODE
Unit: NG0025921
RECALLING
FIRM/MANUFACTURER DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX
REASON
Blood product, which was untested for viral
markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
3104412
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Inc. Indianapolis, IN
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit
4137632
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Inc., Indianapolis, IN.
REASON Blood product, which yielded a platelet count that was
below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units 4507155 (3
parts)
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc.,
Orlando, FL
REASON Blood products, which yielded a platelet count that was
below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION FL
PRODUCT Platelets
CODE
Unit 1142882
RECALLING
FIRM/MANUFACTURER Community Blood Centers of Southern Florida,
Lauderhill, FL
REASON Blood product, labeled with an extended
expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells
b) Recovered
Plasma
CODE a) and b) Unit 06GN26595
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA
REASON Blood products,
collected from an ineligible donor due to a history of intravenous drug use,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit
10753-7939
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ,
REASON Blood products, collected from donors for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Leukocytes
Reduced, Irradiated,
c) Cryoprecipitated AHF,
CODE
a) Units 10043-7797, 10044-2615, 10044-2616,
10044-2627, 10044-2632, 10044-2637;
b) Unit 10044-2646;
c) Unit
10043-7797
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, manufactured from units of Whole
Blood that were designated as low volume collections, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION AZ
PRODUCT Misys Laboratory Blood
Bank Module, Version 6.1,
CODE Version
6.1
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ
REASON
Defects in the design of software could result
in data being out of sync with the accession number, patient and/or units
displayed on the screen.
VOLUME OF PRODUCT IN
COMMERCE 1unit
DISTRIBUTION Nationwide and
Internationally
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 17FG11722,
17FG13237, 17FG13962, 17FG14327, 17FG18723, 17FG18728, 17FJ22726, 17FK07075,
17FK10876, 17FK11670, 17FL10491, 17FL10718, 17FL11228, 17FR04993, 17FR05124,
17FR05125, 17FR05242, 17FV10102, 17GN02982, 17GR14887, 17GR14972, 17GR15931,
17GR15933, 17GR15934, 17GR15935, 17GR16211, 17GR20949, 17GR20950, 17GR20951,
17GR20952, 17GR20953, 17GR20955, 17GR20956, 17GR20957, 17GR20958, 17GR20959,
17GR20960, 17KC43585, 17KC44987, 17KC44989, 17KC44992, 17KC44993, 17KC44999,
17KC45012, 17KM38835, 17KM38836, 17KM38961, 17KM41245, 17KN92516, 17KN94366,
17KQ53046, 17KQ53143, 17KQ53675, 17KQ55718, 17KT59699, 17KT59921, 17KT66694,
17KT68358, 17KX79345, 17KX82534, 17KY53862, 17KY54243, 17KY55175, 17KY57992,
17KY60202, 17KZ28210, 17FM05253, 17FN02088, 17FN02129
RECALLING
FIRM/MANUFACTURER The American National Red Cross, North Central Region,
St. Paul, MN,
REASON Blood products, manufactured from Whole Blood more than 8
hours after collection, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 69 units
DISTRIBUTION MN, WI, SD, OH, MA and
CA
PRODUCT Source Plasma,
CODE
Units: MI123310, MI123735, MI124615, MI126403,
MI127241, MI127712, MI128090, MI128781, MI129341, MI129911, MI131673, MI132308,
MI143473, MI145702, MI148780, MI149574, MI150032, MI150471, MI150759, MI151225,
MI151526, MI151953, MI152246, MI152634, MI152930, MI159318, MI159858, MI165302,
MI164961, MI164538, MI164136, MI163764, MI163252, MI162998, MI162512, MI161632,
MI160897, MI160352, MI165660, MI165807, MI166161, MI166599, MI166994, MI167447,
MI167772, MI168203, MI168640, MI169321, MI169824, MI170652, MI170938, MI191572,
MI194369, MI194565, 04MINA0463, 04MINA3770, 04MINA4707, 04MINA9008, 04MINA9771,
04MINB1084, 04MINE1079, 04MINE2113, 05MINA0853, 05MINA4459, 05MINA7842,
05MINA8428, 05MINA9255, 05MINA9680, 05MINB0991, 05MIMB1425, 05MINB1996,
05MINB5616, 05MINB8427, 05MINB9091, 05MINB9933, 05MINC0941, 05MINC1751,
05MINC2299 05MINC3646
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services L.P., Muncie, IN
REASON Blood products, collected from a donor who had
received a dura mater graft during brain surgery, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 79 units.
DISTRIBUTION CA, NC and
France
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Cryoprecipitated AHF),
c) Recovered Plasma,
CODE
a), b) and
c) Unit: 3770059
RECALLING FIRM/MANUFACTURER LifeShare Blood
Centers, Shreveport, LA
REASON Blood products, collected from
a donor who reported a history of IV drug use, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION LA, NJ and
Switzerland
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets,
c)
Recovered Plasma,
CODE a), b) and c) Unit:
3770030
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA,
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 3 units.
DISTRIBUTION LA, MI and Switzerland
PRODUCT Source Plasma,
CODE
Units: 7030197795, 7030197430, 7030196563,
7030196468, 7030195157, 7030194673, 7030194066, 7030192019, 7030191696,
7030190289, 7030189884, 7030189156, 7030188798, 7030188123, 7030187336,
7030186983, 7030185913, 7030185584, 7030184003, 7030183509, 7030183025,
7030182181, 7030181566, 7030180976, 7030180665, 7030179937, 7030179704
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Inc., San Antonio, TX
REASON
Blood products, collected from a donor who had a
tattoo applied within twelve months of donating, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION UK
PRODUCT Platelets Pheresis
Leucocytes Reduced Irradiated,
CODE Unit:
06KS43607
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southern California Region, Pomona, CA
REASON Blood product, with platelet yield below the specified
minimum requirement, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Units 1158791 -- split
unit
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University
of Cincinnati Medical Center, Cincinnati, OH,
REASON Platelets,
mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Red Blood Cells
CODE
Units: 1001033, 1002474
RECALLING
FIRM/MANUFACTURER Aultman Health Foundation, Canton, OH
REASON Red Cells, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Source Plasma,
CODE
Units: G-30722-083, G-31091-083, G-36159-083,
G-36786-083, G-37663-083, G-42749-083, G-42962-083, G-48822-083, and
G-49248-083.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, Calexico, CA
REASON Blood products which were collected from
a donor who was previously deferred for testing reactive for antibodies to the
human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 9 units
DISTRIBUTION Spain
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit number 12FG14467
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood Products,
collected from a donor in which donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit numbers: 71X03946
(parts 1, 2 and 3)
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Center, Dunwoody, GA,
REASON Platelets, which were not manufactured within
the acceptable time frame from collection, were distributed
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION GA and AL
PRODUCT Red Blood Cells,
Leukocytes Reduced.
CODE Unit number:
36FV07138
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC,
REASON Blood product, collected from
a donor in which donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION SC
PRODUCT Source Plasma.
CODE
Unit numbers OJ211110, OJ237133, OJ236651, OJ236376,
OJ235857, OJ235405, OJ233962, OJ233614, OJ233096, OJ231967, OJ231775, OJ230903,
OJ230522, OJ230174, OJ229840, OJ229465, OJ229082, OJ228745, OJ227747, OJ227474,
OJ226669, OJ226380, OJ225870, OJ225602, OJ225203, OJ224578, OJ224075, OJ223801,
OJ223133, OJ222575, and OJ222303.
RECALLING
FIRM/MANUFACTURER Biolife Plasma Services L.P., Jacksonville, FL
REASON Blood products, which were collected from a donor who was
previously deferred for testing reactive for (HBsAg) hepatitis B surface
antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31
units.
DISTRIBUTION NY and NC
PRODUCT Recovered Plasma,
CODE
Unit numbers 004KL84455 and 004LQ24122.
RECALLING FIRM/MANUFACTURER American National Red Cross, New
England Region, Dedham, MA
REASON Blood
products, which tested negative for viral makers, but was collected from a donor
who was subsequently determined to have previously tested positive for HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit
9403690
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc.,
Orlando, FL
REASON Blood product, which was labeled leukoreduced, but
had an unacceptable white blood cell count, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Source Plasma,
CODE
Unit 0350017877
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., McAllen, TX
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 Spain
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated,
CODE Unit
4728182
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood
Center, Inc., Indianapolis, IN,
REASON Platelets, which were possibly
contaminated with Propionibacterium acnes, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IN
PRODUCT Recovered Plasma,
CODE
Unit 10753-7939
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood
products, collected from donors for whom donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
12KQ35317
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas
Blood Services Region, Charlotte, NC
REASON Red Blood Cells, missing
antibody identification information, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Fresh Frozen Plasma,
CODE
Units: 17FK11480, 17FK11482,17FK11483,
17FK11484, 17FK11486, 17FK11488, 17FK11490, 17FK11491, 17FK11492, 17FK11493,
17FK11494, 17FK11495, 17FK11496, 17FK11498, 17FK11499, 17FK11501, 17FK11502,
17FL10429, 17FL10434, 17FL10436, 17FL13246, 17FL13247, 17FL13248, 17FL13257,
17FR03049,17FV07035, 17GR14887, 17GR14964, 17GR14966, 17GR14972, 17KC43588,
17KE06815, 17KN92504, 17KN92505, 17KN92510, 17KN92516, 17KN92724, 17KT66694,
17KX81337, 17KX83844, 17KX83845 17KY53835, 17KY54243, 17KY57026, 17KY57038,
17KY57043, 17KY57049, 17KY57055
RECALLING FIRM/MANUFACTURER The
American National Red Cross, North Central Region, St. Paul, MN,
REASON
Blood
products, manufactured from Whole Blood more than 8 hours after collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 48
units
DISTRIBUTION MN, WI, SD, OH, MA and CA
PRODUCT Platelet Pheresis
Leukocytes Reduced,
CODE Unit: 8308895 (Part C of
split product)
RECALLING FIRM/MANUFACTURER Florida's Blood Centers
Inc., Orlando, FL
REASON Blood product, collected in an expired bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
WEEK ENDING MAY 27
PRODUCT
Red Blood Cells
Leukocytes Reduced,
CODE Units: 12Y63789,
12Y63796, 12Y63797, 12Y63802
RECALLING FIRM/MANUFACTURER National
Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, processed from overweight units of Whole
Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NC and GA
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced Irradiated,
b) Platelets Pheresis
Leukocytes Reduced,
c) Red Blood Cells,
CODE
a) Units: B212072 (split product), B21179
b)
Unit: B21179
c) Unit: Z110691
RECALLING FIRM/MANUFACTURER Puget
Sound Blood Center, Seattle, WA
REASON Blood products, collected
from a donor who visited a malarial endemic area, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION WA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit 40P08591
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Peoria, IL
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 IL
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Units: 12LT52139 (split
product), 12LT52141, 12LT52142 (split product), 12LT52143, 12LT52144 (split
product), 12LT52147, 12LT52155, 12LT52158, 12LT52159, 12LT52160 (split product),
12LT52161, 12LT52162, 12LT52163, 12LT52165, 12LT52166, 12LT52167 (split
product), 12LT52170 (split product), 12LT52171 (split product), 12LT52172 (split
product), 12LT52173 (split product), 12LT52174, 12LT52175, 12LT52177, 12LT52178
(split product), 12LT52179, 12LT52181, 12LT52182 (split product), 12LT52183
(split product), 12LT52184, 12LT52186 (split product), 12LT52187 (split
product), 12LT52191, 12LT52192, 12LT52193 (split product), 12LT52194 (split
product), 12LT52195 (split product), 12LT52197 (split product)
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood products,
which did not have a pH performed as part of monthly QC, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 55
units
DISTRIBUTION NC
PRODUCT Source Plasma,
CODE
Units: 08729194, 08727947, 08724434, 08723659,
08721259, 08559869, 08558640, 92654181, 92651319, 92129856, 92121478, 90640230,
90634918, 91020239, 91018588, 91016690, 91015051, 91013118, 91011428, 91366023,
91363725, 91362339, 90220012, 90216473, 90211096, 78858015, 78852815, 79013048,
77529305, 75088736, 75087616, 75085285, 75082888, 75080556, 60997685, 60994059,
62980258, 62977692, 62976305, 63388169, 63383041, 63381733, 63099560, 63097979,
93095067, 63094145, 60844743, 59707967, 59705871, 59704096, 59702924, 59700807,
59076704, 59074885, 59073697, 59071891, 59069584, 59068471, 59066804, 59064220,
59063155, 57551302, 57150116, 57148267, 57146928, 57144382, 57142562, 55530453,
55529266, 55524711, 55523554, 55521413, 45319457, 45318146, 45316081, 45314971,
45311451, 45200076, 45197833, 45196799, 46199508, 46197399, 46195449, 46192752,
46192073, 44779412, 44776367, 44773519, 44772789
RECALLING
FIRM/MANUFACTURER Plasma Biological Services Inc., Asheville, NC
REASON
Blood products, collected from a donor who was
previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 89 units
DISTRIBUTION CA
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 0887057
RECALLING
FIRM/MANUFACTURER The Blood Connection Inc, Greenville, SC
REASON Blood product, associated with a corresponding
product that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT Platelets Pheresis
Leukoreduced Irradiated,
CODE Units: C213190
(split product)
RECALLING FIRM/MANUFACTURER Puget Sound Blood
Center, Seattle, WA
REASON Blood products, labeled as leukoreduced, but
which did not meet the requirements for leukoreduced products, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION WA
PRODUCT Source Plasma,
CODE
Units: 0050255215, 0050254198, 0050253962,
0050252884, 0050250512, 0050245535, 0050243987, 0050243436, 0050243214,
0050242853, 0050242635, 0050242313, 0050241996, 0050241725, 0050241224,
0050240927, 0050240668, 0050239810
RECALLING FIRM/MANUFACTURER ZLB
Bioplasma Inc, Beloit, WI
REASON Blood products, collected from a donor who had a
tattoo applied within twelve months of donating, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION UK, Germany and
Korea.
PRODUCT Platelets Pheresis,
CODE
Units: 36P79188, 36P79192
RECALLING
FIRM/MANUFACTURER The American National Red Cross, South Carolina Region,
Columbia, SC
REASON Blood products,
exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION SC and GA
PRODUCT Recovered Plasma,
CODE
Unit: 12FR82817
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood product,
collected from a female donor who had sex with a male who had sex with another
male, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units N-61050-014, N-61075-014, G-73129-014,
G-74477-014, G-74668-014, G-76730-014, G-77290-014, G-79890-014, G-80261-014,
G-80879-014, G-81141-014, G-83876-014, G-84386-014, G-84795-014, &
G-86341-014
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, National City, CA, REASON Source Plasma, collected from a donor for whom
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION CA and
Spain
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 71M655699
RECALLING
FIRM/MANUFACTURER Life South Community Blood Center, Dunwoody, GA
REASON Blood product, associated with a red blood cell product
that failed filtration, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Recovered Plasma,
CODE
Units: 12K76696, 12X00935
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
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 CA
PRODUCT Source Plasma,
CODE
Unit: 02lWID2565
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., Onalaska, WI
REASON
Blood
product, collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MN
PRODUCT Source Plasma,
CODE
Units: LF233198, LF232462, LF232072, LF231399,
LF230818, LF230570, LF229890, LF229469, LF229041, LF228669, LF228290, LF227855,
LF227466, LF227007, LF226578, LF226072, LF225814, LF225206, LF224831, LF224322,
LF223845, LF223151, LF222813, LF221751, LF221142, LF220730, LF220307, LF219841,
LF219454, LF217167, LF216345, LF215844, LF215589, LF215103, LF214836, LF214393,
LF212872
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P.,
Lakeland, FL
REASON Blood products, collected from a donor previously deferred
for a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 37 units
DISTRIBUTION NC
PRODUCT Human Corneas for
Transplantation Tissues,
CODE 16435-OD and
16435-OS
RECALLING FIRM/MANUFACTURER Central Ohio Lions Eye Bank,
Columbus, OH
REASON Human Corneas, collected from a donor who subsequently
tested positive for HBsAg, by another tissue procurement organization, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
tissues
DISTRIBUTION OH
PRODUCT Human Cornea for
Transplantation Tissue,
CODE 16461-OD
RECALLING FIRM/MANUFACTURER Central
Ohio Lions Eye Bank, Columbus, OH
REASON Human Cornea, that was subsequently
found to test repeatedly reactive for antibodies to hepatitis B core antigen
(anti-HBcore) by a different facility, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 tissue
DISTRIBUTION OH
PRODUCT Human OS Cornea for
Transplantation Tissue,
CODE 06-0022-200
RECALLING
FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO
REASON Human cornea, stored in a storage container that may have
been leaking, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION CO
PRODUCT Source Plasma,
CODE
G-90885-077, G-91404-077, G-91821-077, G-92536-077,
G-93011-077, G-93703-077, G-93895-077, G-94984-077, G-95623-077,
G-97291-077
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, Riverside, CA
REASON Source Plasma, that was not properly
quarantined after the receipt of post donation information from the donor
relating to recent body piercing, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 10 units
DISTRIBUTION Spain
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 71W54151-8
(split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Dunwoody, GA
REASON Platelets, possibly contaminated with Pseudomonas
aeruginosa, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) T71902, T71906, T71909, T71911, T71916, T71922,
T71939, T71907, T71917,
T71918, T71923, T71924, T71925, T71926, T71927,
T71929, T71933, T71934,
T71935, T71936, T71937, T71938, T71940 and
T71944;
b) Units: T71915. T71919, T71920
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Center, Traverse City, MI
REASON Red Blood Cells, collected from donors with inaccurate
hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 27 units
DISTRIBUTION MI
PRODUCT Source Plasma,
CODE
Units: 85454064, 85455146, 85458765, 85460621,
6010243927, 010245170, 6010245719, 6010245961, 6010246552, 6010246862,
6010249234, 6010250030
RECALLING FIRM/MANUFACTURER Nabi
Biopharmaceuticals, San Antonio, TX
REASON Blood products, collected from a donor
who had a tattoo applied within twelve months of donating, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION CA, Israel and Korea
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Plasma Frozen,
CODE a) and b) Unit: 003GF22932
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Southern Region,
Atlanta, GA
REASON Blood products, collected
from a donor previously deferred due to a history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Source Plasma,
CODE
Units: 05MINC3458, 05MINC3722, 05MINC4328,
05MINC4581, 05MINC5438, 05MINC8389, 05MINC8676, 05MINC9234, 05MINC9537,
05MIND0351, 05MIND0949, 05MIND1241, 05MIND1830, 05MIND2145, 05MIND2776,
05MIND3085, 05MIND3743, 05MIND4714, 05MIND5031, 05MIND5661, 05MIND6010,
05MIND6657, 05MIND6966, 05MIND7636, 05MIND7958, 05MIND8607,
05MIND8947
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P,
Muncie, IN
REASON Blood products, collected from a donor who disclosed a
history of brain surgery, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 27 units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units: 7030230707, 7030228844, 7030228223,
7030227756, 7030226416, 7030226058, 7030223186, 7030222702, 7030222265,
7030221773, 7030221321, 7030220821, 7030220345, 7030219989, 7030219107,
7030218783, 7030213753, 7030210907, 7030210603, 7030209484, 7030209166,
7030208194, 7030207999, 7030207057, 7030206672, 7030206102, 7030205184,
7030204837, 7030203092, 7030202673, 7030202278, 7030201888, 7030201185,
7030200760, 7030200099, 7030199580, 7030197836, 7030195948, 7030195576,
7030194907, 7030194297, 7030192321, 7030191715, 7030191137, 7030190524,
7030189407, 7030188819, 7030186097, 7030185447
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma Inc, San Antonio, TX
REASON Blood products,
collected from a donor who received a body piercing within twelve months of
donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 49
units
DISTRIBUTION UK
PRODUCT Source Plasma,
CODE
Units: 7030219244, 7030218377, 7030217992,
7030217335, 7030216978, 7030216056, 7030215648, 7030214745, 7030214304,
7030213838
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Inc, San
Antonio, TX
REASON Blood products, collected from a donor who had a tattoo
applied within twelve months of donating, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 10 units
DISTRIBUTION UK
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
17KM55247
RECALLING FIRM/MANUFACTURER American National Red Cross,
North Central Region, St. Paul, MN.
REASON Blood product, manufactured
from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION ME
PRODUCT Fresh Frozen Plasma,
CODE
Units 6850271, 7014004
RECALLING
FIRM/MANUFACTURER HemaCare Corporation, Sherman Oaks, CA
REASON Blood
products, associated with units of Red Blood Cells that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Source Plasma,
CODE
Units 05MINA8244, 05MINA8587,
05MINA9587
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Muncie, IN
REASON Blood products, collected from a donor who was at increased
risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit
8465133
RECALLING FIRM/MANUFACTURER Atlanta Blood Services,
Atlanta, GA
REASON Blood product, which tested positive for West
Nile Virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit number 463298 (part
1 and 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, REASON Blood products, which were possibly contaminated
with Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number
17FJ63423
RECALLING FIRM/MANUFACTURER American National Red Cross
Blood, North Central Region, ST. Paul, MN.
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 MN
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number
6663284
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, REASON Blood product, collected from an unsuitable donor based on
travel to an area considered endemic for malaria, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit number 7092187
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood
product, collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced
Irradiated,
CODE
a) Unit numbers 6593091 and
6596354
b) Unit number 9020737
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO, REASON Blood products, collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit number 9014146
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood
product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit: 0887306
RECALLING
FIRM/MANUFACTURER The Blood Connection Inc. Greenville, SC
REASON Blood product, associated with a corresponding product that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Red Blood Cells (for
further manufacture),
CODE Unit:
12FR82817
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood products, collected from a female donor who
had sex with a male who had sex with another male, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT
a) Platelets,
b) Platelets, Irradiated, Recall # B-1014-6
CODE
a)
Unit: 4360514
b) Unit 4340736
RECALLING
FIRM/MANUFACTURER Florida Blood Services Inc., St. Petersburg, FL
REASON Blood products, processed from Whole Blood units with
extended collection times, were distributed
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION FL and MA
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit
12X05179
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC,
REASON Problem: Blood product,
incorrectly identified as Jka antigen negative, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Capture R-Ready ID Test,
CODE
Lot Number: 21415
Expiration: June 21,
2002
RECALLING FIRM/MANUFACTURER Immucor, Inc, Norcross, GA
REASON Capture-R Ready ID Test kits, packaged with an incorrect
masterlist, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
lot
DISTRIBUTION Nationwide and Internationally
PRODUCT Recovered Plasma,
CODE
Unit: 4832101
RECALLING
FIRM/MANUFACTURER Florida's Blood Centers Inc., Orlando, FL
REASON
Blood
product, collected from a donor with a history of ulcerative colitis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
0627624
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, REASON Blood product, possibly out of controlled storage
for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Unit
0678628
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, REASON Blood product, for which there was no
documentation of weld acceptability for the sterile docking of pedi-packs, was
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Fresh Frozen Plasma,
CODE
Unit 06LM38602
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA,
REASON Blood
product, manufactured from a unit of Whole Blood with an extended collection
time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis,
Irradiated,
CODE Units 040P96359, 040P96368,
06KP18918, 06KS38801, 06KT30580, 211J90266, 211J90267 (split
unit)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA,
REASON Blood products, which were
not returned to controlled storage within the allowable time frame after
irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
CODE
Unit number 443484
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood product, labeled with the incorrect expiration date,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units 12X88143,
12X88171, 12X88125, 12X88162, 12X88165, 12LC37610, 12LC37609, 12LC37606,
12LC37602, 12LC37596, 12GC84472, 12LC37601, 12GC84470, 12GC84471, 12LC37607,
12LJ37185, 12GN57845, 12GN57880, 12GN57887, 12Z31666, 12GC84462, 12LJ37173,
12LJ37205, 12GC84456, 12GC84460, 12GC84464, 12GC84465, 12GC84468, 12GC84469,
12GE48555, 12GE48556, 12GN57841, 12LC37598, 12LC37603, 12LC37612, 12Z31682,
12Z31688, 12X88174, 12GE48541, 12F14117, 12LJ37208, 12Z31659, 12Z31665,
12Z31667, 12GE48568, 12GE48569, 12GE48539, 12GE48540, 12GE48565, 12LJ37213,
12LJ37170, 12LJ37174, 12LJ37204, 12LJ37169, 12LJ37207, 12LJ37202, 12GE48546,
12GE48547, 12GE48550, 12GE48552, 12GE48553, 12GE48554, 12GE48564, 12GE48531,
12Z31657, 12Z31662, 12GC84459, 12LC37611, 12X88127, 12X88138, 12GE48524,
12GE48525, 12GE48527, 12GE48528, 12GE48532, 12GE48534, 12GE48538, 12X88130,
12X88132, 12X88131, 12X88136, 12LJ37162, 12LJ37168, 12LJ37179, 12LJ37187,
12LJ37191, 12LJ37193, 12Z31673, 12Z31677, 12Z31683, 12Z31687, 12Z31672,
12X88166, 12X88169, 12X88170, 12Z31685, 12K49428, 12P10104, 12P10105, 12GE48543,
12GE48544, 12GE48545, 12GE48548, 12GE48557, 12GE48542, 12GC84476, 12GC84477,
12GC84478, 12GC84473, 12GC84475, 12LJ37164, 12X88173, 12GN57837, 12GN57875,
12GL52268, 12X88159, 12F14134, 12GE48551, 12GE48559, 12GE48522, 12GE48526,
12GE48529, 12GE48558, 12GE48563, 12GE48530, 12GE48533, 12GE48535, 12GE48536,
12E13628, 12F14073, 12GK30403, 12GL52248, 12GN57851, 12GN57874, 12F14072,
12GN57848, 12H33084, 12GE48567, 12Z31661, 12Z31671, 12Z31656, 12X88158,
12X88155, 12X88154, 12GC84474, 12GC84466, 12GC84461, 12GC84458, 12X88160,
12X88161, 12X88163, 12X88168, 12Z31668, 12Z31675, 12Z31676
RECALLING
FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region,
Charlotte, NC,
REASON Red Blood Cells, leukoreduced with a faulty filter, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 155
units
DISTRIBUTION NC and SC