FEBRUARY 2008
WEEK ENDING FEBRUARY 2
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE 49GG24827
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region –HT, Tulsa, OK,.
Manufacturer: American Red Cross Blood Services-SW Region, College
Station, TX.
REASON Blood product, collected from a donor
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE1
unit
DISTRIBUTION OK
PRODUCT
a)
Red Blood Cells,
b) Platelets,
CODE
a) Units: 614896, 615402, 615871;
b)
Unit: 615871
RECALLING FIRM/MANUFACTURER Avera McKennan
Hospital & University Health Center, Sioux Falls, SD,
REASON Blood
products, collected from a donor who was taking the drug Finasteride, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION SD,
IA
PRODUCT SoftBank
II version 23.1, 23.1.1.x . , 23.1.2.x With Softscape 1.2.0.x,
CODE
Version 23.1, 23.1.1.x, 23.1.2.x with
Softscape 1.2.0.x
RECALLING FIRM/MANUFACTURERSCC Soft
Computer, Clearwater, FL,
REASON Software, with a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE ts
DISTRIBUTION
Nationwide and
Canada
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 49GP32183
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa OK,
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 OK
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
49Q82400
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, Tulsa OK,
REASON Blood product, associated with a red
cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49GV28430
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa OK
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 OK
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Plasma Frozen,
CODE
a) and b) Unit:
49KE05316
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, 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 TX
PRODUCT
a)
Plasma Frozen,
b) Recovered Plasma,
CODE
a) Unit: 49LG88881;
b) Units:
49KM13808, 49LE07403, 49LG87391
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region – HT, Tulsa OK, .
Manufacturer: American Red Cross Blood Services - SW Region, Waco, TX.
REASON
Blood products,
which tested negative for Hepatitis, but were collected from a donor who
previously tested positive for the Hepatitis B Surface Antigen HbsAg), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TX, CA, and
Switzerland
PRODUCT
a)
Platelets,
b) Fresh Frozen Plasma,
c) Red Blood Cells Leukocytes Reduced,
CODE
a), b), and c) Unit:
5808077
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX,
REASON Blood products, which tested
negative for the human immunodeficiency virus (HIV), but were collected from a
donor who previously tested positive for HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX,
NJ
PRODUCT
a)
Red Blood Cells,
b) Platelets,
c)
Fresh Frozen Plasma,
CODE
a)
Units: G36040, G36056, G36058, G36066, G36130, G36398, G36482,
G36493, G36495, G36506, G36508, G36512, G36633, G36635, G36636, G36685, G36710,
G36713, G36722, G36723, G36730, G36753, G36754, G36755, G36771, G36776, G36777,
G36780, G36781, G36800, G36808, G36814, G36815, G36816, G36819, G36936, G36939,
G37009, G37021, G37159, G37168, G37202, G37221, G37231, G37299, G37372, G37378,
G37389, G37442, G37463, G37465, G37624, G37625, G37690, G37695, G37706, G37720,
G37724, G37752, G37757, G37810, G37815, G37818, G37853, G37856, G37886, G37888,
G37988, G38002, G38075, G38095, G38134, G38176, G38191, G38200, G38208, G38249,
G38274, G38355, G38365, G38367, G38370, G38372, G38373, G38374, G37381, G38383,
G38384, G38385, G38393, G38394, G38398, G38401, G38407, G38408, G38409, G38414,
G38421, G38426, G38430, G38436, G38440, G38466, G38467, G38472, G38473, G38474,
G38475, G38476, G38477, G38478, G38479, G38488, G38491, G38502, G38507, G38527,
G38530, G38532, G38533, G38536, G38540, G38542, G38543, G38546, G38549, G38550,
G38555, G38558, G38560, G38567, G38570, G38577, G38659, G38670, G38686, G38688,
G38694, G38744, G38770, G38819, G38919, G39240, G39383, G39385, G39386, G39631,
G39659, G38649, G38016, G38497, G38641;
b) Units: G36776, G36777, G36780, G38389, G38393, G38507, G38516;
c)
Units: G36489, G36508, G36534, G36630, G36669, G36681,
G37089
RECALLING FIRM/MANUFACTURER The Good Samaritan
Hospital, Lebanon, PA,
REASON Blood products, collected from donors
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 166
units
DISTRIBUTION PA,
MD
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: 18FN14890
RECALLING
FIRM/MANUFACTURER American National Red Cross Great Lakes Region,
Lansing, MI
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 MI
PRODUCT Red
Blood Cells, Leukocytes Reduced
CODE Unit: 003R39182
RECALLING
FIRM/MANUFACTURER The American National Red Cross – Southern Region,
Douglasville, GA
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 GA,
CA
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced,
b) Plasma, Frozen,
CODE
a) and b) Unit:
003LJ42934
RECALLING FIRM/MANUFACTURER The American
National Red Cross – Southern Region, Douglasville, GA
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
GA
PRODUCT Cryoprecipitated
AHF,
CODE Unit:
0235466
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC,
REASON Blood product,
associated with a red cell unit that contained a clot, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 4146601
RECALLING
FIRM/MANUFACTURER Indiana Blood Center, Indianapolis, IN,
REASON
Blood product, with positive
bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT
a)
Platelets Pheresis, Leukocytes Reduced, Irradiated,
b)
Platelets Pheresis, Leukocytes Reduced,
CODE
a) Unit: 4146478, Part A;
b) Unit:
4146478, Part B
RECALLING FIRM/MANUFACTURER Indiana Blood
Center, Indianapolis, IN
REASON Blood
products, with positive bacterial detection testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 72C244232
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody,
GA,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit: 72C368450
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody,
GA,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49GL26462
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT, Tulsa,
OK
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 TX
PRODUCT
a)
Cryoprecipitated AHF,
b) Red Blood Cells Leukocytes
Reduced,
CODE a) and b) Unit:
1003687
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood products, collected from a
donor with a history of Hepatitis A, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION VA,
MN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 182393210
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ,
Manufacturer: Blood Systems, Inc.,
Cheyenne, WY.
REASON Blood product, collected from a donor
who visited a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Source
Plasma,
CODE Units: 0490589001,
0490586391
RECALLING FIRM/MANUFACTURER ZLB Bioplasma,
Inc., Grand Prairie, TX,
REASON Blood products, collected from a donor
whose scheduled physical exam was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC
PRODUCT
a)
Platelets,
b) Fresh Frozen Plasma
CODE a) and b) Unit:
1289028
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood products, associated with a red
cell component that contained clots, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit:
FL02533
RECALLING FIRM/MANUFACTURER Inova Health Care
Services, Blood Donor Services, Sterling, VA
REASON Blood products,
collected from a donor who had previously tested reactive for Hepatitis C (HCV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION VA
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1346886
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood
product, associated with a red cell component that contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Cryoprecipitated
AHF,
CODE Unit:
1191624
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with a plasma
component that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1286652
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with a red
cell component that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
CODE a) and b) Unit:
22GE98379
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, collected from a donor
whose suitability to donate was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: J90674
RECALLING
FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids, MI
REASON
Blood product, which tested negative for
hepatitis, but was collected from a donor who previously tested positive for the
antibody to hepatitis B core antigen (anti-HBc) on two separate occasions, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit:
72C056571
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Dunwoody, GA
REASON Blood
product, with a low platelet count, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells
Leukocytes Reduced Irradiated,
c) Blood and Blood
Products for Reprocessing,
CODE
a)
Unit: 4550729;
b) and c) 5895747
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute – Sylvan N Goldman
Center, Oklahoma City, OK
REASON Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION OK, NJ,
Switzerland
PRODUCT
a)
Fresh Frozen Plasma, Thawed,
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b)
Unit: 1935891
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON
Blood products, collected from a
donor who was at risk 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: 0635258
RECALLING
FIRM/MANUFACTURER West Tennessee Regional Blood Center, Inc.,
Jackson, TN
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 TN
PRODUCT Platelets,
CODE
Unit:
5376224
RECALLING FIRM/MANUFACTURER
Recalling Firm: New
York Blood Center, Inc., Long Island City, NY, Manufacturer: New York Blood Center, Inc.,
Westbury, NY.
REASON Blood product, collected from a donor whose arm
scrub procedure was performed incorrectly, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red
Blood Cells,
CODE Unit:
5423242
RECALLING FIRM/MANUFACTURER New York Blood
Center, Inc., Long Island City, NY
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 NY
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Units: M98637,
M46467
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc.,
Chattanooga, TN,
REASON Blood products,
collected from a donor who provided post donation information regarding multiple
high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION GA, TN,
Switzerland
PRODUCT
a)
Red Blood Cells,
b) Fresh Frozen Plasma,
c) Red Blood Cells Leukocytes Reduced,
d)
Plasma Frozen,
CODE
a) Units:
004V28109, 004Z32935, 004Z31812;
b) Units: 004V28109, 004Z32935;
c) Units:
004KQ59814, 004KS11249, 004KQ62282, 004KT91337, 004E02802;
d) Unit:
004Z31812;
RECALLING FIRM/MANUFACTURER ARC Blood
Services, New England Region, Dedham, MA
REASON Blood products, collected from donors
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION MA, NY,
CA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 4799422
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan
N Goldman Center, Oklahoma City, OK,
Manufacturer: Oklahoma Blood Institute Tulsa Center, Tulsa, OK.
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 OK
PRODUCT
a)
Platelets,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) and b) Unit:
2777024
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood products,
which was collected from a donor who had traveled to a malarial endemic area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49GC20833
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT, Tulsa,
OK
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 TX
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 22FQ49756
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region,
Philadelphia, PA,
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 PA
PRODUCT Red
Blood Cells,
CODE Unit:
4181504
RECALLING FIRM/MANUFACTURER Community Blood
Center, Dayton, OH
REASON Blood product, which was collected from
a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Unit:
V00786
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc.,
Chattanooga, TN,
REASON Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units
DISTRIBUTION FL and
Israel
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: Y62847, Y37803
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc.,
Chattanooga, TN
REASON Blood products, which were collected
from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA,
AL
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 2246297
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON
Blood product, possibly contaminated
with air during collection, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells
Leukocytes Reduced Irradiated,
c) Recovered Plasma,
CODE
a) Units: Y95783; K56698; K42114;
N60617; N47361; L91914; L40116; L15784; N33594; N24082
and N14809;
b) Unit: K83843;
c) Units: K83843; K56698; K42114; N60617;
N47361; Y95783; L91914; L40116; L15784; N33594, N24082
and N14809
RECALLING FIRM/MANUFACTURER Blood Assurance,
Inc., Chattanooga, TN,
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 24 units
DISTRIBUTION TN, GA, NY and
Israel
PRODUCT
a)
Platelets,
b) Red Blood Cells Leukocytes Reduced,
CODE
a) and b) Unit:
Y71402
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc.,
Chattanooga, TN,
REASON Blood products, which were collected
from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN,
GA
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: LH54991
RECALLING
FIRM/MANUFACTURER Rhode Island Blood Center, Providence, RI,
REASON
Blood product, which was collected from
a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1317421
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with a unit of
red blood cells that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Recovered
Plasma,
CODE 49GG24827
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region –HT, Tulsa, OK,
Manufacturer: American Red Cross Blood Services, SW Region, College
Station, TX.
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 Unit: 1618344 (split
unit)
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center
UC Medical Center, Cincinnati, OH,
REASON Blood products,
which were collected from a donor who had traveled to an area considered as
endemic for leishmania, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION OH
PRODUCT Source
Leukocytes,
CODE Unit:
5808077
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX
REASON Blood product, which tested
negative for the human immunodeficiency virus (HIV), but was collected from a
donor who previously tested positive for HIV, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX,
NJ
PRODUCT Source
Plasma,
CODE Units:
G36033, G36034, G36040, G36058, G36059, G36060, G36062, G36065, G36066, G36129,
G36130, G36132, G36133, G36134, G36159, G36163, G36173, G36175, G36232, G36256,
G36259, G36398, G36447, G36449, G36452, G36482, G36483, G36504, G36510, G36511,
G36514, G36517, G36519, G36521, G36527, G36548, G36568, G36585, G36586, G36595,
G36597, G36598, G36599, G36600, G36615, G36617, G36620, G36621, G36622, G36623,
G36624, G36625, G36627, G36629, G36633, G36634, G36635, G36636, G36663, G36667,
G36670, G36672, G36673, G36674, G36677, G36680, G36682, G36683, G36685, G36708,
G36710, G36711, G36712, G36713, G36716, G36718, G36721, G36728, G36734, G36736,
G36737, G36739, G36740, G36741, G36743, G36744, G36745, G36746, G36749, G36752,
G36753, G36754, G36757, G36760, G36761, G36764, G36768, G36771, G36772, G36776,
G36777, G36780, G36781, G36788, G36789, G36792, G36796, G36799, G36800, G36801,
G36802, G36804, G36808, G36812, G36814, G36815, G36816, G36819, G36820, G36825,
G36838, G36839, G36840, G36843, G36845, G36847, G36848, G36851, G36852, G36853,
G36854, G36860, G36862, G36866, G36867, G36883, G36886, G36890, G36893, G36902,
G36905, G36923, G36924, G36927, G36930, G36936, G36938, G36947, G36954, G36956,
G36957, G36966, G36969, G36975, G36976, G36977, G36978, G36980, G36983, G36987,
G36989, G36990, G36992, G36993, G36995, G36996, G36999, G37000, G37002, G37003,
G37004, G37009, G37014, G37018, G37019, G37021, G37023, G37025, G37045, G37048,
G37053, G37054, G37057, G37061, G37062, G37063, G37064, G37066, G37067, G37068,
G37069, G37070, G37076, G37079, G37080, G37081, G37083, G37101, G37108, G37112,
G37115, G37121, G37126, G37130, G37139, G37144, G37146, G37147, G37151, G37159,
G37160, G37162, G37164, G37165, G37166, G37168, G37171, G37174, G37178, G37187,
G37189, G37192, G37201, G32703, G37206, G37212, G37217, G37218, G37220, G37221,
G37222, G37224, G37229, G37232, G37235, G37255, G37256, G37258, G37267, G37270,
G37275, G37281, G37282, G37283, G37285, G37295, G37299, G37303, G37312, G37313,
G37315, G37318, G37319, G37337, G37341, G37343, G37349, G37350, G37352, G37356,
G37358, G37359, G37366, G37372, G37375, G37378, G37381, G37384, G37388, G37390,
G37392, G37398, G37408, G37414, G37434, G37437, G37441, G37442, G37450, G37452,
G37465, G37466, G37484, G37493, G37503, G37505, G37507, G37510, G37513, G37514,
G37515, G37517, G37522, G37523, G37526, G37527, G37536, G37537, G37539, G37545,
G37547, G37548, G37550, G37556, G37558, G37563, G37565, G37566, G37567, G37570,
G37574, G37575, G37576, G37577, G37579, G37581, G37582, G37583, G37589, G37590,
G37594, G37597, G37598, G37600, G37602, G37605, G37606, G37608, G37611, G37612,
G37613, G37617, G37618, G37623, G37626, G37640, G37642, G37645, G37646, G37649,
G37650, G37651, G37656, G37658, G37663, G37666, G37667, G37670, G37673, G37674,
G37681, G37684, G37686, G37687, G37689, G37690, G37691, G37694, G37695, G37698,
G37699, G37701, G37704, G37705, G37706, G37707, G37708, G37719, G37720, G37722,
G37723, G37724, G37725, G37726, G37727, G37728, G37729, G37730, G37731, G37734,
G37737, G37739, G37742, G37757, G37774, G37781, G37789, G37799, G37801, G37816,
G37817, G37822, G37828, G37829, G37835, G37836, G37838, G37849, G37850, G37854,
G37858, G37864, G37865, G37866, G37870, G37880, G37881, G37882, G37884, G37886,
G37887, G37891, G37893, G37899, G37907, G37910, G37912, G37913, G37916, G37917,
G37918, G37928, G37931, G37932, G37933, G37935, G37938, G37940, G37942, G37943,
G37946, G37947, G37948, G37951, G37952, G37954, G37956, G37958, G37959, G37960,
G37961, G37963, G37965, G37969, G37971, G37974, G37975, G37976, G37977, G37985,
G37986, G37987, G37988, G37989, G37990, G37992, G37995, G37999, G38000, G38002,
G38003, G38005, G38010, G38013, G38014, G38016, G38017, G38045, G38046, G38047,
G38053, G38055, G38059, G38064, G38066, G38068, G38070, G38073, G38077, G38078,
G38081, G38085, G38094, G38098, G38110, G38111, G38115, G38117, G38118, G38123,
G38124, G38125, G38127, G38128, G38134, G38135, G38136, G38144, G38145, G38147,
G38151, G38154, G38157, G38159, G38166, G38169, G38170, G38171, G38176, G38177,
G38181, G38183, G38184, G38188, G38191, G38197, G38198, G38200, G38202, G38206,
G38208, G38212, G38213, G38217, G38221, G38225, G38230, G38233, G38240, G38243,
G38246, G38247, G38249, G38274, G38276, G38278, G38280, G38281, G38284, G38285,
G38287, G38289, G38290, G38293, G38296, G38298, G38303, G38307, G38308, G38214,
G38351, G38352, G38355, G38357, G38359, G38361, G38367, G38368, G38370, G38372,
G38373, G38374, G38375, G38376, G38379, G38380, G38381, G38383, G38384, G38389,
G38394, G38408, G38409, G38413, G38414, G38417, G38420, G38426, G38429, G38440,
G38451, G38457, G38475, G38476, G38477, G38479, G38480, G38497, G38502, G38507,
G38510, G38516, G38527, G38530, G38540, G38541, G38542, G38544, G38546, G38550,
G38552, G38555, G38557, G38558, G38559, G38560, G38561, G38565, G38568, G38570,
G38577, G38578, G38579, G38585, G38619, G38620, G38621, G38624, G38627, G38632,
G38633, G38640, G38641, G38645, G38648, G38649, G38653, G38657, G38659, G38661,
G38662, G38663, G38665, G38672, G38686, G38688, G38690, G38692, G38694, G38699,
G38701, G38704, G38710, G38714, G38718, G38721, G38724, G38727, G38729, G38734,
G38735, G38737, G38738, G38740, G38742, G38743, G38744, G38745, G38748, G38753,
G38755, G38758, G38765, G38766, G38767, G38769, G38770, G38771, G38775, G38782,
G38787, G38791, G38792, G38793, G38795, G38797, G38800, G38802, G38805, G38807,
G38810, G38819, G38820, G38821, G38827, G38833, G38842, G38845, G38851, G38863,
G38865, G38881, G38890, G38893, G38896, G38905, G38907, G38909, G38917, G38919,
G38923, G38924, G38928, G38934, G38936, G38937, G38938, G38950, G38988, G38991,
G38997, G38999, G39204, G39206, G39208, G39209, G39210, G39211, G39217, G39222,
G39226, G39232, G39240, G39248, G39250, G39252, G39254, G39264, G39266, G39269,
G39273, G39280, G39285, G39292, G39302, G39305, G39306, G39312, G39313, G39314,
G39315, G39325, G39326, G39336, G39359, G39360, G39373, G39381, G39383, G39385,
G39386, G39387, G39393, G39398, G39399, G39400, G39402, G39403, G39417, G39433,
G39434, G39435, G39440, G39444, G39445, G39446, G39451, G39452, G39453, G39457,
G39465, G39466, G39470, G39471, G39475, G39476, G39478, G39483, G39484, G39490,
G39503, G39505, G39507, G39513, G39514, G39518, G39524, G39526, G39538, G39539,
G39540, G37008, G37677, G37937, G38407, G38478
RECALLING
FIRM/MANUFACTURER The Good Samaritan Hospital, Lebanon, PA,
REASON
Blood products, collected from donors
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 796
units
DISTRIBUTION PA,
MD
PRODUCT
a)
Red Blood Cells,
b) Platelets,
c)
Recovered Plasma,
CODE a), b) and c)
Unit: T26465
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Michigan Community Blood Centers, Grand Rapids, MI,
Manufacturer: Michigan Community
Blood Center, Traverse City, MI. REASON Blood products, collected from a donor
with a history of surgery within the previous 12 months, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MI,
Switzerland
PRODUCT Recovered
Plasma,
CODE Unit:
T26608
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Michigan Community Blood Centers, Grand Rapids, MI,
Manufacturer: Michigan Community Blood Center, Traverse
City, MI. REASON Blood product, which tested negative for
human immunodeficiency virus (HIV), but was collected from a donor who
previously tested positive for HIV, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT
a)
Red Blood Cells,
b) Platelets,
CODE a) and b) Unit:
T26492
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Michigan Community Blood Centers, Grand Rapids, MI,
Manufacturer: Michigan Community Blood Center, Traverse
City, MI. REASON Blood products, collected from a donor
who was taking antibiotics, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION MI
PRODUCT Recovered
Plasma,
CODE Unit:
003R39182
RECALLING FIRM/MANUFACTURER The American
National Red Cross – Southern Region, Douglasville, GA
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 GA,
CA
PRODUCT Platelets
Pheresis Leukocytes Reduced
CODE Units: 32KP67646 (Part A), 32KP67646 (Part
B, 32KP67649, 32KP67657, 32KP67660
RECALLING
FIRM/MANUFACTURER American National Red Cross HOA Blood Services
Region, Peoria, IL,
REASON Blood products,
which were exposed to unacceptable temperatures during shipment, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION IL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 1471426
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
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 TX and
Switzerland
PRODUCT
a)
Cryoprecipitated AHF,
b) Plasma Cryoprecipitated Reduced,
c) Fresh Frozen Plasma,
d) Red
Blood Cells Leukocytes Reduced,
CODE
a) Units: 71S481770; 71S481500;
71S648304; 71S373979;
b) Units: 71S648304; 71S64841X; 71S373979;
c) Units:
71S147884; 71S368619;
d) Units: 71S648304, 71S648297, 71S80649X and
71S898643;
RECALLING FIRM/MANUFACTURER LifeSouth
Community Blood Centers, Inc., Birmingham Region, Birmingham, AL
REASON
Blood products, processed more than
eight hours after collection, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 13
units
DISTRIBUTION AL
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Unit:
55K54464
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON
Blood products, that were not
quarantined after information was received concerning post-donation illness,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AR,
CA
PRODUCT
Recovered
Plasma,
CODE Unit:
49GL26462
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, Tulsa, OK,
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,
CODE Unit:
1304415
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with a plasma
component that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MN, IL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 04LP73715, 04LM89653, 04LP73713,
04LM89653, 04LP73715
RECALLING FIRM/MANUFACTURER American
National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON
Blood products, lacking assurance of
having been maintained at an acceptable temperature during shipping, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION PA,
NJ
PRODUCT Red
Blood Cells,
CODE Unit:
1272135
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, incorrectly labeled as
negative for the Kell antigen, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: 1341469
RECALLING
FIRM/MANUFACTURER Memorial Blood Centers, Saint Paul, MN
REASON
Blood product, associated with a plasma
component that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTIONFL,
MN
PRODUCT Red
Blood Cells,
CODE Unit:
1362217
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with
a plasma component that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells,
CODE Unit:
1359554
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood product, associated with a
plasma component that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT
a)
Red Blood Cells, Leukocytes Reduced,
b) Blood and Blood
Products for Reprocessing,
CODE a) and b) Unit: J15400
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Michigan Community Blood Centers, Grand Rapids, MI,
Manufacturer:
Michigan Community Blood Centers, Bay City, MI. REASON Blood products, collected from a donor
who had surgery within the 12 months prior to donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MI and
Switzerland
PRODUCT Recovered
Plasma,
CODE Units: 004KQ59814,
004KS11249, 004KQ62282, 004KT91337, 004E02802
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA
REASON
Blood products,
collected from donors for whom donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CA
PRODUCT Recovered
Plasma,
CODE Unit:
4799422
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK,
Manufacturer:
Oklahoma Blood Institute Tulsa
Center, Tulsa, OK. 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 Switzerland
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Cryoprecipitated AHF,
CODE
a) and b) Unit:
LM37595
RECALLING FIRM/MANUFACTURER Rhode Island Blood
Center, Providence, RI
REASON Blood products,
collected from a donor who had major surgery within twelve months of donation,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION RI,
NY
PRODUCT Red
Blood Cells Leukocytes Reduced
CODE Unit: Y16167
RECALLING
FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN,
REASON
Blood product, manufactured from Whole
Blood unit that was stored at an incorrect temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
49GC20833
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, Tulsa, OK,
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 TX
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
c) Platelets Leukocytes Reduced,
CODE
a), b) and c) Unit:
LY25397
RECALLING FIRM/MANUFACTURER Rhode Island Blood
Center, Providence, RI,
REASON Quality Control and
Distribution/Distribution of product that did not meet
specifications.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MA,
RI
PRODUCT Recovered
Plasma,
CODE Unit:
22FQ49756
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA
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
WEEK ENDING FEBRUARY 9
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Units: 71X453741 (split product);
71X22522X; and 71X153231 (split product)
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers - Montgomery
Region, Montgomery, AL,
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 5
units
DISTRIBUTION AL
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: LG55278
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence,
RI,
REASON Blood product, which tested positive for
CMV, but was labeled as CMV-negative, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT
a)
Platelets,
b) Red Blood Cells Leukocytes Reduced,
CODE
a) and b) Unit:
027GH13188
RECALLING FIRM/MANUFACTURER ARC Greater
Alleghenies, Johnstown, PA,
REASON Blood products, collected from a donor
who provided post donation information concerning a previous positive test for
the human immunodeficiency virus (HIV), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA,
VA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Recall # 12FL20065
RECALLING
FIRM/MANUFACTURER American Red Cross Carolinas Blood Services
Region, Charlotte, NC,
REASON Blood product, which was collected
from a donor who traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 55S55386
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater
Ozark-Arkansas Region, Little Rock, AR,
REASON Blood product, collected from a donor with a
gender discrepancy on his registration card, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AR
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 5977950
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON
Blood product, which was not
manufactured in accordance with standard operating procedures (SOP), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets,
Pheresis, Leukocytes Reduced,
CODE Unit: 3101389
RECALLING
FIRM/MANUFACTURER Indiana Blood Center, Indianapolis, IN,
REASON
Blood product, which was
possibly contaminated with Propionibacterium acnes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Platelets,
Pheresis, Leukocytes Reduced,
CODE Unit: 1542785
RECALLING
FIRM/MANUFACTURER Indiana Blood Center, Indianapolis, IN,
REASON
Blood product, which was
possibly contaminated with Bacillus species, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1223824
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with a red
cell component that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: Y86111; Y85226; Y85234; Y86109;
Y90369
RECALLING FIRM/MANUFACTURER Blood Assurance Inc.,
Chattanooga, TN,
REASON Blood products, leukoreduced more than
72 hours after collection, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5
units
DISTRIBUTION TN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 314872599;
314872601
RECALLING FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services, Tupelo, MS,
REASON
Blood
components, processed from Whole Blood more than 8 hours after collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 71X489040
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Huntsville, AL,
REASON Blood product, stored in insufficient
volume of plasma, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 22FR03446
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region,
Philadelphia, PA,
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 NJ
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells Leukocytes
Reduced,
c) Platelets Leukocytes Reduced,
CODE
a) b) and c) Unit:
22FX36274
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products,
collected from a donor whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION NJ and
PA
PRODUCT
a)
Platelets,
b) Fresh Frozen Plasma,
CODE a) and b) Unit:
1251177
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood products, associated with a red
cell component that contained clots, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 22KV55764
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region,
Philadelphia, PA,
REASON Blood product, collected from donors
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells Leukocytes
Reduced,
CODE a) and b) Unit:
311311929
RECALLING FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services, Tupelo, MS,
REASON
Blood products,
collected from a donor whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 12KW19239 (Part
2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: American
Red Cross Blood Services, Carolinas Region, Charlotte, NC,
Manufacturer: American Red
Cross Blood Services, Carolinas Region, Winston Salem, NC.
REASON
Blood product, with a low volume, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 72C165437
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody,
GA,
REASON Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Units: 012KY21842 (2
units)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American Red Cross Carolinas Blood Services, Region, Charlotte, NC,
Manufacturer: American Red Cross Blood Services, Carolinas Region,
Winston Salem, NC.
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 GA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 12GE87785
RECALLING
FIRM/MANUFACTURER American Red Cross Carolinas Blood Services
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 SC
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
CODE a) and b) Units:
012V44881, 012V43605
RECALLING FIRM/MANUFACTURER American
Red Cross Carolinas Blood Services Region, Charlotte, NC,
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 AL, NC,
TN
PRODUCT
a)
Red Blood Cells,
b) Red Blood Cells Leukocytes
c) Red Blood Cells Irradiated,
d) Red Blood
Cells Leukocytes Reduced Irradiated,
e) Platelets,
f) Fresh Frozen Plasma,
g) Plasma Frozen,
CODE
a) Units: 004J04673, 004S85007,
and 004V49209;
b) Units: 004F15522, 004L66154, 004M26734, 004N15405,
004N19273, 004S24510, 004V13091, and 004E86282;
c)
Unit: 004R43548;
d) Units: 004R67018 and 004R80123;
e) Units: 004J04673,
004R67018, 004S24510, and 004E86282;
f) Units: 004N19273, 004R43548, and
004S24510;
g) Unit: 004M26734
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham,
MA,
REASON Blood products,
collected from a donor in which donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 22
units
DISTRIBUTION MA, ME, NH,
NY
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 311393414
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood
Services, Tupelo, MS,
Manufacturer: Blood
Systems, Inc., Bedford, TX.
REASON Blood product, which was incorrectly
tested for syphilis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT
a)
Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Red Blood Cells Leukocytes Reduced Irradiated,
d) Fresh Frozen Plasma,
CODE
a) Unit: 41FQ11815;
b) Units:
41LN10799, 41FW42442, 41FQ11662, 41FQ11667, 41FQ11669,
41LR94362, 41LR94364, 41LR94365, 41LP35846, 41LP35872, 41LP35878,
41FR58587, 41FR58592, 41FR58600, 41LP35850, 41LP35852,
41LP35853,
41LP35854, 41FR58605, 41FR58616, 41FR58620,
41FR58623, 41FR58626,
41FY51235, 41FY51238, 41FY51241,
41FY51243, 41FY51250, 41FN66860,
41FN66863, 41FN66868,
41FN66869, 41FN66890, 41FN66894, 41FN66900,
41FN66904,
41FN66908, 41FQ11810, 41FQ11812, 41FQ11820, 41FQ11825,
41FQ11837, and 41FQ11840;
c) Unit: 41FW42440;
d) Units: 41FN66863,
41FN66868, 41FN66894, 41FN66904, and 41FN66908
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL,
REASON Blood products, which were collected in a manner
that may have compromised the sterility of the collection system, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 50
units
DISTRIBUTION AL and
MS
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 012E70978
RECALLING
FIRM/MANUFACTURER American Red Cross Carolinas Blood Services
Region, Charlotte, NC,
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 NC
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 004KQ66949
RECALLING
FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England
Region, Dedham, MA,
Manufacturer:
AC/Manchester, NH, Manchester, NH.
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 NH
PRODUCT Recovered
Plasma,
CODE Unit:
2176342
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ,
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 Scotland
PRODUCT Recovered
Plasma,
CODE Unit:
4309184
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ,
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 Scotland
PRODUCT Recovered
Plasma,
CODE Unit:
W045006021725
RECALLING FIRM/MANUFACTURER Community Blood
Center of Greater Kansas City, Kansas City, MO,
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
a)
Red Blood Cells,
b) Platelets,
CODE Units: a) and b)
1251059
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
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 MN
PRODUCT
a)
Blood Cells Leukocytes Reduced,
b) Platelets
Leukocytes Reduced,
CODE a) and b)
Units: 19GH76642, 19GH77675, 19LF27853, 19LF29189
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN,
REASON Blood products, collected from a donor
who traveled to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION TN, KY,
PR
PRODUCT Blood
Cells Leukocytes Reduced,
CODE Units:
W045006059874, W045006084874
RECALLING
FIRM/MANUFACTURER Community Blood Center of Greater Kansas City,
Kansas City, MO,
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 KS,
MO
PRODUCT
a)
Red Blood Cells (Apheresis),
b) Platelets Pheresis
Leukocytes Reduced,
CODE
a) Units:
004GC19062, 004GC22321;
b) Units: 004GC22321 (Parts 1 & 2), 004GC19106
(Parts 1 & 2)
RECALLING FIRM/MANUFACTURER ARC Blood
Services, New England Region, Dedham, MA,
REASON Blood products, collected from a donor
who traveled to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION MA,
NY
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 197533008 (2
units)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Reno, NV,
REASON Blood products, collected from a donor
who lived in an area with increased risk for human immunodeficiency virus (HIV)
Group O, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION NV
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 012GH34518,
12KQ56982
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services Region, Charlotte, NC,
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 GA and
NC
PRODUCT Platelets,
CODE
Unit:
1239471
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with
a red cell unit that contained a clot, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1266160
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with a red
cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
1272308
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, associated with a red
cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: LL67342
RECALLING
FIRM/MANUFACTURER Rhode Island Blood Center, Providence, RI,
REASON
Blood product, collected from a donor
who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red
Blood Cells Leukocytes Reduced Irradiated,
CODE Unit: LG58930
RECALLING
FIRM/MANUFACTURER Rhode Island Blood Center, Providence, RI,
REASON
Blood product, collected from a donor
who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION RI
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: LM43626
RECALLING
FIRM/MANUFACTURER Rhode Island Blood Center, Providence, RI,
REASON
Blood product,
prepared without the appropriate amount of additive (Adsol), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION RI
PRODUCT Source
Plasma,
CODE Units: 0370129450,
0370129889, 0370130601, 0370131169, 0370131770, 0370132516, 0370133554,
0370134046, 0370151229, and 0370151765
RECALLING
FIRM/MANUFACTURER Biomat USA Inc., Toledo, OH, .
REASON
Blood products, collected from a
donor who received a piercing within 12 months of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION Spain and CA
PRODUCT Recovered
Plasma,
CODE Unit:
55S55386
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR,
REASON Blood product, collected from a donor with a
gender discrepancy on his registration card, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AR,
CA
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 004GE03469 (2
units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC
Blood Services, New England Region, Dedham, MA,
Manufacturer: The American National Red Cross ARC Blood Service New
England Region, Worcester, MA.
REASON Blood products, for which the sterility
may have been compromised, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION MA
PRODUCT Blood
Grouping Reagent anti-Le(a) (LE1) (Murine Monoclonal) BioClone 2.0. for tube
test; Qualitative Test for recognition of the Le(a) (LE1) antigen on human Red
Blood Cells. for in vitro diagnostic use; Meets FDA Potency requirements. Ortho
Clinical Diagnostics,
CODE
DOMESTIC:
Product code 715280; LAB129A; exp. 03/10/08; LAB130A; exp 06/29/08; LAB131A;
exp. 12/27/08;
INTERNATIONAL: Product Code 6901859; LAB129AX; exp. 3/10/08;
LAB130AX; exp/ 06/29/08: LAB131AX; exp. 12/27/08
RECALLING
FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc., Raritan, NJ,
REASON
Reagent Anti Le(a) BioClone 2.0, with
reports of weakened reactivity or false negative reaction when using specific
lots, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2,851 kits
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Panoscreen
3.10mL vial, Reagent Red Blood Cells,
CODE Lot number 03954, Expiration
2006-03-17
RECALLING FIRM/MANUFACTURER Immucor, Inc.,
Norcross, GA,
REASON Blood Bank reagent screening cells,
which may produce unexpected positive reactions at the Anti-Human Globulin phase
of testing, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 256 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 019FZ18167
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN,
REASON Blood product, incorrectly identified as
negative for the e antigen, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
71R422631
RECALLING FIRM/MANUFACTURER Lifesouth Community
Blood Centers Inc., Birmingham Region, Birmingham, AL,
REASON
Blood
component, processed from Whole Blood more than 8 hours after collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 5421874
RECALLING
FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long
Island City, NY,
Manufacturer: New York Blood Center, Inc., Westbury, NY.
REASON
Blood product,
collected from a donor who was at risk for Leishmaniasis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Recovered
Plasma,
CODE Unit:
22FR03446
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA,
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,
CODE Unit:
1299403
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,.
REASON Blood product, associated with a plasma
component that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT
a)
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
b) Red Blood Cells Leukocytes Reduced Irradiated,
CODE
a) Unit: 230087183;
b) Units:
230086401; 230087002; 230086022; 163850358; 163850354
RECALLING
FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services,
Meridian, MS,
REASON Blood product, documented as being out
of controlled storage for more than 30 minutes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION MS
PRODUCT Recovered
Plasma,
CODE Unit:
22KV55764
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON
Blood product, collected from
donors whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49KK03476
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region – HT, Tulsa, OK,
Manufacturer:
American Red Cross Blood Services, SW Region, College Station, TX.
REASON
Blood product,
collected from a donor who was at risk for Leishmaniasis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Recovered
Plasma,
CODE Unit:
12GE87785
RECALLING FIRM/MANUFACTURER American Red Cross
Carolinas Blood Services 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 SC and
CA
PRODUCT Red
Blood Cells,
CODE Unit:
1311085
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 1271692
RECALLING
FIRM/MANUFACTURER Memorial Blood Centers, Saint Paul, MN,
REASON
Blood product, which was manufactured
from a whole blood unit in which an associated blood component contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MN
PRODUCT Red
Blood Cells Leukocytes Reduced Irradiated,
CODE Unit: 71T69176X
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc., Birmingham
Region, Birmingham, AL,
REASON Blood product, which was labeled with
an extended expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh
Frozen Plasma,
CODE Unit:
041FY46336
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American Red Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross
Blood Services, Montgomery, AL.
REASON Blood product, collected from a donor
for whom there was no documentation on the donor record of an arm inspection,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red
Blood Cells,
CODE Unit:
1260256
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN,
REASON Blood product, which
was manufactured from a whole blood unit in which an associated blood component
contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
WEEK ENDING FEBRUARY 16
PRODUCT Red Blood
Cells Pheresis Leukocytes Reduced,
CODE Unit: 027LC62406
RECALLING
FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON
Blood product, associated with
a unit that was found to contain a leak in the storage bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 04H68568
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA
REASON
Blood product, associated with a Fresh
Frozen Plasma unit that was hemolyzed, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Unit: 71X302425
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Huntsville, AL,
REASON Blood product, processed more than eight
hours after collection, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
CODE
a) and b) Unit:
2030692
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA,
REASON Blood products,
collected from a donor who had taken the medication Aricept, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit: 5901801
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON
Blood
product, collected from a donor who had taken the medication Asacol, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets,
CODE
Unit:
2667353
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood product, collected from a donor
who had taken the medication Asacol, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets,
CODE
Unit:
4081037
RECALLING FIRM/MANUFACTURER Community Blood
Council of New Jersey, Inc., Trenton, NJ
REASON Blood product, collected from
a donor who had taken aspirin, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: G16211
RECALLING
FIRM/MANUFACTURER Coastal Bend Blood Center, Corpus Christi, TX,
REASON
Blood product, collected from a donor
who provided post donation information concerning a previous positive test for
the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Procleix
NAT Tracker Version 3.0 Software, Stand Alone Blood,
CODE All lots of Version 3.0 build C,
distributed as material #10009131 for the US market and 10009114 for the
rest-of-world market.
RECALLING
FIRM/MANUFACTURER Novartis Vaccines and Diagnostic, Emeryville, CA
REASON
Software, with a
glitch or defect, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 49 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and
6.0.2,
CODE Sunquest Laboratory Blood
Bank and Blood Donor, version 6.0.1 distributed with Sunquest Laboratory 6.1 and
6.2 and version 6.0.2 distributed with Sunquest Laboratory
6.3
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., Tucson, AZ,
REASON Software, with a defect or glitch, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 283
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT COBE Spectra Disposable Tubing Set, Dual-Needle Extended Life
Platelet Set with LRS Chamber, Catalog Numbers: 777110, 70300, 70310, and
777003015. COBE Spectra Disposable Tubing Set, Single-Needle Extended Life
Platelet Set with LRS Chamber, Catalog Number 70400 and 777003215. COBE Spectra
Disposable Tubing Set, Dual-Needle Extended Life Platelet Set .Catalog Number
70100 and 777003005. Trima LRS Platelet, Plasma, RBC Set with Sharps Protection,
Catalog number 777800100. Trima Accel LRS Platelet, Plasma, RBC Set, Catalog
Number 777800400; 777800401; Catalog Number 777800403. Trima Accel LRS Platelet,
Plasma, RBC + TLR Filter Set, Catalog number 777800450 and 777800451 and
777800453. Trima Accel LRS Platelet, Plasma Set, Catalog number 80300. Trima
Accel LRS PLatelet, Plasma, RBC Set, Catalog Number 80400. Trima Accel LRS
Platelet, Plasma, RBC + Auto P.A.S. Set, Catalog number 80410, 80411, 80413.
Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set, Catalog number
80420. Trima Accel Enhanced Platelet, Plasma, RBC Set, Catalog number 80440 and
80449. Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set, Catalog number
80450. Trima Accel PPC, Plasma, RBC + TLR Filter Set, Catalog number 80460.
Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set, Catalog
number 80480 and 80483. Trima Accel Enhanced PPC, Plasma, RBC Set, Catalog
number 80490 and 80491, CODE
Lot
numbers: 03N0005, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15247; 03N0006, 04NXXXXX,
05NXXXXX, 06NXXXXX, 07N15246; 04NXXXXX, 05NXXXXX, 06NXXXXX; 03N15290, 04NXXXXX,
05NXXXXX, 06NXXXXX, 07N15245, 07N15306. 04NXXXXX, 05NXXXXX, 07N15228; 03N15288,
03N15289, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15216. 04NXXXXX, 05NXXXXX, 07N15244;
04NXXXXX, 05NXXXXX. 777800100. 03N1116, 03N1121, 03N1126, 03N2116, 03N3116,
03N3120, 03N3126, 03N3230, 04NXXXX, 05NXXXX, 06NXXXX, 07N1118, 07N2105, 07N2113,
07N2116, 07N2203, 07N2224, 07N3102, 07N3112, 07N3117, 07N3119, 07N3124, 07N3126,
07N3131, 07N3226, 07N3230; 04NXXXX, 05NXXXX, 06NXXXX, 07N9101, 07N9102, 08N9101;
03N3128, 04NXXXX, 05NXXXX, 06NXXXX, 07N3116. 04NXXXX, 05NXXXX, 06NXXXX, 07N3105;
07N9104; 03N3130, 04NXXXX, 05NXXXX, 07N3213. 03N0002, 03N1003, 03N1004, 03N2123,
04NXXXX, 05NXXXX, 06NXXXX, 07N2110, 07N2112, 07N2124. 03N2129, 03N3124, 04NXXXX,
05NXXXX. 06NXXXX, 07N3111, 07N3118, 07N3123. 05NXXXX, 06NXXXX; 06NXXXX, 05NXXXX,
06NXXXX. 05NXXXX. 04NXXXX, 06NXXXX, 07N2219, 07N3109, 07N3205; 03N2119, 03N2121,
03N2122, 03N2127, 03N2128, 03N2226, 04NXXXX, 05NXXXX, 06NXXXX, 07N1111, 07N1116,
07N1123, 07N2126. 03N3121, 05NXXXX, 07N3313. 04NXXXX, 06NXXXX. 05NXXXX; 05NXXXX.
03N3123, 04NXXXX, 06NXXXX, 07N3113; 03N9102, 04NXXXX, 06NXXXX,
07N9103
RECALLING FIRM/MANUFACTURER Gambro BCT, Inc.,
Lakewood, CO
REASON Secondary platelet collection bags, which
may have an inadequate weld, possibly allowing a small leak, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 582,558
sets
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Recovered Plasma,
CODE a) and b) Unit:
49GR45416
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, Tulsa, OK,
REASON Blood products,
which was collected from a donor who was previously deferred for testing
reactive for Hepatitis B surface antigen (HBsAg), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK and
Switzerland
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 19GH79288, 019GH79290, 019GH79292,
019GH79295, 019GH79296
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN,
REASON Blood products, for which the sterility
may have been compromised, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5
units
DISTRIBUTION TN
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Platelets,
c) Fresh Frozen Plasma,
CODE
a) Units: 19GP22788, 19GP22790, 19GP22791,
19GP22803, 19GP22804, 19GP22808, 19GP22810, 19GP22813,
19GP22817, 19GP22818;
b) Units: 19GP22788, 19GP22790, 19GP22791, 19GP22793,
19GP22803, 19GP22804, 19GP22808, 19GP22809, 19GP22813,
19GP22816, 19GP22818;
c) Unit: 19GP22808
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley
Region, Nashville, TN
REASON Blood products, for
which the sterility may have been compromised, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 22
units
DISTRIBUTION TN,
KY
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced, CODE W045006096227 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER Community Blood Center of
Greater Kansas City, Kansas City, MO,
REASON Blood products,
which were leukoreduced greater than 72 hours after collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MO
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Unit: 53GT12953
RECALLING
FIRM/MANUFACTURER American National Red Cross-Greater Chesapeake
& Potomac Region, Baltimore, MD
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 MD
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 53LT94862
RECALLING
FIRM/MANUFACTURER American National Red Cross-Greater Chesapeake
& Potomac Region, Baltimore, MD
REASON Blood product, for which the sterility
may have been compromised, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Unit: 1254536 (2
units)
RECALLING FIRM/MANUFACTURER Memorial Blood
Centers, Saint Paul, MN
REASON Blood products, which were not
manufactured according to specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 2104198
RECALLING
FIRM/MANUFACTURER Bergen Community Region Blood Center, Paramus, NJ,
REASON
Blood product, labeled leukoreduced
without the assurance that it met the criteria for a leukoreduced product, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Recovered Plasma,
CODE a) and b) Unit:
041LH52930
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Birmingham, AL,
REASON Blood products,
collected from a donor previously deferred due to history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL and
Switzerland
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X283720
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Wiregrass
Region, Dothan, AL
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 71X282679;
71X282679
RECALLING FIRM/MANUFACTURER Lifesouth Community
Blood Centers Inc - Birmingham Region, Birmingham, AL
REASON
Blood products,
with platelet count below the specified minimum requirement, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X414724
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Wiregrass
Region, Dothan, AL
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X452058 (split product, 2
units)
RECALLING FIRM/MANUFACTURER Lifesouth Community
Blood Centers Inc - Birmingham Region, Birmingham, AL,
REASON
Blood product,
with platelet count below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 318650535
RECALLING
FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services,
Tupelo, MS,
REASON Blood product, collected from a donor
taking the drug Avodart, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced, CODE Units: 163861824,
163861824
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Blood Systems, Inc/dba United Blood Services, Meridian, MS,
Manufacturer: Blood Systems,
Inc/dba United Blood
Services, Flowood, MS.
REASON Blood products, collected using an
abbreviated screening process, for which the donor was not eligible, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MS
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 2130429 (2
units)
RECALLING FIRM/MANUFACTURER Central Jersey Blood
Center, Shrewsbury, NJ,
REASON Blood products, which were possibly
contaminated with Propionibacterium Acnes, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MO,
NJ
PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated,
CODE
Unit: 2132791
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON
Blood product, which was possibly
contaminated with Propionibacterium Acnes, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
Human Tissue for transplantation: (1) [Talus, Fresh Aseptic, Right
(Code # 070129-105); Talus Lenght: 5.0 cm, Talus Width: 2.6cm, Part Code:
32647001;
(2) [Talus, Fresh Aseptic, Left (Code # 070129-104); Talus
Length: 7.0 cm, Talus Width: 2.3cm, Part Code: 32647002;
(3) [Femoral hemi
Condyle Lateral, Fresh Aseptic, Right (Code # 070129-102); Lenght 1: 5.0 cm,
Tibia Width: 4.2cm, Width 1: 2.0cm; Part Code: 32147001; and
(4) [Femoral
Hemi Condyle Medial, Fresh Aseptic, Right (Code # 070129-101); Lenght 1: 5.0 cm,
Tibia Width: 4.2cm, Width 1: 2.0cm; Part Code: 32247001,
CODE
Units: 070129105, 070129104, 070129102,
070129101
RECALLING FIRM/MANUFACTURER
Recalling
Firm: AlloSource, Inc., Centennial, CO,
Manufacturer: Gift of Hope, Organ & Tissue Donor Network, Elmhurst,
IL.
REASON Human
tissue for transplantation, collected from a donor who was not properly
evaluated for hemodilution, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 tissues
DISTRIBUTION AZ, CO, IL,
OR
PRODUCT
a)
Platelets,
b) Red Blood Cells Leukocytes Reduced,
c) Source Leukocytes,
CODE
a), b) and c) Units:
5986530
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX,
REASON Blood products, collected from
a donor who was previously deferred, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3
components
DISTRIBUTION TX, NE, and
CA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 004FR15138
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 NY
PRODUCT Recovered
Plasma,
CODE Unit:
5901801
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX
REASON Blood product, collected from a donor
who had taken the medication Asacol, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Recovered
Plasma
CODE Unit: G16211
RECALLING
FIRM/MANUFACTURER Coastal Bend Blood Center, Corpus Christi, TX
REASON
Blood product, collected from a donor
who provided post donation information concerning a previous positive test for
the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT
a)
Pedvax HIB. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate. The product is shipped 10 single dose vials per carton.
NDC # 0006-4897-00,
b) COMVAX.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant Vaccine). The product is shipped
10 single dose vials per carton. NDC # 0006-4898-00,
CODE
a) Domestic Lot numbers 0677U exp
1/11/2010, 0820U exp 1/12/2010, 0995U exp 1/16/2010, 1164U
exp 1/18/2010, 0259U exp 10/17/2009, 0435U exp
10/18/2009, 0436U exp 10/19/2009, 0437U exp 10/19/2009,
0819U exp 1/9/2010, and 1167U exp 1/10/2010. Lot number
shipped to China J2438 exp 10/24/2009.
CDC Lot numbers
1690U exp 3/21/2010, 1685U exp 2/22/2010,
1686U exp
2/25/2010, 1687U exp 3/15/2010, 1688U exp 3/16/2010, and
1689U exp 3/19/2010;
b) Domestic Lot numbers 0376U exp 1/5/2010 and 0377U exp
1/8/2010. CDC Lot numbers 1727U exp 4/12/2010, 1668U exp
3/13/2010, and 0658323 exp 4/10/2010
RECALLING
FIRM/MANUFACTURER Merck & Co., Inc., West Point, PA
REASON Vaccines, with a lack of sterility assurance,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,129,180
doses + 890,938 CDC
DISTRIBUTION Nationwide and
China
PRODUCT White-Faced Hornet Venom Protein, Allergenic Extract Hymenoptera
Venom Product, Multidose 13.0 mL (1300MCG per vial, 12 dose), freeze dried.
Sterile Albumin Saline with Phenol (0.4%), CODE Lot No. 1332101C Final Exp:
06/18/2010
RECALLING FIRM/MANUFACTURER Hollister Stier
Laboratories LLC, Spokane, WA
REASON Allergenic Extracts, with a potential for
sterlity to be compromised, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 90
vials
DISTRIBUTION Nationwide
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Red Blood Cells
(Apheresis) Leukocytes Reduced Irradiated, c) Red Blood Cells Leukocytes Reduced,
d) Red Blood Cells Leukocytes Reduced Irradiated,
CODE
a) Unit: 7197645;
b) Units: 7215096,
7197645;
c) Units: 7219131, 7219247, 7216681, 7196504, 7196481, 7197771,
7195344, 7222023, 7198890, 7198809, 7222022, 7197629,
7211122, 7125230, 7225146, 7197748, 7195068, 7224447,
7216922, 7197615, 7226131, 7226912, 7195297,
7211140,
7211139, 7197745, 7210120, 7211188, 7195184, 7196508, 7195453, 7216675, 7225570, 7197767, 7219210, 7226655, 7226252,
7226649, 7197367, 7224394, 7224462, 7216797, 7216979,
7197362, 7216769, 7195247, 7125242,
7194295, 7219820,
7196498, 7192118, 7197754, 7225494, 7216848, 7195187,
7207162, 7200587, 7197368, 7219272, 7224460, 7197522, 7219244, 7219273, 7216886, 7195326, 7226085, 7125243, 7198819, 7220041,
7196486, 7195078,
7195064, 7216081, 7226134, 7200674,
7226290, 7224445, 7197766, 7211129, 7219101, 7216890,
7226287, 7197752, 7197735, 7226802, 7196472, 7211073,
7211043, 7211060, 7225483, 7211116, 7219269, 7225140, 7219839, 7225486,
7197773, 7225074, 7211105, 7224440, 7225302, 7160434,
7195456, 7225339, 7224486, 7225449, 7219836, 7197756,
7226803, 7196509, 7211195, 7195325, 7194294, 7226096,
7194075, 7196487, 7210012, 7216642, 7197476, 7225350,
7211130, 7216634, 7216633, 7219752, 7197594, 7226643, 7195293, 7197592, 7219249, 7197515, 7197421, 7195266, 7216680, 7219716,
7224389, 7225175, 7207689, 7186834, 7226808, 7216857,
7226240, 7226680, 7211172, 7211166,
7211046, 7213974,
7225169, 7219265, 7210121, 7225100, 7211131, 7192128,
7226902, 7216844, 7208441, 7226810, 7225023, 7225142;
d) Units: 7211044,
7226645, 7225077, 7200679, 7225015, 7216499, 7190950,
7219233
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK
Manufacturer: Southwest Oklahoma
Blood Institute, Lawton, OK. REASON Blood products, which were stored outside the
acceptable temperature range, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 168 units
DISTRIBUTION OK,
TX
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Units: 9067173; 9067174; 9067175; 9067176;
9067178; 9067181
RECALLING FIRM/MANUFACTURER The Blood
Connection, Inc., Piedmont, SC
REASON Blood products, which may have been
exposed to unacceptable temperatures during storage, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION SC, TN, NY,
NC
PRODUCT Recovered Plasma,
CODE
Unit: 004FR15138
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
WEEK ENDING FEBRUARY 23
PRODUCT Platelets,
CODE
Unit:
2744442
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Recovered Plasma,
CODE
Unit: W045006001013
RECALLING
FIRM/MANUFACTURER Community Blood Center of Greater Kansas City,
Kansas City, MO,
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 CA
PRODUCT Source Plasma,
CODE
Unit:
NG0150859
RECALLING FIRM/MANUFACTURER DCI Biologicals
Nacogdoches, LLC, Nacogdoches, TX
REASON Blood product, collected from
a donor who had been incarcerated, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION England
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 163895861
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood
Services, Meridian, MS,
Manufacturer:
Blood Systems Inc/dba United Blood Services, Flowood, MS. .
REASON
Blood product, labeled
leukoreduced without the assurance that it met the criteria for a leukoreduced
product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X43350X
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc - Birmingham
Region, Birmingham, AL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X411967
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc - Birmingham
Region, Birmingham, AL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X424312
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc -
Huntsville, AL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X41475X
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc - Wiregrass
Region, Dothan, AL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X384660
RECALLING
FIRM/MANUFACTURER Lifesouth Community Blood Centers Inc - Birmingham
Region, Birmingham, AL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 2102236
RECALLING
FIRM/MANUFACTURER Bergen Comm Region Blood Center, Paramus, NJ,
REASON
Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Recovered Plasma,
CODE a) and b) Units:
Y61859
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc.,
Chattanooga, TN,
REASON Blood products, collected from a donor
who lived in an HIV Group O risk area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION TN
and NY
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: L46411
RECALLING
FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN,
REASON
Blood product, collected from a donor
who reported travel to leishmania and malarial endemic risk areas, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN, GA, AL, Israel and
Switzerland
PRODUCT Red Blood Cells,
CODE
Units: 71R858346;
71Q224444
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers - Montgomery Region, Montgomery, AL,
REASON Blood products,
collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Platelets Leukocytes Reduced,
CODE
Unit: 71X650905
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 71X631651
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Gainesville, FL,
REASON Blood product, with platelet count below
the specified minimum requirement, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Fresh Frozen Plasma,
CODE a) and b)
Units: 5183296
RECALLING FIRM/MANUFACTURER
Recalling
Firm: New York Blood Center, Inc., Long Island City, NY,
Manufacturer: New York
Blood Center, Inc., Westbury, NY.
REASON Blood product, collected from a donor
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated,
CODE
Units: 4174006,
1858487
RECALLING FIRM/MANUFACTURER Indiana Blood Center,
Indianapolis, IN,
REASON Blood products, for which the
documentation of irradiation was incomplete, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IN
PRODUCT Red Blood Cells,
CODE
Units: LE19147,
LE17606
RECALLING FIRM/MANUFACTURER Inova Health Care
Services, Blood Donor Services, Sterling, VA
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 VA and D.C
PRODUCT Plasma, Frozen,
CODE
Unit: 53FE66910
RECALLING
FIRM/MANUFACTURER American National Red Cross-Greater Chesapeake and
Potomac Region, Baltimore, MD
REASON Blood product, collected from
a donor with a history of hepatitis, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT
a)
Red Blood Cells,
b) Platelets,
c)
Fresh Frozen Plasma, ;
d) Red Blood Cells Leukocytes
Reduced,
e) Recovered Plasma,
CODE
a) Units: 53FF08719, 53FF12456, 53GN31558,
53KS38350, 53KW37023, 53L14863, 53X82016;
b) Units:
53FF08719, 53X82016;
c) Units: 53KW37023, 53L14863, 53X82016;
d) Units:
53L25009, 53L33187;
e) Units: 53GN31558, 53KS38350, 53L25009, 53L33187,
53FF08719
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD
REASON
Blood products, collected from a donor
who was previously deferred for testing positive for the Hepatitis C virus (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
19
units
DISTRIBUTION SC, MD, VA, CA and
D.C.
PRODUCT
a)
Red Blood Cells,
b) Recovered Plasma,
CODE a) and b) Unit:
GH32530
RECALLING FIRM/MANUFACTURER Inova Health Care
Services, Blood Donor Services, Sterling, VA
REASON a) and b) Unit:
GH32530
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ,
VA
PRODUCT
Red
Blood Cells Leukocytes Reduced,
CODE Units: 004E02970,
004Z25746
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC
Blood Services, New England Region, Dedham, MA,
Manufacturer: ARC/North Shore
Donor Center, Danvers, MA.
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 NY, MA,
CA
PRODUCT
a)
Fresh Frozen Plasma,
b) Red Blood Cells Leukocytes
Reduced,
CODE a) and b) Unit:
53R47179
RECALLING FIRM/MANUFACTURER American National
Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD
REASON
Blood products, that tested negative for
viral markers, but was collected from a donor that subsequently reported a
previous reactive test for Hepatitis B, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION D.C.
and MD
PRODUCT
Red Blood Cells,
CODE Unit: T21869
RECALLING
FIRM/MANUFACTURER Northern Illinois Blood Bank dba Rock River Valley
BC, Rockford, IL
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 FL
PRODUCT
a) Red
Blood Cells,
b) Platelets,
c)
Fresh Frozen Plasma,
CODE a), b), and
c) Unit: 53J44373
RECALLING FIRM/MANUFACTURER American
National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD,
REASON
Blood product, collected from a donor who
was previously deferred for a history of receiving an ear piercing, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MD and
D.C.
PRODUCT
Whole Blood Leukocytes Reduced,
CODE Unit: 2448628
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio,
TX,
REASON Blood product, collected from a donor
who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Unit: 04R94268
RECALLING
FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA
REASON
Blood product, collected from a donor
who had received a tattoo within twelve months of donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Unit: 2667645
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX
REASON Blood product, collected from a donor who
received a human bite within 12 months of donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT
a) Platelets Pheresis Leukocytes Reduced,
b)
Platelets Pheresis Irradiated,
CODE
a)
Units: X52598, X96675 (split unit), X95515, J72229, and J64313(split
unit);
b) Units: N39120, X52598
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA.
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 9
units
DISTRIBUTION VA, NC and
NY
PRODUCT
Red
Blood Cells Leukocytes Reduced,
CODE Unit: 041FN66469
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL
REASON
Blood product, which tested negative for
HIV, but was collected from a donor who previously tested positive for HIV, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
Red
Blood Cells Leukocytes Reduced,
CODE Unit: 318106645
RECALLING
FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services,
Tupelo, MS,
REASON Blood product, which was collected from
a donor who traveled to a malarial endemic area was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT
a) Fresh Frozen Plasma,
b) Red Blood Cells
Leukocytes Reduced,
CODE a) and b)
Unit: 1650557
RECALLING FIRM/MANUFACTURER Community Blood
Council of New Jersey, Inc., Trenton, NJ
REASON Blood products,
collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT
Platelets Pheresis Leukocytes Reduced,
CODE Units: 004GP68622 Part 1; 004GP68622 Part
2; 004GP68622 Part 3
RECALLING FIRM/MANUFACTURER ARC
Blood Services, New England Region, Dedham, MA,
REASON Blood products, which did not meet the
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION RI,
ME, MA
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Unit: W045006027039
RECALLING
FIRM/MANUFACTURER Community Blood Center of Greater Kansas City,
Kansas City, MO,
REASON Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MO
PRODUCT
Red Blood Cells
CODE Unit: W045006027698
RECALLING
FIRM/MANUFACTURER Community Blood Center of Greater Kansas City,
Kansas City, MO
REASON Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KS
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Units: 163850606; 163850605;
163850607
RECALLING FIRM/MANUFACTURER Blood Systems Inc/dba United Blood Services, Meridian,
MS
REASON Blood
components, processed from Whole Blood more than 8 hours after collection, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MS and
AL