APRIL 2004
WEEK ENDING APRIL 3
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit 33GV41007.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
REASON Blood products, which were collected from a donor who was taking the
medication Avodart (dusteride), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and CT.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Recovered Plasma.
CODE
a) and b) Unit numbers: 53FL04501, 53FL12153, 53GM42009.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, that 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 6 units.
DISTRIBUTION MD, D.C., and CA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Plasma.
d) Recovered Plasma.
CODE
a) and b) Units 29KL05404, 29FN28677;
c) Unit 29FN28677;
d) Unit 29KL15404.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, collected from a donor who engaged in
high risk behavior associated with an increased risk of infection with the
human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION VA, NC, and CA.
PRODUCT Plasma Frozen.
CODE Unit number: 53FN96605.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 29GM92967.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, which tested negative for hepatitis,
but were collected from a donor who disclosed a previous positive test for
hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC and CA
PRODUCT Fresh Frozen Plasma.
CODE Unit number: L92645.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond,
VA.
REASON Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number S39842.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
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 CA.
PRODUCT Source Plasma.
CODE Unit numbers: G-25986-093, G-25232-093, G-25004-093,
N-19840-093, N-19796-093, G-96181-093,
G-94488-093,
G-88286-093, G-82434-093, G-82125-093, G-07421-093, G-63885-093, G-63553-093,
G-62702-093,
G-62418-093,
G-60913-093, G-59946-093, G-58898-093, G-57720-093, G-57461-093, G-56052-093,
G-55868-093,
G-55124-093,
G-54764-093, and G-53928-093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp.,
Brownsville, TX.
REASON Blood products, collected from a donor who had received
tattoos within the prior 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION CA, NC, and Spain.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units W045003042843, W045003042835, W045003042831,
W045003042827, W045003042893, W045003042929, W045003042920, W045003042913,
W045003042907, W045003042933, W045003042851, W045003042830, W045003042880,
W045003042894, W045003042884, W045003042900, W045003042978, W045003042957.
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater
Kansas City, Kansas City, MO.
REASON Blood products, collected from donors with inaccurate
hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION KS and MO.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 53J71056.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from a donor who provided
post donation information of testing positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and D.C.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number S39843.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
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 CA.
PRODUCT Red Blood Cells.
CODE Unit number P04865.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
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 CA.
PRODUCT Red Blood Cells..
CODE Unit number S35452.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
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 CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 12801-5948.
RECALLING FIRM/MANUFACTURER Recall Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood product, collected using a phlebotomy method that
may have compromised the sterility of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NM.
PRODUCT Source Plasma.
CODE Unit numbers 6270293481, 6270292625, 6270292244,
6270290893, 6270290489, and 6270289242.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., South Salt
Lake City, UT.
REASON Blood products, collected from a donor whose medical
history screening did not include questioning regarding risk factors for new
variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit numbers 6270256441, 6270256896, 6270261504,
6270262124, 6270272050, 6270272993, 6270274477, 6270275483, 6270276859,
6270286424, 6270288439, 6270288878, 6270290983, 6270292276, 6270293124, and
6270293873.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., South Salt
Lake City, UT.
REASON Blood products collected from an unsuitable donor due
to a history of residing in an area considered at increased risk of exposure to
new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells for manufacture, non-injectables.
b) Recovered Plasma.
CODE
a) and b) Unit number 53KW23236.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from a donor who provided
post donation information of testing positive for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL, CA, and DC.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets, Leukoreduced.
c) Recovered Plasma.
CODE
a), b), and c) Unit # 16GR04676.
RECALLING FIRM/MANUFACTURER The American Red Cross, Central
Ohio Region, Columbus, OH.
REASON Blood products, collected from a donor at increased
risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 12KL55031.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Carolinas Region, Charlotte, NC.
Manufacturer: The American National Red
Cross, Winston-Salem, NC.
REASON Blood product, collected from an unsuitable donor based
on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Red Blood Cells.
CODE Unit number 12GM62039.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Carolinas Region, Charlotte, NC.
Manufacturer: The American National Red
Cross, Asheville, NC.
REASON Blood product, collected from an unsuitable donor based
on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE
a) and b) Unit numbers 12GN523341 and 12LS48833.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Carolinas Region, Charlotte, NC.
Manufacturer: The American National Red
Cross, Asheville, NC.
REASON Blood products, that tested negative for the antibody
to hepatitis C virus (anti-HCV), but were collected from an ineligible donor
based on the subsequent disclosure of a previous positive test for anti-HCV,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC and CA.
PRODUCT Recovered Plasma.
CODE Unit 33GV41007.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
REASON Blood products, which were collected from a donor who
was taking the medication Avodart (dusteride), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and CT.
PRODUCT Platelets Pheresis.
CODE Unit number E85041.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
REASON Blood product, collected in an expired collection bag,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukoreduced.
c) Platelets.
CODE
a) Unit 2058789;
b) Units 2058781, 2058793;
c) Unit 2058784.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY.
REASON Blood Products, with unacceptable test results, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION KY.
PRODUCT Source Plasma.
CODE Unit numbers G-25016-093, G-25327-093, G-25613-093,
G-25930-093, G-26200-093, G-26529-093, G-26793-093, G-27162-093, G-27401-093,
G-27748-093, G-29089-093, G-29261-093, G-29991-093, G-30357-093, G-30507-093,
G-30862-093, G-31032-093, G-32019-093, and G-32898-093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation,
Brownsville, TX.
REASON Blood products, that tested negative for viral markers,
but were collected from an unsuitable donor based on ear piercing within the
previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION NC, Switzerland, and the United Kingdom.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Units: 01LF14990, 01LF14991.
RECALLING FIRM/MANUFACTURER The American Red Cross, New
York-Penn Region, West Henrietta, NY.
REASON Blood products, labeled with extended expiration dates,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells. .
CODE Unit number 71H82497-0.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Responsible Firm: LifeSouth Community Blood Centers, Northeast Georgia
Region, Gainesville, GA.
REASON Blood product, collected from a donor that did not
answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Source Plasma.
CODE Unit number JG0046917.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.
REASON Blood product, collected from a donor that did not
answer medical history questions concerning behavior known to increase risk of
infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Platelets.
CODE Unit numbers: 4134780, 4134779.
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH.
REASON Blood products, collected in a manner that may have compromised
the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Recovered Plasma.
CODE
a) and b)
Unit number: 016LV92622.
RECALLING FIRM/MANUFACTURER American Red Cross, Central Ohio Region, Columbus,
OH.
REASON Blood products, collected from a donor who engaged in multiple
high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Red Blood Cells, Leukoreduced, Irradiated.
CODE
a) Units: 18FZ28725, 18FT62487, 18FT62488, 18FT62490, 18FT62491, 18FT62492,
18FT62493, 18FT62495, 18FT62496, 18FZ29590, 18FK68995, 18FK65999, 18FZ29819,
18FQ81594, 18FS66708, 18FK70692, 18FX45416, 18FW39480, 18FQ72701, 18FJ47664,
18FT54553, 18FW27872, 18FW27962, 18FJ48517, 18GK19660, 18FV37093, 18FQ75310,
18FQ75313, 18FQ75314, 18FQ75316, 18FQ75318, 18FQ75322, 18GK20411, 18FW31111,
18GH83541, 18GH83548, 18FT59186, 18FZ27447, 18FW33281;
b)
Unit: 18GK20405.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, manufactured from units of whole blood more than
eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION KY, MA, and MI.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 18233-6552.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY, and Switzerland.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 18233-6347.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history screening
was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukoreduced.
c) Platelets.
d) Platelet pheresis.
CODE
a) Units: 71J506154, 71J511312, 71J598241;
b) Unit: 71J630847;
c) Units: 71J549479, 71J863981;
d) Unit: 71W537185.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers Inc.,
Gainesville, FL.
REASON Blood Products, incorrectly tested for Cytomegalovirus (CMV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION FL, and AL.
PRODUCT Red Blood Cells.
CODE Unit number 7515187.
RECALLING FIRM/MANUFACTURER Manatee Community Blood Center, Bradenton,
FL.
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 FL.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 7422790.
RECALLING FIRM/MANUFACTURER Manatee Community Blood Center, Bradenton,
FL.
REASON Blood product, collected from an ineligible donor due to recent
ingestion of an aspirin-like medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Red Blood Cells.
CODE Unit number 2051501.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, in which the corresponding Platelets were
contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Source Plasma.
CODE Units 40224572, 42758600, 42570141, 42210269, 42202998, 42200666,
28695417, 41140154, 41137185, 41130520, 40744438, and 40741635.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Medford, OR.
REASON Blood products, which were collected from a donor who had
received a tongue piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit 71W469448.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center,
Gainesville, FL.
REASON Blood product, which yielded a platelet count that was below the
acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
CODE
a) Units 01Q63783, 01KM16426, and 01KF64192;
b) Units 01Q63783 and 01KF64192.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West
Henrietta, NY.
REASON Blood products, which were collected from a donor who had
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION NY.
PRODUCT
a) Cryoprecipitate.
b) Cryoprecipitate Poor Plasma.
CODE a) and b) Unit 2113269.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, in which the corresponding Red Blood Cells were
contaminated with Staphylococcus warneri, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION DE.
PRODUCT Platelets.
CODE Unit number 2043850.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, collected from an ineligible donor due to recent
ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Platelets.
CODE Unit numbers 027FY09588, 027GM86068, 027GM86110, 027GX70520,
027GX70530, and 027LE58857.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Alleghenies Region, Johnston, PA.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION PA, VA, and MD.
PRODUCT Platelets.
CODE Unit number 2021266.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, associated with a unit of Red Blood Cells that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
Cryoprecipitated
AHF.
CODE Unit number 6713531.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood product, associated with a unit of Red Blood Cells that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 6004190.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood product, associated with a unit of Red Blood Cells that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 113383935-split.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Dba United Blood
Services, El Paso, TX.
REASON Blood products, which tested reactive for West Nile Virus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Unit numbers: 6270188720, 6270189490, 6270189982, 6270190563,
6270191344, 6270191916, 6270192819, 6270193746, 6270194787, 6270195004,
6270195674, 6270195833, 6270196213, 6270196564, 6270196755, 6270197152,
6270197869, 6270198059, and 6270197682.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., South Salt Lake City,
UT.
REASON Blood products, collected from a donor previously deferred due to
history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION NC.
PRODUCT Fresh Frozen Plasma.
CODE Unit 027LX15465.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Alleghenies Region, Johnstown, PA.
REASON Blood Product, corresponding to a unit of clotted Red Blood
Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 units.
DISTRIBUTION WV.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 8105856.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood product, that was labeled leukoreduced but was not tested to
determine the white blood cell count as required in the firm's standard
operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 16LL71985, 16LL72015, 16LL72053, and 16LL72098.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central
Ohio Region, Columbus, OH.
REASON Blood products that failed to meet the minimum specification for
product volume were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Platelets, Leukocytes Reduced Pooled.
d)
Fresh Frozen Plasma.
e) Recovered Plasma.
CODE
a) Unit numbers 0855626 and 0902160;
b) Unit number 0902160;
c) Pool number 0082103 (contained recalled unit 0855626);
d) Unit number 0855626;
e) Unit number 0902160;
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products tested negative for viral markers but were
collected from an ineligible donor due to a risk factor for increased incidence
of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 5 units; 1 pool.
DISTRIBUTION OH, FL, and KY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Units 21GL83284, 21GL83290, 21GL83297, 21GL83383, 21GL83384, 21GL83386,
21GL83395, 21GL83405, 21GL83406, 21GL83412, 21GL83422, 21GL83429, 21GL83437,
21GL83314, 21GL83321, 21GL83371;
b) Unit 21GL83441.
RECALLING FIRM/MANUFACTURER American National Red Cross, Portland, OR.
REASON Blood products, collected from donors with unacceptable
hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION OR, and WA.
PRODUCT Red Blood Cells, Leukocytes Removed, Irradiated.
CODE Unit number 03GJ77150.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region,
Atlanta, GA.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Platelets.
CODE Unit number: FC85274.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, dba Heartland Blood
Centers, Aurora, IL.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit J62755.
RECALLING FIRM/MANUFACTURER Regional Health Resource Center, Urbana, 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 Cryoprecipitated AHF.
CODE Unit 9886242.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA.
REASON Blood product, prepared from an overweight whole blood unit, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Source Plasma.
CODE Unit numbers: 6270207536, 6270207883, 6270208488, 6270210516,
6270211055, 6270211303, 6270211869, 6270212054, 6270212567, 6270212828,
6270213312, 6270213728, 6270214898, 6270215188, 6270216468, 6270216635, 6270217118,
6270217364, 6270217873, 6270218557, 6270218775, 6270229926, 6270231539,
6270233320, 6270238665, 6270239485, 6270239774, 6270240463, 6270241136,
6270270238, 6270273298, 6270275601, and 6270275940.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., South Salt Lake City,
UT.
REASON Blood products, collected from an unsuitable donor based on
previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced (Apheresis).
c) Cryoprecipitated AHF.
CODE
a),
and c), Unit 128001716;
b) Units 128017934 - split.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from donors who did not have a complete
medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AZ, NM, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units FC40960, F40388, and C87387;
b) Unit F40388;
c) Units FC40960 and C87387.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, IL.
REASON Blood products, which were collected from a donor who was born or
emigrated from an area with increased risk of human immunodeficiency virus
(HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL, and Switzerland.
PRODUCT
Red Blood
Cells.
CODE Unit numbers 7260190 and 7261377.
RECALLING FIRM/MANUFACTURER Department of the Air Force, 375th Medical
Group, Scott AFB, IL.
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 2 units.
DISTRIBUTION NJ and Bahrain.
PRODUCT
a) Fresh Frozen Plasma.
b) Recovered Plasma.
CODE
a) Unit number 02LC21122;
b) Unit number 02LC25121.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central
Plains Region, Wichita, KS.
REASON Blood products collected from an unsuitable donor due to a
history of travel to an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KS and CA.
PRODUCT Red Blood Cells.
CODE Unit number: 71H809942.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Northeast
Georgia Region, Gainesville, GA
REASON Blood product, collected from a donor with a low body temperature,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Plasma.
CODE Unit 03E38023.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern
Region, Atlanta, GA.
REASON
Blood
product, manufactured from a whole blood unit with an extended collection time,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
CODE
a) Unit numbers: 3452513, 3452516, 3452518, 3452519, 3452520, 3452521, 3452522,
3452523, 3452524, 3452525,
3452526, 3452527, 3452528, 3452529, 3452530, 3452531, and 3452532;
b) Unit numbers: 3452519, 3452521, 3452523, 3452526, and 3452528.
RECALLING FIRM/MANUFACTURER Recalling Firm: LifeSource, Glenview, IL.
Manufacturing Firm: LifeSource Gurnee Donor Center, Gurnee, IL.
REASON Blood products, manufactured from Whole Blood units that were
stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION IL, IN, and WI.
PRODUCT Red Blood Cells.
CODE Units 12LJ37351, 12LJ37353, 12LJ37355, 12LJ37356, 12LJ37363.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross,
Carolinas Blood Services Region, Charlotte, NC.
Manufacturing Firm: American Red Cross, Asheville Center, Asheville, NC.
REASON Blood products, prepared from whole blood units that were stored
at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC.
PRODUCT Recovered Plasma.
CODE
Unit
18233-6552.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY, and Switzerland.
PRODUCT Recovered Plasma.
CODE Unit 18233-6347.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX, and Switzerland.
PRODUCT
Recovered
Plasma.
CODE Unit 20LF46601.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red
Cross, Lewis and Clark Region, Boise, ID
Responsible Firm: The American National Red Cross, Idaho Falls, ID.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Irradiated.
c) Fresh Frozen Plasma.
CODE
a) Unit numbers 027GF14514, 027GF14516, 027GF14518, 027GF14674, 027GF14675,
027GF14677, 027GF14678,
027GF14772, 027GF14774, 027GF14928, 027GF14930, 027GF14932, 027GF15215,
027P62332, 027P62338, 027P62355,
027P62364, 027P62371, 027P62378, 027P62382, 027P62419, 027P62434, 027P62440,
027P62442, 027P62460, 027P62462, 027P62467, 027P62473, 027P62477, 027P62486,
027P62489, 027P62506, 027P62510, 027P62524, 027P62529, 027P62531, 027P62535,
027P62537, 027P62573, 027P62575, 027P62578, 027P62586, 027P62602, 027P62609,
027P62642, 027P62656, 027P62659, 027P62667, 027P62696, 027P62706, 027P62721,
027P62727, 027P62730, 027P62767, 027P62781, 027P62786, 027P62790, 027P62797,
027P62807, 027P62810, 027P62812,
027P62824, 027P62855, 027P62858, 027P62874, 027P62879, 027P62885, 027P62892,
027P62899, 027P62911, 027P62927, 027P62968, 027P62971, 027P62987, 027P62988,
027P62992,027P62999, 027P63043, 027P63047, 027P63063, 027P63066, 027P63069,
027P63071, 027P63076, 027P63085, 027P63088, 027P63099, 027P63107, 027P63113, 027P63145,
027P63176, 027P63181, 027P63184, 027P63206, 027P63231, 027P63242, 027P63245,
027P63250, 027P63262, 027P63281, 027P63290, 027P63292, 027P63301, 027P63304,
027P63310, 027P63316,
027P63364, 027P63368, 027P63371, 027P63375, 027P63390, 027P63462, 027P63467,
027P63475, 027P63490, 027P63509, 027P63515, 027P63542, 027P63570, 027P63577,
027P63586, 027P63590, 027P63593, 027P63597, 027P63651, 027P63662, 027P63666,
027P63672, 027P63674, 027P63676, 027P63699, 027P63710, 027P63713, 027P63719,
027P63754, 027P63849, 027P63853, 027P63890, 027P63897, 027P63901, 027P63906,
027P63940, 027P63942, 027P63946, 027P63949, 027P63958, 027P63996, 027P64002,
027P64005, 027P64016, 027P64017,
027P64027, 027P64031, 027P64044, 027P64045, 027P64063, 027P64066, 027P64070,
027P64074, 027P64075, 027P64087, 027P64090, 027P64092, 027P64095, 027P64128,
027P64141, 027P64143, 027P64148, 027P64153, 027P64160, 027P64173, 027P64176,
027P64179, 027P64186, 027P64194, 027P64208, 027P64215, 027P64218, 027P64234,
027P64240, 027P64260, 027P64263, 027P64290, 027P64292, 027P64297, 027P64301,
027P64307, 027P64309, 027P64313, 027P64327, 027P64357, 027P64363, 027P64373,
027P64376, 027P64383, 027P64402,
027P64405, 027P64410, 027P64415, 027P64419, 027P64421, 027P64549, 027P64553,
027P64556, 027P64559, 027P64578, 027P64580, 027P64588, 027P64590, 027P64629,
027P64634, 027P64640, 027P64669, 027P64673, 027P64691, 027P64692, 027P64695,
027P64698, 027P64701, 027P64721, 027P64728, 027P64732, 027P64733, 027P64738,
027P64745, 027P64771, 027P64774, 027P64779, 027P64781, 027P64785, 027P64788,
027P64804, 027P64808, 027P64813, 027P64825, 027P64826, 027P64832, 027P64834,
027P64841, 027P64844, 027P64853,
027P64875, 027P65129, 027P65132, 027P65143, 027P65145, 027P65150, 027P65157,
027P65195, 027P65198, 027P65200, 027P65204, 027P65209, 027P65228, 027P65230,
027P65234, 027P65239, 027P65247, 027P65254, 027P65257, 027P65265, 027P65267,
027P65276, 027P65278, 027P65353, 027P65356, 027P65358, 027P65364, 027P65380,
027P65386, 027P65390, 027P65394, 027P65404, 027P65408, 027P65423, 027P65438,
027P65450, 027P65453, 027P65458, 027P65460, 027P65462, 027P65477, 027P65480,
027P65482, 027P65493, 027P65498,
027P65544, 027P65547, 027P65553, 027P65563, 027P65566, 027P65569, 027P65578,
027P65590, 027P65591, 027P65597, 027P65634, 027P65636, 027P65658, 027P65665,
027P65668, 027P65699, and 027P65704;
b) Unit numbers 027GF15213, 027GF15217, 027P62332, 027P62343, 027P62368,
027P62416, 027P62434, 027P62451,
027P62477, 027P62600, 027P62685, 027P62713, 027P62885, 027P62890, 027P62896,
027P62899, 027P62922, 027P62930, 027P62984, 027P63146, 027P63155, 027P63198,
027P63232, 027P63240, 027P63258, 027P63284, 027P63299, 027P63308, 027P63395,
027P63402, 027P63480, 027P63482, 027P63503, 027P63658, 027P63728, 027P63729,
027P63751, 027P63853, 027P63894, 027P63897, 027P63901, 027P63946, 027P63964,
027P64003, 027P64023, 027P64031, 027P64045, 027P64095, 027P64125, 027P64143,
027P64171, 027P64179, 027P64181,
027P64208, 027P64211, 027P64258, 027P64332, 027P64357, 027P64402, 027P64421,
027P64559, 027P64561, 027P64665, 027P64745, 027P64849, 027P65155, 027P65209,
027P65239, 027P65245, 027P65420, 027P65438, 027P65442, 027P65465, 027P65502,
027P65571, 027P65626, and 027P65708;
c) Unit numbers 027P62346, 027P62368, 027P62386, 027P62416, 027P62467,
027P62489, 027P62505, 027P62506, 027P62510, 027P62524, 027P62529, 027P62531,
027P62575, 027P62578, 027P62667, 027P62696, 027P62685, 027P62706, 027P62713,
027P62727, 027P62771, 027P62781, 027P62786, 027P62802, 027P62851, 027P62858,
027P62874, 027P62892, 027P62917, 027P62922, 027P62930, 027P62938, 027P62971,
027P62984, 027P62987, 027P62988, 027P63069, 027P63155, 027P63198, 027P63204,
027P63240, 027P63242, 027P63250, 027P63262,
027P63299, 027P63301, 027P63304, 027P63308, 027P63316, 027P63318, 027P63368,
027P63390, 027P63458, 027P63462, 027P63480, 027P63495, 027P63503, 027P63509,
027P63515, 027P63570, 027P63577, 027P63586, 027P63593, 027P63597, 027P63651,
027P63662, 027P63666, 027P63672, 027P63676, 027P63710, 027P63713, 027P63723,
027P63729, 027P64003, 027P64005, 027P64070, 027P64075, 027P64074, 027P64092,
027P64121, 027P64125, 027P64153, 027P64168, 027P64181, 027P64215, 027P64218,
027P64234, 027P64240, 027P64258,
027P64263, 027P64290, 027P64297, 027P64307, 027P64313, 027P64363, 027P64415,
027P64419, 027P64561, 027P64575, 027P64580, 027P64582, 027P64629, 027P64634,
027P64640, 027P64669, 027P64698, 027P64701, 027P64733, 027P64738, 027P64781,
027P64804, 027P64825, 027P64834, 027P64844, 027P64849, 027P65155, 027P65204,
027P65225, 027P65228, 027P65254, 027P65356, 027P65420, 027P65442, 027P65458,
027P65482, 027P65626, 027P65668, and 027P65704.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Alleghenies Region, Johnstown, PA.
REASON Blood products, collected from donors whose medical history
screening may have been inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 508 units.
DISTRIBUTION PA, WV, KY, OH, VA, and MD.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
c)
Recovered Plasma.
CODE a), b), and c) Unit 027GX68385.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Johnstown, PA.
REASON Blood products, which were collected from a donor in which donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA, and CA.
PRODUCT Red Blood Cells, Irradiated.
CODE Unit number: FC45529.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, dba Heartland Blood
Centers, Aurora, IL.
REASON Blood product, labeled with the incorrect expiration date, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Autologous.
CODE Unit G87260.
RECALLING FIRM/MANUFACTURER Rock River Valley Blood Center, Rockford,
IL.
REASON Autologous Red Cells, lacking a "Biohazard" label, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells.
CODE
Unit number
6805285.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood product, that did not have the additive solution included, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 9382437, 9402866, 9365241, 9381985, 9407028, and
9394406.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA.
REASON Blood products, that remained at room temperature for 35 minutes
during leukodepletion, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MS.
PRODUCT Plasma, Frozen.
CODE Unit numbers: 20FM25160, 20GS20633, 20FM25129, 20FM25144,
20FM25149, 20FM25152, 20FM25161, 20FZ19619, 20FM25137, 20FM25142, 20FM25153,
20FC21529, 20FC21537, 20FC21549, 20FC21553, 20FC21554, 20FC21557, 20FC21559,
20FC21586, 20FM25154, 20GH18513, 20GH18518, 20GS20628, 20GS20640, 20GY12767,
20GY12771, 20GY12772, 20FC21593, 20FC21595, 20FC21598, 20FM21601, 20FC21605,
20FC21607, 20FC21610, 20FC21611, 20FC21618, 20FM25121, 20FM25126, 20FM25133,
20FM25143, and 20FM25148.
RECALLING FIRM/MANUFACTURER American Red Cross, Lewis and Clark Region,
Boise, ID.
REASON
Blood
products, that lacked assurance of proper storage temperatures due to
inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 41 units.
DISTRIBUTION MT.
PRODUCT Source Plasma.
CODE Unit 80FRFXMFA.
RECALLING FIRM/MANUFACTURER International BioResources, LLC, Rockford,
IL.
REASON Blood product, which was collected from a donor in which there
was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Recovered Plasma
CODE Unit 128001716.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from donors who did not have a complete
medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ, NM, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 23148-2926.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Billings, MT.
REASON Blood products, collected from an ineligible donor due to a
history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MT.
PRODUCT
Red Blood
Cells, Leukocytes Reduced.
CODE Unit numbers 21FS29585, 21KK71157, 21KK71159, 21KK71187, 21KS15675,
21KS15683, 21GL90100, 21GL90104, 21GL90105, 21GL90106, 21KC68631, 21KK71166,
21KK71170, and 21KL62517.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red
Cross, Pacific Northwest Region, Portland, OR.
Manufacturer: American Red Cross Blood Services, Yakima, WA.
REASON Blood products possibly exposed to unacceptable shipping
temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION WA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) Unit numbers: 042J49705, 042R70778, 042FS80957;
b) Unit numbers: 042J49705, 042FS80957.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern Ohio
Region, Cleveland, OH,
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 41LH49633.
RECALLING FIRM/MANUFACTURER American Red Cross, Alabama Region,
Birmingham, AL.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT Red Blood Cells.
CODE Unit number: 4229211.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, IN.
REASON Blood product, collected from a donor who reported travel to an
area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Red Blood Cells.
CODE Unit number: 5155662.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, TX.
REASON Blood product, collected from a donor who had lived in an area
designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 2276871.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, TX.
REASON Blood products, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but were collected from a donor that
previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and FL.
PRODUCT Platelets Pheresis.
CODE Unit number: 2513823.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, TX.
REASON Blood product, collected from an ineligible donor due to use of
the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Unit number 08093332.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Columbus, OH.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Allergenic Extracts Vials. Non-glycerin allergenic products in 5
mL, 10 mL, and 50 mL vials. The name of the specific extract is stated on the
vial. 17 products include:
a) Acacia Golden;
b) Bahia Grass;
c) Cedar Mountain;
d) Cedar Red;
e) Elm American;
f) Maple, Hard/Sugar;
g) Mulberry Mix RW;
h) Pecan Tree;
i) Sagebrush, Mugwort;
j) Sheep Sorrel;
k) Walnut, Black;
l) AP Housedust Mix;
m) Alternaria tenuis;
n) Candida albicans;
o) Epicoccum nigrum;
p) PMG #4 Grass;
q) PMG Mite Mix.
CODE
a) Lot # A43C2180, exp. 7/01/2005;
b) Lot #s A43G3905 & A43C2299, exp. 7/01/2005;
c) Lot # A43D2458, exp. 7/01/2005;
d) Lot #s A43F3492, A4314533, A4314535, exp. 7/01/2005;
e) Lot #s A43A1158, A43J5006, A43B1876, A43G3710, exp. 7/01/2005;
f) Lot #s A43C2295, A43J5010, exp. 7/01/2005;
g Lot #s A4314819, A43G3719, exp. 7/01/2005;
h) Lot #s A43C1976, A43F3351, A43B1633, exp. 7/01/2005
i) Lot # A43K5605, exp. 7/01/2005;
j) Lot #s A43F3340, A43D2376, exp. 7/01/2005;
k) Lot #s A4314645, A43F3359, A43E3131, exp. 7/01/2005;
l) Lot #s A43B1925, A43C2128, exp. 7/01/2005;
m) Lot #s A43E3130, A4314725, A43G3906, A43G3810, A43G3812, A43E3133, exp.
7/01/2005;
n) Lot #s A43D2633, A43H4195, A43C2127, exp. 7/01/2005;
o) Lot #s A43G3707, A43J5339, A43E3203, A43A1469, A4219616, exp. 7/01/2005;
p) Lot # G33G3807, exp. 7/01/2004;
q) Lot # G33G3805, exp. 7/01/2004.
RECALLING FIRM/MANUFACTURER Hollister Stier Laboratories LLC, Spokane,
WA.
REASON Misbranded Allergenic Extracts were distributed.
VOLUME OF PRODUCT IN COMMERCE 232 vials.
DISTRIBUTION Nationwide.
PRODUCT Red Blood Cells.
CODE Unit number: KE98810.
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation, Dba
BloodSource Sacramento, Sacramento, CA.
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 CA.
PRODUCT Fresh Frozen Plasma.
CODE
Unit
number: 41FT63166.
RECALLING FIRM/MANUFACTURER American Red Cross, Alabama Region,
Birmingham, AL.
REASON Blood products, which were produced from a Whole Blood lacking
phlebotomy documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT Red Blood Cells.
CODE Unit number: 1633025.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, TX.
REASON
Blood
product, collected from a donor whose arm inspection was not documented, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b)
Recovered Plasma.
CODE a) and b) Unit numbers: 5197872 and 6103177.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, TX.
REASON Blood products, that tested negative for antibody to hepatitis C
virus (anti-HCV), but were collected from a donor that previously tested
repeatedly reactive to anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX, Switzerland, and Austria.