DECEMBER 2003
WEEK ENDIND DECEMBER 6
PRODUCT Source Plasma.
CODE Units 0820847522, 0820846792, and 0820846441.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON
Blood
products, which were collected from a donor in which the questions regarding
Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit numbers 0820847552, 0820847180, 0820846460, and 0820846208.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
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 4 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit numbers 0820847539, 0820846868, and 0820846419.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
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 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0410922872, 0410922682, and 0410922144.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Oak Park, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0410923479, and 0410922710.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Oak Park, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0820847456, 0820846543 and 0820846066.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation
record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0820847685 and 0820846107.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 69239311, 69235467, 69225451, 69204623, 69198069, 69193477,
and 69185649.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Evansville, IN.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation
record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Units 0820847492, 0820846844 and 0820846429.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT
Source
Plasma.
CODE Units 0820847398, 0820846635 and 0820845994.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation
record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0820846185 and 0820946623.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Units 0820847690, 0820847353, 0820846586, and 0820846296.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
REASON Blood products, which were collected from a donor in which the
questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the
donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC.
PRODUCT Source Plasma
CODE Unit number: 02GMIE7353.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Walker, MI.
REASON Blood product, collected from a donor whose medical history screening
did not include questions regarding risk factors for Creutzfeldt-Jakob disease
(vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: FM72430.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
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 RI.
PRODUCT Source Plasma.
CODE Unit numbers 0410909205, 0410908973, 0410905035, and 0410903438.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Oak Park, MI.
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 4 units.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 13GL14700 and 13FV19628.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southeastern Michigan Region, Detroit, MI.
REASON Blood products, that were not leukoreduced within the appropriate
time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Source Plasma.
CODE Unit: 02RMIB0423.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Grand Rapids, MI.
REASON Blood product, that tested negative for viral markers, but was collected
from a donor whose medical history was not determined at the time of donation,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Platelets, Leukocytes Removed.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Unit 13FV19511, 13FV16184;
b) and c) Unit 13FV19511;
d) Unit 13FV16184.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Blood products, collected from a donor who reported being exposed
to Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI, and PA.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma..
CODE
a)
and b) Unit 13FN89020.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Blood products, collected from a donor taking the drug Evista,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells.
CODE Unit numbers: 1425795 and 1425864.
RECALLING FIRM/MANUFACTURER Department of the Army, Womack Army Medical
Center, Fort Bragg, NC.
REASON Blood products, which had an unsuitable sample submitted for
viral testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and NC.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) Unit numbers: F139674, F139692, F139694, F139755, and F139931;
b) Unit numbers: F139674, F139692, F139694, F139748, F139755, and F139757.
RECALLING FIRM/MANUFACTURER Recalling Firm: Puget Sound Blood Center,
Seattle, WA.
Manufacturer: Puget Sound Blood Center, Everett, WA. Firm initiated
recall is complete.
REASON Whole blood units, collected in 450 mL blood bags using 500 mL
bag collection parameters, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION WA, and OR.
PRODUCT
Platelets
Pheresis.
CODE
Unit number
55FP18630.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozarks
- Arkansas Region, Little Rock, AR.
REASON Blood product, corresponding to a blood product that was possibly
contaminated with Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Platelets, for Further Manufacture.
c) Recovered Plasma.
CODE a), b), and c) Unit FG72999.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood products, which were collected from a donor who had
received a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA, RI, and Switzerland.
PRODUCT Source Plasma.
CODE Units G-05177-139, G05362-139, G-06046-139, G-06207-139.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Mobile, AL.
REASON Source Plasma, that tested negative for antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a
donor that subsequently tested anti-HIV by PCR reactive, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Spain.
PRODUCT
Source
Plasma..
CODE Units G-35465-139, G-35681-139, G-37746-139, G-38387-139,
G-38673-139, G-40367-139, G-40781-139, G-43934-139, G-44045-139,
G-49388-139,
G-49621-139.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Mobile, AL.
REASON Blood products, collected from an unsuitable donor due to
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 11 units.
DISTRIBUTION Spain.
PRODUCT Source Plasma.
CODE Unit numbers 69292460, 69289514, 69279386, 69275999, 69271342,
69263231, 69261695, 69254116, 69252006, 69246098, 69244131, 69239182, 69236723,
69231261, 69211720, 69203664, 69197703, 69195143, 69189326, 69186837, 69180903,
and 69178726.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Evansville, IN.
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 22 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Unit numbers 69158070, 69152740, 69149467, 69144295, 69140495,
69135439, 69132476, 69127441, 69123986, 69119125, 69116919, 69105425, 69103247,
69099014, 69096358, 69091995, 69089435, 69085420, 69083365, 69079733, 69076176,
69073519, and 69069512.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Evansville, IN.
REASON Blood products, collected from an ineligible donor due to
possible previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Unit numbers 0181090015, 0181089703, 0181089401, 0181089172,
0181088815, 0181088543, 0181088321, 0181088052, 0181087656, 0181087416,
0181087133, 0181086834, 0181086584, 0181085724, 0181085047, 0181084848,
0181084386, 0181084056, and 0181083713.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Columbus, OH.
REASON Problem: 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 19 units.
DISTRIBUTION NC.
PRODUCT Whole Blood.
CODE Unit KC23347.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Reading, PA.
REASON Blood product, collected from a donor who had not completed a CJD
increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells.
CODE Unit V05609.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Blood product, collected from a polycythemic donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b)
Plasma.
c) Cryoprecipitated AHF.
CODE a), b), and c) Unit number: 22LJ67814.
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn-Jersey
Region, Philadelphia, PA.
REASON Blood products, collected from a donor who was taking the
medication, Imuran, for the treatment of Crohn's Disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA, and NJ.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit 34G85284.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region,
Dedham, MA.
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 2 units.
DISTRIBUTION NH.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 36FP18739 (part 2).
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, River
Valley Region, Louisville, KY.
REASON Blood product, in which the corresponding blood component was
contaminated with Staphylococcus epidermidis and implicated in a transfusion
reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Red Blood Cells, Irradiated.
CODE Unit V01039.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Blood product, for which documentation of irradiation was
incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FK76098.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
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 MA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FK75119.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
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 RI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b)
Unit number 33GV44557.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut
Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of
the medical history questions concerning behavior known to increase risk of
infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT.
PRODUCT Source Plasma.
CODE
Unit
numbers 0590270897, 0590270641, 0590270384, 0590270107, 0590270002, and
0590269782.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Allentown, PA.
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
a) Red Blood Cells.
b) Red Blood Cells Deglycerolized.
c) Platelets.
d) Fresh Frozen Plasma.
e) Cryoprecipitated AHF.
f) Buffy Coat.
g) Platelets, For Further Manufacturing into Non-injectables.
h)
Recovered Plasma.
CODE
a) Units 21S49030, 21S42252, 21S28365, 21S10340,21F76736, 21F68637, 21F43891,
21F31994, 21H09760, 21F04938, 21F92129, 21G83174, 21F72825, 21F66606, 21F38665,
21F30365, 21F21493, 21F09896, 21F01585, 21J30215, 21F78607, 21F47201, 21F36976,
21F28175, 21F06739, 21F98607, 21F92198, 21F78622, 21F56321, and 21F51357;
b) Unit 21F19704;
c) Units 21S49030, 21F84330, 21F68637, 21F31994, 21H09760, 21F72825, 21F66606,
21F38665, 21F30365, 21F21493, 21F09896, 21F01585, 21F47201, 21F36976, 21F19704,
21F06739, 21F98607, 21F92198, and 21F56321;
d) Units 21S10340, 21F68637, 21F31994, 21H09760, 21F92129, 21F72825, 21F66606,
21F21493, 21F09896, 21F01585, 21J30215, 21F47201, 21F36976, 21F28175, 21F19704,
21F06739, 21F98607, 21F78622, 21F56321, and 21F51357
e) Unit 21F04938;
f) Units 21F72825, 21F09896, and 21F01585;
g) Units 21S28365 and 21S10340;
h) Units 21S49030, 21S42252, 21S28365, 21F04938, 21G83174, 21F76736, and
21F43891.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Pacific
Northwest Region, Portland, OR.
REASON Blood products, which were collected from a donor who admitted to
having a history of viral hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 30 units;
b) 1 unit;
c) 19 units;
d) 21 units;
e) 1 unit;
f) 3 units;
g) 2 units;
h) 7 units.
DISTRIBUTION OR, WA, CA, and Switzerland.
PRODUCT Source Plasma.
CODE Unit numbers: 0530328359, 0530327758.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lexington, KY.
REASON Blood products, collected from a donor who did not respond to the
questions regarding risk factors for variant Creutzfeldt-Jakob (vCJD) disease,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 13FW09470.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southeastern Michigan Region, Detroit, MI.
REASON Blood product, manufactured from a unit of Whole Blood more than
8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Source Plasma.
CODE Unit numbers FW092022, FW091806, FW090219, FW090821, FW090621, FW091175,
and FW091431.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Fort Wayne,
IN.
REASON Blood products, collected from an ineligible donor due to use of
the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION England.
PRODUCT Human Tissue for Transplantation, Femoral Vein.
CODE Model number V060, serial number 8042362.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Human tissue for transplantation, associated with tissue that was
found to test positive for microorganisms at a different facility, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION FL.
PRODUCT
Source
Plasma.
CODE Unit numbers: G-16318-070, G-16893-070, G-17190-070, G-17654-070.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Vancouver,
WA.
REASON Blood products, collected from a donor who was permanently
deferred at another center for unreliable information regarding a tattoo, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Spain.
PRODUCT Source Plasma.
CODE Unit number: 02GMIB3026.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Walker, MI.
REASON Blood product, collected from a donor whose medical history
questions were not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma.
CODE Unit number: 02RMIA6006.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Grand Rapids, MI.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 33GM19732.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut
Region, Farmington, CT.
REASON Blood product, manufactured from a unit of Whole Blood that had a
discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.
PRODUCT Plasma.
CODE Unit number 04GK60233.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Blood product, stored at an incorrect temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 9580555.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX.
REASON Blood product, that was not properly quarantined after the donor
of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT
Platelets
Pheresis, Leukocytes Removed.
CODE
Unit
number: 7789458.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, IN.
REASON Leukoreduced product, that had a white blood cell count performed
using a sample exceeding the time frame requirement for analysis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Fresh Frozen Plasma.
CODE Unit number: 20GR15206.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood
Services, Boise, ID.
Manufacturer: American Red Cross Blood Services, Great Falls, MT.
REASON Blood product, collected from a donor who failed to answer the
question whether any vaccinations had been received in the past four weeks, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MT.
CODE
a) Donor #68139, Model #T030, Serial #7980070; Model #T030, Serial #7980005,
Model #T030, Serial #7979893;
b) Donor #68139, Model #T090, Serial #7979915, Model #T090, Serial #7979904;
c) Donor #68139, Model #T080, Serial #7979995; Model #T080, Serial #7979987,
Model #T080, Serial #7979945.
RECALLING FIRM/MANUFACTURER CryoLife, Inc, Kennesaw, GA.
REASON Human tissue, procured from a donor whose tissue was initially
positive for Steptococcus species (group A, beta-hemolytic), was implanted. The
recipient developed an infection from the same microorganism.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION AZ, CO, KY, TN, and TX.
PRODUCT Platelets.
CODE Unit number: 24218-1900.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Rapid City, SD.
REASON Blood products, manufactured after clots were detected during the
leukocyte reduction process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SD.
PRODUCT Source Plasma.
CODE Unit numbers G-16712-070, G-16867-070, G-17438-070, G-18025-070,
G-18253-070, G-18650-070, G-19063-070, G-19261-070, G-19594-070, G-19778-070,
G-20444-070, G-20640-070, F-00005-070, F-00213-070, F-01357-070, F-01783-070,
F-02339-070, F-02494-070, F-02883-070, and F-06054-070.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic
Corporation, Los Angeles, CA.
Manufacturer: Alpha Therapeutic Corporation, Vancouver, WA.
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 20 units.
DISTRIBUTION North Carolina and
Spain.
PRODUCT Source Plasma.
CODE Unit numbers 02FINA1588, 02FINA1829, 02FINA2253, 02FINA2456,
02FINA2815, 02FINA3118, 02FINA3322, 02FINA3588, and 02FINA3915.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Fort Wayne,
IN.
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 9 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Unit numbers 0820847510, 0820846613, and 0820846283.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Detroit, MI.
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 COMMERCE3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE
Unit numbers:
F-26184-014, F-25754-014, F-25389-014, F-24914-014, F-24575-014, F-23943-014,
F-23748-014, F-22938-014, F-22712-014, F-22138-014, and F-20707-014.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic, National City, CA.
REASON Blood products, collected from a donor who was not deferred upon
the discovery of a new tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION Sweden.
PRODUCT Source Plasma.
CODE Unit numbers: G-78414-070, G-78705-070, G-79119-070, G-79333-070,
G-80262-070, G-83907-070, G-84061-070, and G-84497-070.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic
Corporation, Los Angeles, CA.
Manufacturing Firm: Alpha Therapeutic Corporation, Vancouver, WA.
REASON Blood products, collected from a donor who had a tattoo applied
within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION Spain and Switzerland.
PRODUCT
a) Red Blood Cells.
b)
Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Units F69455, E54651, C95140, Y80043, X87770;
b) Units F69455, E54651, X87770;
c) Units F69455, E54651, C95140;
d) Units Y80043, X87770.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood
Centers, Aurora, IL.
REASON Blood products, collected from a donor whose sexual partner had
resided in a HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION IL, IN, and
Switzerland.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 7868746.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, 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 IL.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 2728633.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, 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 IL.
PRODUCT Source Plasma.
CODE Unit numbers G-27471-009, G-27692-009, G-28182-009, and
G-28442-009.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic
Corporation, Los Angeles, CA.
Manufacturer: Alpha Therapeutic Corporation, Tacoma, WA.
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 4 units.
DISTRIBUTION Spain.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 2026044.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, collected from an ineligible donor due to a
medical diagnosis of porphyria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE
a) unit numbers 55FR24713, 55FR24714, 55FR24715, 55FR24721, 55R41405, 55R41407,
55F89593, 55FG46281, 55FH52782, 55R41410, 55R41415, 55S21268, 55S21273,
55S21274, 55L39661, 49K60960, 49W37516, 55R41473, 18GS61832, 18GS61833,
18GS61834, 18GS61836, 18GS61838, 55FH53101, 55FR24672, 55FR24686, 55FR24708,
55S21236, 55S21240, 55W35111, 55W35117, 55FH52885, 55FR24775, 55FH52778,
55FR24720, 55S21269, 36GE24165, 36GK10227, 36GK10251, 36LE06952, 55FG46520,
55FH52981, 55FH53088, 55W35254, 55L39807, 55FH52878, 55FR24751, 55FL07629,
55L39811, 36Q72432, 36FY27918, 55FY06335, 49M40038, 49W38332, 55FG46545,
55FH53018, 55FR24765, 55S21374, 50LJ38581,
50LJ38729, 18GJ61823, 18GJ61839, 24KE41560, 24KM72925, 24KV11375, 24KY49484,
24KZ29484, 55W35067, 55W35215, 55FG46492, 55FY06347, 55S21377, 55S21407,
55W35112, 55W35121, 55FK22430, 55FH52779, 55FH52780, 55T13266, 55FK22553,
55FR24895, 55FR24924, 55S21409, 55FG46473, 55FG46479, 55FG46484, 55FH52990,
55FH53012, 55FH53017, 55FH53021, 55FH53032, 55FH53038, 55FH53040, 55L39871,
55Z51377, 55Z51391, 55FG46288, 55FG46300, 55FG46305, 55FG46314, 55FG46325,
55FG46327, 55FG46332, 55FG46333, 55FG46345, 55FH52929, 55FH52948, 55FN20370,
55T13264, 55V20881, 55J20890, 55H85913, 55FW01661, 55FW01662, and 55C60799;
b) unit numbers 55FP19047, 55FP19061, 55FP19065, 55FP19060, 55FP19064,
55FP19052, 55FP19055, and 55FP19053; and the following units were distributed
as two split products: unit numbers 55FP19045 and 55FP19046
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Ozarks - Arkansas Region, Little Rock, AR.
REASON Blood products possibly exposed to unacceptable storage
temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 115 units;
b) 12 units.
DISTRIBUTION MO, and AK.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Fresh Frozen Plasma.
CODE a) and b)Unit number 18N87593.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, collected from a donor who had not completed a
CJD related question regarding whether a bovine insulin injection had been
received, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit
numbers 18FY07334 and 18FR80204
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes
Region, Lansing, MI.
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 MI.
PRODUCT Source Plasma.
CODE Unit numbers 69391750 and 6140027883.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Evansville, IN.
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 2 units.
DISTRIBUTION NC, and CA.
PRODUCT Source Plasma.
CODE Unit numbers BMMTYF, BMMRHN, BMMQTP, BMMQPZ, BMMPZJ, BMMPFR,
BMMPCV, BMLZCW, BMLYZZ, and BMLYLD.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., West Lafayette,
IN.
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 10 units.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 24218-1890.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Rapid City, SD.
REASON Blood products, manufactured after clots were detected during the
leukocyte reduction process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SD.
PRODUCT Source Plasma.
CODE Unit number: 450719.
RECALLING FIRM/MANUFACTURER Aventis Bio Services, Flint, MI.
REASON Blood product, collected from a donor in which donor suitability
was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18GL33449.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, that were not leukoreduced within the appropriate
time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Source Plasma.
CODE Unit number 833037.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit number 832513.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit number 831342
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit number 459237.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Fresh Frozen Plasma.
CODE Unit numbers: 55FP21998, 55FP22000.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Greater
Ozarks - Arkansas Region, Little Rock, AR.
REASON
Blood
products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.