MARCH 2005
WEEK ENDING MARCH 5
PRODUCT
Human Tissue for Transplantation.
CODE
2004-12-6107, 2004-12-6108.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Kansas City, MO.,
REASON
Human tissue for transplantation, procured from a donor who tested negative
for antibody to hepatitis C virus (anti-HCV), but was subsequently found to
have tested positive for the hepatitis C virus by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Corneas.
DISTRIBUTION
Kansas City, MO.
PRODUCT
Recovered Plasma.
CODE
Unit 0375106.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood product, collected from an ineligible donor due to previous blood product
administration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Platelets, Leukocytes Reduced.
CODE
Unit C62135, R34834.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN.
REASON
Platelets, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units C61920, C61921, H12672, H12708, R34645, R34648, R34650, R34663.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN.
REASON
Red Cells, lacking proper pre-transfusion testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
IN.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 11GE23823.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO.
REASON
Blood products, which tested negative for hepatitis B surface antigen (HBsAg),
but were collected from a donor who previously tested positive for HBsAg, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 71M478630.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Marion Region, Ocala, FL.
REASON
Blood products, that tested negative for Hepatitis B surface antigen (HBsAg)
and for the antibody to Hepatitis B core antigen (anti-HBc), but were collected
from a donor who had close contact with an individual who had positive test
results for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Platelets Pheresis Leukocytes Reduced.
d) Platelets Pheresis Leukocytes Reduced
Irradiated.
CODE
a) and b) Unit K56345;
c) and d) Unit V02446.
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA.
REASON
Blood products, which were collected from donors in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) and b) Unit number K15328.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN.
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
TN.
PRODUCT
Platelets.
CODE
Unit number N55636.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number K84812.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product collected from an unsuitable donor due to a possible history of
residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Platelets.
CODE
Unit number K81141.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number K71628.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
PRODUCT
Source Plasma.
CODE
F-00894-117, F-01572-117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, Lubbock, TX
REASON
Blood product, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 030GX65848, 030GX65853.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern Pennsylvania Region, Ashley, PA
REASON
Blood products, collected using a hematocrit centrifuge that did not have quality
control properly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
Source Plasma.
CODE
Units G07736117, G36449117, G36757117, G37230117, G41136117, G44868117, G45055117,
G45847117, G48358117, G48762117, G50928117, and G51169117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, LLC, Lubbock, TX, California, Spain, the United Kingdom, and
Switzerland
REASON
Blood products, which were collected from a donor who was incarcerated and who
engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA, Spain, the United Kingdom, and Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit V06870.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA
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
VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 2703289.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Blood product, which tested initially reactive for an infectious disease on
an invalidated test run but subsequently tested negative on a single repeat
run, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Red Blood Cells, Deglycerolized, Leukocytes Reduced, Irradiated.
CODE
Unit number: 0911625.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Blood product, which was not adequately examined for residual glycerol, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Unit numbers N72280, N49965, and M31196;
b) Unit number N49965;
c) Unit numbers N72280 and M31196.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to behavior known to increase risk of infection with
human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TN, and NY.
PRODUCT
Platelets.
CODE
Unit number K59305.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, collected from an ineligible donor due to use of the medication
Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2153484.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE
REASON
Blood product, collected from an ineligible donor due to use of the medication
Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
PRODUCT
Source Plasma.
CODE
Unit numbers G-92194-195 and G-92765-195.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, San Antonio, TX
REASON
Blood products, 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
reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 04P55140.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA
REASON
Blood product, collected in a manner that may have compromised the sterility
of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.
PRODUCT
Whole Blood.
CODE
Unit number 030LL03613.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA
REASON
Blood product, collected from an ineligible donor due to use of a medication,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 33GY87203.
RECALLING FIRM/MANUFACTURER
American Red Cross, Connecticut Region, Farmington, CT
REASON
Blood product, corresponding to a unit of Platelets possibly contaminated with
Micrococcus sp. and Klebsiella oxytoca, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number: 3172285.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL
Manufacturing Firm: LifeSource Villa Park, Villa Park, IL.
REASON
Blood products, corresponding to a unit of Platelets possibly contaminated with
Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Source Plasma.
CODE
Unit numbers: G-70441-021, F-01316-021, F-03028-021, F-03160-021, and F-04222-021
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Oklahoma City, OK
REASON
Blood products, collected from a donor who received a tattoo within twelve months
prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 Units.
DISTRIBUTION
Spain and NC.
PRODUCT
Platelets.
CODE
Unit number: KJ70089.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood product, corresponding to Red Blood Cells that were possibly contaminated
with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Source Plasma.
CODE
Unit numbers: 150026381, 150026644, 150027280, 150027598, 150028144, 150028445,
150028950, 150029305, 150029803, 150030080, 150031093, 150031721, 150032040,
150032599, 150032942, 150034196, 150034573, 150035026, 150035482, 150035872,
150036277, 150036648, 150037086, 150037588, 150037985, 150038375, 150039192,
150039742, 150039950, 150040553, 150040761, 150041318, 150044156, 150044957,
150045127, 150045536, 150045713, 150046234, 150046446, 150046966, 150047067,
150047530, 150047653, 150048144, 150048304, 150050153, 150050392, 150050987,
150051199, 150051671, 150051938, 150052367, 150053932, 150054346, 150054821,
150055121, 150055461, 150055815, 150056190, 150056369, 150056915, 150057197,
150057540, 150059531, 150059976, 150060233, 150060578, 150060831, 150061246,
150061442, 150061852, 150062273, 150062516, 150062928, 150063160, 150063459,
and 150063702.
CALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI
REASON
Blood products, collected from an ineligible donor based on a previously reactive
test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
77 units.
DISTRIBUTION
Spain.
PRODUCT
Red Blood Cells.
CODE
Unit number: GV64359.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood product, corresponding to Platelets that were possibly contaminated with
Bacillus subtilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
c) Plasma.
CODE
a), b) and c) Unit V17151.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA
REASON
Blood products, collected from a donor whose donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.
PRODUCT
Source Plasma.
CODE
Unit numbers: G-92990-040, G-93602-040,
G-93858-040, G-94370-040, G-94735-040, G-05027-040,
G-05216-040, G-05917-040, G-06697-040, G-09194-040,
G-10141-040, G-10335-040, G-13018-040, G-13177-040,
G-14342-040, G-14912-040, G-15267-040, G-15518-040,
G-16080-040, N-06617-040, N-06651-040, G-32904-040,
G-33117-040, G-33567-040, G-33791-040, and G-35221-040.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Killeen, TX
REASON
Blood products, collected from a donor who had unexplained needle marks, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units.
DISTRIBUTION
CA, NC, and Germany.
PRODUCT
Platelets Pheresis.
CODE
Unit number K68744.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, collected from an ineligible donor due to use of a medication,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Source Plasma.
CODE
Unit numbers 0400014261 and 0400014343.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Wilmington, DE
REASON
Blood products, that tested negative for viral markers, but were collected from
a donor that did not have the physical examination performed properly, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.
PRODUCT
Source Plasma.
CODE
Unit number 05462797.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN
REASON
Blood product tested negative for viral markers but was 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
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 7753379.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, 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
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 11FZ46171.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and AR.
PRODUCT
Red Blood Cells.
CODE
Unit 71 L33071-7.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Lake City, FL
REASON
Blood product, collected from a donor whose partner had a confirmed positive
test for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells Pheresis, Irradiated.
CODE
Units 71M12444-6 (2 components).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL
REASON
Blood products, for which documentation of irradiation was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells.
CODE
Unit K34532.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA
REASON
Blood product, collected from an unsuitable donor due to the use of the medications
Estrace and Zestril, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated.
CODE
Unit numbers: 3010989, 3020685, and 3020686.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane WA
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.
PRODUCT
Platelets.
CODE
Unit KJ69493.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood product, which was manufactured from a whole blood unit in which the corresponding
red blood cell unit contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit P11900.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN
REASON
Platelets, with a positive bacterial detection screen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
Red Blood Cells.
CODE
Unit 5158651.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ
REASON
Blood product, corresponding to a unit of clotted Fresh Frozen Plasma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Recovered Plasma.
CODE
Unit 11GE23823.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO
REASON
Blood products, which tested negative for hepatitis B surface antigen (HBsAg),
but were collected from a donor who previously tested positive for HBsAg, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit V14132.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA
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
VA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 2039459.
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN
REASON
Platelets, collected from a donor who previously tested positive for HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Platelets, Irradiated.
CODE
Unit number K17608.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, untested for human immunodeficiency virus (HIV) and hepatitis
C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit numbers K38546 and K43530 (distributed as four split units).
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood products, that were found to be out of specification for red blood cell
recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TN, and AL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number L40353.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma. .
CODE
a) and b) Unit number: 2121397.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Blood products, collected from a donor whose medical history screening was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
AlphaNine SD, Coagulation Factor IX (Human).
CODE
Lot CV02003A.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, CA
REASON
Coagulation Factor Concentrate, that failed stability testing at 3 months when
stored at 30ƒ C, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot.
DISTRIBUTION
AZ, PA, TN, MN, LA, and New England.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) and b) unit number K64537.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood products, collected from an ineligible donor due to use of a medication,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN and GA.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Platelets.
CODE
a), b), and c) Unit V06698.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA
REASON
Blood products, collected from a donor whose donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 18FQ91014, 18FQ91018, 18FQ91019, 18FQ91020, 18FQ91021, 18FQ91022,
18FQ91023, 18FQ91024, 18FQ91027, 18FQ91028, 18FQ91029, 18FQ91030, 18FQ91031,
18FQ91032, 18FQ91033, 18FQ91034, 18FQ91035, 18FQ91036, 18GQ91037, 18FQ91038,
18FQ91039, 18FQ91040, 18FQ91042, 18FQ91043, 18FQ91044, 18FQ91046, 18FQ91048,
18GF47000, 18GF47001, 18GF47004, 18GF47005, 18GF47006, 18GF47008, 18GF47010,
18GN26801, 18GN26802, 18GN26804, 18GN26807, 18GN26808, 18GN26810, 18GN26812,
18GN26813, 18GN26815, 18GN26816, 18GN26817, 18GN26818, 18GN26819, 18GN26820,
18GN26821, 18GN26822, 18GN26825, 18GN26827, 18GN26828, 18GN26829, 18GN26830,
18GN26831, 18GN26832, 18GN26833, 18GN26834 and 18GN26835.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI
REASON
Blood products, collected without daily quality control being performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
60 Units.
DISTRIBUTION
MI and PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 40LV05536.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL
REASON
Blood product, that did not have the complete amount of additive solution included,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Source Plasma.
CODE
Unit 77428554.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN
REASON
Blood product, collected from a donor whose eligibility to donate was not adequately
verified, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
WEEK ENDING MARCH 12
PRODUCT
Red Cells (Apheresis) Leukocytes Reduced.
CODE
Unit #200369403.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON
Red Cells, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit #200373375.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette, LA..
REASON
Platelets, collected on equipment that had not been properly validated for use,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Source Plasma.
CODE
Unit numbers: 74932528, 74934652, 76679964, 76681400, 76683954, 76685316, and
76687365.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Seattle, WA
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 38C20745.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN
REASON
Red Cells, without proper pre-transfusion testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
Source Plasma.
CODE
Unit numbers: 19115870, 19114170, 19112565, 19111179, 10359259, 10357262, 10355183,
10353448, 09418479, 09238398, 09235915, 09234130, 08389749, 08387936, 08384904,
08383037, 08381064, 08818836, 08815408, 08814227, 09269668, 09268623, 09266315,
10341674, GP103728, GP103614, GP103346, GP102810, GP099403, GP099315, GP098913,
GP098817, GP098499, GP098395, GP101872, GP101718, GP101660, GP101474, GP101368,
GP100991, GP100771, GP100679, GP100442, GP100359, and GP106383.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN
REASON
Blood products, that tested negative for viral markers, but were collected from
a donor that was subsequently determined to have multiple risk factors for increased
incidence of infection with human immunodeficiency virus (HIV), were distributed.
45 Units.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
IL, CA, and Germany.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Pheresis Leukocytes Reduced.
CODE
a) Units O4G58905, 04GR23384A, 04FP70983,
04GJ14606, 04GL67536, 04GP56152, 04GR23123,
04KC27716, 04KE42414, 04FR84423, 04G58901,
04G58917, 04M24720, 04F17794, 04F18787,
04G59158, 04J63988, 04LE52384, 04M24740,
04N29857, 04S62142, 04Z08114, 04Z08120,
32KS11787, 32KS11800, 104FP70974, 04E73133,
04E73147, 04E73521, 04E73530, and 2057247;
b) Units 104FP70974, 2057247, 04GR23384A,
04FP70983, 04GJ14606, 04GL67536, 04GP56152,
04GR23123, 04KC27716, and 04KE42414.
RECALLING FIRM/MANUFACTURER
UMass Memorial Medical Center, Worcester, MA
REASON
Blood products, which were inadequately irradiated due to a malfunction of the
irradiation device, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
MA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 26118-6197.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR
REASON
Blood products, collected from donors whose health history screening was inadequately
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR
PRODUCT
Source Plasma.
CODE
Unit number: 73671305.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Seattle, WA
REASON
Blood product, untested for hepatitis B surface antigen (HBsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE
Unit numbers 83730108, 83727856, 83724206.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Spokane, WA
REASON
Blood products, collected from a donor whose medical history screening did not
include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE
Unit numbers 78868489 and 78869318.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc. Yakima, WA
REASON
Blood products, collected from a donor whose medical history screening did not
include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE
Unit numbers 78866089, 78867154, 90010828, 90013799, 90015083, 90016448, 90151903,
90152931, and 90155123.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Yakima, WA
REASON
Blood products, that tested negative for viral markers, but were collected from
a donor that was previously deferred due to a risk factor for increased incidence
of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
CA.
PRODUCT
Source Plasma,
CODE
Unit numbers 370476487 and 370477760.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Medford, OR
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma. .
CODE
a) and b) Unit number FS58231.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 6484395.
RECALLING FIRM/MANUFACTURER
Community Blood Bank, Inc., Rancho Mirage, CA
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to behavior known to increase risk of infection with
human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit number 2750142.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, 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 04N28784.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA
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
Platelets.
CODE
Unit number KM16089.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood product, possibly contaminated with Streptococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Platelets Pheresis.
b) Fresh Frozen Plasma (Apheresis).
CODE
a) and b) Unit number 07FM09202.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ
REASON
Blood products, possibly contaminated with Staphylococcus sp. bacteria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 04GP57124 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA
REASON
Blood product, possibly contaminated with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 6019620.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS
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
MS.
PRODUCT
Source Plasma.
CODE
Unit numbers: 52497940, 52424847,52402975, 52400919, 33060569, 33055190, 33052311,
33047003, 33045412, 32990508, 32977004, and 32975475.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Spokane, WA
REASON
Blood products collected from a donor who had been previously deferred by another
center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit V06866.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA
REASON
Blood product, collected from a donor in which door suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Source Plasma.
CODE
Units XR74373, and XR75519.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fargo, ND
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
PRODUCT
Recovered Plasma.
CODE
Unit number 26118-6197.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR
REASON
Blood products, collected from donors whose health history screening was inadequately
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Source Plasma.
CODE
Unit number 91238440.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Everett, WA
REASON
Blood product, that tested negative for hepatitis B surface antigen (HbsAg),
was not quarantined after the donor of the product subsequently tested reactive
for HbsAg and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit numbers 108LJ26166 (distributed as two split products), 108LJ26167, and
108LJ26164.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ
REASON
Blood products, exposed to extended shipping times, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AZ.
PRODUCT
Source Plasma.
CODE
Unit number VA-149255.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 150248525.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX
REASON
Blood product that was possibly out of controlled storage for more than 30 minutes
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number 3022486.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number 9009110A.
RECALLING FIRM/MANUFACTURER
Wellmont Health System, Kingsport, TN
REASON
Blood product, labeled with the incorrect expiration date, was distributedl.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
WEEK ENDING MARCH 19
PRODUCT
Source Plasma.
CODE
Unit numbers: 93438100, 93439374.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kennewick, WA
REASON
Blood products, collected from a donor who had elevated alanine aminotransferase
(ALT) levels, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO.
PRODUCT
Source Plasma. Recall # B-0734-5.
CODE BWSVDL, BWSTQX, BWQTHP, BWQSVT, BWQSKZ, BWQRZP, BWQRPL, BWPVCL,
BWPTYF, BWPTMC, BWPSYZ, BWPSMP, BWPSCK, BWPRRJ, BWPRDD, BWMBJW, BWLZWJ, BWLZLK,
BWLYYV, BWLYQC, BWLYDR, BWMNGO, BWMMVS, BWMLSB, BWMLGK, BWMKXT, BWMKNC, BWMKDP,
BWMJRX, BWMJHQ, BWMHVZ, BWMHMY, BWMGSQ, BWMFRY, BWMFJJ, BWKBTZ, BWKBLY, BWJZWM,
BWJZJQ, BWJVYC, BWJJDB, BWJHQF, BWJDTQ, BWJDFM, BWJGPT, BWJGBR, BWJFLF, BWJCRT,
BWJCBT, BWJBLV, BWHZWY, BWHZGN, BWHYNS.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., Tulsa, OK.
REASON
Blood products, collected from a donor who failed to disclose a previous positive
test for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units.
DISTRIBUTION
IL, and Germany.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit FW29535.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA
REASON
Blood product, corresponding to Platelets that were contaminated with gram positive
cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Human Corneas for Transplantation. Recall # B-0739-5.
CODE
2005-0092 (CNOS) & 2005-0092 (CNOD).
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Oregon, Portland, OR,
REASON
Human tissue, procured from a donor who may have participated in high-risk behaviors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas.
DISTRIBUTION
NY, and CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 2626591 (Parts A & B).
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL
Manufacturing Firm: LifeSource Oak Lawn, Oak Lawn, IL.
REASON
Platelets, possibly contaminated with gram-positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 22GW96812.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus
warneri, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 22FS26179.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood products, in which the corresponding Platelets were contaminated with
Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 22FX07951.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus
capitis, 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 8364545.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and Switzerland.
PRODUCT
RAPID HIV Test Kits.
CODE
Test Kits.
RECALLING FIRM/MANUFACTURER
UPS Supply Chain Solutions, d.b.a. FDTS, Alpharetta, GA
REASON
Unapproved, HIV diagnostic test kits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
646 Kits.
DISTRIBUTION
Nationwide.
PRODUCT
Source Plasma.
CODE
Unit F30508143.
RECALLING FIRM/MANUFACTURER
Advanced BioServices, LLC (formerly known as Tri-Cities Plasma Corp.), Johnson
City, TN
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 8959312, 8959320.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from donors who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and MI.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
CODE
a) Units 6951562, 6876348;
b) Units 8370498, 8519910, 8316891;
c) Units 8316891, 6951562, 8519910.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA,
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
LA, and MI.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 8958312, 9554788.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA,
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 8951230.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 7219970 (split unit).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, which were possibly contaminated with Corynebacterium species,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
PRODUCT
Cryoprecipitated AHF, Pooled.
CODE
Unit numbers: 10732, 10747, 10750, 10751, 10799, 10805, 10811, 10816, 10847,
10849, 10853, 10858, 10864, 10865, 10866, 10868, 10869, 10875, 10879, 10933,
10938, 10939, 10940, 10943, 10950, 10952, 10956, 10959, 10982, 11029, 10736,
10737, 10753, 10756, 10757, 10758, 10759, 10768, 10772, 10774, 10787, 10804,
10807, 10843, 10871, 10878, 10909, 10911, 10912, 10915, 10917, 10920, 10924,
10945, 10948, 10953, 10954, 10957, 10964, 10969, 10970, 11011, 11012, 11016,
11022, 11055, 10741, 10742, 10766, 10771, 10776, 10777, 10778, 10779, 10780,
10781, 10798, 10801, 10803, 10813, 10814, 10815, 10817, 10820, 10821, 10823,
10824, 10825, 10826, 10828, 10829, 10830, 10831, 10832, 10833, 10834, 10835,
10836, 10838, 10840, 10842, 10860, 10862, 10863, 10867, 10870, 10872, 10876,
10880, 10881, 10883, 10886, 10888, 10890, 10892, 10893, 10894, 10895, 10896,
10897, 10898, 10899, 10900, 10901, 10902, 10903, 10907, 10908, 10914, 10916,
10918, 10919, 10921, 10922, 10923, 10926, 10927, 10928, 10929, 10931, 10934,
10936, 10937, 10941, 10944, 10946, 10947, 10949, 10951, 10955, 10958, 10965,
10967, 10983, 10984, 10987, 10988, 10989, 10990, 10992, 10993, 11013, 11018,
11023, 11024, 11025, 11026, 11027, 11030, 11031, 11032, 11034, 11075, 11078,
11080, 11081, 11101, 11105, 11109, 11112, 11113, 11114, 10752, 10754, 10755,
10760, 10763, 10765, 10770, 10789, 10791, 10792, 10793, 10794, 10795, 10796,
10932, 10935, 10942, 10783, 11047, 11048, 10806, 10819, 10845, 10857, 10861,
10734, 10735, 10746, 10748, 10786, 10788, 10802, 10852, 10854, 10855, 10856,
10877, 10904, 10905, 10906, 10910, 10913, 10930, 10960, 10968, 10972, 10975,
10976, 10977, 10978, 10979, 10980, 11045, 11049, 10764, 10767, 10773, 10809,
10844, 10846, 10873, 10874, 10738, 10739, 10744, 10859, 10882, 10887, 10889,
10885, 10782, 10808, 10812.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR
REASON
Pooled Cryoprecipitate, that failed to meet the minimum specifications for fibrinogen
levels, was distributed.
VOLUME OF PRODUCT IN COMMERCE
255 units.
DISTRIBUTION
OR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 8954566, 9554612, 9554618.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from donors who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
LA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 7220276.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Platelets, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 8707243.
RECALLING FIRM/MANUFACTURER
Our Lady of Lourdes Regional Medical Blood Center, Lafayette, LA
REASON
Blood products, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and LA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 53FE88833.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD
REASON
Red Cells, collected from a donor taking the medication, Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Units FG52314, FK35887.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI
REASON
Blood products, collected from a donor taking Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
RI and Switzerland.
PRODUCT
Recovered Plasma.
CODE
Unit 8519274.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Plasma Frozen.
d) Cryoprecipitated AHF.
e) Cryoprecipitated AHF, Pooled.
f) Recovered Plasma.
CODE
a) Unit numbers: 21V68362, 21KS02102, 21V65396,
21GE11865, 21V57493, 21KF03262, 21V51637, and
21V49872;
b) and c) Unit number: 21GE14710;
d) Unit numbers: 21KF03262, 21V51637, and 21V49872;
e) Unit numbers: 21V65396, 21V57493;
f) Unit numbers: 21V68362, 21KS02102, 21V65396,
21GE11865, 21V57493, and 21V47653.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR
REASON
Blood products, which were collected from a donor who was taking the medication,
Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
OR, CA, UT, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 8512575.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Red Blood Cells, Leukocytes Reduced,
Irradiated.
d) Cryoprecipitated AHF.
e) Recovered Plasma.
f) Platelets for Manufacturing Use Only.
CODE
a) Unit 9556213;
b) Units 8955012, 8529765;
c) Unit 8370918;
d) and e) Unit 8529765;
f) Unit 8370918.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
LA, NY, PA, and Switzerland.
PRODUCT
a) Whole Blood, Leukocytes Removed.
b) Red Blood Cells.
c) Red Blood Cells, Leukocytes Reduced.
d) Platelets.
e) Platelets, Irradiated.
f) Platelets Pheresis.
g) Platelets Pheresis, Irradiated.
h) Fresh Frozen Plasma.
i) Fresh Frozen Plasma (Apheresis).
j) Plasma Frozen.
k) Plasma.
l) Cryoprecipitated AHF.
CODE
a) Unit number: 32LL71985;
b) Unit numbers: 32KH98711 32GL60331 32FC29398,
32FC29416 32FC29421 32KQ27019 32KF64705 32KQ27504,
32KQ27750 32KF65086 32KH99893 32KF65365 32KF65379,
32KE00090 32KE00131 32KE00134 32KE00136 32KE00138,
32KE00141 32KE00142 32KE00148 32FE62748 32KE00153,
32KF65348 32KQ28624 32GL61028 32FE64102 32KL03082,
32FC29400 32LL72406 32LL72414 32LL72421 32KQ28739,
32FE64087;
c) Unit numbers: 32FE62739 32FE62756 32FE62725 32KQ27783,
32KQ27786 32KQ27804 32FC29636 32KH99715 32KL02927
32KQ28978;
d) Unit numbers: 32KM15951 32LL71168 32GL60297 32GL60314,
32GL60315 32GL60317 32GR01393 32KH98870 32GL60412
32KF64664 32KQ27325 32KH99075 32KF64698 32KF64705,
32KF64755 32KH99219 32KQ27504 32KQ27538 32KQ27635
32KQ27678 32KQ27751 32KQ27772 32KQ27856 32KQ27871,
32KF65102 32KH99715 32KJ56331 32KJ56339 32GR02454
32KH99854 32KH99900 32KH99907 32KF65268 32KF65283,
32KF65298 32KF65318 32KJ56580 32KJ56594 32KJ56602
32KF65351 32KF65353 32KF65354 32KF65356 32KF65358,
32KF65359 32KF65360 32KF65361 32KF65363 32KF65365
32KF65367 32KF65369 32KF65371 32KF65372 32KF65375,
32KF65377 32KF65379 32KF65380 32KM16241 32KM16242
32KM16243 32KM16244 32KM16245 32KM16246 32KM16248,
32KM16249 32KM16250 32KM16252 32KM16253 32KM16254,
32KM16255 32KM16256 32KM16261 32KE00082 32KE00084,
32KE00085 32KE00086 32KE00087 32KE00088 32KE00089,
32KE00090 32KE00091 32KE00092 32KE00093 32KE00095,
32KE00096 32KE00097 32KE00098 32KE00099 32KE00100,
32KE00101 32KE00102 32KE00103 32KE00104 32KE00105,
32KE00106 32KE00107 32KE00108 32KE00109 32KE00112,
32KE00113 32KE00114 32KE00116 32KE00117 32KE00118
32KE00119 32KE00120 32KE00121 32KE00122 32KE00123
32KE00125 32KE00127 32KE00130 32KE00131 32KE00132
32KE00133 32KE00134 32KE00135 32KE00136 32KE00137
32KE00138 32KE00139 32KE00142 32KE00143 32KE00144
32KE00146 32KE00147 32KE00293 32KJ56752 32GR03130
32KJ56807 32KJ56829 32KE00380 32GL61103 32KQ28964
32KQ28971 32KF65579 32KF65595 32KJ56941 32KF65637
32KQ29064 32KQ29078 32KH98718 32KH98732 32KQ27518
32KQ27555 32KQ27542 32KF65373 32KF65374 32KM16259
32KM16260 32KM16263 32KE00081 32KE00110 32KE00111
32KE00128 32KE00129 32KF65430 32KQ28846 32KL03067
32KQ28942 32KQ28949 32KE00148 32KE00149 32KE00151
32KE00152 32KE00153 32KF65342 32KF65343 32KF65344
32KF65346 32KF65347 32KF65349 32KF65350 32KJ56617
32KF65416 32KF65424 32GE25792 32KQ28693 32GR02891
32GE25785 32KF65445 32KQ28686 32KE00277;
e) Unit numbers: 32KF65355 32KM16247 32KM16251
32KE00083 32KE00140 32KE00141 32KJ56856 32KF65572;
f) Unit numbers: 32KP11703 32FP05782 (Parts 1 & 2),
32FP05783 32FP05784 (Parts 1 & 2) 32FP05786 (Parts 1
& 2) 32FP05787 (Parts 1 & 2) 32FP05788 (Parts 1 & 2)
32FP05789 32KP11714 32KP11715 (Parts 1 & 2) 32KP11716
(Parts 1 & 2) 32KP11720 32FP05797 (Parts 1 & 2)
32GP09833 32KP11755 32GP09925 32GP09948 (Parts 1 & 2)
32KP11938 (Parts 1 & 2) 32FP05866 (Parts 1 & 2)
32GP09956 (Parts 1 & 2) 32GP09978 (Parts 1 & 2)
32KP12003 32GP09996 32KP12010 32KP12017 (Parts 1 & 2)
32KP12029 32FP05893 (Parts 1 & 2) 32KP12049 (Parts 1 &
2) 32KP12038;
g) Unit numbers: 32FP05785;
h) Unit numbers: 32KM15951 32LL71168 32GF34390
32GL60412 32KL02802 32GM05192 32KJ56135 32KF65086
32KF65102 32KH99715 32KJ56323 32KJ56339 32KQ28191
32GR02734 32KH99878 32KH99900 32KF65232 32KF65268
32KF65318 32KJ56580 32KJ56602 32KF65354 32KF65355
32KF65356 32KF65358 32KF65362 32KF65365 32KF65367
32KF65372 32KF65379 32KF65380 32KM16241 32KM16245
32KM16246 32KM16247 32KM16250 32KM16251 32KM16252
32KM16256 32KE00092 32KE00101 32KE00102 32KE00104
32KE00107 32KE00117 32KE00122 32KE00131 32KE00133
32KE00134 32KE00136 32GL60394 32KE00138 32KE00140
32KE00142 32KE00144 32KE00148 32KF65342 32KF65343
32KF65350 32GR02891 32KF65416 32KF65424 32GE25792
32GR03071 32KC05524 32KQ28693 32KE00293 32KE00350
32KE00358 32GR03130 32KJ56807 32KE00380 32KQ28861
32GF34960 32GL61111 32KJ56856 32KQ28964 32KQ28971
32KF65637 32KQ29064 32KQ29078 32KH98718 32KF65373
32KE00111 32KL03067;
i) Unit numbers: 32FP05785 32FP05789 32GP09874;
j) Unit numbers: 32FE62745 32FE64118 32FE64146
32FE64188;
k) Unit numbers: 32LL72007 32KJ56800 32KJ56849;
l) Unit numbers: 32GL60318 32GL60319 32GL60320
32GL60321 32GL60322 32GL60323 32GL60324 32GL60325
32GL60326 32GL60327 32GL60328 32GL60329 32GL60330
32GL60331 32GL60332 32GL60333 32GL60334 32GL60336
32GL60337 32GL60338 32GL60339 32GL60340 32GL60341
32GL60342 32GL60343 32GL60344 32GL60345 32GL60346
32GL60347 32GL60348 32GL60349 32GL60350 32GR01423
32KQ27182 32KJ56116 32LL72007 32GE25615 32GE25732
32GE25755 32KJ56673 2KJ56687 32KJ56726 32KQ28624
32KQ28646 32GE25814 32KQ28709 32KQ28716 32KE00300
32KQ28739 32KQ28753 32KQ28768 32KQ28790 32KQ28797
32KQ28820 32GR03145 32KJ56800 32KJ56849 32KQ2754.1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Madison, WI
Manufacturing Firm: American Red Cross, National Testing Laboratory, Eagan,
MN.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
435 units.
DISTRIBUTION
IL, WI, CA, IA, SC, PA, GA, MI, and OH.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 7219904.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 21Q97038.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR
REASON
Blood products, collected from an ineligible donor due to a history of jaundice,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 22KX66872, 22KX66882, 22KX66894, 22KX66918, and 22KX66876.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood products, collected using a hematocrit centrifuge that did not have quality
control performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NJ, and PA.
PRODUCT
Red Blood Cells.
CODE
Unit 22LJ86111.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Red Blood Cells, mislabeled for the M antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 8375394.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white
blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Red Blood Cells.
CODE
Unit numbers: 9008244, 9008281, 9008342, 9008435, 9008172, 9008187, 9008398,
9008376, 9008476, 9008450, 9008447, and 9008475.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
AK, and ID.
PRODUCT
Source Plasma. .
CODE
Unit number: XR38557.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Fargo, ND
REASON
Blood product, 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
Red Blood Cells.
CODE
Unit number: 6704020.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc, Anchorage, AK
REASON
Blood product, that did not have the complete amount of additive solution included,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK.
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated.
CODE
Unit number: LN93024.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Jackson, TN
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
WEEK ENDING MARCH 26
PRODUCT
Source Plasma
CODE
Units G72559117, G72126117, G70835117, G70524117, G69393117, G67174117, G66751117,
G64384117, G58195117, G58036117, G57443117, G57316117, G51231117, G50957117,
G48228117, G45951117, G45056117, G44656117, N05199117, and N05179117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, LLC, Lubbock, TX
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency
virus (anti-HIV), but were collected from a donor who previously tested repeatedly
reactive for anti-HIV and indeterminate by the Western Blot test , were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC, and Switzerland.
PRODUCT
Platelets.
CODE
Units 7041761, 7041762.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood products, collected from donors who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 53LT83790, 53LT82919, 53LT80882.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 53LT83003, 53LT83316.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and DC.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 53R23481.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
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
MD.
PRODUCT
Red Blood Cells.
CODE
Unit 7080624.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 81st Medical Group/SGSC, Keesler AFB, MS
REASON
Blood product, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Africa.
PRODUCT
Red Blood Cells.
CODE
Units W001703000744, W001703000748.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 81st Medical Group/SGSC, Keesler AFB, MS
REASON
Blood products, which tested repeatedly reactive for the antibody to the human
t-lymphotropic virus type I/II (antiHTLV-I/II) but tested negative by confirmatory
test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 53P95098 (Part 1 and Part 2).
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
REASON
Platelets, possibly contaminated with Bacillus subtilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Recovered Plasma.
CODE
a), b), and c) Unit 53GM53124.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD, DC, and CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 7220341.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, which was not properly quarantined after receiving post donation
information concerning high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Plasma, Frozen.
CODE
a) Unit 53FR58273;
b) Unit 53GF55901;
c) Units 53GF55901, 53R87004.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
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
4 units.
DISTRIBUTION
MD, and DC.
PRODUCT
Platelets Pheresis.
CODE
Unit 0891494.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN
REASON
Blood product, collected from a donor whose arm scrub was incorrectly performed,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 9455421.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN
REASON
Blood product, which tested positive for the hepatitis C virus (HCV), but was
not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Irradiated.
b) Platelet Pheresis, Leukocytes Reduced
Irradiated.
CODE
a) Units 22GW91209, 22GW91213, 22GW91214,
22KP91487, 22KT57446;
b) Units 22KG60174, 22KG69777, 22KG69778,
22KG74005, 22KG74499, 35P44389.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn Jersey Region, Philadelphia, PA
REASON
Blood products, lacking assurance of proper storage temperatures due to inaccurate
documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
PA, and NJ.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 4130363.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Blood product, not quarantined after receiving information concerning a post
donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 22KW58193.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood products, in which the corresponding Platelets were possibly contaminated
with coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 53J92841.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
REASON
Blood products, collected from a donor who disclosed a history of hepatitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells Pheresis, Leukocytes Reduced.
CODE
a) Unit 101860987;
b) Units 102989773 (split unit).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ
REASON
Blood products, collected from donors who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AZ.
PRODUCT
Source Plasma.
CODE
Unit 0490333812.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prarie, TX
REASON
Source Plasma, collected from a donor whose medical history screening did not
include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD)
and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 53GH61646.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma, Frozen.
CODE
a) Unit 53FL16859;
b) Units 53Q00247,53Q00243, 53Q00238, 53Q00241.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
REASON
Blood products, manufactured from units of whole blood more than eight hours
after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MD, and DC.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 22KW58201.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood product, in which the corresponding Platelets were possibly contaminated
with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT CryoVein, Saphenous Vein.
CODE
Tissues 7192905, 7192875.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON
Human tissues, possibly processed using an expired anti-microbial solution,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MD.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 22FN66880, 22LJ81445, 22LP03752;
b) Units 22KL10391, 22LJ81445.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON
Blood products, associated with a platelet pool implicated in a transfusion
reaction and possibly contaminated with gram positive rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA, and NJ.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 7056018 (split unit).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
REASON
Platelets, possibly contaminated with Diptheroid bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and NY.
PRODUCT
Human Tissue For Transplantation.
a) Patellar Ligament Hemi Frozen Aseptic;
b) Achilles Tendon Frozen Aseptic;
c) Tibialis Tendon Anterior Frozen Aseptic;
d) Tibialis Tendon Posterior Frozen Aseptic;
e) Patellar Ligament Whole Frozen Aseptic.
CODE
a) Tissues 045679-105, 045679-106;
b) Tissue 045063-102;
c) Tissue 045063-103;
d) Tissue 045063-104;
e) Tissue 045707-102.
RECALLING FIRM/MANUFACTURER
Allo Source, Inc., Centennial, CO
REASON
Human tissues, in which sterility testing may not have been valid, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 tissues.
DISTRIBUTION
CO, and IL.
PRODUCT
Recovered Plasma.
CODE
Unit 101860987.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ
REASON
Blood product, collected from donors who did not have a complete medical history
interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.