OCTOBER 2003
PRODUCT
a) Platelet, Pheresis.
b) Platelets.
CODE
a) Unit 7045890, 7047566, 7055336, 7055748, 7055933, 7056472 and 7057040;
b) Unit 1753940.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products, collected from a donor taking the drug Lodine,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 14 units (split units);
b) 1 unit.
DISTRIBUTION TX.
PRODUCT Plasma.
CODE Unit number 53G55737.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product 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 1 unit.
DISTRIBUTION MD.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) FT06292.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor
Services, Annandale, VA.
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 VA, and NJ.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number FE81351.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor
Services, Annandale, VA.
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 VA.
PRODUCT Red Blood Cells.
CODE Unit number KS12681.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor
Services, Annandale, VA.
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 VA.
PRODUCT Red Blood Cells.
CODE Unit number L23345.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, 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 VA.
PRODUCT Source Plasma.
CODE Unit numbers FFJGDY, FFJFYP, FFJFRJ, FFJFMW, FFJDWX, FFHWBP,
FFHVWT, FFHVCW, FFHTXB, FFHTMY, and FFHTJV.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Lynchburg, VA.
REASON Blood products, that
tested negative for viral markers, but were collected from an unsuitable donor due
to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION IL.
PRODUCT Source Plasma.
CODE Unit numbers 77130808, 77088451, 76397448, 76049620, 75748418,
75741860, 75657369, 75651725, 75938826, 75932572, 75379803, 75371869, 74854943,
74850983, 74626410, 74623082, 74526710, 74524020, 73154136, 63190199, and
63187458.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Richmond, VA.
REASON Blood products, that tested negative for hepatitis B surface antigen
(HBsAg), but were collected from an ineligible due to previous reactive testing
for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION CA.
PRODUCT
Platelets
Pheresis, Leukocytes Reduced.
CODE Unit numbers 1277729A, 1277932A, 1278076B, 1278266, 1277729B,
1277932B, 1278088A, 1278298, 1277736, 1277940, 1278088B, 1278306A, 1277746A,
1277950, 1278097, 1278306B, 1277746B, 1277963A, 1278100A, 1278313A, 1277767,
1277963B, 1278100B, 1278313B, 1277771, 1277978A, 1278135, 1278315, 1277778,
1277978B, 1278155, 1278322, 1277792, 1278024, 1278165, 1278346A, 1277798,
1278030, 1278177, 1278346B, 1277813, 1278035A, 1278193, 1278349A, 1277835,
1278035B, 1278220, 1278349B, 1277916, 1278050, 1278227, 1277921A, 1278062,
1278246, 1277921B, 1278076A, and 1278238.
RECALLING FIRM/MANUFACTURER Houchin Blood Services,Bakersfield, CA.
REASON Blood products, that were labeled leukoreduced but were collected
during of period of increased leukoreduction failures due to elevated white
blood cell counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION Ca.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 1944553.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
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 KY.
PRODUCT Platelets.
CODE Units Y31870, Y31871, Y31872, Y31873, and Y31874.
RECALLING FIRM/MANUFACTURER Central Pennsylvania Blood Bank,
Hummelstown, PA.
REASON Blood products, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA.
PRODUCT Corneas.
CODE Tissue numbers 2003-04-3003, 2003-04-3004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks,
Columbia, MO.
Manufacturer: Heartland Lions Eye Bank, St. Louis, MO.
REASON Human corneas, collected from a donor with bacterial
endocarditis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION NY and CA.
PRODUCT Source Plasma.
CODE Units 44800635, 47188716.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson,
TN.
REASON Blood products, collected from a donor that had a piercing within
twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Units 92523838, 92521926, 90169977, 90167959, 90165689, 90162190.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson,
TN.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE 41664209, 41663332, 41661680, 41660829, 42168980, 42167938,
42166153, 42165057, 42163343, 42162674, 42161004, 40659848, 40658070, 40657073,
40654362, 40651927, 40651101, 30619784.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., East
Jackson, TN.
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 was subsequently determined to have a previous react test for
anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit 0367709.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie,
PA.
REASON Blood products, collected
from donor who took the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit 0376423.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie,
PA.
REASON Blood products, that tested repeatedly reactive for antibodies to
human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.
PRODUCT
Corneas.
CODE Tissue numbers 02-1189 OD
and 02-1189 OS.
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA.
REASON Human corneas, collected from a donor who had been incarcerated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION WA.
PRODUCT Fresh Frozen Plasma.
CODE Unit number 12796-1393.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood product 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 1 unit.
DISTRIBUTION NM.
PRODUCT Source Plasma.
CODE Unit numbers 75487553, 75486297, 75484101, 75482954, 75027100,
KP77777, 75023676, 75022075, 74430000, 74428557, KP77572, KP77516, 74424214,
74422654, 73350040, 73348511, KP77362, 73345367, 73343035, 73341727, 75299330,
75297848, 75295226, KP77108, 75292041, 75290696, KP76921, 72449875, 72447758,
72443118, 72444511, 72419182, KP76630, 72378038, 72375020, KP76537, KP76424,
62088770, 62086103, 62084253, 62019293, 62016094, 62014274, KP76156, KP76091,
61337756, 61335769, 61239418, KP75839, 61232778, 60089663, KP75663, 60085528,
KP75539, 60081032, KP75516, KP75372, 59270317, 59267942, 59266143, 58938638,
58935149, 58930724, KP74604, 58147597, KP74511, 58141090, 56586619, 56584417,
56580976, KP74348, KP74232, 58165829, 56569193, 56566550, 56563757, 56561487,
56657852, 56656404, 56655223, and 56653892.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis,
TN.
REASON Blood products, that tested negative for hepatitis, but were
collected from an ineligible donor due to previous reactive testing for
hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 81 units.
DISTRIBUTION CA, IL, and NC.
PRODUCT
a) Platelets.
b) Cryoprecipitated AHF.
c) Fresh Frozen Plasma.
d) Plasma, Cryoprecipitate Reduced.
CODE
a) Unit numbers 30GH23642, 30GH23543, 30GE08443, 30GE08464, 30GG45405,
30GF11426, 30GG46538, 30GS10116, 30GH28043, 30GH29216, 30GF13696, 30GX22862,
30GG64049, 30LL00024, 30GJ32756, 30GX35075, 30GN18736, 30GN18855, 30GX35847,
30GX38081, 30GM03163, and 30GH26881;
b) Unit numbers 30GJ57644, 30GR09661, 30GJ57484, 30GJ55326, 30GL32563,
30GY24484, 30GW59408, 30GG68978, 30GH23543, 30GH23987, 30GE08443, 30GN09747,
30GG45405, 30GF11426, 30GG46538, 30GX17042, 30GX17041, 30GX17030, 30GX17029,
30GX17027, 30GG47683, 30GF13696, 30GX22862, 30GG62254, 30GX23443, 30GG64049,
30LL00024, 30GH47764, 30GN15945, 30GX32107, 30GT05698, 30GH51794, 30GH51789,
30GY19694, 30GX39184, 30GN69089, 30GG67313, and 30GH26881;
c) Unit numbers 30GW62728, 30GV00658, 30GF39454, 30GY23861, 30GH23642,
30GH23567, 30GS10116, 30GH28043, 30GH29216, 30GH35283, 30GX25795, 30GJ32756,
30GM00240, 30GJ34481, 30GX35075, 30GN18742, 30GN18736, 30GY20942, 30GN18855,
30GX35847, 30GX38081, 30GM03163, 30GL36491, 30GN64627;
d) Unit numbers 30GJ57644, 30GR09661, 30GJ57484, 30GW59408, 30GG68978,
30GH23987, 30GX32107, and 30GN69089.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern
Pennsylvania Region, Ashley, PA.
REASON Blood products, associated with units of Red Blood Cells that
contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 22 units;
b) 38 units;
c) 24 units;
d) 8 units.
DISTRIBUTION PA, CT, GA, MA, MD, MI, and NY.,
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit 2385543.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, TX.
REASON Blood products, collected from a donor who resided in an area
considered at increased risk of exposure to new variant Creutzfeldt-Jakob
Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Platelets.
CODE Unit M77187.
RECALLING FIRM/MANUFACTURER Blood Assurance, Inc., Chattanooga, TN.
REASON Platelets, collected from a donor who had taken aspirin, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
CODE
a) and b)
Unit 980396.
RECALLING FIRM/MANUFACTURER W.E. & Lela I. Stewart Blood Center,
Tyler, TX.
REASON Blood products, collected from a donor who tested reactive for
Hepatitis B core antibody (HbcAb) on two occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Unit QYP498.
RECALLING FIRM/MANUFACTURER Alabama Plasma, Inc, Birmingham, AL.
REASON Blood product, which was not tested for syphilis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF.
d) Fresh Frozen Plasma.
e)
Plasma for Further Manufacture.
f) Recovered Plasma.
CODE
a) Unit numbers H536675, H528433, H515111, 427749, 422334, 405019, 399726, and
395468;
b) Unit numbers H536675, 427749, 422334, 405019, 399726, and 395468;
c) Unit number H528433;
d) Unit numbers 399726 and 395468;
e) Unit number H515111;
f) Unit numbers H536675, H528433, H515111, 427749, 422334, and 405019.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank,
Springfield, IL.
REASON Blood products, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but were collected from a donor that
previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 8 units;
b) 6 units;
c) 1 unit;
d) 2 units;
e) 1 unit;
f) 6 units.
DISTRIBUTION IL, MO, and CA.
PRODUCT Red Blood Cells.
CODE Unit number 2007835.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington,
KY.
REASON Blood product was not irradiated but was distributed with
labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 8469898.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Lake Charles, LA.
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 MI.
PRODUCT Source Plasma.
CODE Unit numbers CYGFHT, CYDYYC, CYGFLQ, CYGFPD, CYGFJM, CYGFGF,
CYGDZK, CYGDWW, CYHDVX, CYHDLK, CYHDHG, CYHDDB, CYHDBK, CYHCVY, and CYGFMD.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc,
Knoxville, TN.
Manufacturer: Aventis Bio-Services, Inc., Hamilton, OH.
REASON Blood products, collected from donors 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 15 units.
DISTRIBUTION IL.
PRODUCT Source Plasma.
CODE Unit 01GJBMHH .
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Cleveland, OH.
REASON Blood product, which was not tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT
Red Blood
Cells Leukocytes Reduced.
CODE Units 50LH38060 and 50LH38061.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western
Lake Erie Region, Toledo, OH.
REASON Blood product, which was collected in a manner that may have
compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH, and IL.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 1665795 (distributed as two split products).
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc., East
Orange, NJ.
REASON Blood products, that were labeled leukoreduced but were not
tested to determine the white blood cell count as required in the firm's
standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.
PRODUCT Source Plasma.
CODE Unit numbers 7030204812, 7030204400, 7030203305, 7030200404,
7030200283, 7030199291, 7030199080, 7030198122, 7030197956, 7030196950,
7030196823, 7030196021, 7030195468, 7030194225, 7030193895, 7030193268,
7030192879, 7030191359, and 7030190591.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma, Inc.San
Antonio, TX.
REASON Blood products, collected from an ineligible donor due to
previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION United Kingdom.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 17KC39481.
RECALLING FIRM/MANUFACTURER The American Red Cross, North Central
Region, St. Paul, MN.
REASON Blood products, collected from A donor whose health history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MN.
PRODUCT Source Plasma.
CODE Unit 02EWIC3295.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Deerfield,
IL.
REASON Blood product, collected in a manner that may have affected the
sensitivity of viral marker test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma.
CODE Unit 31 8GX6740.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc,
Knoxville, TN.
Manufacturer: Aventis Bio-Services, Inc., Minneapolis, MN.
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), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.
PRODUCT
a) Platelets.
b) Recovered Plasma.
CODE a) and b) Unit number 4966151.
RECALLING FIRM/MANUFACTURER Our Lady of the Lake Hospital, Inc., Baton
Rouge, LA.
REASON Blood products, collected from an ineligible donor due to
previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA and FL.
PRODUCT Source Plasma.
CODE Unit numbers 0200284877, 0200284420, 0200284163, 0200283714,
0200283272, 0200283015, 0200282643, 0200282321, 0200281833, 0200281651,
0200281132, 0200280897, 0200280588, 0200280431, 0200277313, 0200276899, 0200276142,
0200275658, 0200275076, 0200274868, 0200274610, 0200274449, 0200274110,
0200273426, and 0200272650.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc.Norman, OK.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION United Kingdom.
PRODUCT Recovered Plasma.
CODE Unit 22KT46430.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Penn
Jersey Region, Philadelphia, PA.
REASON Blood product, which was collected from a donor with a history of
hepatitis A, was distributed.lk
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number T45002.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, corresponding to a unit of Platelets that failed
quality control testing for pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.
PRODUCT Source Plasma.
CODE Unit numbers BFFQMS and BFFQSL.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Fort Worth, TX.
REASON Blood products, collected from a donor whose health history
screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT Recovered Plasma.
CODE Unit 17KC39481.
RECALLING FIRM/MANUFACTURER The American Red Cross, North Central
Region, St. Paul, MN.
REASON Blood products, collected from A donor whose health history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 24216-1014, 24216-1007..
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, that may have been shipped at an unacceptable
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells.
CODE Unit numbers C40051, C40055, C40107, C40108, C40113, C40117,
C40118, C40120, C40122, C40123, and C40127.
RECALLING FIRM/MANUFACTURER Heritage Valley Health System, Valley
Medical Facilities, Inc., Beaver, PA.
REASON Blood products, collected in expired collection bags, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION PA.
PRODUCT Source Plasma.
CODE Unit number 53-DDNCKF-B.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Melrose Park,
IL.
REASON Blood product, collected from a donor that did not answer medical
history questions concerning behavior known to increase risk of infection with
the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Source Plasma.
CODE Unit number 53-DDPHWH-O.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Melrose Park,
IL.
REASON Blood product, collected from a donor with an elevated body
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Source Plasma.
CODE Unit number 80-FRDXVV-O.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Rockford, IL.
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 Fresh Frozen Plasma.
CODE Unit 6961232.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange,
NJ.
REASON Blood product, which was prepared from a Whole Blood unit with an
extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT Cryoprecipitated AHF.
CODE Unit 6852524.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange,
NJ.
REASON Blood product, which the corresponding red blood cells were
found, during filtering, to have clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT
Source
Plasma.
CODE Unit 00EWIC0791.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P. (Formerly
Community Bio-Services), Eau Claire, WI.
REASON Blood product, collected from a donor who received MMR vaccine 24
days prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT
Corneas.
CODE Tissue numbers 0203-0179-OS and 0203-0179-OD.
RECALLING FIRM/MANUFACTURER Old Dominion Eye Foundation, Inc., Richmond,
VA.
REASON Corneas, not tested for infectious disease markers, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION NY.
PRODUCT Cryoprecititated AHF.
CODE J36519, J36521, J36523,
J36524, J36525, J36526, J36531, J36535, J36536, J36541, J36542, J36543, J36545,
J36549, J36552, J36560, J36563, J36566, J36567, J36569, J36580, J36583, J36588,
J36590, J36601, J36607, J36608, J36609, J36620, J36621, J36633, J36638, J36641,
J36647, J36660, J36665, J36666, J36679, J36684, J36686, J36696, J36698, J36699,
J36700, J36726, J36732, J36733, J36735, J36740, J36745, J36748, J36752, J36753,
J36754, J36757, J36758, J36771, J36775, J36786, J36798, J36799, J36806, J36809,
J36810, J36816, J36819, J36820, J36821, J36825, J36828, J36830, J36854, J36861,
J36862, J36887, J36903, J37355, J37940, J37951, J37955, J37962, J37963, J37964,
J44442, J37974, J39497.
RECALLING FIRM/MANUFACTURER Regional Health Resource Center, Urbana, IL.
REASON Blood products, manufactured without quality control performed,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 86 units.
DISTRIBUTION IL.
PRODUCT Red Blood Cells.
CODE 1273829, 2767574, 3963308, 1275371, 3957191, 3963311, 1275442,
3957944, 3963313, 1277192, 3958949, 3963314, 2746980, 3959084, 3963322,
2752011, 3959140, 3963336, 2756329, 3959176, 3964509, 2757442, 3959720,
3965417, 2758836, 3960287, 6000333 2763684, 3963290, 2764133A, 3963293,
2764133B, 3963294, 2765033, 3963297, 2766738, 3963298, 2767252, 3963302.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 39 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells Deglycerolized.
CODE Unit 22LW55981.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Philadelphia, PA.
REASON Blood product, which tested positive for the S-antigen but was
labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE 27FS15594.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Johnstown, PA.
REASON Blood product, collected from a donor who did not answer the
questions related to ever having Chagas' disease or Babesiosis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 8404640.
RECALLING FIRM/MANUFACTURER Texoma Regional Blood Center, Sherman, TX.
REASON Blood product, collected from a donor who was taking Lanoxin, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE WSN002761, WSN002772.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.
REASON Blood products, collected from a donor who had been previously
deferred at another center, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.
PRODUCT Cryoprecipitated AHF.
CODE Unit number 1612686.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc., East
Orange, NJ.
REASON Blood product, associated with a unit of Red Blood Cells that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT Platelets Pheresis, Leukocuytes Reduced.
CODE Unit number 1466502 (distributed as two split products).
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc., East
Orange, NJ.
REASON Platelets Pheresis with elevated platelet counts were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 1664720.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, Inc., East
Orange, NJ.
REASON Platelets Pheresis with elevated platelet counts were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
CODE a) and b) unit numbers
0924426 and 08937730.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati
Medical Center, Cincinnati, OH.
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 4 units.
DISTRIBUTION OH.
PRODUCT Source Plasma.
CODE Unit numbers 7030118179, 7030117744, 7030117605, 7030117201,
7030116841, 7030116494, 7030116243, 7030115951, 7030115757, 7030115159,
7030114940, 7030141125, 7030140627, 7030135278, 7030135065, 7030134298,
7030133925, 7030133222, 7030132924, 7030132234, 7030127481, 7030127178,
7030126682, 7030126403, 7030125866, 7030125659, 7030125055, 7030124784,
7030124202, 7030123926, 7030123175, 7030122434, 7030122266, 7030121703,
7030121560, 7030121033, 7030120913, 7030120432, 7030120356, 7030119807,
7030119598, 7030119116, 7030118946, and 7030118347.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., San Antonio, TX.
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.
VOLUME OF PRODUCT IN COMMERCE 44 units.
DISTRIBUTION NY and the United
Kingdom.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number R59169.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, corresponding to a blood product that was
associated with an adverse reaction in a recipient and may have been
contaminated with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT
Human Tissue of various types.
a) CryoVein, Saphenous Vein;
b) CryoGraft, Hemi Patellar Tendon;
c) CryoGraft, Medial Meniscus-Bone-Left;
d) CryoGraft, Medial Meniscus-Bone-Right;
e) CryoGraft, Lateral Meniscus Bone-Right;
f) CryoGraft, Lateral Meniscus-Bone-Left;
g) CryoArtery, Pulmonary Artery;
h) CryoArtery, Pulmonary Hemi-Artery;
i) CryoArtery, Ascending Thoracic Aorta;
j) CryoArtery, Descending Thoracic Aorta;
k) CryoGraft, Achilles Tendon;
l) CryoGraft, Quadriceps Tendon;
m) Semitendinosus/Gracilis Tendons;
n) CryoVein, Femoral Vein with valve;
o) CryoVein, Femoral Vein;
p) CryoGraft, Pericardium;
q) CryoArtery, Alt. Ascending Thoracic Aorta;
r) CryoGraft, Pulmonary Branch Patch;
s) CryoGraft, Pulmonary Trunk Patch;
t) CryoGraft, Patellar Tendon, Whole.
CODE
Donor #20893, Serial #3915069, Model #V010,
Donor #20727, Serial #3917584, Model #V010,
Donor #20727, Serial #3917576, Model #V010,
Donor #20668, Serial #3894578, Model #V010,
Donor #20668, Serial #3894886, Model #V010,
Donor #19912, Serial #3864928, Model #V010,
Donor #19912, Serial #3864901, Model #V010,
Donor #19236, Serial #3890783, Model #V010,
Donor #19236, Serial #3890791, Model #V010,
Donor #19005, Serial #3821323, Model #V010,
Donor #18498, Serial #3829979, Model #V010,
Donor #18019, Serial #3822427, Model #V010,
Donor #18019, Serial #3822451, Model #V010,
Donor #18019, Serial #3822478, Model #V010,
Donor #17747, Serial #3806251, Model #V010,
Donor #17747, Serial #3806278, Model #V010,
Donor #17740, Serial #3804798, Model #V010,
Donor #17740, Serial #3804771, Model #V010,
Donor #17740, Serial #3804801, Model #V010,
Donor #17391, Serial #3793796, Model #V010,
Donor #17391, Serial #3793788, Model #V010,
Donor #17391, Serial #3793761, Model #V010,
Donor #16823, Serial #3771725, Model #V010,
Donor #16823, Serial #3771733, Model #V010,
Donor #14798, Serial #3703891, Model #V010,
Donor #14798, Serial #3703827, Model #V010,
Donor #14493, Serial #3713091, Model #V010,
Donor #14493, Serial #3713083, Model #V010,
Donor #21068, Serial #3921948, Model #V010,
Donor #21068, Serial #3921921, Model #V010,
Donor #20457, Serial #3888436, Model #V010,
Donor #20457, Serial #3888428, Model #V010,
Donor #20309, Serial #3889394, Model #V010,
Donor #20309, Serial #3889408, Model #V010,
Donor #20170, Serial #3893944, Model #V010,
Donor #20170, Serial #3893952, Model #V010,
Donor #20031, Serial #3869318, Model #V010,
Donor #20031, Serial #3869547, Model #V010,
Donor #19564, Serial #3854177, Model #V010,
Donor #19564, Serial #3859169, Model #V010,
Donor #19195, Serial #3863492, Model #V010,
Donor #19195, Serial #3863506, Model #V010,
Donor #19195, Serial #3863484, Model #V010,
Donor #318933, Serial #3845508, Model #V010,
Donor #318933, Serial #3845516, Model #V010,
Donor #18788, Serial #3837378, Model #V010,
Donor #18788, Serial #3817377, Model #V010,
Donor #18187, Serial #3816087, Model #V010,
Donor #18187, Serial #3816052, Model #V010,
Donor #18187, Serial #3816044, Model #V010
Donor #18187, Serial #3816079, Model #V010,
Donor #18170, Serial #3817067, Model #V010,
Donor #18170, Serial #3817075, Model #V010,
Donor #17798, Serial #3810429, Model #V010,
Donor #15400, Serial #3755363, Model #V010,
Donor #15400, Serial #3755444, Model #V010,
Donor #26142, Serial #6064051, Model #V010,
Donor #26142, Serial #6064078, Model #V010,
Donor #25126, Serial #6029558, Model #V010,
Donor #25126, Serial #6029604, Model #V010,
Donor #25126, Serial #6029639, Model #V010,
Donor #25126, Serial #3029612, Model #V010,
Donor #23685, Serial #3984605, Model #V010,
Donor #23685, Serial #3984664, Model #V010,
Donor #23685, Serial #3954613, Model #V010,
Donor #23685, Serial #3984621, Model #V010,
Donor #21791, Serial #3926307, Model #V010,
Donor #21791, Serial #3925293, Model #V010,
Donor #21791, Serial #3925315, Model #V010,
Donor #22096, Serial #3938204, Model #V010,
Donor #22096, Serial #3938212, Model #V010,
Donor #22245, Serial #3941043, Model #V010,
Donor #22245, Serial #3941035, Model #V010,
Donor #22245, Serial #3941027, Model #V010,
Donor #23303, Serial #3972496, Model #V010,
Donor #23456, Serial #3976068, Model #V010,
Donor #23456, Serial #3976041, Model #V010,
Donor #25882, Serial #6071368, Model #V010,
Donor #25882, Serial #6071376, Model #V010,
Donor #30518, Serial #6223257, Model #V010,
Donor #30518, Serial #6223249, Model #V010,
Donor #29961, Serial #6212271, Model #V010,
Donor #29961, Serial #6212247, Model #V010,
Donor #29961, Serial #2612298, Model #V010,
Donor #29961, Serial #2612263, Model #V010,
Donor #29961, Serial #2612255, Model #V010,
Donor #28093, Serial #6137385, Model #V010,
Donor #28093, Serial #6137393, Model #V010,
Donor #28093, Serial #6137377, Model #V010,
Donor #27639, Serial #6105106, Model #V010
Donor #27639, Serial #6105114, Model #V010,
Donor #27157, Serial #6089453, Model #V010,
Donor #27157, Serial #6089461, Model #V010,
Donor #27086, Serial #6113869, Model #V010,
Donor #27086, Serial #6113842, Model #V010,
Donor #26734, Serial #6090761, Model #V010,
Donor #26734, Serial #6090826, Model #V010,
Donor #26177, Serial #6070256, Model #V010,
Donor #26177, Serial #6070264, Model #V010,
Donor #26177, Serial #6070272, Model #V010,
Donor #26517, Serial #6080995, Model #V010,
Donor #26517, Serial #6081002, Model #V010,
Donor #26913, Serial #6088287, Model #V010,
Donor #26913, Serial #6088295, Model #V010,
Donor #27131, Serial #6087213, Model #V010,
Donor #27131, Serial #6087221, Model #V010,
Donor #30298, Serial #6217605, Model #V010,
Donor #30298, Serial #6217613, Model #V010,
Donor #30298, Serial #6217591, Model #V010,
Donor #30515, Serial #6222994, Model #V010,
Donor #30515, Serial #6222986, Model #V010,
Donor #31001, Serial #6244645, Model #V010,
Donor #31001, Serial #6244661, Model #V010,
Donor #31001, Serial #6244653, Model #V010,
Donor #31118, Serial #6248497, Model #V010,
Donor #31118, Serial #6248489, Model #V010,
Donor #31118, Serial #6248519, Model #V010,
Donor #31295, Serial #6254039, Model #V010,
Donor #31295, Serial #6254012, Model #V010,
Donor #33878. Serial #6329535, Model #V010,
Donor #33878. Serial #6329543, Model #V010,
Donor #25296, Serial #6035485, Model #V010,
Donor #25296, Serial #6035493, Model #V010
b) Donor #20668, Serial #4065379, Model #T030,
Donor #20668, Serial #4065344, Model #T030,
Donor #20668, Serial #4065336, Model #T030,
Donor #20668, Serial #4065352, Model #T030,
Donor #26142, Serial #4101456, Model #T030,
Donor #26142, Serial #4101472, Model #T030,
Donor #26142, Serial #4101464, Model #T030,
Donor #26142, Serial #4101448, Model #T030,
Donor #21611, Serial #4067533, Model #T030,
Donor #21611, Serial #4067649, Model #T030,
Donor #21611, Serial #4067843, Model #T030,
Donor #24135, Serial #4090594, Model #T030,
Donor #24135, Serial #4090551, Model #T030,
Donor #24135, Serial #4090578, Model #T030,
Donor #24135, Serial #4090586, Model #T030,
Donor #21611, Serial #4067526, Model #T030;
c) Donor #20668, Serial #4065298, Model #M030,
Donor #14798, Serial #4044614, Model #M030,
Donor #14493, Serial #4043707, Model #M030,
Donor #26142, Serial #4101413, Model #M030,
Donor #21611, Serial #4067568, Model #M030,
Donor #24135, Serial #4090535, Model #M030,
Donor #33286, Serial #4159438, Model #M030;
d) Donor #20668, Serial #4065271, Model #M010,
Donor #14798, Serial #4044592, Model #M010,
Donor #26142, Serial #4101391, Model #M010,
Donor #21611, Serial #4067584, Model #M010,
Donor #24135, Serial #4090519, Model #M010,
Donor #33286, Serial #4159403, Model #M010,
Donor #14493, Serial #4043723, Model #M010;
e) Donor #20668, Serial #4065328, Model #M020,
Donor #14798, Serial #4044584, Model #M020,
Donor #14493, Serial #4043715, Model #M020,
Donor #26142, Serial #4101405, Model #M020,
Donor #21611, Serial #4067576, Model #M020,
Donor #24135, Serial #4090527, Model #M020,
Donor #33286, Serial #4159411, Model #M020;
f) Donor #20668, Serial #4065328, Model #M040,
Donor #14798, Serial #4044606, Model #M040,
Donor #14493, Serial #4043693, Model #M040,
Donor #26142, Serial #4101421, Model #M040,
Donor #21611, Serial #4067541, Model #M040,
Donor #24135, Serial #4090543, Model #M040,
Donor #33286, Serial #4159446. Model #M040;
g) Donor #12456, Serial #3648311, Model #A030,
Donor #19564, Serial #3850226, Model #A030,
Donor #18904, Serial #3842061, Model #A030,
Donor #18454, Serial #3823563, Model #A030,
Donor #18438, Serial #3847438, Model #A030,
Donor #18187, Serial #3818713, Model #A030,
Donor #21691, Serial #3910687, Model #A030,
Donor #21865, Serial #3928713, Model #A030,
Donor #21892, Serial #3930858, Model #A030,
Donor #21912, Serial #3933938, Model #A030,
Donor #22346, Serial #3950611, Model #A030,
Donor #22884, Serial #3963691, Model #A030,
Donor #23367, Serial #3974553, Model #A030,
Donor #26639, Serial #6086039, Model #A030,
Donor #26262, Serial #6066216, Model #A030,
Donor #27053, Serial #6100546, Model #A030,
Donor #28558, Serial #6154476, Model #A030,
Donor #30308, Serial #6218873, Model #A030,
Donor #20924, Serial #6241565, Model #A030,
Donor #32982, Serial #6953638, Model #A030,
Donor #33878, Serial #6328245, Model #A030,
Donor #31482, Serial #6261442, Model #A030,
Donor #21863, Serial #3928748, Model #A030,
Donor #25751, Serial #6048293, Model #A030,
Donor #23456, Serial #3986033, Model #A030,
Donor #23456, Serial #3976025, Model #A030;
h) Donor #21791, Serial #3925285, Model #PH00,
Donor #21791, Serial #3925277, Model #PH00,
Donor #25882, Serial #6071341, Model #PH00,
Donor #26517, Serial #6081029, Model #PH00,
Donor #26517, Serial #6081037, Model #PH00,
Donor #26913, Serial #6088414, Model #PH00,
Donor #31721, Serial #6270425, Model #PH00,
Donor #32591, Serial #6301142, Model #PH00,
Donor #20170, Serial #3893618, Model #PH00,
Donor #20170, Serial #3893596, Model #PH00;
i) Donor #12456, Serial #3648303, Model #A010,
Donor #18854, Serial #3843726, Model #A010,
Donor #18170, Serial #3817121, Model #A010,
Donor #13690, Serial #3679209, Model #A010,
Donor #10709, Serial #3604349, Model #A010,
Donor #27887, Serial #6129285, Model #A010;
j) Donor #22346, Serial #3950603, Model #A020,
Donor #22286, Serial #6962556, Model #A020;
k) Donor #24135, Serial #4090608, Model #T010,
Donor #24135, Serial #4090616, Model #T010,
Donor #33286, Serial #4159543, Model #T010,
Donor #33286, Serial #4159535, Model #T010;
l) Donor #33286, Serial #4159489, Model #T050,
Donor #33286, Serial #4159497, Model #T050;
m) Donor #33286, Serial #4159519, Model #T070,
Donor #33286, Serial #4159527, Model #T070;
n) Donor #29961, Serial #6212212, Model #V061,
Donor #31295, Serial #6254055, Model #V061;
o) Donor #29961, Serial #6212239, Model #V060,
Donor #28093, Serial #6137415, Model #V060,
Donor #28093, Serial #6137407, Model #V060,
Donor #27157, Serial #6089445, Model #V060,
Donor #27157, Serial #6089437, Model #V060,
Donor #27639, Serial #6105203, Model #V060,
Donor #27639, Serial #6105211, Model #V060,
Donor #26734, Serial #6090788, Model #V060,
Donor #26734, Serial #6090664, Model #V060,
Donor #26177, Serial #6070221, Model #V060,
Donor #26177, Serial #2070248, Model #V060,
Donor #30515, Serial #6223001, Model #V060,
Donor #30515, Serial #6223028, Model #V060,
Donor #31118, Serial #6248527, Model #V060,
Donor #31118, Serial #6248535, Model #V060,
Donor #31295, Serial #6254047, Model #V060,
Donor #33878, Serial #6329519, Model #V060,
Donor #33878, Serial #6329527, Model #V060;
p) Donor #26912, Serial #6088201, Model #PM00,
Donor #26927, Serial #6103782, Model #PM00,
Donor #26927, Serial #6103804, Model #PM00;
q) Donor #27027, Serial #6099696, Model #A015;
r) Donor #28542, Serial #6153844, Model #P020;
s) Donor #23787, Serial #3987922, Model #P010,
Donor #26913, Serial #6088422, Model #P010,
Donor #26914, Serial #6088589, Model #P010,
Donor #30298, Serial #6217834, Model #P010;
t) Donor #33286, Serial #4159454, Model #T020,
Donor #33286, Serial #4159462, Model #T020.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Various tissues for transplant, which were collected from donors
who may not have been properly evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 123 units;
b) 16 units;
c) 7 units;
d) 7 units;
e) 7 units;
f) 7 units;
g) 26 units;
h) 10 units;
i) 6 units;
j) 2 units;
k) 4 units;
l) 2 units;
m) 2 units;
n) 2 units;
o) 18 units;
p) 3 units;
q) 1 unit;
r) 1 unit;
s) 4 units;
t) 2 units
DISTRIBUTION Nationwide and Internationally.
PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 41GP52240.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood product, which was labeled as leukoreduced, but did not
meet the requirement for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) 2908064, 2916183, 6138159, 2904253, 2918561, 2904254, 6138166, 2937712;
b) 2908064, 2916183, 6138159, 2904253, 2937712, 6138166;
c) 2918561, 2904254;
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, corresponding to platelets that were implicated
in a transfusion reaction and were possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION TX and Switzerland.
PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 41FP37775.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT Platelets.
CODE Units 4502112, 4504651.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston,
TX.
REASON Blood products, collected from an ineligible donor based on
living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Platelets Pheresis Leukoreduced.
CODE Unit 6139736.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor who had taken
aspirin within three days of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.
CODE Unit 6186087.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor who had traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 2896349.
RECALLING FIRM/MANUFACTURER Carter-BloodCare, Bedford, TX.
REASON Blood products, which were collected from a donor who had
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b)
Platelets.
CODE a) and b) Unit 6167155.
RECALLING FIRM/MANUFACTURER Carter-BloodCare, Bedford, TX.
REASON Blood products, which were collected from a donor with a recent
history of mononucleosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Platelets.
CODE Unit 4250244.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston,
TX.
REASON Blood product, which was collected in a manner that may have
compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 4442599.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston,
TX.
REASON Blood products, which were collected from a donor who had
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 41GE67282.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood product, which was collected in a manner that may have
compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 41FL92517.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood products, which were collected in a manner that may have
compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL, and
Switzerland.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 41GM52818.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood products, which were collected from a donor in which the
risk factors for Creutzfeldt Jakob Disease (CJD) was not determined at the time
of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL.
PRODUCT Fresh Frozen Plasma.
CODE Unit 2897183.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which may have been prepared from Whole Blood with
an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) Units 4444173, 4426240;
b) Unit 4444173.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston,
TX.
REASON Blood products, corresponding to platelets that were contaminated
with Staphylococcus and implicated in an adverse reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells.
b) Plasma.
CODE a) and b) Unit 6772042.
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange,
NJ.
REASON Blood products, which were prepared from Whole Blood in which the
corresponding Cryoprecipitated AHF was clotted, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and NJ.
PRODUCT Source Plasma.
CODE Unit 00EWID8403.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P. (Formerly
Community Bio-Services), Eau Claire, WI.
REASON
Blood
Product, collected from a donor who disclosed receiving Hepatitis B vaccine
less than 48 hours before donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Cryoprecipitated AHF.
CODE Unit 030GL23663.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region,
Dedham, MA.
REASON Blood Product, lacking assurance of proper temperature storage
during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
CODE a) and b) Unit 6157616.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor with a history of colitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Capture-P Ready Screen Test Kit.
CODE
Lot 30895,
Exp. 8/22/03; Lot 32937, Exp. 9/5/03.
RECALLING FIRM/MANUFACTURER Immucor, Inc, Norcross, GA.
REASON Test kits, packaged with a Reactivity List that contained a
typographical error, were distributed.
VOLUME OF PRODUCT IN COMMERCE 199 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Red Blood Cells.
CODE Unit 7501077.
RECALLING FIRM/MANUFACTURER Lane Memorial Blood Bank, Eugene, OR.
REASON Autologous Red Cells, which tested repeatedly reactive for
antibody to hepatitis B core antigen (anti-Hbcore) and antibody to the
hepatitis C virus (anti-HCV), were distributed without the
"Biohazard" label on the bag.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.
PRODUCT Source Plasma.
CODE GPBLTX, GPBHXV, GPBHMV, GPBGTG, GPBGHP, 857158, 856975, 856281,
856092, 837212, 836859, 836317, 836076, 834805, 834644, 834392, 834233, 833922,
833776, 837051, 833543, 833352, 833183, 833060, 832770, 832234, 832092, 831823,
831708, 831427, 831121, 143555, 143538, 004015.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc, Flint, MI.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 34 units.
DISTRIBUTION IL, and NC.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 3894467.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor in which donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) and b)
Unit 2909395.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor in which donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 2990078.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which were collected from a donor in which donor
suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and NY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 0943356.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
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 OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 24219-9962.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Rapid City, SD.
REASON Blood product was collected in a manner that may compromise the
sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SD.
PRODUCT Red Blood Cells.
CODE Unit number 17J09879.
RECALLING FIRM/MANUFACTURER The American National Red Cross, North
Central Region, St. Paul, MN.
REASON Blood product, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but was collected from a donor that
previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit W1632959.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey,
Trenton, NJ.
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 2 units.
DISTRIBUTION NJ.
PRODUCT
Platelets.
CODE Unit FC20-05616.
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey,
Trenton, NJ.
REASON Blood product, collected from an ineligible donor due to recent
ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 2984544.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Red Cells, collected from a donor whose hemoglobin was not
documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit 0391645.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie,
PA.
REASON Blood products, which were collected from a donor who was taking
the medication finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and Austria.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 0149740 (double RBC product).
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor who traveled to a
malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 2862679.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor whose hemoglobin
was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 5465597.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor whose hemoglobin
was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 08W41430.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Oakland,
CA.
REASON Blood product, which was collected from a donor who had traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 2075467.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., Newark, DE.
REASON Blood products, which were collected from a donor who had
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 301808737.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, Bismarck, ND.
REASON Blood product, which was collected from a donor who had traveled
to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION ND.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 38L75818 and 38H99976.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood products, collected from an unsuitable donor based on
living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 13Y87356.
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 Red Blood Cells Leukocytes Reduced.
CODE Unit 13FE24696 and 13GX63448.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southeastern Michigan Region, Detroit, MI.
REASON Blood products, manufactured from units of Whole Blood more than
8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 13FY85188, 13FC5367, 13FC35366, 13GR41672, 13FV17756, and
13GX61930.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southeastern Michigan Region, Detroit, MI.
REASON Blood products, manufactured from units of Whole Blood more than
8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MI.
PRODUCT Fresh Frozen Plasma.
CODE Unit 41LR78893.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood product, in which
the corresponding blood component was contaminated with Pseudomonas fluorescens
and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT Source Plasma.
CODE Unit 0125152, 0125507, 0126677, 0127193, 0129546, 0129693, 0130280,
0130435, 0131219, 0131623, 0132498.
RECALLING FIRM/MANUFACTURER Westgate Biologicals, Inc., College Station,
TX.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 41FV56720.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Birmingham, AL.
REASON Blood product, in which the corresponding blood component was
contaminated with Ralstonia (Burkholderia) pickettii and implicated in a
transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 12797-0484.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
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) Platelets.
CODE a) and b) Unit 53FE75842.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood products, collected from an unsuitable donor based on
living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION DC.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Red Blood Cells, Washed.
c) Recovered Plasma.
CODE
a) and c) Unit 042FS74579;
b) and c) Unit 042FE76125.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
Ohio Region, Cleveland, OH.
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 OH, CA, and Switzerland.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 8422668.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm
Beach, FL.
REASON Blood products, collected from a donor whose record of responses
to the medical history questions concerning behavior known to increase risk of
infection with the human immunodeficiency virus (HIV) could not be located, 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 8482923 and 8440712.
RECALLING FIRM/MANUFACTURER South Florida Banks, Inc., West Palm Beach,
FL
REASON Blood products, collected from an ineligible donor due to use of
the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION FL, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit 29FJ40892 and 29KL13527;
b) Unit 29FW46400, 29FK39618, and 29FJ39147.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, collected from an ineligible donor due to use of
the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC, VA, MD, DC, CA
and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 33GS40402.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut
Region, Farmington, CT.
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 CT.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 53FE77209.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
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 MD.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE a) and b) Unit 53FE77209.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake
and Potomac Region, Baltimore, MD.
REASON Blood products, 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 D.C.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 53FH01292.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD.
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 1 unit.
DISTRIBUTION MD.
PRODUCT Source Plasma.
CODE Unit numbers NF203616, NF203793, NF204050, and NF204193.
RECALLING FIRM/MANUFACTURER Biolife
Plasma Services L.P., Nutterfort, WV.
REASON Blood products, that tested negative for viral markers, but were
collected from an unsuitable donor due to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit numbers 77137104, 77131546, 77086143, 77083258, 76397547,
76394805, 76162589, 63177435, 63173499, 72236918, 72232811, 74400881, 72837382,
72831076, 72807668, 72801369, 72717677, 71829685, 71820590, 71706955, 71620046,
71615370, 71489704, 61439610, 61435933, 61431454, 61388703, 61382312, and
60780140.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Richmond, VA.
REASON Blood products, that tested negative for the antibody to
hepatitis C virus (anti-HCV), but were collected from an ineligible donor due
to previous reactive testing for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 2941342.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, manufactured in a manner that may have compromised
the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 13GE11173, 13Ge11201.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Red Cells, incorrectly tested and labeled for the S antigen, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 13FM86350.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Red Cells, incorrectly tested and labeled for the Fy(b) antigen,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Fresh Frozen Plasma.
CODE Unit 2897248.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was prepared from Whole Blood with an
extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 1039197, 1051074, 1051084, and 1051100.
RECALLING FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN.
REASON Blood products that were out of controlled storage for more than
30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 24KG56780.
RECALLING FIRM/MANUFACTURER The American National Red Cross, River
Valley Region, Louisville, KY.
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 KY.
PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Units 2965076.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Platelets.
CODE Unit 2922404.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, manufactured with an incorrect ratio of
anticoagulant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 13LG96994, 13LG96999, 13LG97005, 13FM13422, 13GW17122,
13GW17104, 13GW18543, 13GL09473, 13GV33727, 13FQ09747, 13FV07085, 13GR34313,
13GW15791, 13GW15787, 13GL08044, 13FV08086.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Blood products, that may not have been leukoreduced within a 24
hour time frame, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION MI.
PRODUCT Source Plasma.
CODE FJMIS0127N FJMIS0127RA,
FJMIS0128N, FJMIS0128RA, FJMIS0129RA,FJMIS0129N, FJMIS0130N, FJMIS0130RA,
FJMIS0131N, FJMIS0131RA, FJMIS0131, FJMIS0132, FJMIS0132CX,FJMIS0133CX,
FJMIS0133, FJMIS0134CX,
FJMIS0134, FJMIS0135CX, FJMIS0135, FJMIS0136CX, FJMIS0136, FJMIS0137CX, FJMIS0137,
FJMIS0138CX, FJMIS0138, FJMIS0139, FJMIS0139CX, 0335S0141CX, 0335S0141NX,
0335S0142CX, 0335S0142NX.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Source Plasma, that was exposed to unacceptable storage
temperatures and was not properly relabeled as Source Plasma, Salvaged, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE a), b) and c) Unit T03886.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Traverse
City, MI.
REASON Blood products, collected from a donor with an elevated body
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI, and Switzerland.
PRODUCT Source Plasma.
CODE Unit 08634958.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor with an elevated body
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Human Corneas For Transplantation.
CODE Units 00490301 and 00490302.
RECALLING FIRM/MANUFACTURER Lions Eye Bank of Lexington, Lexington, KY.
REASON Corneas, which tested negative for the antibody to the human
immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but subsequently tested
repeatedly reactive for HIV-1 p24 antigen and indeterminate by confirmatory
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 7423741.
RECALLING FIRM/MANUFACTURER Manatee Community Blood Center, Bradenton,
FL.
REASON Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Source Plasma.
CODE Unit numbers FXPWMQ, FXPVHV, FXPTXN, FXPRWC, and FXPRQD.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc.
Manufacturer: Aventis Bio-Services, Inc., Akron, OH.
REASON Blood products, collected from a donor that did not answer
medical history questions concerning signs and symptoms and behavior known to
increase risk of infection with the human immunodeficiency virus (HIV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION IL.
PRODUCT Recovered Plasma.
CODE Unit 29FJ40892, 29KL13527, 29FW46400, 29FK39618, and 29FJ39147.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, collected from an ineligible donor due to use of
the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC, VA, MD, DC, CA and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 35FH81344, 35FH81347, and 35FH81348.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian
Region, Roanoke, VA.
REASON Blood products, that were not leukoreduced within the appropriate
time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit T23683.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
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 VA.
PRODUCT Red Blood Cells.
CODE Unit 12470-5518 and 12791-8207.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from an ineligible donor due to a
history of ulcerative colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NM.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit
21KL59113.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Portland,
OR.
REASON Red Cells, that did not have the complete amount of additive
solution included, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
***CORRECTION***
Red Blood Cells, Leukocytes Reduced, the CODE Unit # was incorrect, it should
read Unit # 53GF48288.