JANUARY 2005
WEEK ENDING JANUARY 1
PRODUCT
Source Plasma.
CODE
Units: F-22778-011, F-27249-011, F-27788-011, F-28189-011, F-29064-011, F-29389-011,
F-30075-011, F-30763-011, F-31180-011, F-31764-011, F-32149-011, F-34888-011,
F-35337-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA.
Manufacturing Firm: Alpha Therapeutic Corporation, Portland, OR.
REASON
Blood products, collected from a donor who had body piercing within twelve
months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
Spain.
PRODUCT
Red Blood Cells, Leukoreduced.
CODE
Unit FH36178.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale, VA.
REASON
Blood product, collected from a donor who disclosed travel to an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Platelets, Irradiated.
CODE
Unit number: 6476013.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL.
REASON
Blood product, which was not tested for CMV, but was labeled as negative for
CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Fresh Frozen Plasma.
CODE
Units FM06460, LV35600, KE60846, LR49385, LV41492, FW19484, GV51671, FW09111,
GR45703, KM08839, KE59573, KE58537, KK63543, LV33128 KK66061, KK64767, KK62526,
KK61537, KM08784, KS74757.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA.
REASON
Failure to quarantine blood products that tested negative for viral markers,
but were collected from donors who subsequently tested positive.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
PA.
PRODUCT
Source Plasma.
CODE
Units 02GWIF8588 02GWIF9603 02GWIG0344 02GWIG1184 02GWIG5246 02GWIG6103 02GWIG8980
02GWIG9411 02GWIH0638 02GWIH1039 02GWIH2846 02GWIH3547 02GWIH4067 02GWIH5227
02GWIH5658 02GWIH6928 02GWIH8496 02GWIH8751 03GWIA0675 03GWIA0973 02GWIF1496.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Green Bay, WI.
REASON
Source Plasma, collected from a donor taking Proscar, was distributed
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
MI, and Austria
PRODUCT
Source Plasma.
CODE
Units 02GWIE4535, 02GWIE7937, 02GWIF9334, 02GWIF9939, 02GWIG2465.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Green Bay, WI.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Austria.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 4223950.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) Units (85 units) 13FY94501, 13FY94502,
13FY94503, 13FY94504, 13FY94505, 13FY94506,
13FY94507, 13FY94510, 13FY94512, 13FY94513,
13FY94515, 13FY94516, 13FY94518, 13FY94519,
13FY94521, 13FY94522, 13FY94523, 13FY94525,
13FY94526, 13FY94527, 13FY94528, 13FY94529,
13FY94530, 13FY94531, 13FY94532, 13FY94533,
13FY94536, 13FY94537, 13FY94539, 13FY94540,
13FY94541, 13FY94542, 13FY94543, 13FY94544,
13FY94545, 13FY94546, 13FY94547, 13FY94548,
13FY94549, 13FY94551, 13FY94553, 13FY94554,
13FY94555, 13FY94556, 13FY94557, 13FY94558,
13FY94560, 13FY94561, 13FY94562, 13FY94563,
13FY94564, 13FY94565, 13FY94566, 13FY94567,
13FY94568, 13FY94571, 13FY94572, 13FY94573,
13FY94574, 13FY94575, 13FY94576, 13FY94577,
13FY94578, 13FY94579, 13FY94580, 13FY94584,
13FY94586, 13FY94589, 13FY94591, 13FY94593,
13FY94594, 13FY94595, 13FY94597, 13FY94598,
13FY94599, 13FY94600, 13FY94601, 13FY94603,
13FY94604, 13FY94606, 13FY94609, 13FY94610,
13FY94611, 13FY94612 13FY94613;
b) Units 13FY94501, 13FY94503, 13FY94506,
13FY94513, 13FY94514, 13FY94516, 13FY94520,
13FY94522, 13FY94524, 13FY94525, 13FY94526,
13FY94528, 13FY94529, 13FY94530, 13FY94531,
13FY94532, 13FY94533, 13FY94536, 13FY94542,
13FY94543, 13FY94545, 13FY94546, 13FY94548,
13FY94551, 13FY94557, 13FY94558, 13FY94562,
13FY94567, 13FY94578, 13FY94579, 13FY94580,
13FY94588, 13FY94589, 13FY94591, 13FY94595,
13FY94598, 13FY94599, 13FY94601, 13FY94604,
13FY94606, 13FY94609, 13FY94610, 13FY94611,
13FY94612, 13FY94613.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON
Blood products, collected with the use of expired iodine scrubs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
130 units.
DISTRIBUTION
MI.
PRODUCT
Human Corneas for Transplantation.
CODE
Tissues: OB-2004-03-29-1 L-01 & OB-2004-03-29-2 R-01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD.
Manufacturer: Medical Eye Bank of Maryland & Washington Eye Bank, Baltimore,
MD,.
REASON
Human tissue for transplantation, that tested repeatedly reactive for antibodies
to Hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NJ, and DC.
PRODUCT
Red Blood Cells.
CODE
Unit number: L86063.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL.
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
IL.
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units 007FT07142, 007FT07147, 007FT07161, 007FT07162 (split unit), and 007FT07163.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tucson, AZ.
REASON
Blood products, which were labeled as leukoreduced without having been tested
for a residual white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AZ.
PRODUCT
Red Blood Cells.
CODE
Unit number: 6531616.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL.
REASON
Blood product, collected from a donor in which donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number: 6534732.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL
REASON
Platelet pheresis unit, associated with a positive bacterial culture, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Red Blood Cells, Leukocytes Removed, Irradiated.
CODE
a) Unit number: FE70215;
b) Unit number: FE63069.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Platelets.
CODE
Unit number: 6552613, Platelet pool number 6550670.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Platelets.
CODE
Unit number: 6558707.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc.Lakeland, FL.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Red Blood Cells. ;
b) Recovered Plasma.
CODE
a) and b) Unit number: 6435252.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL.
REASON
Blood products, collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Switzerland and FL.
PRODUCT
Source Plasma.
CODE
Units 00MWID9823, 00MWIE0337, 0IMWIB0712, 01MWIB1876,
01MWIB2268, 01MWIB3291, 01MWIB3732, 01MW/B8070,
01MWIB9526, 00MWIEI136, 00MWIEI742, 00MWIE2933,
00MWIE3725, 00MWIEA240, 00MWIE5362, 00MWIE5619,
00MWIE6778, 00MWlE7072, 00MWIE8245, 00MWIE8565,
00MWIF2603, 00MWIF3231, 00MWIF4364, 00MWIF5485,
00MWIF5850, 00MWIG0528, 00MWIG1289, 00MWIG2848,
00MWIG3914, 00MWIG4190, 00MWIG5188, 00MWIG5459,
01MWIA2949, 01MWIA5697, 01MWIA9163, 01MWIB0219,
01MWIB4756, 01MWIB5164, 01MWIB6591, 01MWIB7625,
and 01MWIB9066.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Menasha, WI.
REASON
Blood products, which were collected from an ineligible donor based on the
subsequent disclosure of a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
MI, and Austria.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 0841732.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA.
REASON
Blood products, which were collected from a donor who had engaged in multiple
high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 1210201.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, 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
Red Blood Cells.
CODE
Unit 13FC13407.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region,
Detroit, MI.
REASON
Red Cells, mislabeled as to antigen typing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Platelets Pheresis.
CODE
Unit E85732.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE
Units 02GWID7351, 02GWID7924, 02GWID8832, 02GWIE0390, 02GWIE3203, 02GWIE3808,
02GWIE4756, 02GWIE5355, 02GWIE6269, 02GWIE6945, 02GWIE7851, 02GWIE8613, 02GWIF0708,
02GWID9502, 02GWIE2376.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Green Bay, WI.
REASON
Blood products, collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
MI, and Austria.
PRODUCT
Platelets.
CODE
Unit 4146156.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL.
REASON
Blood product, incorrectly tested for Cytomegalovirus (CMV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells.
CODE
Units Z00677, Z00678, Z00679, Z00680, Z00681, Z00682, Z00683, Z00684, Z00685,
Z00686.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA.
REASON
Blood products, which were shipped at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.
WEEK ENDING JANUARY 8
PRODUCT
Source Plasma.
CODE
Units HV039391, HV035542, HV035379, HV035087, HV034900, HV034631, HV034503, HV034272, HV034058, HV033805, HV033621, HV033360, HV033136, HV039210, HV032572, HV031863, HV030451, HV024860, HV023950, HV020013, HV019809.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Huntsville, AL.
REASON
Source Plasma, collected from a donor who tested negative for anti-HIV-1/2, but previously tested positive for anti-HIV-1/2, was distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
NC.
PRODUCT
Human Tissue for Transplantation.
a) Tissues CryoVein, Saphenous Vein;
b) CryoGraft, Tibialis Tendon;
c) CryoGraft, Achilles Tendon;
d) Semitendinos us/Gracilis Tendons;
e) CryoArtery, Pulmonary Artery;
f) CryoGraft, Quadriceps Tendon;
g) CryoGraft, Hemi Patellar Tendon;
h) CryoGraft, Medial Menicus Bone-Right;
i) CryoVein, Femoral Vein;
j) CryoGraft, Hemi Patellar Tendon;
k) CryoGraft, Lateral Meniscus Bone-Right;
l) CryoGraft, Lateral Meniscus Bone-Left;
m) CryoVein, Femoral Vein;
n) CryoArtery, Pulmonary Monocusp Hemni-Artery;
o) CryoVein, Femoral Vein with Valve;
p) CryoGraft, Plumonary Trunk Patch;
q) CryoGraft, Pulmonary Branch Patch;
r) CryoArtery, Femoral Popliteal Artery;
s) CryoGraft, Plumonary Branch Patch Š SG;
t) CryoArtery, Aortoiliac Artery.
CODE
a) Donor #40019, Serial #6528228,
Donor #40064, Serial #6532403,
Donor #41193, Serial #6576354,
Donor #42311, Serial #6613233,
Donor #43625, Serial #6652511,
Donor #45465, Serial #6699040,
Donor #45556, Serial #6709928,
Donor #45556, Serial #6714285,
Donor #45607, Serial #6735826,
Donor #45607, Serial #6735837,
Donor #46877, Serial #6780908,
Donor #47432, Serial #6832048,
Donor #49319, Serial #6869084,
Donor #49319, Serial #6873704,
Donor #49338, Serial #6850813,
Donor #49785, Serial #6881356,
Donor #49999, Serial #7102018,
Donor #54956, Serial #7234933,
Donor #54967, Serial #7226138,
Donor #55912, Serial #7165200,
Donor #62532, Serial #7814612;
b) Donor #40047, Serial #4240405,
Donor #41323, Serial #4257294,
Donor #41905, Serial #4265386,
Donor #42311, Serial #4277163,
Donor #43362, Serial #4287512,
Donor #43362, Serial #4287512,
Donor #43383, Serial #4287586,
Donor #43383, Serial #4287600,
Donor #43389, Serial #4289863,
Donor #45459, Serial #6703147,
Donor #45460, Serial #6711179,
Donor #45504, Serial #6715655,
Donor #45610, Serial #6713482,
Donor #45610, Serial #6713572,
Donor #45636, Serial #6705999,
Donor #45636, Serial #6715491,
Donor #46529, Serial #6754688,
Donor #48997, Serial #6904285,
Donor #49164, Serial #6883291,
Donor #49343, Serial #6871538,
Donor #49753, Serial #6884748,
Donor #49763, Serial #6905601,
Donor #49763, Serial #6905628,
Donor #50985, Serial #7042248,
Donor #54932, Serial #7240340,
Donor #59836, Serial #7837532;
c) Donor #40063, Serial #4240529,
Donor #41905, Serial #4265408,
Donor #41905, Serial #4265521,
Donor #45465, Serial #6711236,
Donor #46500, Serial #6771102;
d) Donor #40109, Serial #4236025,
Donor #43362, Serial #4287524,
Donor #45601, Serial #6713247,
Donor #46529, Serial #6754677,
Donor #46529, Serial #6754744,
Donor #48939, Serial #6852658,
Donor #50048, Serial #7103309;
e) Donor #41180, Serial #6574777,
Donor #45401, Serial #6714389,
Model #A030;
f) Donor #41323, Serial #4256735;
g) Donor #41323, Serial #4257413,
Donor #41905, Serial #4265475,
Donor #49300, Serial #6858662,
Donor #49300, Serial #6863528,
Donor #52886, Serial #7068718,
Donor #52886, Serial #7068787;
h) Donor #43058, Serial #6637086,
Donor #45305, Serial #6700044;
i) Donor #43608, Serial #6652591,
Donor #49776, Serial #6883886,
Donor #47206, Serial #6756583;
j) Donor #45305, Serial #6700017,
Donor #46529, Serial #6754644,
Donor #46529, Serial #6754663;
k) Donor #45305, Serial #6700052;
l) Donor #45436, Serial #6704840,
Donor #47804, Serial #6812821;
m) Donor #45563, Serial #6714224,
Donor #54955, Serial #7240212;
n) Donor #46494, Serial #6770937;
o) Donor #49780, Serial #6882437;
p) Donor #49782, Serial #6896617;
q) Donor #51035, Serial #7144860,
Donor #65903, Serial #7955990;
r) Donor #54940, Serial #7155010;
s) Donor #55750, Serial #7253267;
t) Donor #58490, Serial #7410687,
Donor #63969, Serial #7893628.
RECALLING FIRM/MANUFACTURER CryoLife, Inc. Kennesaw, GA.
REASON
Human tissues, processed with instruments that may not have been adequately sterilized, were distributed.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Canada.
PRODUCT CryoGraft, Pulmonary Monocusp Hemi-Artery.
CODE
Tissue 8353839.
RECALLING FIRM/MANUFACTURER CryoLife, Inc. Kennesaw, GA.
REASON
Human tissue, procured from a donor who may have participated in high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MI.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 6534674.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.
CODE
Units 6563900 B&C.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells.
CODE
Unit E07351.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE
a) and b) Unit G98385.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL. and Austria.
PRODUCT
a) Fresh Frozen Plasma.
b) Recovered Plasma.
CODE
a) Unit number: 6527065;
b) Unit number: 6499785.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Blood products, collected from a donor in which donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and Austria.
PRODUCT
Source Plasma.
CODE
Unit numbers 02GWIH8504, 03GWIA2218, 03GWIA3811, 03GWIA4423, 03GWIA5977, 03GWIA6930, and 03GWIA7479.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant
Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Austria.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number FE66458.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON
Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number FE50646 (distributed as three split units).
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON
Blood products, that tested out of specification for pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL, and GA.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number: S32854.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA.
REASON
Blood products, collected from a donor who reported receiving immune serum globulin for possible exposure to Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit number: S30898.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Delta Blood Bank, Stockton, CA.
Manufacturing Firm: Delta Blood Bank, Stockton, CA.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT CryoVein, Saphenous Vein.
CODE
Tissue numbers 8235475, 8137618, 8137605.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw.
REASON
Human tissue, associated with tissue that tested positive for microorganisms at a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues.
DISTRIBUTION
PA, TX, and WV.
PRODUCT
Red Blood Cells, Irradiated.
CODE
Unit numbers FE57624 and FE60765.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Aurora, IL.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells.
CODE
Unit number W91198.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI.
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
Platelets.
CODE
Unit number M46095.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Fresh Frozen Plasma (Apheresis),
CODE
Unit number 7797534.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN.
REASON
Blood product, collected by a method that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 4804491.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN.
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
IN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 3422468.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN.
REASON
Blood product, that tested out of specification for pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
Source Plasma.
CODE
Unit number 03OWIA3620.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Oshkosh, WI.
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
Austria.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) and b) Unit number: K32262.
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, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units LK24844-1 and LK24844-2.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 042J51578.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northern Ohio Region, Cleveland, OH.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease
(vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and CA.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) Units L82921, K54601, L83135, T69532;
b) Units K54601, T69532, K94271.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
VA.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit number: Y12037.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Unit number: 029FP97354.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic Region, Norfolk, VA.
REASON
Platelets, not manufactured according to manufacturerÕs specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
CODE
a) and b) Unit number: FS72453.
RECALLING FIRM/MANUFACTURER
Inova Health System, Annandale, VA.
REASON
Blood products, collected from an ineligible donor due to behavior known to increase the risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 0669962.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood products, collected from a donor who used beef bovine insulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma. .
CODE
a), b), and c) Unit number: 0653997.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood products, collected from a donor who used beef bovine insulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
PRODUCT
Platelets. .
CODE
Unit L37059.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA.
REASON
Blood product, which was manufactured from a whole blood unit in which the corresponding red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 units.
DISTRIBUTION
VA.
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit 40P01928.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL.
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
MO.
PRODUCT Red Blood Cells Leukocytes Reduced.
CODE
Units 40LV03632, 40GK54648, and 40FW32069.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL, and MA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 40LV03633, 40GK54649, and 40FW32067.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 1198540.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, 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
Red Blood Cells Leukocytes Reduced.
CODE
Unit 0679326.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, 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
Red Blood Cells.
CODE
Unit 0683159.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, 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
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers 1670989A and 1670989C.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit number 6207723.
RECALLING FIRM/MANUFACTURER
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
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) and b) Unit numbers FG97141, LE89604.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI.
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
MI, RI, and NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 0662304.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin test performed during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Blood Cells, Leukocytes Reduced.
CODE
Unit number: 261185685.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR.
REASON
Blood product, collected using a hematocrit centrifuge that did not have quality control performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
Source Plasma.
CODE
Unit HV012591.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Huntsville, AL.
REASON
Source Plasma, collected from a donor who tested negative
for anti-HIV-1/2, but previously tested positive for anti-
HIV-1/2, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells,
CODE
Unit 6522550.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Blood product, which tested initially reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Source Plasma.
CODE
Unit numbers 02GWIH3456, 02GWIH4254, 02GWIH5367, 03GWIA3906, 03GWIA4625, 03GWIA8339, 03GWIA8738, and 03GWIA9863.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant
Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Austria.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 19250-5141, 19250-5140; and the following units were distributed as two split products: unit numbers 19250-1188 and 19250-1189.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NV, and CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 19249-2029, 19249-3938, 19248-4299, 19248-3265, 19248-4438, 19248-4103, 19248-4572, 19248-5332, 19248-5306, 19248-4592, 19248-3921, 19248-5021, and 19248-4832.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV.
REASON
Blood products that were manufactured using expired antigen typing reagents were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 Units.
DISTRIBUTION
NV, and CA.
PRODUCT
Platelets.
CODE
Unit numbers 4835518, 4835519, and 4835520.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON
Blood products, manufactured from units of Whole Blood stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 0830615.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood product that was labeled as leukoreduced, but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Platelets, Irradiated.
CODE
Unit number 0799631.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco,
CA.
Manufacturer: Blood Centers of the Pacific, North Bay Center, Fairfield, CA,
REASON
Blood product that was removed from controlled storage for more than allowed was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 04KT65714.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood product, collected from an ineligible donor due to a history of a chronic ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
WEEK ENDING JANUARY 15
PRODUCT
Haemonetics Mobile Collection Systems.
CODE
MCS+ 9000, MCS+ 7000, MCS+8100
Model Numbers: LN 09000-110-E, LN 07000-110-E, LN 08100-110-E
RECALLING FIRM/MANUFACTURER
Haemonetics Corporation, Braintree, MA.
REASON
Apheresis systems, with possible leaks in the base of the collection bowl, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
651 instruments distributed.
DISTRIBUTION
Nationwide.
PRODUCT
Red Blood Cells.
CODE
Unit 6501457.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Blood product, for which the donor history record could not be located, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
CODE
a) and b) Unit 6516764.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
Source Plasma.
CODE
Units SX040744, SX041990, SX051611, and SX051808.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., San Marcos, TX.
REASON
Blood products, which were collected from a donor who had received tattoos within
twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 0792207.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 0850085.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit FE75817.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON
Blood Product, which was labeled as leukoreduced, but did not meet the requirements
of a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukoreduced. .
CODE
Unit 9591005.
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL.
REASON
Blood Product, which was leukoreduced twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Platelets.
CODE
Unit S79273.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON Blood Product, collected during a blood drive where donor confidentiality was
compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Source Plasma. .
CODE
Unit 02MWIC3094.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Menasha, WI.
REASON
Source Plasma, untested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) Unit 4611799;
b) Units 4630734, 4616507, 4611799.
RECALLING FIRM/MANUFACTURER
Anne Arundel Medical Center Blood Bank, Annapolis, MD.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD.
PRODUCT
a) Red Blood Cells, Leukoreduced,
b) Plasma, Frozen,
CODE
a) and b) Unit 029KN39416.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region,
Norfolk, VA.
REASON
Blood products, collected from a donor considered to be at increased risk of
exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and NC.
PRODUCT
Red Blood Cells.
CODE
Unit KS35801.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON
Blood product, collected from a donor who reported travel to an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 53GQ15850.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD.
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
MD.
PRODUCT
Red Blood Cells.
CODE
Unit 8737305.
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital Blood Bank, Baltimore, MD.
REASON
Blood product, collected from a donor who disclosed travel to an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
PRODUCT
Human Cornea Tissue.
CODE
Tissue # 2004-11-43.
RECALLING FIRM/MANUFACTURER
Wichita Eye Foundation, Wichita, KS.
REASON
Human cornea, collected from a donor who subsequently tested positive for HBsAg
by another tissue procurement organization, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MO.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number: 306597709.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Fargo, ND.
REASON
Blood product, associated with a positive bacterial culture, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
PRODUCT
Red Blood Cells.
CODE
Unit 04LJ07344.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood product, collected from a donor who resided in a malarial endemic area,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
PRODUCT
Red Blood Cells.
CODE
Unit 04FK55245.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood product, collected from a donor who traveled to an area considered endemic
for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 261195892, 261195900-1, 261195900-2, 261195903-1, 261195903-2, 261195918-1,
261195918-2, 261195933, 261195934, 261195936, 261195941, 261195943-1, 261195943-2,
261195949, 261195950, 261195952-1, 261195952-2, 261195954, 261195959, 261195979.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Texarkana, TX.
REASON
Blood products, collected from donors with unacceptable hematocrit determinations,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
AK and TX.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 0856738, 0860676, 0857476-1, 0857476-2.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
REASON
Blood products, collected from unsuitable donors based on travel to areas considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NJ.
PRODUCT
Red Blood Cells Leukoreduced.
CODE
Units: 150224432, 150224070, 150225011, 150224132, 150224661.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lubbock Center, Lubbock, TX.
REASON
Blood products, which tested positive for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TX.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Unit number: E94664.
RECALLING FIRM/MANUFACTURER
HCSC - Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON
Blood product, collected from a donor with diarrhea, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 0919628.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
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
NJ.
PRODUCT
Red Blood Cells.
CODE
Unit 0894248.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
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
NJ.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 21KC75460, 21KC75476, 21KC75649, 21FS30800,
21FZ11658, 21FZ11681, 21W56857, and 21K87030.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
OR.
PRODUCT
Red Blood Cells.
CODE
Units E84790, E92559, E85655, E93320, E91653, and E91559.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON
Blood products, which exceeded the manufacturer's acceptable product specifications,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
PA.
PRODUCT
Source Plasma.
CODE
Units:
45690013 56761191 57260723 57265018 57267876 59324201 56766028 62338608 44975432
44978969 46515681 46518309 41604441 41601617 71542478 71662060 41606872 41609163
41610398 63066258 57265353 56533217 59337614 41608999 59331513 59334293 56533514
56534979 41506479 46510631 45681295 45683336 46519283 41509326 59718055 59326960
41602898 41606025 71664767 44973322 45685477 44973230 41602096 45681455 45682940
59713289 46519009 56765564 60684103 44980504 57266770 41604274 41505359 41505854
41601112 62344432 44979256 41603949 41506110 41601327 41604090 41604748 59336020
41508343 41600580 41601204 46512772 44977078 41603826 41601631 41610367 44971755
44971359 59321019 59322191 44974244 56462296 46514226 46516091 57265155 44975760
44972448 44975746 44975753 46517319 44971694 44975692 44978990 59326601 59331568
46517289 56534122 56537079 44972974 71660783 44972868 44973421 44975111 44978372
45690143 46512659 56761047 57264141 44978075 46511539 46511010 63066821 46514196
56539134 44980450 56469028 46517692 44979317 46511751 46512789 62966856 57261553
59323129 71550176 71663548 71665665 57262314 56765519 60681645 46516008 57264127
56470437 56533293 57268354 56462746 56464351 56531152 59325369 45685903 56537574
56539578 45690235 57264660 45688164 45690372 56761658 71669991 71548098 45690228
45683268 45687365 56468106 56469820 59712022 57263847 57266756 57268156 56533903
62108577 62348638 57265063 56461879 56464382 56466287 57263571 59331728 56533958
57262871 59325086 57266411 57268392 60546111 56468939 57267524 56468977 62108560
62332316 56533736 59340317 56530865 56470161 56462647 56765861 56463910 56466430
56536409 56470307 56535051 56760835 56465952 62984522 71547534 62105019 56536294
56534559 56537338 56469714 56539677 56535464 56538120 56530827 56767216 62335423
62984102 56763553 56535013 56534962 59320975 59324591 59325888 56767148 62342681
62344241 56761290 56766370 56768237 56767759 56767957 56767711 59321873 59326144
56767414 62342643 62963985 60547514 59325338 59324850 59324652 60545671 59331216
56767926 56770407 59331674 59711179 59337492 71540610 71542119 59336136 60541581
59339601 59339595 62961011 60545961 59334187 60545565 60543141 60545381 62104685
59340065 60544063 62335874 60544384 60684769 60687500 62103817 60682932 60682949
62346023 71666358 62984966 62987530 63065459 71664583 62102124 62337083 60689450
62102469 62108478 59711148 62335898 59711889 59712008 60687135 60690340 62337403
59719335 60689276 71547718 59712428 62331579 71666303 62102766 62333061 62337052
62102476 62337366 62101608 59718208 62101844 62343671 62333900 62109666 62101387
62337113 62333320 62334976 62333276 62335744 71546087 62968560 62331548 62966849
62110471 62333337 63070019 63069358 63070026 62335515 62965293 62969529 62963145
62968461 63061000 63068009 62969857 62987073 62983907 62988971 62968324 63067576
62983587 62983532 63064841 63065176 63067255 71550442 63068313 63070163 63066920
63068641 71667232 63066913 63068665 71547879 63064858 63066227 63067170 71542379
71666938 71665580 71546261 71661698 71664590 71663098 71547176 71664576 71664828
71669250 71781518
02PVAB4062 02PVAB4197 03PVAA0436 02PVAA0024 02PVAA9012 02PVAA5666 02PVAA1371
02PVAA1490 02PVAA1878 02PVAA2575 02PVAA2928 02PVAA4775 02PVAA0592 02PVAA1261
02PVAA2840 02PVAB4055 02PVAA2769 02PVAA2844 02PVAA2884 02PVAA2946 02PVAA6110
02PVAA0947 02PVAB0006 02PVAB0854 02PVAA9170 02PVAA0310 02PVAA3062 02PVAB3834
02PVAA2725 02PVAA0596 02PVAA6496 02PVAA0284 02PVAA2209 02PVAA9352 02PVAA2855
02PVAA5339 02PVAA2260 02PVAA6478 02PVAA2624 02PVAB2680 02PVAA3879 02PVAB1587
02PVAA6508 02PVAA8028 02PVAB2826 02PVAB3485 02PVAA6513 02PVAA9662 02PVAB0011
02PVAB0514 02PVAA9168 02PVAB3356 02PVAB6592 02PVAB3025 02PVAB0648 02PVAB5656
02PVAB1690 02PVAB3179 02PVAB5280 02PVAB6533
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Portsmouth, VA.
REASON
Blood Products, collected from donors whose donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
404 units..
DISTRIBUTION
CA, MI, and NY.
PRODUCT
Source Plasma.
CODE
Unit numbers: 75996406, 75997823, 76323362.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Petersburg, VA.
REASON
Blood products, collected from a donor in which donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 004LJ10812.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA.
REASON
Blood product, which was labeled as being negative for unexpected antibodies,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NH.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 153971132, 153964803, 153970930, 153969892, 153972645, 153972594,
153970929, and 153970960.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX.
REASON
Blood products, that lacked assurance of proper shipping temperatures due to
inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 Units.
DISTRIBUTION
TX.
PRODUCT
Platelets Pheresis.
CODE
Unit number: 8099212.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
REASON
Blood product, exposed to unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE
a), b) and c) Unit E48273.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA.
REASON
Blood products, collected from an unsuitable donor due to behavior associated
with an increased risk of infection with the human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
PRODUCT
Human Corneal Tissue.
CODE
Tissues 04-0521 and 04-0522.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior
to distribution, but was subsequently found to test repeated reactive for
the Hepatitis B Surface Antigen (HBsAg) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells Units.
b) Platelets.
c) Fresh Frozen Plasma.
d) Cryoprecipitated AHF.
CODE
a) Units KH49666, KH49661, KL14039, GG84742,
GV59857, KE66453, KE65414, KE67758;
b) Units FW25597, KL14039, KE65414;
c) Units KH49666, KH49661, KL14039, KE 66453,
KE65414, KE67758;
d) Unit KH49666.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
PA, and RI.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.
CODE
Unit number 0939929.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 26120-3991-01 and 26120-3991-02.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR.
REASON
Blood products, collected from a donor whose health history screening was
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 26169-6284.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR.
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
AR.
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE
Unit numbers 26120-1591-1 and 26120-1591-2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR.
Manufacturer: Blood Systems, Inc., Texarkana, TX.
REASON
Blood products, collected by a method that may have compromised the sterility
of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 21LC04195.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON
Blood product, collected by a method that may have compromised the sterility
of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
CODE
a) and b) Unit 0861307.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
REASON
Blood products, collected from a donor who engaged in high-risk behavior,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and NY.
PRODUCT
Recovered Plasma.
CODE
Unit number 1631777.
RECALLING FIRM/MANUFACTURER
Department of the Army, Armed Services Blood Bank Center, Tacoma, WA.
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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Platelets.
b) Cryoprecipitated AHF.
c) Cryoprecipitated AHF, Pooled. ;
d) Fresh Frozen Plasma.
e) Plasma, Cryoprecipitate Reduced.
CODE
a) Unit numbers 21GW16029, 21GC55138, 21GE02911, and
21GE06052;
b) Unit numbers 21GY43371, 21GY42594, 21GY42420,
21GY41233, 21GH99072, 21GH98213, 21GH98026,
21GH98366, 21GW14867, 21GZ02249, 21GZ01772,
21KK17288, 21KJ25341, 21KG24250, 21KE06739,
21GJ99214, 21GE05646, 21GE04814, 21GE03990,
21GE03313, and 21GE03200;
c) Pool number 551 (contained recalled unit 21GE05377);
d) Unit numbers 21GM91206, 21GM85335, 21GM85122,
21GN02077, 21GV04998, 21GL33091, 21GL33060,
21GL32972, 21Q87857, 21Q87773, 21Q86904,
21Q89751, 21Q83364, 21Q83360, and 21GE06052;
e) Unit numbers 21GY43371, 21GY42594, 21GH98366,
21GJ99214, 21GE04814, 21GE03990, 21GE03313, and
21KE06739.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region,
Portland, OR.
REASON
Blood products, manufactured from units of Whole Blood that were designated
as traumatic collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units, 1 pool.
DISTRIBUTION
Nationwide and PR.
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit numbers 26120-0509-1, 26120-0509-2,
26120-0516-1, 26120-0516-2, 26120-0525-1,
26120-0525-2, 26120-0532-1, 26120-0532-2,
26120-0536-1, 26120-0536-2, 26120-0551-1,
26120-0551-2, 26120-0568-1, 26120-0568-2,
26120-0569-1, 26120-0569-2, 26120-0570-1,
26120-0588-1, 26120-0588-2, 26120-0596-1,
26120-0596-2, 26120-0600-1, 26120-0600-2,
26120-0612-1, 26120-0612-2, 26120-0619-1,
26120-0619-2, 26120-0623-1, 26120-0623-2,
26120-0630-1, 26120-0630-2, 26120-0636-1,
26120-0636-2, 26120-0644-1, 26120-0644-2,
26120-0648-1, 26120-0648-2, 26120-0658-1,
26120-0658-2, 26120-0659-1, 26120-0659-2,
26120-0663-1, 26120-0663-2, 26120-0666-1,
26120-0666-2, 26120-0676-1, 26120-0676-2,
26120-0681-1, 26120-0681-2, 26120-0691-1,
26120-0691-2, 26120-0695-1, 26120-0695-2,
26120-0699-1, 26120-0699-2, 26120-0709-1,
26120-0709-2, 26120-0712-1, 26120-0712-2,
26120-0715-1, 26120-0715-2, 26120-0718-1,
26120-0718-2, 26120-0720-1, 26120-0720-2,
26120-0725-1, 26120-0725-2, 26120-0730-1,
26120-0730-2, 26120-0738-1, 26120-0738-2,
26120-0739-1, 26120-0739-2, 26120-0751-1,
26120-0751-2, 26120-0754-1, 26120-0754-2,
26120-0763-1, 26120-0763-2, 26120-0768-1,
26120-0768-2, 26120-0789-1, 26120-0789-2,
26120-0796-1, 26120-0796-2, 26120-0799-1,
26120-0799-2, 26120-8805-1, 26120-8805-2,
26120-8824-1, 26120-8824-2, 26120-8888-1,
26120-8888-2, 26120-8889, 26120-8892-1,
26120-8892-2, 26120-8898-1, 26120-8898-2,
26120-8900-1, 26120-8900-2, 26120-8908-1,
26120-8908-2, 26120-8912-1, 26120-8912-2,
26120-8920-1, 26120-8920-2, 26120-8927-1,
26120-8927-2, 26120-8929-1, 26120-8929-2,
26120-8936-1, 26120-8936-2, 26120-8937-1,
26120-8937-2, 26120-8955-1, 26120-8955-2,
26120-8961-1, 26120-8982-1, 26120-8982-2,
26120-8986-1, 26120-8986-2, 26120-8993-1,
26120-8993-2, 26120-8994-1, 26120-8994-2,
26120-8995-1, 26120-8995-2, 26120-8997-1,
26120-8997-2, 26120-8998-1, 26120-8998-2,
26120-9003-1, 26120-9003-2, 26120-9005-1,
and 26120-9038-1;
b) Unit numbers 26120-0511, 26120-0524, 26120-0528,
26120-0530, 26120-0543, 26120-0548, 26120-0550,
26120-0565, 26120-0567, 26120-0582, 26120-0583,
26120-0585, 26120-0604, 26120-0616, 26120-0629,
26120-0634, 26120-0635, 26120-0637, 26120-0664,
26120-0674, 26120-0675, 26120-0687, 26120-0693,
26120-0694, 26120-0696, 26120-0707, 26120-0710,
26120-0711, 26120-0714, 26120-0717, 26120-0721,
26120-0724, 26120-0726, 26120-0727, 26120-0743,
26120-0748, 26120-0761, 26120-0776, 26120-0779,
26120-0783, 26120-0793, 26120-8812, 26120-8828,
26120-8830, 26120-8890, 26120-8909, 26120-8914,
26120-8916, 26120-8917, 26120-8924, 26120-8931,
26120-8935, 26120-8941, 26120-8944, 26120-8948,
26120-8950, 26120-8956, 26120-8960, 26120-8962,
26120-8971, 26120-8976, 26120-8979, 26120-8991,
26120-9020, 26120-9023, 26120-9042, 26120-9053,
26120-9063, 26120-9072, 26120-9090, 26120-9092,
26120-9103, 26120-9108, 26120-9113, and 26120-9129.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR.
Manufacturer: Blood Systems, Inc., Hot Springs, AR.
REASON
Blood products, collected from donors that were incorrectly tested for
hematocrit,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
210 units.
DISTRIBUTION
AR, OK, MS, TX, NV, and FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Units 0872738, 0876546.
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ.
REASON
Blood products, which were incorrectly labeled as being negative for unexpected
antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
PRODUCT
Capture Solid Phase Test Systems - Capture-R Ready-Screen Test Wells.
CODE
Lot G113 - 350 units.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot.350 units.
DISTRIBUTION
Nationwide and Canada.