OCTOBER 2004
WEEK ENDING OCTOBER 2
SAFETY ALERT
PRODUCT
Sample First Sampling Systems which are components of the following Baxter Fenwal
Blood-Pack units: 4R1486, 4R1487, 4R3322, 4R3323, 4R3324, 4R3454, 4R3455, and
4R3456.
CODE:
This relates to systems usage and codes are irrelevant.
RESPONSIBLE FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL.
REASON
The infectious disease testing sample collected in the Sample First sample pouch
may become diluted with anticoagulant if the cannula is inadvertently broken,
or if clamping is compromised during Blood-Pack handling.
VOLUME OF PRODUCT IN COMMERCE
107,214 units.
DISTRIBUTION
TX, MA, PA, MO, IL, RI, IA, IN, MN, LA, CA, AZ, and FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers: E00576, PPKF and PPK2.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL.
REASON
Blood product, contaminated with Oerskovia xanthineolytica, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 24630-7532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc. Rapid City, SD.
REASON
Blood products, collected from a donor whose medical history screening was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
PRODUCT
Human Tissues for Transplantation, Corneas.
CODE
NY-04-05-015 OU.
RECALLING FIRM/MANUFACTURER
Sight Society of Northeastern New York, dba Lions Eye Bank at Albany, Albany,
NY.
REASON
Human tissues for transplantation, that tested negative for viral markers, but
was procured from an ineligible donor due to a high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Tissues.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 027P68791.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON
Blood product, in which the corresponding whole blood unit was contaminated
with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
PRODUCT
Red Blood Cells (Apheresis).
CODE
Unit number 22FZ00636.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product was collected in a manner that may compromise the sterility of
the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 9034189 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC.
REASON
Blood products, collected using automated equipment that had not been validated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
GA and SC.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
a) Unit numbers 9034693 and 9034747; and the following units
were distributed as two split units, unit numbers 9034919
and 9034720;
b) Unit number 9034693.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC.
REASON
Blood products, collected using automated equipment that had not been validated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
GA and SC.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
a) Unit numbers 9025228 and 9025256; and the following unit
was distributed as two split units, unit number 9025227;
b) Unit number 9025228.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC.
REASON
Blood products, collected using automated equipment that had not been validated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
SC.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 22KG77115.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product, in which the corresponding whole blood unit was contaminated
with gram positive bacilli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 2503378 -- split A.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL.
REASON
Platelets, with a decreased plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.;
b) Recovered Plasma. .
CODE
a) and b) Unit numbers 49KT03614 and 49GE00986.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, OK, and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 21GL76582.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR.
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
OR.
PRODUCT
Red Blood Cells (Apheresis).
CODE
Unit number 22GL08371.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product was collected in a manner that may compromise the sterility of
the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE
a), b), and c) Unit number 0034115
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL.
REASON
Blood products, collected from an ineligible donor due to use of the drug
Proscar,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.
PRODUCT
Platelets, Leukocytes Reduced.
CODE
Unit number 22KC28392.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product collected from an ineligible donor due to history of close contact
with an individual having viral hepatitis.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Red Blood Cells.
CODE
Unit 4221862.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
REASON
Blood products, which were collected from a donor who was taking the medication
Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK and NJ.
PRODUCT
Red Blood Cells.
CODE
Unit numbers: W11293, W11294, W11295, W11290, W11291.
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Wausau, WI.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
WI.
PRODUCT
Recovered Plasma.
CODE
Unit number: 24630-7532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc. Rapid City, SD.
REASON
Blood products, collected from a donor whose medical history screening was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated.
CODE
Unit number: 71J465211.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit numbers: 71L614462 and 71L522186.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 3971672, 2979195.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON
Blood products, that failed to meet the leukocyte reduced criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 0793803.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, NC.
REASON
Blood product that was out of controlled storage for 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
Source Plasma.
CODE
Unit numbers 04ATXC3364, 04ATXC3366, 04ATXC3367, 04ATXC3375, 04ATXC3377, 04ATXC3378,
04ATXC3382, 04ATXC3383, 04ATXC3384, 04ATXC3386, 04ATXC3390, 04ATXC3398, 04ATXC3399,
04ATXC3400, 04ATXC3401, 04ATXC3403, 04ATXC3404, 04ATXC3405, 04ATXC3409, 04ATXC3413,
04ATXC3421, 04ATXC3423, 04ATXC3424, 04ATXC3428, 04ATXC3429, 04ATXC3435, 04ATXC3437,
04ATXC3441, 04ATXC3443, 04ATXC3444, 04ATXC3447, 04ATXC3452, 04ATXC3455, 04ATXC3456,
04ATXC3457, 04ATXC3458, 04ATXC3459, 04ATXC3462, and 04ATXC3467.
RECALLING FIRM/MANUFACTURER
Plasma Center-Tyler, Inc., Austin, TX.
REASON
Blood products, untested tested for human immunodeficiency virus (HIV) p24 antigen
by the enzyme immunoassay (EIA) test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
Austria.
PRODUCT
Red Blood Cells.
CODE
Unit number: E65215.
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Miller Memorial Blood Center, Bethlehem,
PA.
REASON
Blood product, collected from a donor when quality control for hemoglobin testing
was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
Unit 22FC17689.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product, corresponding to Platelets that were contaminated with Propionibacterium
acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Recovered Plasma.
CODE
Unit 4221862.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
REASON
Blood products, which were collected from a donor who was taking the medication
Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK and NJ.
WEEK ENDING OCTOBER 9
PRODUCT
Platelets Leukocytes Reduced.
CODE
Unit number 22KX62899.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PR.
WEEK ENDING OCTOBER 16
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit S52686.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw Valley, Saginaw, MI.
REASON
Blood products, corresponding to Platelets that were contaminated with coagulase
negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells (Apheresis).
CODE
Unit number 6687510.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 6684748 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL.
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), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 7018895.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark,
DE.
REASON
Blood product, that was initially incorrectly tested for viral markers and re-tested
repeatedly reactive for hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.
PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE
a) Unit number 1074687;
b) Unit numbers 598013, 598023, 598225, 1074654, and 1074687.
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital and University Health Center, Sioux Falls, SD.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MN and FL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE
a), b), and c) Unit number 9242652.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus
(anti-HCV),
but were collected from an ineligible donor based on the disclosure of a previous
positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
DE, and MD.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Plasma,
d) Red Blood Cells for Further Manufacture,
e) Recovered Plasma,
CODE
a) Units 4136359, 4134337, 4133208, and 4132313;
b) Units 4133208 and 4132313;
c) Unit 4134337;
d) Unit 4135422;
e) Units 4136359 and 4135422.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON
Blood products, which were collected from a donor who had a history of hepatitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
IL and FL.
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Cryoprecipitated AHF,
c) Plasma Cryoprecipitate Reduced,
CODE
a), b), and c) Unit 20GM75704.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID.
REASON
Blood products, which were collected from a donor who was at risk for Creuztfeldt
Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.
PRODUCT
Red Blood Cells.
CODE
Unit 2290423.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Centers, Spokane, WA.
REASON
Blood product, which was collected from a donor who was taking a nonsteroidal
anti-inflammatory drug (NSAID), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.
PRODUCT
Red Blood Cells.
CODE
Unit 1237992.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Centers, Spokane, WA.
REASON
Blood product, which tested repeated reactive for the antibody to the human t-lymphotropic virus type I/II
(anti-HTLV-I/II) but tested negative by a confirmatory
test, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit LE84602.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., DBA Rhode Island Blood Center, Providence,
RI.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
Source Plasma.
CODE
Unit number 07330902.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN.
REASON
Blood product tested negative for viral markers but was collected from an ineligible
donor due to a risk factor for increased incidence of infection with human immunodeficiency
virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 2383755.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood products collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
a) Unit numbers 01GY86243, 01GY86247, 01GY86260, 01GY86275,
01KJ56432, 01KJ56526, 01LC50201, 01LH55711, 01LJ30292,
01LJ30293, 01LJ30294, 01LJ30296, 01LJ30298, 01LJ30299,
01LJ30301, 01LN32855, 01LN38237, 01LN38239, 01LN38246,
01LN38247, 01LN38252, 01LN38254, 01LN38259, 01LN38260,
01LS45587, 01LS45591, 01LS45598, 01LS45612, 01LS45613,
01LS45617, 01LT46600, 01LT46650, 01LV60753, 01LV60757,
01LV60764, 01LV60768, 01LV60772, 01LV60780, 01LV60781,
01LV60782, 01LV60795, and 01LW34025;
b) Unit numbers 01GE45096, 01LJ30289, 01LJ30303, 01LN38245,
01LN38250, 01LN38256, and 01Y51565.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY.
REASON
Blood products, that tested out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units.
DISTRIBUTION
NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number LR85787.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
PRODUCT
Recovered Plasma.
CODE
Unit numbers D03-02509 and D04-00404.
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Farmingham, MA.
REASON
Blood products, 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), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
Recovered Plasma..
CODE
Unit numbers 1074627, and 598009.
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital and University Health Center, Sioux Falls, SD.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MN and FL.
PRODUCT
Platelets.
CODE
Units 0365321, 0365325, and 0365330.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood products, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.
PRODUCT
Plasma.
CODE
Unit numbers 20LC59848, 20LS15336, 20LS15340, 20LN27348, 20LN27349, and 20LN27350.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID.
REASON
Blood products, which were not frozen within 24 hours of whole blood collection,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
OR and ID.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit numbers 42R74167, 42FX30132, 42FX30156, 42FX30175, 42FX30193, 42FX30195,
42FC13879, 42FP00505, 42FP00506, 42FZ03799, 42FS85142, 42H41195, 42F58387, 42FZ03282,
42FZ03283, 42H41196, 42FH27540, 42FX30176, 42K70920, 42K70923, 42J51637, 42K70967,
42K70969, 42FE87170, 42FG06901, 42FR06289, 42G49553, 42FH27541, 42FH27912, 42FS85479,
42K70968, 42FJ22847, 42G49191, 42FG06885, 42FG06886, 42FG06903, 42FG06919, 42FG06920,
42FG06922, 42FG06923, 42T26932, 42FG07011, 42FH27499, 42FP00145, 42W36011, 42W36013,
42FH27542, 42GE12115, 42GE12116, 42FH27575, 42FH27577, 42FH27949, 42X89178,
42FE88022, 42FS85143, 42GC07518, 42T26627, 42FG06902, 42FG06921, 42FH27534,
42FP00146, 42GE12118, 42R74719, 42FH27574, 42W36041, 42FH27909, 42FS85481, 42K70921,
42FP00504, 42FJ22846, 42W36400, 42FZ03797, 42FZ03798, 42FZ03800, 42FZ03801,
42X89179, 42F58382, 42FR06288, 42S00226, 42FG07014, 42W36039, 42FC13907, 42FP00534,
42GC07963, 42GC07965, 42GC07967, 42FR07288, 42J51636, 42R74740, 42FH27573, 42GC07519,
42FE87171, 42FX30159, 42FX30194, 42K70924, 42FP00147, 42R74720, 42R74721, 42FH27543,
42FG07012, 42W36012, 42W36037, 42FZ03765, 42FZ03796, 42GE12117, 42FJ22845, 42FG07013,
42FE88023, 42T26933, 42GE12119, 42FX30174, 42W36396, 42FX30128, 42FX30129, 42FX30134,
42FX30157, 42FX30177, 42FX30196, 42FC13906, 42FC13909, 42W36397, 42FZ03763,
42FZ03764, 42X89181, 42G49190, 42T26613, 42T26615, 42T26628, 42W35835, 42W35836,
42FC13550, 42FC13552, 42FR06287, 42H41193, 42H41194, 42S00225, 42T27069, 42T27070,
42FH27498, 42GE12132, 42FH27576, 42FS85480, 42FX30158, 42W36372, 42FC13908,
42W36395, 42GC07966, 42FC13551, 42FR06290, 42G49554, 42S00224, 42FH27500, and
42GE12133.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON
Blood products, manufactured by a method that may have resulted in the products
being out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
153 units.
DISTRIBUTION
OH.
PRODUCT
Plasma.
CODE
Unit numbers K85547, L82458, L82489, L82912, N03092, N03136, N03726, N04400,
N04424, N03085, N04428, N01338, N02334, N02333, N02165, N02169, N02174, N02182
and N02187.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
MI.
WEEK ENDING OCTOBER 23
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) and b) Unit number: 027P68152.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON
Blood products, associated with a positive bacterial culture, which identified
Sphingomonas paucimobilis as the isolate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and PA.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.
CODE
Unit E04500.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL.
REASON
Platelets, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Source Plasma.
CODE
Units BY0081013, BY0081234, BY0081539, BY0081749, BY0082116, BY0082324, BY0082909,
BY0082977.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX.
REASON
Blood products, collected from a donor who lived in western Europe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.
PRODUCT
Source Plasma.
CODE
Units CS0179785, CS0195693.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX.
REASON
Blood products, collected from a donor who was at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
PRODUCT
Plasma Cryoprecipitate Reduced.
CODE
Unit 21KL69179.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
REASON
Blood product, which did not have a documented time for which it was placed
into the freezer, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 2372493 (split unit).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
PRODUCT
Platelets Irradiated.
CODE
Unit E00934.
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA.
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
WA.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 2374447.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood product, which was collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
PRODUCT
a) Plasma, Frozen,
b) Cryoprecipitated AHF.
c) Plasma, Cryoprecipitate Reduced.
CODE
a) Units 21FJ29806, 21V85993, 21V85990, 21KE16498, 21FL66734,
21FL68118, 21FL68141, 21GE37589, 21GW36060;
b) 21KC65264, 21KC69754, 1KJ82663, 21KJ82674, 21KC69699,
21KC69682, 21V86488, 21KC63737, 21KG81250, 21KJ77581,
21KJ78082, 21KK69077, 21KL60199, 21KH80670, 21KK69069,
21KZ14945, 21Y77016, 21KC58883, 21Y77029, 21Y77202;
c) Unit 21KC63737.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR.
REASON
Blood products, corresponding to Red Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
WA, OR, CA, TX, OK, and GA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 2368943.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX.
REASON
Blood products, collected from a donor who lived in western Europe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Vienna, Austria, and TX.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit GE70829.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA.
REASON
Blood products, corresponding to a unit of clotted red cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 38FV12108 -- split unit.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON
Blood products, not properly quarantined after the receipt of post donation
information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE
a), b), and c) Unit number 2372945.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood products collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0059-5;
Recovered Plasma.
CODE
a) and b) Unit number 2348391.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood products collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Austria.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE
a), b) and c) Unit number FK96334.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI.
REASON
Blood products that tested initially reactive for antibodies to hepatitis C
virus (anti-HCV) were not re-tested in duplicate and were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
RI and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 5550901.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL.
Manufacturer: LifeSource Oak Lawn, Oak Lawn, IL.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency
virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently
reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number: 18N89811.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood products, collected in a manner that may have compromised their sterility,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI, and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 030GV12197.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON
Red Cells, collected from a donor whose hemoglobin was not documented, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE
a) and b) Unit 8107897.
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Service, Inc., Elyria, OH.
REASON
Blood products, collected from a donor using condylox gel, a medication for
the treatment of venereal warts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and OH.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 18FJ72211 and 18GN29726;
b) Unit 18FJ72211.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood products, collected from a donor using Tazorac, a topical medication for
the treatment of psoriasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit 2356608.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX..
REASON
Blood products, which were collected from a donor who was at risk for Creuztfeldt
Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Cryoprecipitated AHF,
d) Cryoprecipitated AHF Pooled,
CODE
a) Unit 21KJ44430;
b) and c) Unit 21KK45412;
d) Unit 21KK44430.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
REASON
Blood products, which were collected from a donor who tested negative for the
antibody to the hepatitis B core antigen (anti-HBc) but had previously tested
positive for anti-HBc on two separate occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OR and WA.
PRODUCT
a) Fresh Frozen Plasma,
b) Plasma Cryoprecipitate Reduced,
c) Cryoprecipitated AHF,
CODE
a) Units 21KF31604, 21GL82596, 21FT42805, and 21FS27945;
b) and c) Units 21KZ16988 and 21GY86431.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
REASON
Blood products, which were manufactured from whole blood units in which the
corresponding red blood cell components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
WA, OR, CA, and GA.
PRODUCT
Sterile Water for Injection USP 30 ml (Used as diluent with Antihemophilic Factor/von
Willebrand's Factor Complex (human) Dried, Pasteurized, Humate-P.
CODE
Lots: 02111011, 05311011, 10411011, 12111011, 13511011, 18011011, 19211011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Behring, King of Prussia, PA.
Manufacturer: Aventis Behring Gmbh, Marburg, Germany.
REASON
Sterile Water, in which sterility could not be assured due to cracked vials,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 lots, 36,935 vials.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Red Blood Cells.
CODE
Unit number: 1221945.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH.
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
OH.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 04R08358.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Recovered Plasma.
CODE
a) and b) Unit number 04Y95608.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency
virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently
reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA and CA.
PRODUCT
Source Plasma.
CODE
Unit numbers: 0057788, 0057951, 0058201, 0058485, 0058713, 0059068, 0059218,
0059651, 0059801, 0060203, 0060336, 0060722, 0061275, 0061327, 0061943, 0062003,
0064125, 0064444, 0065568, 0067813, 0067843, 0072446, 0072647, 0073446, 0073717,
0073823, and 0074147.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
Austria and the United Kingdom.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 3077581.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH.
REASON
Blood product, collected from a donor who had resided in an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 38C14528.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN.
REASON
Blood product, which may have not met the acceptable hematocrit specifications,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
Source Plasma.
CODE
Unit 03GMIF4831.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker, MI.
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
NC.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 7061901.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit number FG97391.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI.
REASON
Blood product, that was found to be out of specification for red blood cell
recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
CODE
a) Units 38FH23971, 38FH23972, 38FH23973, 38FH23974, 38FH23978,
38FH23980, 38FH23982, 38FH23983, 38FH23984, 38FH23985,
38FH23986 and 38FH23987;
b) Units 38FH22293, 38FH22294, 38FH22295, 38FH22296, 38FH22297,
38LC73361, 38LC73362, 38LC73363, 38LC73364, 38LC73365,
38LC73366, 38LC73367, 38LC73368, 38LC73369, 38LC73370,
38LC73372, 38LC73373, 38LC73374, 38LC73375, and 38LC73376.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
IN.
WEEK ENDING OCTOBER 30
PRODUCT
Source Plasma.
CODE
Units 86888165, 86886536, 86881807, 86891257, 86884730, 86882774, 86831673,
86828680, 86814492, 86892100, 86885843, 86883184, 86876278, 86872171, 86860963,
86859790, 86889131, 86855549, 86850490, 86880909, 86876766, 86874625, 86890724,
86887571, 86885379, 86882255, 86879811, 86877329, 86874694, 86871198, 86866941,
86864428, 86876599, 86874182, 86870924, 86868730, 86865524, 86863216, 86859608,
86856508, 86854252, 86851305, 86849630, 86846301, 86840118, 86838979, 86834674,
86832922, 86829595, 86826440, 86822190, 86820066, 86814935, 86812351, 86808422,
86806572, 86804257, 86802390, 69746536, 69743252, 69739309, 69736865, 69732409,
69730054, 86821070, 86817615, 86890878, 86888103, 86867023, 86865937, 86859936,
86857659, 86854641, 86850551, 86847742, 86845700, 86842174, 86840255, 86836951,
86834803, 86831147, 86828765, 86959216, 86816755, 86843911.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX.
REASON
Blood products, collected from donors whose medical history screenings did not
include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD)
and variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
IL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit FE55660 - split B.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora,
IL.
Manufacturing Firm: Heartland Blood Centers, Tinley Park,
IL.
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
IL.
PRODUCT
Red Blood Cells (Apheresis).
CODE
Unit 33GN000353 (split unit).
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT.
REASON
Blood products, which may have not met the acceptable hematocrit specifications,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.
PRODUCT
Platelets, Leukocytes Reduced Irradiated.
CODE
Unit number 71W56510X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham,
AL.
REASON
Blood product was not properly irradiated but was distributed with labeling
that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
PRODUCT
Trima Accel Automated Blood Collection System Tubing Sets
- Trima Accel LRS Platelet, Plasma, RBC Set;
- Trima Accel Platelet, Plasma, RBC & TLR Filter Set.
CODE
Lot Number 05KXXXX and 06KXXXX.
RECALLING FIRM/MANUFACTURER
GAMBRO BCT, Inc., Lakewood, CO.
REASON
Trima Accel Automated Blood Collection System tubing sets, that collected significantly
lower yields/concentrations of platelets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50,682 sets.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE
a) Unit numbers LM31432, LM32389, LM31821, and LM32632;
b) Unit numbers LM30801, LM30807, LM30902, LM30918, LM31027,
c) LM31397, LM31544, LM32218, LM32212, LM32219, and LM32379;
Unit numbers LM30167, LM30173, LM30176, LM30178, LM30192,
LM30198, LM30200, LM30319, LM30323, LM30329, LM30339,
LM30344, LM30351, LM30468, LM30471, LM30474, LM30477,
LM30488, LM30491, LM30500, LM30505, LM30545, LM30555,
LM30570, LM30587, LM30801, LM30807, LM30813, LM30820,
LM30842, LM30845, LM30847, LM30853, LM30860, LM30872,
LM30875, LM30892, LM30902, LM30907, LM30910, LM30920,
LM30927, LM30933, LM31018, LM31025, LM31027, LM31187,
LM31180, LM31318, LM31339, LM31342, LM31347, LM31351,
LM31354, LM31385, LM31390, LM31392, LM31397, LM31400,
LM31411, LM31414, LM31415, LM31425, LM31432, LM31435,
LM31438, LM31441, LM31454, LG27705, LG27708, LG27710,
LG27713, LG27715, LG27717, LG27723, LM31495, LM31497,
LM31538, LM31540, LM21542, LM31544, LM31546, LM31548,
LM31549, LM31553, LM31580, LM31562, LM31573, LM31587,
LM31555, LM31565, LM31581, LM31567, LM31841, LM31845,
LM31842, LM31849, LM31816, LM31818, LM31835, LM31826,
LM31986, LM31943, LM31974, LM31948, LM31950, LM31971,
LM31989, LM31983, LM31960, LM31942, LM31956, LM31952,
LM31977, LM31993, LM31967, LM31992, LM31980, LM31990,
LM31963, LM32003, LM32011, LM32019, LM32033, LM32054,
LM32057, LM32060, LM32062, LM32079, LM32082, LM32084,
LM32085, LM32100, LM32104, LM32107, LM32110, LM32113,
LM32121, LM32123, LM32126, LM32129, LM32134, LM32135,
LM32125, LM32138, LM32167, LM32182, LM32185, LM32183,
LM32191, LM32193, LM32194, LM32196, LM32199, LM32204,
LM32115, LM32218, LM32227, LM32225, LM32229, LM32210,
LM32212, LM32219, LM32207, LM32236, LM32230, LM32250,
LM32245, LM32252, LM32249, LM32241, LM32247, LM32243,
LM32257, LM32266, LM32270, LM32275, LM32280, LM32330,
LM32343, LM32350, LM32360, LM32365, LM32369, LM32372,
LM32390, LM32399, LM32406, LM32407, LM32408, LM32413,
LM32416, LM32461, LM32462, LM32483, LM32487, LM32491,
LM32493, LM32495, LM32498, LM32501, LM32503, LM32507,
LM32510, LM32515, LM32593, LM32595, LM32596, LM32598,
LM32599, LM32604, LM32612, LM32615, LM32617, LM32620,
LM32623, LM32626, LM32628, LM32629, LM32632, LM32636,
LM32638, LM32641, LM32647, LM32650, LM32651, LM32654,
LM32656, LM32659, LM32663, LM32666, LM32668, LM32671,
LM32672, LM32675, LM32712, LM32719, LM32721, LM32726,
LM32731, LM32734, LM32752, LM32759, LM32735, LM32744,
LM32745, LM32747, LM32769, LM32772, LM32866, LM32825,
LM32838, LM32891, LM32870, LM32864, LM32819, LM32821,
LM32893, LM32879, LM32885, LM32833, LM32887, LM32869,
LM32880, LM32940, LM32910, LM32941, LM32925, LM32923,
LM32904, LM32898, LM32920, LM32917, LM32914, LM32916,
LM32902, LM32933, LM32912, LM32908, and LM32927.
RECALLING FIRM/MANUFACTURER
Lancaster General Hospital Blood Bank, Lancaster, PA.
REASON
Blood products, collected from donors that did not answer a medical history
question concerning behavior known to increase risk of infection with the human
immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
295 units.
DISTRIBUTION
PA, and MD.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 71H827806.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc.
Montgomery Region, Montgomery, AL.
REASON
Blood product, which was labeled leukoreduced but failed quality control testing
due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 71L09115X, 71L478970, 71L479143, 71L479167, 71L79180, and 71L574134.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham,
AL. .
REASON
Blood products exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AL.
PRODUCT
a) Red Blood Cells, Irradiated.
b) Platelets Pheresis, Irradiated.
CODE
a) Unit numbers 71J800700 and 71J800945;
b) Unit number 71W511028.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham,
AL. .
REASON
Blood products that were possibly out of controlled storage for more than 30
minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.