Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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June 29, 2005
05-26

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0839-5
CODE
Unit numbers: C64588, R37135
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by telephone on April 15, 2005. Firm initiated recall is complete.
REASON
Red Blood Cells, with incomplete compatibility testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1248-5
CODE
Unit number: 4525222
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on October 3, 2002, December 18, and 19, 2003, and January 27, 2004.
Manufacturer: Oklahoma Blood Institute, Norman Center, Norman, OK. Firm initiated recall is complete.
REASON
Blood product, collected from a donor without documentation of an acceptable hematocrit or hemoglobin test, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1281-5;
b) Platelets, Recall # B-1282-5;
c) Fresh Frozen Plasma, Recall # B-1283-5
CODE
a), b), and c) Unit number: 4512347
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on March 20, and 21, 2003. Firm initiated recall is complete.
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
3 units
DISTRIBUTION
OK, MI, FL, and NB

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed, Irradiated,
Washed, Recall # B-1329-5
b) Recovered Plasma, Recall # B-1330-5
CODE
a) and b) Unit number: 9605537
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc. Anchorage, AK, by facsimile on October 24, 2003 and by letter, dated October 27, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK, and PA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1331-5
b) Recovered Plasma, Recall # B-1332-5
CODE
a) and b) Unit number: 6035970
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc. Anchorage, AK, by letter, dated February 3, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK, and PA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1339-5
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1340-5
c) Fresh Frozen Plasma, Recall # B-1341-5
d) Recovered Plasma, Recall # B-1342-5
CODE
a) Unit number: 4622067
b) Unit numbers: 4636450, 4526685
c) Unit number: 4526685
d) Unit numbers: 4636450, 4526685, and 4622067
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on April 29 and 30, 2003, and May 2, 2003, and by letter on August 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who gave a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OK, TX, NY, NJ, Switzerland, and Austria

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1360-5
CODE
Unit numbers: H84693, F14978, J10163, F14973
RECALLING FIRM/MANUFACTURER
Costal Bend Blood Center, Corpus Christi, TX, by facsimile transmission dated September 10, 2002. Firm initiated recall is complete.
REASON
Platelets, implicated in a transfusion reaction and contaminated with Group G Streptococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1367-5
CODE
Unit number: 027GH24226
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on January 11, 2005, and by letter on January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that tested positive for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Human tissue for Transplantation, Corneas, Recall # B-1371-5
CODE
Corneas numbers: CT200503-7-2-R-01 and CT200503-7-1-L-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD, by letter on May 2, 2005.
Manufacturer: Connecticut Eye Bank and Visual Research Foundation, Inc, New Britain, CT. Firm initiated recall is complete.
REASON
Human Tissue for Transplantation, that tested reactive for antibodies to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
MA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1372-5
CODE
unit numbers: 4563104, 4487580, and 4348446
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 4, 2003, and letter on July 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Source Plasma, Recall # B-1374-5
CODE
Unit numbers: 00GMIE0436, 00GMID9133, 00GMID8345, 00GMID7925, 00GMIA3523, 99GMID2134, 99GMIC1956, 99GMIC1676, 99GMIC3105, 99GMIC4089, 99GMIE7558, and 99GMIE7826
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker, MI, by facsimile on June 16, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA and Austria

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1376-5
CODE
Unit numbers LE05107 and LE02939
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter on August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and VA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1377-5
b) Platelets, Recall # B-1378-5
CODE
a) and b) Unit number S29953
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by facsimile on October 19, 2001. Firm initiated recall is complete.
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
Fresh Frozen Plasma, Recall # B-1382-5
CODE
Unit number: E81394
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on April 27, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1383-5
b) Recovered Plasma, Recall # B-1384-5
CODE
a) and b) Unit number: KC38981
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by facsimile on January 6, 2005 and by telephone dated January 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD and NJ

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1385-5
b) Platelets, Recall # B-1386-5
c) Fresh Frozen Plasma, Recall # B-1387-5
CODE
a), b), and c) Unit number: KK72051
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 21, 2005. Firm initiated recall is ongoing.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who provided post donation information regarding having previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Source Plasma, Recall # B-1388-5
CODE
Unit numbers: 03205273, 04541424, 04206903
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Louisville, KY, by facsimile on May 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1389-5
CODE
Unit number: 016LJ12500
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by e-mail on October 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from an ineligible donor due to a history of jaundice with mononucleosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1390-5
b) Platelets, Recall # B-1391-5
CODE
a) and b) Unit number: 2037630
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letters dated September 1, 2004 and September 23, 2004. Firm initiated recall is complete.
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
KY

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1395-5
CODE
Unit number: E77887
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on April 13, 2004, and by letter on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1396-5
CODE
Unit number: 27P67000
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on January 8, 2004. Firm initiated recall is complete.
REASON
Platelets with an elevated platelet count based on volume of product were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1398-5
CODE
Unit number: GW55320
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by telephone on October 11, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested positive for microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1488-5
b) Recovered Plasma, Recall # B-1489-5
CODE
a) and b) Unit number: LL09359
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by facsimile on August 27, 2002, and by letter, dated August 29, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, and Switzerland

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1512-5
CODE
Unit numbers: LE09301-1 and LE09301-2
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 30, 2005. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1513-5
CODE
Unit numbers: 1094256, 1094269, 1094272, 1061171, 1103539, 1102958, 1102952, 1102946, and 1103521 (unit distributed as two split products)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on December 14, 2004. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1514-5
CODE
Unit number: 18225-0647
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by facsimile on March 8, 2001.
Manufacturer: Blood Systems, Inc, Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor that subsequently disclosed behavior known to increase risk of infection with human immunodeficiency virus (HIV0, was not quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1516-5
CODE
Unit numbers: 15011-8841, 15011-8844, 15011-8852, 15011-8855, 15011-8862, 18223-5421, 18223-5423, 18223-5606, 18223-5607, 18223-5608, 18223-5610, 18223-5613, 18223-5680, 18223-5683, 18223-5687, 18223-5688, 18223-5689, 18223-5691, 18223-5693, and 18233-5435
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on September 12, 2000, and by letters on October 26, 2000, and December 21, 2000.
Manufacturer: Blood Systems, Inc, Casper, WY. Firm initiated recall is complete.
REASON
Blood products that lacked documentation of use of the sterile connecting device were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
TX and WY

_______________________________
PRODUCT
a) Red Blood Cell, Irradiated, Recall # B-1517-5
b) Platelets, Recall # B-1518-5
CODE
a) and b) Unit number: E150541
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on November 7, 2002. Firm initiated recall is complete.
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
WA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Leukocytes, for further manufacturer, Recall # B-1284-5
CODE
Unit number: 4512347
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on March 20, and 21, 2003. Firm initiated recall is complete.
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
1 unit
DISTRIBUTION
OK, MI, FL, and NB

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1364-5
CODE
Unit number: 027GX86992
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on November 22, 2004. Firm initiated recall is complete.
REASON
Blood product, that did not have the additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1365-5
b) Platelets Pheresis, Leukocytes Reduced Irradiated,
Recall # B-1366-5
CODE
a) Unit numbers: 017FX82060, 027GE18343, 027GF17029, 027P71729
b) Unit number: 033FP46852
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on December 8, 2004, and by letter on December 15, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly stored in incorrect storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WV and KY
________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1368-5
CODE
Unit number: 007FY18497
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on February 8, 2004, and by letter on February 9, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for
hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1369-5
CODE
Unit number: 10291-1432
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter on November 19, 2004. Firm initiated recall is complete.
REASON
Blood product possibly exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1370-5
CODE
Unit numbers 10185-2747, 10185-6326, 10184-9638, 10185-5322, 10185-6364, 10185-7321, 10184-9709, 10185-8262, 10185-2572, 10184-9790, 10186-1462, 10185-6829, 10185-3992, 10184-9678, 10185-6745, and 10186-1481
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 9, 2004. Firm initiated recall is complete.
REASON
Blood product possibly exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1373-5
CODE
Unit numbers 4563104, 4487580, and 4348446
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 4, 2003, and letter on July 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1375-5
CODE
Unit number: GP07653
RECALLING FIRM
Inova Health Care Services, Sterling, VA, by letter on September 29, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1379-5
b) Recovered Plasma, Recall # B-1380-5
CODE
a) and b) Unit number: C21875
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 21, and 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not properly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1381-5
CODE
Unit number: 8739373
RECALLING FIRM
Union Memorial Hospital Blood Bank, Baltimore, MD, by telephone on October 22, 2004, and by letter on January 21, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1397-5
CODE
Unit number: 10186-5284
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 21, 2004. Firm initiated recall is complete.
REASON
Blood product possibly exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Source Plasma, Recall # B-1508-5
CODE
Unit numbers: MI059824, MI056139, MI056845, MI057515, MI057881, MI059191, MI059591, MI056793, MI060651, MI060655, MI060312, MI061312, MI060154, MI061784, MI062865, MI062915, MI062674, MI063467, MI064105, MI064756, MI064859, MI063008, MI062764, MI067790, MI068551, MI068593, MI067035, MI068685, MI069142, MI069557, MI064416, MI077719, MI071019, MI079182, MI071752, MI072303, MI073163, MI073770, MI078337, MI078516, MI078872, MI078829, MI079442, MI071224, MI072770, MI072848, MI073210, MI073590, MI073840, MI073812, MI074623, MI076113, MI076296, MI076638, MI079299, MI072700, MI077032, MI076429, MI077382, MI077557, MI077061, MI078118, MI078288, MI078244, MI077464, MI078303, MI079954, MI081222, MI080561, MI088871, MI088971, MI087759, MI087451, MI080016, MI080041, MI083352, MI083914, MI084040, MI084044, MI084166, MI084316, MI084960, MI089382, MI085150, MI085322, MI084536, MI083648, MI085526, MI085621, MI085557, MI084963, MI085825, MI085842, MI086503, MI084825, MI084277, MI087141, MI087497, MI086570, MI087813, MI088714, MI088668, MI087684, MI088449, MI090257, MI091342, MI091383, MI092053, MI092097, MI093653, MI093809, MI092328, MI093836, MI093951, MI094285, MI094512, MI094457, MI094982, MI094568, MI094972, MI096289, MI099266, MI099659, MI096374, MI094254, MI096427, MI096607, MI096611, MI096274, MI096677, MI097807, MI097908, MI098008, MI098404, MI095826, MI094609, MI098341, MI090450, MI092033, MI093271, MI093660, MI094655, MI093665, MI094935, MI096300, MI096605, MI096670, MI095913, MI097381, MI097372, MI098712, MI099182, MI099657, MI101110, MI101178, MI101571, MI102146, MI102082, MI103881, MI103736, MI104408, MI104533, MI101190, MI102391, MI102381, MI102751, MI103566, MI106544, MI107016, MI109543, MI109283, MI108558, MI107581, MI107767, MI107276, MI107760, MI108052, MI108666, MI107306, MI105086, MI105701, MI105925, MI106357, MI105469, MI105117, MI104676, MI109824, MI101151, MI110090, MI113529, MI110355, MI111093, MI111564, MI111221, MI112783, MI114656, MI115341, MI116473, MI116205, MI115439, MI117288, MI117396, MI119124, MI119702, MI119834, MI110471, MI111999, MI111811, MI114234, MI111097, MI116056, MI117421, MI116569, MI117474, MI118115, MI118263, MI118283, MI119535, MI119983, MI119201, MI111024, MI110452, MI116195, MI119825, MI121700, MI122398, MI126339, MI121656, MI128094, MI120033, MI120181, MI120165, MI120763, MI120988, MI120526, MI121118, MI121808, MI120980, MI121712, MI121888, MI121884, MI122266, MI122516, MI123272, MI124248, MI124281, MI125002, MI122412, MI122067, MI121732, MI120146, MI120192, MI120472, MI121047, MI121441, MI126020, MI126087, MI128492, MI128471, MI128816, MI129092, MI127322, MI131194, MI131788, MI132689, MI133145, MI131422, MI131487, MI132114, MI132333, MI132844, MI132982, MI133119, MI133231, MI133482, MI134822, MI135084, MI133183, MI132719, MI133752, MI132504, MI145026, MI144966, MI145357, MI145639, MI147381, MI147513, MI147820, MI145156, MI148197, MI147845, MI149274, MI148786, MI149038, MI148688, MI149872, MI149980, MI145027, MI146321, MI147147, MI147570, MI151036, MI153591, MI153312, MI153621, MI150639, MI151107, MI152142, MI151323, MI151029, MI154419, MI152535, MI155228, MI155760, MI154146, MI155960, MI156083, MI156504, MI156929, MI158053, MI159292, MI152277, MI153344, MI154475, MI154555, MI154831, MI154124, MI156607, MI157636, MI157991, MI158413, MI159502, MI159575, MI159661, MI159948, MI160470, MI166368, MI165391, MI166802, MI168175, MI169005, MI161074, MI161887, MI161007, MI162078, MI164562, MI164754, MI164248, MI165050, MI165248, MI164919, MI165230, MI164941, MI161347, MI162065, MI162290, MI162776, MI163713, MI164131, MI163894, MI164199, MI164155, MI164355, MI164558, MI164782, MI162675, MI165083, MI164713, MI164939, MI165200, MI163606, MI165197, MI165577, MI165593, MI165701, MI169234, MI168438, MI162766, MI165896, MI166335, MI167437, MI167249, MI168042, MI168386, MI166391, MI168388, MI168420, MI168473, MI168800, MI168428, MI169594, MI160909, MI165280, MI172310, MI171324, MI170739, MI171332, MI172193, MI178347, MI175805, MI170015, MI170415, MI171047, MI173616, MI174943, MI171475, MI174337, MI173499, MI172450, MI172554, MI172491, MI172676, MI173251, MI173166, MI173451, MI173554, MI173678, MI173652, MI174136, MI174134, MI174303, MI175014, MI175051, MI175113, MI176319, MI176720, MI176852, MI174795, MI177271, MI177421, MI177079, MI177551, MI177554, MI172523, MI170780, MI174764, MI172367, MI173122, MI173436, MI173380, MI173481, MI178055, MI178830, MI177908, MI178204, MI178454, MI177579, MI178518, MI178746, MI177401, MI175248, MI175021, MI177959, MI176616, MI181562, MI182385, MI181544, MI188048, MI180982, MI181230, MI181145, MI181153, MI181330, MI181391, MI181864, MI182277, MI184313, MI185249, MI188406, MI188826, MI188858, MI188965, MI185838, MI180181, MI180780, MI184824, MI186170, MI187524, MI188708, MI188439, MI188894, MI181337, MI181080, MI180505, MI180153, MI181419, MI181089, MI181448, MI181873, MI180248, MI180432, MI180114, MI180769, MI181169, MI185309, MI189547, MI180974, MI181603, MI188079, MI180172, MI180215, MI190062, MI190493, MI190603, MI192241, MI193398, MI193465, MI193206, MI192472, MI194071, MI194430, MI195012, MI194324, MI190114, MI190501, MI192958, MI193382, MI190661, MI190005, MI194107, and MI192493
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile and electronic mail between November 22, 2004, and December 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
521 units
DISTRIBUTION
CA, NC, MA, and France

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-1515-5
CODE
Unit numbers 12798-7216, 12798-8630, 12798-9155, 12798-9532, 12799-1074, 12799-1131, 12799-1205, and 12799-1245
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 7, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NM

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1519-5
b) Platelets. Recall # B-1520-5
CODE
a) Unit number: E152522
b) Unit number: C168286, E152517, and F139175
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on April 22, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA

END OF ENFORCEMENT REPORT FOR JUNE 29, 2005

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