MARCH 2002
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 12FG81607.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
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 TN.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
CODE a) and b) Unit number 03KL07272.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Southern Region, Atlanta, GA
Manufacturer:
American Red Cross Blood Services, Miami, FL.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor based on the application
of a tattoo within the previous 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.
PRODUCT Plasma, Cryoreduced, For Further Manufacturing Use,
CODE Unit number 03KT03575.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Southern Region, Atlanta, GA
Manufacturer: American Red Cross Blood Services, Miami,
FL.
REASON Blood product, that was not properly quarantined
after the donor provided information concerning an accidental needlestick
during the previous twelve months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT Immune Globulin Intravenous (Human);
Venoglobulin?-S, 10% Solution; (10 g, 100 ml)
CODE Lot number GR1038A.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, Los Angeles, CA
REASON Human immunoglobulin, with anti-complementary
activity (ACA) levels that exceeded specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,351 vials.
DISTRIBUTION FL and GA.
PRODUCT Allergenic extracts labeled in part "ALLERGENIC
EXTRACT **,
CODE Three custom mixes that contain Aspergillus
Fumigatus lot H483911
a)
"SACRAMENTO 4 MOLD MIX ** Strength: 1:50 w/v ** 10 mL ** "Lot No.
J31I3208, Exp. Date 10/04/2004.
a)
"ADE OFFICE USE "T" ** Strength: Concentrate 50 mL *** "Lot
No. B21I3030, Exp. Date 02/01/2003.
a)
"SCOTT MOLD MIX ** Strength 1:10 w/v
10 mL*** "Lot No. 131I2921, Exp. Date 09/19/2004.
59 Custom patient prescriptions that
contain Aspergillus
Fumigatus
lot H483911
a)
"ENVIRONMENTAL TS" Lot no. T01-010873 Exp. date 09/20/2002
a)
"5mL ENVIR/STD. CAT RF" Lot no. T01-010878 Exp. date 09/20/2002, Lot
no. T01-011606 Exp. date 10/10/2002
a)
"ENVIR/STD MITE TS" Lot no. T01-011680 Exp. date 10/11/2002, Lot no.
T01-011784 Exp. date 10/17/2002
a)
"5mL ENVIR/STD MITE RF"
Lot
no. T01-011083 Exp. date 09/26/2002
Lot
no. T01-011166 Exp. date 09/27/2002
Lot
no. T01-011462 Exp. date 10/04/2002
Lot
no. T01-011468 Exp. date 10/04/2002
Lot
no. T01-011599 Exp. date 10/10/2002
Lot
no. T01-011602 Exp. date 10/10/2002
Lot
no. T01-011690 Exp. date 10/11/2002
Lot
no. T01-011829 Exp. date 10/17/2002
a)
"ENVIR/STD MITE TS+2" Lot no. T01-011551 Exp. date 10/10/2002
a)
"5mL MOLD RF"
Lot
no. T01-011285 Exp. date 10/03/2002
Lot
no. T01-011456 Exp. date 10/04/2002
Lot
no. T01-011570 Exp. date 10/10/2002
Lot
no. T01-011579 Exp. date 10/10/2002
"10mL
MOLD RF" Lot no. T01-011202 Exp. date 09/27/2002
a)
"5mL MOLD/STD CAT RF Lot no. T01-011801 Exp. date 10/17/2002
"10mL
MOLD/STD CAT RF" Lot no. T01-011631 Exp. date 10/10/2002
a)
"MOLD/STD MITE TS+1" Lot no. T01-011123 Exp. date 09/27/2002, Lot no.
T01-011124 Exp. date 09/27/2002
a)
"5mL MOLD/STD MITE RF" Lot no. T01-010877 Exp. date 09/20/2002
a)
"MOLD/STD MITE TS" Lot no. T01-011549 Exp. date 10/10/2002
a)
"5mL MOLD/STD MITE RF"
Lot
no. T01-010942 Exp. date 09/20/2002
Lot
no. T01-010949 Exp. date 09/20/2002
Lot
no. T01-011286 Exp. date 10/03/2002
a)
"5mL POLLEN RF"
Lot
no. T01-010954 Exp. date 09/20/2002
Lot
no. T01-011290 Exp. date 10/03/2002
"10mL
POLLEN RF"
Lot
no. T01-011758 Exp. date 10/11/2002
a)
"5mL POLLEN/STD POL RF"
Lot
no. T01-010889 Exp. date 09/20/2002
Lot
no. T01-010891 Exp. date 09/20/2002
Lot
no. T01-010896 Exp. date 09/20/2002
Lot
no. T01-010902 Exp. date 09/20/2002
Lot
no. T01-010904 Exp. date 09/20/2002
Lot
no. T01-011131 Exp. date 09/27/2002
Lot
no. T01-011186 Exp. date 09/27/2002
Lot
no. T01-011366 Exp. date 10/03/2002
Lot
no. T01-011453 Exp. date 10/04/2002
Lot
no. T01-011575 Exp. date 10/10/2002
Lot
no. T01-011596 Exp. date 10/10/2002
Lot
no. T01-011604 Exp. date 10/10/2002
Lot
no. T01-011711 Exp. date 10/11/2002
Lot
no. T01-011785 Exp. date 10/17/2002
Lot
no. T01-011795 Exp. date 10/17/2002
Lot
no. T01-011805 Exp. date 10/17/2002
Lot
no. T01-011818 Exp. date 10/17/2002
"10mL
POLLEN/STD POL RF"
Lot
no. T01-011039 Exp. date 09/26/2002
Lot
no. T01-011729 Exp. date 10/11/2002
Lot
no. T01-011732 Exp. date 10/11/2002
Lot
no. T01-011985 Exp. date 10/18/2002
a)
"10mL POLLEN/MOLD RF" Lot no. T01-011327 Exp. date 10/03/2002
a)
"5mL POLLEN/ST MITE RF"
Lot
no. T01-011353 Exp. date 10/03/2002
Lot
no. T01-011369 Exp. date 10/03/2002
Lot
no. T01-011787 Exp. date 10/17/2002
"10mL
POLLEN/ST MITE RF"
Lot
no. T01-011485 Exp. date 10/04/2002
Lot
no. T01-011640 Exp. date 10/10/2002
a) "POLLEN/STD POL TS+1" Lot no.
T01-011544 Exp. date 10/10/2002
Stock
fills of Aspergillus Fumigatus filled from Aspergillus Fumigatus lot H483911
a) "ASPERGILLUS FUMIGATUS ** Strength 1:10
w/v ** 50 mL, Lot No. K31I2841, Exp. Date 09/24/2004; Lot No. H41I2851, Exp. Date
09/24/2004.
RECALLING FIRM/MANUFACTURER Hollister-Stier
Laboratories, LLC, Spokane, WA
REASON Lack of assurance of sterility. The recalled products passed release
sterility testing, but a subsequent lot filled from the same bulk extract
failed sterility testing.
VOLUME OF PRODUCT IN COMMERCE 69 units.
DISTRIBUTION Nationwide.
PRODUCT Cryoprecipitated AHF
CODE Unit number 03V06690.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Southern Region, Atlanta, GA
Manufacturer:
American Red Cross Blood Services, Miami, FL.
REASON Blood product, manufactured from a unit of whole blood
whose collection time was extended, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
WEEK ENDING MARCH 9
PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh
Frozen Plasma; d) Source Leukocytes.
CODE a) and c) Unit 8524588, 8690328, 0484764; b) Units
0073682, 8690328; d) Unit 8524588.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Blood products, collected from a donor with a
history of having tested positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION KY and FL.
PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Units 32KP21617, 32KP21618 (split into 2 units),
32KP21619, 32KP21620, 32KP21621.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Badger-Hawkeye Region, Madison, WI
REASON Blood products, labeled with extended expiration
dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL, IA, MI and WI.
PRODUCT Various Tissues for Transplant.
CODE Saphenous Vein Allograft- Model Number V010, Serial
Numbers 6549977 and 6549985;
Femoral
Vein with Valve Allograft - Model Number V061, Serial Number 6549616;
Tibialis
Tendon Allograft - Model Number T080, Serial Numbers 4248244, 4248279 and
4248287.
RECALLING FIRM/MANUFACTURER CryoLife Inc., Kennesaw, GA
REASON Various tissues for transplant were collected from a
donor who had not been properly evaluated.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION AZ, FL, IN, MA and UT.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 12GS29844.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red
Cross Blood Services, Carolinas Region, Charlotte, NC
Manufacturer:
American Red Cross Blood Services, Carolinas Region, Durham, NC.
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 NC.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 12KE67714.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Red
Cross Blood Services, Carolinas Region, Charlotte, NC.
Manufacturer:
American Red Cross Blood Services, Carolinas Region - Wilmington, Wilmington,
NC.
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 SC.
PRODUCT Human Cornea Tissue
CODE Units (Group A, Corneas 1-14)
99-3485 99-4225 99-4703 2000-06-2499 2000-01-0175
99-3486 99-4226 99-4704 2000-06-2500 2000-01-0176
2000-05-2235 2000-05-2115
2000-05-2236 2000-05-2116
(Group
B, Corneas 15 & 16))
2000-06-2493
2000-06-2494
(Group
C, Corneas 17-22)
2000-06-2774 2000-06-2765 2000-06-2776
2000-06-2777 2000-06-2766 2000-06-2778
(Group
D, Corneas 23-30)
2000-06-2541 2000-06-2619 2000-07-3043
2000-07-2895 2000-06-2542 2000-06-2620
2000-07-3044 2000-07-2896
RECALLING FIRM/MANUFACTURER Recalling Firm: Central
Florida Lions Eye and Tissue Bank Inc., Tampa, FL.
Responsible
Firm: (Contract lab that performed suspect testing), Bryce Clinical Labs,
Tampa, FL.
REASON Human corneas, not tested or improperly tested for
Hepatitis B surface antigen (HBsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION Nationwide and internationally.
PRODUCT Source Plasma.
CODE Unit G33730051.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic
Corporation, City of Industry, CA
REASON Blood product, which was collected from a donor who
admitted to recently experiencing an unexplained 10-lb weight loss, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT Source Plasma.
CODE Units 0370412903, 0370412916, 0370413071,
0370413015, 0370413023, 0370413049, 0370413074, 0140982030, 7020148146,
0420861591, and 0420861598.
RECALLING FIRM/MANUFACTURER NABI, Miami, FL
REASON Blood products, which were untested for the
antibodies to the hepatitis B surface antigen (anti-HBsAg), the antibodies to
the human immunodeficiency virus 1/2 (anti-HIV-1/2), the antibodies to the
hepatitis C encoded virus (anti-HCV), and the HIV-1 Antigen, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION NC, NY and internationally.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 01GW50865 and 01GQ51041.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Albany,
NY.
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 NY.
PRODUCT a) Platelets, Leukocytes Reduced; b) Fresh Frozen
Plasma.
CODE a) and b) Unit number 42X47994.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern Ohio Region, Cleveland, OH
REASON Blood products, collected from a donor that did not
answer one of the medical history questions concerning behavior known to
increase risk of infection with the human immunodeficiency virus (HIV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI and OH.
PRODUCT a) Red Blood Cells; b) Platelets, Irradiated.
CODE a) and b) Unit number 50H06499.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Western Lake Erie Region,Toledo, OH
REASON Blood products, collected from an unsuitable donor
based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells.
CODE Unit numbers 0438914 and 0597590.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, that were not properly quarantined
after the donors of the products reported post donation illnesses, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and KY.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE a) and b) Unit 24GQ22679.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, River Valley Region, Louisville, KY
REASON Blood products, which were manufactured from an
overweight whole blood unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.
PRODUCT Source Plasma
CODE Unit A02973520.
RECALLING FIRM/MANUFACTURER Community Bio-Resources
Inc., Hoover, AL
REASON Blood product, which was collected from a donor who
had received the MMR vaccine within 2 weeks of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Platelets
CODE Unit 2107987.
RECALLING FIRM/MANUFACTURER LifeShare Inc., Elyria, OH
REASON Blood product, which was collected in a manner that
compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets; d) Fresh Frozen Plasma
CODE a)Units 26164-1236, 26164-1237, 26164-1238,
26164-1240, 26164-1242, 26164-1243, 6164 1244, 26164-1247, 26164-1250,
26164-1251, 26164-1253, 26164-1256, 26164-1258, 26164-1300, 26164-1366,
26164-1367, 26164-1368, 26164-1369, 26164-1371, 26164-1372, 26164-1374,
26164-1375, 26164-1387, 26164-1389, 26164-1396, 26164-1398, 26164-1401,
26164-1403, 26164-1405, 26164-1409, 26164-1414, 26164-1416, 26164-1419,
26164-1422, 26164-1424, 26164-1436, 26164-1438, 26164-1444, 26164-1446,
26164-1448, 26164-1450, 26164-1452, 26164-1454, 26164-1456, 26164-1460,
26164-1470, 26164-1472, 26164-1474, 26164-1475, 26164-1476, 26164-1498, 26164-1499,
26164-1501, 26164-1502, 26164-1504, 26164-1505, 26164-1507, 26164-1508,
26164-1509, 26164-1522, 26164-1566, 26164-1570, 26164-1630, 26164-1634,
26164-1722, 26164-1835, 26164-1843, 26164-3937, 26164-3939, 26164-3942,
26164-3944, 26164-3946, 26164-3950, 26164-3959, 26164-3966, 26164-3969,
26164-3970, 26164-3972, 26164-3985, 26164-3995, 26164-3997, 26164-3998,
26164-4003, 26164-4004, 26164-4014, 26164-4016, 26164-4018, 26164-4020,
26164-4022, 26164-4026, 26164-4027, 26164-4029, 26164-4040, 26164-4042,
26164-4051, 26164-4053, 26164-4062, 26164-4064, 26164-4069, 26164-4071,
26164-4077, 26164-4079, 26164-4081, and 26164-4090;
b)
Units 26164-1279, 26164-1280, 26164-1281, 26164-1282, 26164-1283, 26164-1284,
26164- 1286, 26164-1290, 26164-1293, 26164-1295, 26164-1298, 26164-1378,
26164-1381, 26164-1385, 26164-1393, 26164-1477, 26164-1478, 26164-1479,
26164-1484, 26164-1485, 26164-1506, 26164-1530, 26164-1535, 26164-1539,
26164-1541, 26164-1543, 26164-1545, 26164-1551, 26164-1552, 26164-1553,
26164-1554, 26164-1555, 26164-1557, 26164-1558, 26164-1560, 26164-1561,
26164-1562, 26164-1564, 26164-1569, 26164-1576, 26164-1581, 26164-1583,
26164-1587, 26164-1592, 26164-1597, 26164-1601, 26164-1604, 26164-1605,
26164-1609, 26164-1612, 26164-1613, 26164-1615, 26164-1616, 26164-1641,
26164-1644, 26164-1651, 26164-1654, 26164-1680, 26164-1725, 26164-1730,
26164-1731, 26164-1732, 26164-1740, 26164-1741, 26164-1744, 26164-1745,
26164-1746, 26164-1747, 26164-1787, 26164-1811, 26164-1870, 26164-6694,
26164-1727, 26164-1836-01, and 26164-1836-02;
c)
Units 26164-1507, 26164-1508, 26164-1509, 26164-1566, 26164-1567, 26164-1570,
26164-1572, 26164-1574, 26164-1634, 26164-1835, 26164-1843,
26164-3939,
26164-3942, 26164-3946, 26164-3950, 26164-3959, 26164-3966, 26164-3969, 26164-3970,
26164-3972, 26164-3985, 26164-4014, 26164-4016, 26164-4022, 26164-4027,
26164-4029, and 26164-4042;
d)
Units 26164-1237, 26164-1238, 26164-1242, 26164-1243, 26164-1244, 26164-1253,
26164-1256, 26164-1405, 26164-1409, 26164-1414, 26164-1475,
26164-1520,
26164-1522, 26164-1567, 26164-1583, 26164-1597, 26164-1730, 26164-1740,
26164-1744, 26164-3959, 26164-3966, 26164-3970, 26164-3985, 26164-3992,
26164-3995, 26164-3998, 26164-4014, 26164-4018, 26164-4020, 26164-4026,
26164-4029, and 26164-4040.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Hot
Springs, AR
REASON Blood products that were collected from donors in
which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 238 units.
DISTRIBUTION AR, TX, VA and LA.
PRODUCT Cryoprecipitated AHF
CODE Unit number E23417.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, that contained antibodies to the red
blood cell antigens C and D (anti-C and anti-D), but were incorrectly labeled
as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Fresh Frozen Plasma
CODE Units C16886, C16897, C16898, C16900, C16904,
C16920, C17340, C17353, C17354, C17356, C17361, C17362, C17368, C17380, C17384,
C17388, C32051, C32068, C32070, C32091, C51060, C51061, C51282, C68742, C71150,
C94686, C94688, C94692, C96749, W78089, X46968, X46974, X46976, X46977, X48503,
X48506, Y15177, Y15212, Y15213, Y15218, Y15762, Y15763, Y15765, Y21675, Y77939,
Y83868, Y84995, Y91280, Y91316, Y93144, Y93145, Y93146, Y93156, Y93157, Y93158,
Y93235, Y93939, Y93941, Y93942, Y93974, Y94181, Y94182, Y95173, and Y95185.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood product, which was manufactured in a manner
that compromised the sterility of the units, was distributed.
VOLUME OF PRODUCT IN COMMERCE 64 units.
DISTRIBUTION IL and IN.
PRODUCT Fresh Frozen Plasma
CODE Units 03C05600,
03C05601, 03C05602, 03C05607,
03C05610, 03C05612,
03C05613, 03C05615, 03C05622,
03C05624, 03C05625,
03C05627, 03C05628,
03F06223, 03F06225, 03KC07809, 03KC07810, 03KC07814, 03KC07817,
03KC07818, 03KC07819, 03KE09750, 03KE09752, 03KE09756, 03KE09758, 03KM08197,
03KM08205, 03KM08207, 03KM08210, 03KM08212, 03KM08213, 03KM08538, 03KM08540,
03KR04395, 03KR04396, 03KR04398, 03R03082,
03R03083, 03R03084, 03R03085.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Southern Region, Atlanta, GA
Manufacturer:
American Red Cross, Miami, FL.
REASON Fresh Frozen Plasma products, that may not have been
separated and frozen within eight hours of phlebotomy, were distributed.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION FL.
PRODUCT Corneas for Transplant
CODE Unit numbers 01-1975 and 01-1976.
RECALLING FIRM/MANUFACTURER Minnesota Lions Eye Bank,
Minneapolis, MN
REASON Corneas for transplant that were collected from a
donor who tested repeatedly reactive for HIV-1 p24 antigen, but was not
neutralized, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MN.
PRODUCT Fresh Frozen Plasma
CODE Units FR30007-2, FR30007-3, FR30036-1, FR30036-2, FR30183-1,
FR30183-2, FR30183-3, FR30206-1, FR30206-2, FR30887-1, FR30887-2,
FR30914-1,
FR30914-3, FR31094-1, FR31094-2, FR31094-3, FR31126-1, FR31126-2, FR31131-1,
FR31131-2, FR31144-2, FR31144-3, FR31177-1,
FR31177-2,
FR31244-1, FR31244-2, FR31270-1, FR31270-2, FR31270-3, FR31356-1, FR31356-2,
FR31356-3, FR31358-1, FR31358-2, FR31358-3,
FR31383-1,
FR31383-2, FR31383-3, FR31388-1, FR31388-2, FR31388-3, FR31439-1, FR31439-2,
FR31439-3, FR31474-1, FR31474-2, FR31497-1,
FR31497-2,
FR31497-3, FR31518-1, FR31518-2, FR31633-1, FR31633-2, FR31633-3, FR31649-1,
FR31649-2, FR31649-3, FR31656-1, FR31656-2,
FR31656-3,
FR31735-1, FR31735-2, FR31735-3, FR31761-1, FR31761-2, FR31761-3, FR31801-1,
FR31801-2, FR31801-3, FR31814-1, FR31814-2,
FR31814-3,
FR31823-1, FR31823-2, FR31823-3, FR31840-1, FR31840-2, FR31840-3, FR31867-1,
FR31867-2, FR31867-3, FR31869-1, FR31869-2,
FR31869-3,
FR31916-1, FR31916-2, FR31916-3, FR31981-1, FR31981-2, FR31981-3, FR31999-1,
FR31999-2, FR31999-3, FR32152-1, FR32152-2,
FR32152-3,
FR32274-1, FR32274-2, FR32336-1, FR32336-2, FR32394-1, FR32394-2, FR32394-3,
FR32397-1, FR32397-2, FR32397-3, FR32428-1,
FR32428-2,
FR32435-1, FR32435-2, FR32454-1, FR32454-2, FR32454-3, FR32462-2, FR32462-3,
FR32488-1, FR32488-2, FR32488-3, FR32510-1,
FR32510-2,
FR32511-1, FR32511-2, FR32614-1, FR32614-2, FR32614-3, FR32624-1, FR32624-2,
FR32624-3, FR32698-1, FR32698-2, FR32706-1,
FR32706-2,
FR32706-3, FR32715-1, FR32715-2, FR32769-1, FR32769-2, FR32769-3, FR32782-1,
FR32825-1, FR32825-2, FR32851-1, FR32851-2,
FR32876-1,
FR32876-2, FR32942-1, FR32942-2, FR32957-2, FR32957-3, FR33049-1, FR33049-2,
FR33049-3, FR33215-1, FR33215-2, FR33434-1,
FR33481-1,
FR33481-3, FR33552-1, FR33552-2, FR33628-1, FR33628-2, FR33693-1, FR33693-2,
FR33693-3, FR33722-1, FR33722-2, FR33775-1,
FR33775-2,
FR33775-3, FR33801-1, FR33801-2, FR33801-3, FR34086-1, FR34086-2, FR34086-3,
FR34198-1, FR34198-2, FR34198-3, FR34216-1,
FR34216-2,
FR34216-3, FR34273-1, FR34273-2, FR34273-3, FR34323-1, FR34323-2, FR34402-1,
FR34402-2, FR34415-1, FR34415-2, FR34415-3,
FR34438-1,
FR34438-2, FR34438-3, FR34470-1, FR34470-2, FR34560-1, FR34560-2, FR34664-1,
FR34664-2, FR34672-1, FR34672-2, FR34688-1,
FR34688-2,
FR34688-3, FR34690-1, FR34690-2, FR34698-2, FR34698-3, FR34719-1, FR34719-2,
FR34738-1, FR34738-2, FR34806-1, FR34806-2,
FR34812-1,
FR34857-1, FR34857-2, FR34857-3, FR34858-1, FR34858-2, FR34858-3, FR34878-1,
FR34878-2, FR34878-3, FR34976-1, FR34976-2,
FR34976-3,
FR35084-1, FR35084-2, FR35128-1, FR35128-2, FR35219-1, FR35219-2, FR35337-1, FR35337-2,
FR35337-3, FR35344-1, FR35344-2,
FR35344-3,
FR35397-1, FR35397-2, FR35418-1, FR35418-2, FR35436-1, FR35436-2, FR35462-1,
FR35462-2, FR35492-1, FR35492-2, FR35510-1,
FR35510-2,
FR35530-1, FR35530-2, FR35572-1, FR35592-1, FR35592-2, FR35682-1, FR35682-2,
FR35695-1, FR35695-2, FR35760-1, FR35760-2,
FR35760-3,
FR35784-2, FR35934-1, FR35934-2, FR35986-1, FR35986-2, FR35986-3, FR36173-1,
FR36173-2, FR36220-1, FR36220-2, FR36228-1,
FR36228-2,
FR36249-1, FR36249-2, FR36340-1, FR36349-1, FR36349-2, FR36372-1, FR36372-2,
FR36428-1, FR36428-2, FR36428-3, FR36479-1,
FR36479-2,
FR36587-1, FR36587-2, FR36681-1, FR36681-2, FR36681-3, FR36685-1, FR36685-2,
FR36707-1, FR36707-2, FR36713-1, FR36715-1,
FR36715-2,
FR36791-1, FR36791-2, FR36792-1, FR36792-2, FR36890-1, FR36912-1, FR36917-1,
FR36924-1, FR36924-2, FR36933-1, FR36933-2,
FR36951-1,
FR36978-1, FR37002-1, FR37008-1, FR37008-2, FR37014-1, FR37014-2, FR37073-1,
FR37081-1, FR37088-1, FR37088-2, FR37088-3,
FR37090-1,
FR37090-2, FR37110-1, FR37110-2, FR37119-1, FR37148-1, FR37203-1, FR37228-1,
FR37261-1, FR37359-1, FR37359-2, FR37426-1,
FR37508-1,
FR37510-1, FR37510-2, FR37586-1, FR37590-1, FR37593-1, FR37613-1, FR37613-2,
FR37615-1, FR37615-2, FR37630-1, FR37655-1,
FR37655-2,
FR37669-1, FR37669-2, FR37674-1, FR37674-2, FR37763-1, FR37763-2, FR37782-1,
FR37782-2, FR37794-1, FR37794-2, FR37867-1,
FR37867-2,
FR37902-1, FR37970-1, FR37996-1, FR37996-2, FR38006-1, FR38047-1, FR38051-1,
FR38066-1, FR38094-1, FR38134-1, FR38134-2,
FR38172-1,
FR38181-1, FR38222-1, FR38268-1, FR38297-1, FR38348-1, FR38355-1, FR38441-1,
FR38447-1, FR38617-1, FR38740-1, FR38740-2,
FR38746-1,
FR38746-2, FR38767-1, FR38827-1, FR38994-1, FR38994-2, FR39133-1, FR39133-2,
FR39287-1, FR39287-2, FR39441-1, FR39441-2,
KZ51586-1,
KZ51586-2, KZ51590-1, KZ51590-2, KZ51590-3, KZ51613-1, KZ51613-2, KZ51642-1,
KZ52207-1, KZ52207-2, KZ52209-1, KZ52209-2, KZ52339-1, KZ52339-2, KZ52339-3,
KZ52387-1, KZ52387-2, KZ52468-1, KZ52468-2, KZ52485-1, KZ52485-2, KZ52655-1,
KZ52655-2, KZ52675-1, KZ52675-2, KZ52693-1, KZ52693-2, KZ52693-3, KZ52711-2,
KZ52713-1, KZ52713-2, KZ52753-1, KZ52753-2, KZ52753-3, KZ52767-1, KZ52767-2,
KZ52767-3, KZ52776-1, KZ52776-2, KZ52776-3, KZ52791-1, KZ52791-2, KZ52951-1,
KZ52951-2, KZ52951-3, KZ52965-1, KZ52965-2, KZ52969-1, KZ52969-2, KZ52969-3,
KZ52974-1, KZ52974-2, KZ52974-3, KZ52985-1, KZ52985-2, KZ52990-1, KZ52990-2,
KZ53005-1, KZ53005-2, KZ53162-1, KZ53162-2, KZ53164-1, KZ53164-2, KZ53186-1,
KZ53186-2, KZ53186-3, KZ53190-1, KZ53190-2, KZ53260-1, KZ53260-2, KZ53260-3,
KZ53283-1, KZ53283-2, KZ53283-3, KZ53360-1, KZ53360-2, KZ53360-3, KZ53389-1,
KZ53389-2, KZ53389-3, KZ53467-1, KZ53467-2, KZ53467-3, KZ53524-1, KZ53524-2,
KZ53524-3, KZ53570-1, KZ53570-2, KZ53625-1, KZ53625-2, KZ53625-3, KZ53639-1, KZ53639-2,
KZ53639-3, KZ53657-1, KZ53657-2, KZ53700-1, KZ53700-2, KZ53700-3, KZ53747-1,
KZ53747-2, KZ53747-3, KZ53763-1, KZ53763-2, KZ53777-1, KZ53777-2, KZ53847-1,
KZ53847-2, KZ53946-1, KZ53946-2, KZ53950-1, KZ53950-2, KZ53965-1, KZ53965-2,
KZ53980-1, KZ53980-2, KZ53983-1, KZ53983-2, KZ54014-2, KZ54033-1, KZ54033-2,
KZ54033-3, KZ54056-1, KZ54056-2, KZ54061-1, KZ54061-2,
KZ54061-3,
KZ54074-1, KZ54074-2, KZ54113-1, KZ54113-2, KZ54113-3, KZ54144-1, KZ54144-2,
KZ54144-3, KZ54162-1, KZ54162-2, KZ54162-3, KZ54226-1, KZ54226-2, KZ54265-1,
KZ54265-2, KZ54285-1, KZ54285-2, KZ54307-1, KZ54307-2, KZ54338-1, KZ54338-2,
KZ54355-1, KZ54355-2, KZ54355-3, KZ54371-1, KZ54371-2, KZ54371-3, KZ54418-1,
KZ54421-1, KZ54421-2, KZ54435-1, KZ54435-2, KZ54435-3, KZ54467-1, KZ54467-2, KZ54467-3,
KZ54818-1, KZ54818-2, KZ54818-3, KZ54824-1, KZ54824-2, KZ54824-3, KZ54831-1,
KZ54831-2, KZ54831-3, KZ54903-1, KZ54903-2, KZ54903-3, KZ54966-1, KZ54966-2,
KZ55041-1, KZ55041-2, KZ55041-3, KZ55058-1, KZ55058-2, KZ55058-3, KZ55087-1,
KZ55087-2, KZ55087-3, KZ55147-1, KZ55147-2, KZ55204-1, KZ55204-2, KZ55204-3,
KZ55227-1, KZ55227-2, KZ55236-1, KZ55236-2, KZ55236-3, KZ55243-1, KZ55243-2,
KZ55277-1, KZ55277-3, KZ55317-1, KZ55317-2, KZ55317-3, KZ55324-1, KZ55324-2,
KZ55370-1, KZ55370-2, KZ55493-1, KZ55493-2, KZ55493-3, KZ55628-1, KZ55628-2,
KZ55628-3, KZ55666-1, KZ55666-2, KZ55666-3, KZ55668-1, KZ55668-2, KZ55668-3,
KZ55685-1, KZ55685-2, KZ55685-3, KZ55708-1, KZ55708-2, KZ55755-1, KZ55755-2,
KZ55759-1, KZ55759-2, KZ55776-1, KZ55776-2, KZ55864-1, KZ55864-2, KZ55870-1,
KZ55870-2, KZ55911-1, KZ55911-2, KZ55983-1, KZ55983-2, KZ55988-1, KZ55988-2,
KZ55997-1, KZ55997-2, KZ56002-1, KZ56002-2, KZ56084-1, KZ56084-2, KZ56084-3,
KZ56132-1, KZ56132-2, KZ56132-3, KZ56136-1, KZ56136-2,
KZ56136-3,
KZ56221-1, KZ56221-2, KZ56290-1, KZ56290-2, KZ56290-3, KZ56302-1, KZ56302-2,
KZ56339-1, KZ56339-2, KZ56365-1, KZ56365-2, KZ56398-1, KZ56398-2, KZ56398-3,
KZ56456-1, KZ56456-2, KZ56456-3, KZ56475-1, KZ56475-2, KZ56499-1, KZ56499-2,
KZ56499-3, KZ56514-1, KZ56514-2, KZ56514-3, KZ56611-1, KZ56611-2, KZ56633-1,
KZ56633-2, KZ56687-1, KZ56687-2, KZ56687-3, KZ56703-1, KZ56703-2, KZ56735-1,
KZ56735-2, KZ56744-1, KZ56744-2, KZ56744-3, KZ56775-1, KZ56775-2, KZ56779-1,
KZ56779-2, KZ56779-3, KZ56793-1, KZ56793-2, KZ56796-1, KZ56796-2, KZ56818-1,
KZ56818-1, KZ56854-1, KZ56854-2, KZ56854-3, KZ57006-1, KZ57006-2, KZ57006-3,
KZ57020-1, KZ57020-2, KZ57020-3, KZ57089-1, KZ57089-2, KZ57089-3, KZ57106-1,
KZ57106-2, KZ57106-3, KZ57126-1, KZ57126-2, KZ57186-1, KZ57186-2, KZ57197-1,
KZ57197-2, KZ57197-3, KZ57206-1, KZ57206-2, KZ57206-3, KZ57227-1, KZ57227-2,
KZ57227-3, KZ57237-1, KZ57237-2, KZ57358-1, KZ57358-2, KZ57427-1, KZ57427-2,
KZ57427-3, KZ57473-1, KZ57473-2, KZ57476-1, KZ57476-2, KZ57476-3, KZ57493-1,
KZ57493-2, KZ57497-1, KZ57497-2, KZ57524-1, KZ57524-2, KZ57681-1, KZ57681-2,
KZ57834-1, KZ57834-2, KZ57834-3, KZ57947-1, KZ57947-2, KZ57959-1, KZ57959-2,
KZ58110-1, KZ58110-2, KZ58120-1, KZ58120-2, KZ58163-1, KZ58163-2, KZ58219-1,
KZ58219-2, KZ58268-2, KZ58268-3, KZ58306-1, KZ58306-2, KZ58321-1, KZ58321-2,
KZ58321-3, KZ58395-1, KZ58395-2, KZ58395-3, KZ58457-1, KZ58457-2, KZ58472-1,
KZ58472-2, KZ58503-1, KZ58503-2, KZ58524-1, KZ58524-2, KZ58541-1, KZ58541-2,
KZ58555-1, KZ58555-2, KZ58555-3, KZ58687-1, KZ58687-2, KZ58721-1, KZ58721-2,
KZ58765-1, KZ58765-2, KZ58906-2, KZ58906-3, KZ58910-1, KZ58910-2, KZ58910-3,
KZ58981-1, KZ58981-2, KZ59068-1, KZ59068-2, KZ59068-3, KZ59129-2, KZ59129-3,
KZ59153-1, KZ59153-2, KZ59153-3, KZ59172-1, KZ59172-2, KZ59288-1, KZ59288-2,
KZ59370-1, KZ59377-1, KZ59377-2, KZ59377-3, KZ59406-1, KZ59406-2, KZ59406-3,
KZ59426-1, KZ59432-1, KZ59432-2, KZ59485-1, KZ59563-1, KZ59563-2, KZ59587-1,
KZ59587-2, KZ59587-3, KZ59629-1, KZ59634-1, KZ59660-1, KZ59706-1, KZ59719-1,
KZ59793-1,
KZ59807-1,
KZ59838-1, KZ59842-1, KZ59842-2, KZ59860-1, KZ59860-2, KZ59860-3, KZ59865-1,
KZ59878-1, KZ59878-2, KZ59878-3, KZ59949-1, KZ59949-2, KZ59949-3, KZ59954-1,
KZ60104-1, KZ60104-2, KZ60124-1, KZ60151-1, KZ60172-1, KZ60250-1, KZ60250-2,
KZ60256-1, KZ60276-1, KZ60319-1, KZ60319-2, KZ60356-1, KZ60356-2, KZ60377-1,
KZ60382-1, KZ60444-1, KZ60460-1, KZ60460-3, KZ60485-1, KZ60485-2, KZ60489-1,
KZ60489-2, KZ60634-1, KZ60634-2, KZ60644-1, KZ60644-2, KZ60681-1, KZ60688-2,
KZ60747-1, KZ60747-2, KZ60750-1, KZ60760-2, KZ60760-3, KZ60796-3, KZ60817-1,
KZ60825-1, KZ60854-1, KZ60854-2, KZ60854-3, KZ60866-1, KZ60900-1, KZ60956-1,
KZ60956-2, KZ60980-1, KZ61032-1, KZ61083-1, KZ61123-1, KZ61145-1, KZ61148-1,
KZ61269-1, KZ61307-1, KZ61318-1, KZ61450-1, KZ61450-2, KZ61514-2, KZ61517-1,
KZ61590-1, KZ61687-1, KZ61687-2, KZ61735-1, KZ61735-2, KZ61759-1, KZ61759-2.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin Inc., Milwaukee, WI
REASON Fresh Frozen Plasma, labeled with the incorrect
anticoagulant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 907 units.
DISTRIBUTION WI
PRODUCT Human Cornea for Transplantation
CODE Units 2001052145 and 2001052146.
RECALLING FIRM/MANUFACTURER Central Florida Lions Eye
and Tissue Bank, Inc., Tampa, FL
REASON Human tissue, which was collected from a donor who
tested repeatedly reactive for the antibody for hepatitis C encoded virus
(anti-HCV) and negative by RIBA, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.
PRODUCT Leukoreduced Red Blood Cells
CODE Units 49FJ83113, 49FJ83117, and 49FJ83122.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southwest Region, Tulsa, OK
REASON Blood products, which were not prepared within the
appropriate time frame after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OK.
PRODUCT Recovered Plasma
CODE Units 26164-1240, 26164-1247, 26164-1250,
26164-1251, 26164-1258, 26164-1290, 26164-1293, 26164-1294, 26164-1296,
26164-1298, 26164-1300, 26164-1375, 26164-1378, 26164-1381, 26164-1383,
26164-1385, 26164-1387, 26164-1389, 26164-1393, 26164-1396, 26164-1401,
26164-1403, 26164-1416, 26164-1424, 26164-1474, 26164-1476, 26164-1498,
26164-1502, 26164-1507, 26164-1509, 26164-1562, 26164-1581, 26164-1592,
26164-1741, 26164-1745, 26164-3939, 26164-3942, 26164-3944, 26164-3946, 26164-3950,
26164-3969, 26164-3972, 26164-3997, 26164-4003, 26164-4004, 26164-4016,
26164-4022, 26164-4027, 26164-4042, 26164-4051, 26164-4053, 26164-4062,
26164-4064, 26164-4069, 26164-4071, 26164-4081, 26164-4085, 26164-1280,
26164-1281, 26164-1283, 26164-1284, 26164-1286, 26164-1366, 26164-1367,
26164-1368, 26164-1371, 26164-1372, 26164-1374, 26164-1412, 26164-1436,
26164-1438, 26164-1444, 26164-1446, 26164-1448, 26164-1450, 26164-1454,
26164-1456, 26164-1460, 26164-1478, 26164-1485, 26164-1499, 26164-1501, 26164-1504,
26164-1506, 26164-1526, 26164-1527, 26164-1530, 26164-1532, 26164-1535,
26164-1539, 26164-1541, 26164-1543, 26164-1545, 26164-1547, 26164-1548,
26164-1551, 26164-1552, 26164-1553, 26164-1554, 26164-1555, 26164-1557,
26164-1558, 26164-1560, 26164-1561, 26164-1722, 26164-1725, 26164-1732,
26164-3937, and 26164-4024.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Hot
Springs, AR
REASON Blood products that were collected from donors in which
donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 109 units.
DISTRIBUTION AR, TX, VA and LA.
PRODUCT Red Blood Cells
CODE Unit number E23417.
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Bank, Springfield, IL
REASON Blood products, that contained antibodies to the red
blood cell antigens C and D (anti-C and anti-D), but were incorrectly labeled
as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
WEEK ENDING MARCH 16
PRODUCT Platelets.
CODE Unit 9294776.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood product, which was incorrectly tested and
found negative for the antibody to the human T-lymphotropic virus types I &
II (anti-HTLV-I/II) on initial testing but tested repeatedly reactive for
anti-HTLV-I/II upon subsequent retesting, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Recovered Plasma.
CODE a) Unit number 8935070; b) Unit number 8984762; c)
Unit numbers 8935070 and 8984762.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood products, that tested negative for antibodies
to human immunodeficiency virus (anti-HIV), but were collected from a donor
that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION LA and Switzerland.
PRODUCT Red Blood Cells
CODE Unit number 8969834.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood product, collected from an unsuitable donor
based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Red Blood Cells
CODE Unit number 9271171.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood product, that tested repeatedly reactive for
the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II),
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
CODE a) and b) Unit number 9293817.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood products, corresponding to a unit of Red Blood
Cells that was possibly contaminated with coagulase negative Staphylococcus sp.
bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets.
CODE a) Unit numbers 01KT58194, 01KT56643, and 01KY17555;
b) Unit numbers 01KT58194 and 01KT56643.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, New York-Penn Region,
West
Henrietta, NY. Manufacturer: American Red Cross Blood Services, Binghamton,
NY.
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 5 units.
DISTRIBUTION NY and PA.
PRODUCT Ragweed Mix - Giant/Short, Allergenic Extract, 50
milliliter bottle, 10,000 PNU/ml.
CODE Lot number E1021046.
RECALLING FIRM/MANUFACTURER Allergy Laboratories of
Ohio, Inc., Columbus, OH
REASON Allergenic extract, labeled with an incorrectly high
antigen E concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION PA.
PRODUCT Platelets.
CODE Unit number 03F05224.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross,Southern Region, Atlanta, GA
Manufacturer:
American Red Cross Blood Services, Miami, FL.
REASON Blood product, that tested reactive for the
causative agent of Chagas’ disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE a) Unit 06GR52567; b) Units 06GR52567 and 06GR63455.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Los Angeles, CA
REASON Blood products, which were collected from a donor
who had a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells.
CODE Unit numbers 8730906 and 8730907.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood products, labeled with the incorrect
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.
PRODUCT Red Blood Cells, Irradiated.
CODE Unit number 9227748.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood product, labeled with the incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Whole Blood.
CODE Unit number 9259896.
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood product, collected in an expired collection
bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.
PRODUCT Corneas.
CODE Numbers 183-OD, 129-OD, 120-OD, 132-OS, 135-OS,
116-OD, 131-OD, 173-OD, 183-OS, 116-OS, 167-OD, 114-OS, 115-OS, 128-OD, 132-OD,
167-OS, 110-OD, 110-OS, 178-OD, 178-OD (Sclera), 123-OD, C-01-113-OD,
C-01-113-OS, C-01-121-OD, C-01-128-OS, C-01-114-OD, C-01-
178-OS,
C-01-121-OS, C-01-122-OS, C-01-123-OS, 120-OS, C-01-169-OD, C-01-184-OD, and
C-01-184-OS
RECALLING FIRM/MANUFACTURER Lions Eye and Tissue Bank,
Inc., Lions of District 22-C Eye Bank, Seabrook, MD
REASON Corneas that tested negative for human
immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg), but were
tested using kits that had not been approved for use with cadaveric blood
samples, were distributed.
VOLUME OF PRODUCT IN COMMERCE 34 corneas.
DISTRIBUTION MD, DC, NY, CA, NJ and Jordan.
WEEK ENDING MARCH 23
PRODUCT a) Plasma Pheresis, Frozen Units; b) Platelets, Pheresis, Leukoreduced.
CODE a) Unit 42KF05440, 42KF04174, 42KF03583; b) Units
42KF06239, 42KF06146 (split into two units), 42KF05851 (split into two units),
42KF05668, 42KF05440, 42KF04174, 42KF04089, 42KF04000(split into two units),
42KF03583, 42KF03505, 42KF03400 (split into two units).
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
REASON Blood products, collected from a donor taking the
drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION OH.
PRODUCT Platelets
CODE Unit 1842400.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Lexington, KY
REASON Platelets, which were prepared from a unit collected
from a donor who had taken aspirin within three days of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 16LW51679.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Central Ohio Region, Columbus, OH
REASON Blood products, collected from a donor whose
hematocrit had not been documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a) b) and c) Unit 24KG42313.
RECALLING FIRM/MANUFACTURER American National Red Cross
Blood Services, River Valley Region, Louisville, KY
REASON Blood products, collected from a donor taking the
drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY.
PRODUCT Recovered Plasma.
CODE FG47179.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services
Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood product, collected from a donor taking the
drug Lupron, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit FK42096.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services
Inc., dba Rhode Island Blood Center,Providence, RI
REASON Blood product, collected from a donor whose
hemoglobin had not been documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT Red Blood Cells.
CODE Unit FJ75216.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services
Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, 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 RI.
PRODUCT Corneas
CODE Units 2002-02-5003, 2002-02-5004.
RECALLING FIRM/MANUFACTURERRecalling Firm: Heartland Lions Eye Banks, Columbia,