JANUARY 2001
WEEK ENDING JANUARY 5
PRODUCT
Red
Blood Cells.
CODE
Unit
#3947869.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Recovered Plasma.
CODE
Unit
#7598750.
MANUFACTURER
Department of Air Force,
Lackland AFB, Texas.
DISTRIBUTION
Texas.
QUANTITY
1 unit
was distributed.
REASON
Blood
product tested negative for anti-HCV, but was collected from a donor who
previously tested reactive for anti-HCV.
PRODUCT
a)
Platelets, Pheresis; b) Platelets, Pheresis, Leukocytes Reduced.
CODE
Unit
Numbers: a) 40P76511 (two units), 40P76598, 40P76611 b) 40P76492, 40P76493,
40P76494 (two units), 40P76495, 40P76496 (two
units), 40P76497, 40P76498,
40P76499 (two units), 40P76501, 40P76502, 40P76504, 40P76505, 40P76506, 40P76507
(two units), 40P76508, 40P76510
(two units), 40P76512 (two
units), 40P76513 (two units), 40P76514, 40P76515 (two units), 40P76516 (two
units), 40P76517, 40P76518, 40P76519
(two units), 40P76520 (two
units), 40P76522, 40P76523 (two units), 40P76525 (two units), 40P76526 (two
units), 40P76527, 40P76528, 40P76529
(two units), 40P76530,
40P76531 (two units), 40P76533 (two units), 40P76534, 40P76535, 40P76537,
40P76538 (two units), 40P76540, 40P76541
(two units), 40P76542 (two
units), 40P76543, 40P76544, 40P76545 (two units), 40P76546 (two units), 40P76547,
40P76548, 40P76549 (two units),
40P76550 (two units),
40P76551, 40P76552, 40P76553, 40P76555, 40P76556, 40P76557 (two units),
40P76558, 40P76559, 40P76560, 40P76561, 40P76563 (two units), 40P76564, 40P76567
(two units), 40P76568 (two units), 40P76569, 40P76570, 40P76571, 40P76572,
40P76573, 40P76574, 40P76575, 40P76576 (two units), 40P76577, 40P76578 (two
units), 40P76579, 40P76580 (two units), 40P76581 (two units), 40P76582,
40P76583, 40P76584 (two units), 40P76585, 40P76586 (two units), 40P76587,
40P76589, 40P76590, 40P76591 (two units), 40P76592 (two units), 40P76593,
40P76594, 40P76595, 40P76596, 40P76597, 40P76599, 40P76600, 40P76601, 40P76602
(two units), 40P76603 (two units), 40P76604, 40P76605, 40P76607 (two units),
40P76608, ,40P76609, 40P76610 (two units), 40P76613, 40P76615, 40P76617 (two
units), 40P76619 (two units), 40P76622, 40P76623, 40P76624 (two units),
40P76625, 40P76627 (two units), 40P76639, 40P76641, 40P76642, 40P76644,
40P76645.
MANUFACTURER
American Red Cross Blood
Services, Peoria, Illinois.
DISTRIBUTION
Illinois, Missouri,
Wisconsin, Arkansas, Michigan, Alabama, Maryland.
QUANTITY
a) 4
units; b) 202 units were distributed.
REASON
Platelets were not stored
under continuous agitation and controlled temperature.
PRODUCT
a) Red
Blood Cells; b) Platelets.
CODE
Unit
Numbers: a) H98449 and T00352; b)
T00352.
MANUFACTURER
Tacoma-Pierce County Blood
Bank, doing business as Cascade Regional Blood Services, Tacoma,
Washington.
DISTRIBUTION
Washington
state.
QUANTITY
a) 2
units; b) 1 unit was distributed.
REASON
Blood
products were collected from a donor who reported travel to an area designated
as endemic for malaria.
PRODUCT
a) Red
Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Red Blood Cells,
Washed.
CODE
Unit
Numbers: a) 22404-2217, 22405-2748; b) 22407-7484; c)
22406-2572.
MANUFACTURER
Blood
Systems, Inc., Las Vegas, Nevada.
RECALLED
BY Blood Systems, Inc.,
Scottsdale, Arizona
DISTRIBUTION
Arizona and
Nevada.
QUANTITY
a) 2
units; b) 1 unit; c) 1 unit distributed.
REASON
Blood
products were collected from a donor who reported travel to an area designated
as endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#19239-8006.
MANUFACTURER
Blood
Systems, Inc., Reno, Nevada.
RECALLED
BY Blood Systems, Inc.,
Scottsdale, Arizona
DISTRIBUTION
Nevada.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
a) Red
Blood Cells; b) Fresh Frozen Plasma.
CODE
Unit
#19241-5962.
MANUFACTURER
Blood
Systems, Inc., Reno, Nevada.
RECALLED
BY Blood Systems, Inc.,
Scottsdale, Arizona
DISTRIBUTION
Nevada.
QUANTITY
1 unit
of each component was distributed.
REASON
Blood
products were distributed after a donor provided post donation information
regarding high risk behavior.
PRODUCT
Red
Blood Cells Leukoreduced.
CODE
Unit
#03GH44546.
MANUFACTURER
American Red Cross Blood
Services, Atlanta, Georgia.
DISTRIBUTION
Georgia.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor whose hematocrit had not been
documented.
PRODUCT
Red
Blood Cells.
CODE
Unit
#2709725.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#2719929.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#5000326.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#3949023.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who had traveled to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
Numbers: 2731465 and 2735920.
MANUFACTURER
Houchin Blood Services,
Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
2
units were distributed.
REASON
Blood
products were collected from a donor who reported travel to an area designated
as endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#22405-4411.
MANUFACTURER
Blood
Services, Inc., Las Vegas, Nevada.
RECALLED
BY Blood Systems, Inc.,
Scottsdale, Arizona
DISTRIBUTION
Nevada.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
a) Red
Blood Cells; b) Platelets.
CODE
Unit
#10593-1280.
MANUFACTURER
Blood
Systems, Inc., Scottsdale, Arizona.
DISTRIBUTION
Arizona.
QUANTITY
1 unit
of each component was distributed.
REASON
Blood
products were collected from a donor who reported travel to an area designated
as endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
Numbers: 23142-2628, 23142-2631, 23142-2634, 23142-2641, 23142-2645, 23142-2647,
23142-2648, 23142-2651.
MANUFACTURER
United
Blood Services, Billings, Montana.
RECALLED
BY Blood Systems, Inc.,
Scottsdale, Arizona
DISTRIBUTION
Montana and
Wyoming.
QUANTITY
8
units were distributed.
REASON
Blood
products were collected in a manner that compromised the sterility of the
units.
PRODUCT
Platelets, Pooled.
CODE
Unit
#PO4542.
MANUFACTURER
The
Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was not properly filtered.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#K10868.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Louisiana.
DISTRIBUTION
Louisiana.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected in a bag that had a tab cover that came off the sterile
port during processing.
PRODUCT
a) Red
Blood Cells; b) Recovered Plasma.
CODE
Unit
#FL05504.
MANUFACTURER
Central Illinois Community
Blood Bank, Springfield, Illinois.
DISTRIBUTION
Illinois and
Switzerland.
QUANTITY
1 unit
of each component was distributed.
REASON
Blood
products were collected from a donor with a history of Multiple
Sclerosis.
PRODUCT
a) Red
Blood Cells; b) Recovered Plasma.
CODE
Unit
Numbers: a) 3768914 and 3768921; b)
3768914.
MANUFACTURER
Gulf
Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION
Texas,
Pennsylvania, New Jersey.
QUANTITY
a) 2
units; b) 1 unit.
REASON
Blood
products were collected from donors who had lived in the Central African
Republic.
PRODUCT
Recovered Plasma.
CODE
Unit
#0707759.
MANUFACTURER
Blood
Centers of the Pacific, San Francisco, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was untested for viral markers.
PRODUCT
Red
Blood Cells.
CODE
Unit
#3672814.
MANUFACTURER
Gulf
Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION
Texas.
QUANTITY
1 unit
was distributed.
REASON
Blood
product tested positive for the Kell antigen, but was labeled as Kell antigen
negative.
PRODUCT
Fresh
Frozen Plasma.
CODE
Unit
#3777994.
MANUFACTURER
Gulf
Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION
Texas.
QUANTITY
1 unit
was distributed.
REASON
Blood
product tested negative for the antibodies to human immunodeficiency virus,
types 1 and 2 (anti-HIV-1/2), but was collected
from a donor who was not
asked questions intended to determine whether the donor participated in
activities at an increased risk of infection
with
HIV.
PRODUCT
a) Red
Blood Cells; b) Recovered Plasma.
CODE
Unit
#2708080.
MANUFACTURER
Houchin Community Blood
Bank, Bakersfield, California.
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
products tested negative for antibodies to human immunodeficiency virus, types 1
and 2 (anti-HIV-1/2), but were collected from an unsuitable donor due to
behavior known to increase the risk of infection with HIV.
PRODUCT
Platelets, Pheresis,
Leukocytes Reduced.
CODE
Unit
Numbers: 19239-4859 and
19239-4896.
MANUFACTURER
Blood
Systems, Inc., Reno, Nevada.
RECALLED
BY Blood systems, Inc.,
Scottsdale, Arizona and Blood Systems, Inc., Reno, Nevada
DISTRIBUTION
Texas
and Nevada.
QUANTITY
2
units were distributed.
REASON
Blood
products were labeled with extended expiration dates.
PRODUCT
Cryoprecipitate AHF.
CODE
Unit
#E22859.
MANUACTURER Carolina-Georgia
Blood Center, Inc., Greenville, South Carolina.
DISTRIBUTION
South
Carolina.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was manufactured from a unit of plasma, that had been produced from a
unit of Whole Blood that had an extended collection time, and was not frozen
within eight hours of phlebotomy.
PRODUCT
Red
Blood Cells, Irradiated.
CODE
Unit
Numbers: G65059, G65073, G64790, G64763, G64878, S96532.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Iowa.
DISTRIBUTION
Illinois.
QUANTITY
6
units were distributed.
REASON
Blood
products were labeled with extended expiration dates.
PRODUCT
a)
Panocell-10 Reagent Red Blood Cells, b) Panocell-10, Ficin Treated Reagent Red
Blood Cells.
CODE
Lot
Numbers: a) 24637 and 34875; b) 24637-E.
MANUFACTURER
Immucor, Inc., Norcross,
Georgia.
DISTRIBUTION
Nationwide.
QUANTITY
Over
700 antibody identification panels were distributed.
REASON
Reagent Red Blood Cells
tested positive for the P1 antigen, but were labeled negative for the P1
antigen.
PRODUCT
Red
Blood Cells.
CODE
Unit
#4709772.
MANUFACTURER
Central Indiana Regional
Blood Center, Inc., Indianapolis, Indiana.
DISTRIBUTION
Indiana.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor whose hematocrit was not
determined.
PRODUCT
Platelets.
CODE
Unit
#6536816.
MANUFACTURER
Michigan Community Blood
Centers, Grand Rapids, Michigan.
DISTRIBUTION
Michigan.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who had taken the medication
tetracycline.
PRODUCT
Red
Blood Cells, Leukoreduced.
CODE
Unit
numbers: 41GJ8375, 41GJ58382, 41GJ58388, 41GJ58392, 41GJ58396, 41FN49291,
41FN49297, 41FN49305, 41FN49308, 41FN49310, 41FL82454, 41FL82455, 41FL82456,
41FL82457, 41FL82459, 41FL82460, 41FL82461, 41FL82462, 41FL82463, 41FL82464,
41FL82465, 41FN49290, 41LW72975, 41GM34938, 41GM34931, 41FT38934, 41FT38935,
41FT38936, 41LW72976, 41GM34938, 41GM34931, 41FT38934, 41FT38935, 41FT38936,
41FT38937, 41FT38939, 41FT38940, 41FT38941, 41FT38944, 41FT38945, 41FT38946,
41FT38949, 41FT38950, 41FT38953, 41FT38955, 41FT38957, 41FT38958, 41FT38959,
41FT38960, 41FT38961, 41FT38962, 41FT38963, 41FT38964, 41FT38966, 41FT38967,
41FT38968, 41LP18257, 41LP18263, 41GJ58343, 41GJ58344, 41GJ58346, 41GJ58347,
41GJ58348, 41GJ58350, 41GJ58351, 41GJ58352, 41GJ58353, 41GJ58354, 41GJ58355,
41GJ58356, 41GJ58357, 41GJ58358, 41GJ58361, 41GJ58364, 41GJ58366, 41GJ58368,
41GJ58369, 41GJ58370.
MANUFACTURER
The
American National Red Cross, Birmingham, Alabama.
DISTRIBUTION
Alabama.
QUANTITY
73
units were distributed.
REASON
Blood
products were inappropriately collected in 450 ml collection sets, and labeled
as having been collected in a 500 ml collection set.
PRODUCT
Red
Blood Cells.
CODE
Unit
#LX02769.
MANUFACTURER
Inova
Health Care Services, Annandale, Virginia.
DISTRIBUTION
Maryland.
QUANTITY
1 unit
was distributed.
REASON
tested
reactive for syphilis.
PRODUCT
a) Red
Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Red Blood Cells,
Leukocytes Reduced, Irradiated; d) Platelets; e) Platelets, Irradiated; f)
Platelets, Leukocytes Reduced; g) Platelets, Pheresis; h) Platelets, Pheresis,
Leukocytes Reduced; i) Platelets, Pheresis, Leukocytes Reduced; j)
Cryoprecipitated AHF; k) Cryoprecipitated AHF,
Pooled; l) Fresh Frozen
Plasma; m) Plasma Frozen within 24 Hours After Phlebotomy; n) Plasma,
Cryoreduced.
CODE
Unit
numbers:
a)
17KJ85315, 17FS08201, 17FK08202, 17FZ21613, 17KK75471, 17KX54954, 17KX55109,
17KJ85622, 17KL75806, 17FZ21894, 17KK75641, 17KK75673, 17KK75711, 17KK75718,
17KJ85803, 17KW02680, 17KW02202, 17KH81929, 17KW02734, 17KC06828, 17KR67044,
17KR66942, 17FZ22140, 17KC06960, 17KC07041, 17KC07088, 17FZ22319, 17KC07511,
17KP78032, 17KP78039, 17KK76372, 17KK76379, 17KK76394, 17KP78069, 17KC07609,
17GT77989;
b)
17KJ85823, 17FZ22094, 17FW24867, 17FW24927, 17KK76254, 17KK76327, 17KQ37338,
17KK76313, 17KK76407, 17FZ22470, 17FZ22477, 17FZ22478,
17KK76501;
c)
17FZ22308;
d)
17FZ21621, 17KK75471, 17KH81519, 17FZ21785, 17KR66886, 17FZ21894, 17KK75711,
17KJ86098, 17FZ22125, 17FZ22133, 17FZ22140, 17FZ22148, 17FZ22155, 17FZ22162,
17FZ22203, 17FZ22268, 17FZ22276, 17FZ22290, 17FZ22319, 17FZ22334, 17FZ22381,
17FZ22396, 17FZ22403, 17FZ22410,
17FZ22417, 17KP78032, 17KP78039, 17KF90805, 17KP78069, 17KF90823, 17FZ22449,
17FZ22463, 17KC07595, 17KC07602, 17KC07609, 17KP78132, 17KP78163, 17KW03655,
17KW03669, 17FZ22465, 17FZ22468, 17FZ22484;
e)
17FZ21576;
f)
17KQ36795, 17KQ37338;
g)
17FX26371, 17FX26375, 17FX26377, 17FX26382 17FX25838;
h)
17FQ00301, 17FX25847, 17FX25862, 17FX25868, 17FX25869, 17FX25871, 17FX25886,
17FQ00303, 17FQ00306, 17FX25907, 17FX25955, 17FX26158, 17FX26294, 17FX26361,
17FX26368, 17FX26371, 17FX26378,
17FX26387, 17FQ00298, 17FX25837, 17FX25841;
i)
(Split units designated by product numbers 12710 and 12750) Units 17FX25870, 17FX25872, 17FX25961,
17FX26021, 17FX26051, 17FX26124, 17FX26134, 17FX26254, 17FX26320, 17FX26343,
17FX26369, 17FX26378, 17FX25834, 17FX25835, 17FX25839;
j)
17KF85315, 17KJ85629, 17KJ85803, 17KJ85823, 17KN61210, 17FZ22396,
17FZ22403;
k)2504, 2458, 2518, 2605,
2564, 2667, 2669, 2630, 2633, 2666;
l)
17FZ21718, 17KH81519, 17FZ21785, 17KJ86091, 17KK76300,
17FZ22469;
m)
17FZ22319;
n)
17KC07088.
MANUFACTURER
American National Red Cross,
National Testing Laboratory, Eagan,
Minnesota.
RECALLED
BY American Red Cross, St. Paul
Minnesota
DISTRIBUTION
Alabama, Georgia, Indiana,
Massachusetts, Michigan, Minnesota, and Wisconsin.
QUANTITY
a) 36
units; b) 13 units; c) 1 unit; d) 42 units; e) 1 unit; f) 2 units; g) 5 units;
h) 21 units; i) 17 units; j) 7 units; k) 10 units; l) 6 units; m) 1 unit; n) 1
unit.
REASON
Blood
products were not tested for syphilis in accordance with the manufacturers
instructions.
PRODUCT
Red
Blood Cells, Leukoreduced.
CODE
Unit
numbers: 16LS69511, 16LV58367, 16LV58376, 16LY86523.
MANUFACTURER
American Red Cross Blood
Services, Columbus, Ohio.
DISTRIBUTION
Ohio.
QUANTITY
4
units were distributed.
REASON
Blood
products were not tested for CMV antibody in accordance with the manufacturers
instructions were distributed with labels stating that they tested negative for
CMV.
PRODUCT
Various tissue for
transplants.
a)
Lateral Meniscus, Bone, Left;
b)
Hemi-Patellar Tendon;
c)
Saphenous Vein;
d)
Pulmonary Hemi-Artery;
e)
Ascending Thoracia Aorta.
CODE
Serial
numbers: a) 4094417; b) 4094433, 4094441, 4094468, 4094476; c) 6081169, 6081126,
6081177; d) 6081053; e) 6081088.
MANUFACTURER
CryoLife, Incorporated,
Kennesaw, Georgia.
DISTRIBUTION
Arkansas, California,
Florida, Illinois, Maryland, South Carolina and Tennessee.
QUANTITY
a) 1
unit; b) 4 units; c) 3 units; d) 1 unit; e) 1 unit were
distributed.
REASON
Various tissue for
transplant were collected from donors who had not been properly
evaluated.
PRODUCT
Saphenous Vein.
CODE
Serial
numbers: 3832791, 3832805, 3832813.
MANUFACTURER
CryoLife, Incorporated,
Kennesaw, Georgia.
DISTRIBUTION
Maryland.
QUANTITY
3
units were distributed.
REASON
Various tissue for
transplant were collected from a donor who had not been properly
evaluated.
PRODUCT
Various tissues for
transplant. a) Saphenous Vein; b) Medial Meniscus, Bone, Right; c) Achilles
Tendon.
CODE
Serial
numbers: a) 3741141, 3741168; b) 4052552; c) 4052579,
4052587.
MANUFACTURER
CryoLife, Incorporated,
Kennesaw, Georgia.
DISTRIBUTION
Connecticut, Georgia,
Massachusetts, Michigan and Canada.
QUANTITY
a) 2
units; b) 1 unit; c) 2 units were distributed.
REASON
Various tissue for
transplant were collected from a donor who had not been properly
evaluated.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#K14809 (Split unit A and B), K14135.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Iowa.
DISTRIBUTION
Texas.
QUANTITY
3
units were distributed.
REASON
Blood
products had high platelet counts.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#K13427.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Iowa.
DISTRIBUTION
Iowa.
QUANTITY
1 unit
was distributed.
REASON
Blood
product had a high platelet count.
PRODUCT
Platelets, Pheresis.
CODE
Contact FDA, Center for
Biologics Evaluation and Research, Office of Compliance (301) 827-6202 for
individual unit numbers recalled.
MANUFACTURER
American Red Cross Blood
Services, Baltimore, Maryland
DISTRIBUTION
Maryland, Virginia and
District of Columbia.
QUANTITY
137
units were distributed.
PRODUCT
Red
Blood Cells.
CODE
Unit
#09FT23197.
MANUFACTURER
American Red Cross Blood
Services, North Platte, Nebraska.
RECALLED
BY American Red Cross Blood
Services, Omaha, Nebraska
DISTRIBUTION
Colorado.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who traveled to areas designated endemic for
malaria.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#09FP25266.
MANUFACTURER
American Red Cross Blood
Services, Omaha, Nebraska.
DISTRIBUTION
Colorado.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#W77463.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Iowa.
DISTRIBUTION
Virginia.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who had traveled to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#V83951.
MANUFACTURER
Mississippi Valley Regional
Blood Center, Davenport, Iowa.
DISTRIBUTION
Virginia.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Platelets, Pheresis.
CODE
Unit
numbers: 03KR06552, 03KR06480.
MANUFACTURER
American Red Cross Blood
Services, Atlanta, Georgia.
DISTRIBUTION
Georgia.
QUANTITY
2
units were distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
a) Red
Blood Cells; b) Platelets.
CODE
Unit
#Y15504.
MANUFACTURER
Aurora
Area Blood Bank, Auroa, Illinois.
DISTRIBUTION
Illinois and
Louisiana.
QUANTITY
1 unit
of each component was distributed.
REASON
Blood
products were collected from a donor who reported travel to an area designated
as endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#04FF16462.
MANUFACTURER
American Red Cross, Dedham,
Massachusetts.
DISTRIBUTION
New
York.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#0614605.
COLLECTION
SITE Blood Centers of the
Pacific, Burlinghame, California.
RECALLED
BY Blood Centers of the
Pacific, Irwin Center, San Francisco, California
DISTRIBUTION
California.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#42FJ85383.
MANUFACTURER
American Red Cross Blood
Services, Cleveland, Ohio.
DISTRIBUTION
Ohio.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported travel to an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
#15007-1679.
MANUFACTURER
United
Blood Services, Texas Blood, Lubbock, Texas.
RECALLED
BY Blood Systems, Incorporated,
Scottsdale, Arizona
DISTRIBUTION
Texas.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who had traveled to an area designated as
endemic for malaria.
PRODUCT
a) Red
Blood Cells; b) Platelets.
CODE
Unit
numbers: a) Y32717, Y12785, X88587, X71539, X22442, W92489, W64461, W30834; b)
W92489.
MANUFACTURER
Aurora
Area Blood Bank, Aurora, Illinois.
DISTRIBUTION
Illinois and
Indiana.
QUANTITY
a) 8
units; b) 1 unit were distributed.
REASON
Blood
products were collected from a donor who had lived in an area designated as
endemic for malaria.
PRODUCT
Red
Blood Cells.
CODE
Unit
numbers: 18FE67714, 18FK39085, 18FZ02788, and 18FE67761.
MANUFACTURER
American Red Cross, Lansing,
Michigan.
DISTRIBUTION
Michigan and
Arizona.
QUANTITY
4
units were distributed.
REASON
The
blood products failed hematocrit quality control testing.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#27P46997.
MANUFACTURER
The
American National Red Cross, Johnstown, Pennsylvania.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit
was distributed.
REASON
The
Platelets Pheresis had an elevated platelet count.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#27P41967.
MANUFACTURER
The
American National Red Cross, Johnstown, Pennsylvania.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit
was distributed.
REASON
The
Platelets Pheresis had an elevated platelet count.
PRODUCT
Platelets, Pheresis.
CODE
27P41990 (split
unit).
MANUFACTURER
The
American National Red Cross, Johnstown Pennsylvania.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit
was distributed.
REASON
The
Platelets Pheresis had an elevated platelet count.
PRODUCT
Platelets, Pheresis.
CODE
27GE10486.
MANUFACTURER
The
American National Red Cross, Johnstown Pennsylvania.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit
was distributed.
REASON
The
Platelets Pheresis had an elevated platelet count based on the volume of product
collected.
PRODUCT
Platelets, Pheresis.
CODE
27P47942.
MANUFACTURER
The
American National Red Cross, Johnstown Pennsylvania.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit
was distributed.
REASON
The
Platelets Pheresis had an elevated platelet count based on the volume of product
collected.
PRODUCT
Platelets, Pheresis.
CODE
Unit
numbers: 36FP10270 and 36FP10298.
MANUFACTURER
The
American National Red Cross, Columbia, South Carolina.
DISTRIBUTION
Puerto
Rico and South Carolina.
QUANTITY
2
units were distributed.
REASON
Platelets Pheresis had an
elevated platelet count.
PRODUCT
Platelets,
Pheresis.
CODE
Unit
#2310266 (split unit).
MANUFACTURER
LifeShare, Inc., Elyria,
Ohio.
DISTRIBUTION
Ohio.
QUANTITY
1 unit
was distributed.
REASON
Platelets Pheresis with a
decreased platelet count were distributed.
PRODUCT
Red
Blood Cells.
CODE
Unit
#36C53197.
MANUFACTURER
American Red Cross Blood
Services, Columbia, South Carolina.
DISTRIBUTION
South
Carolina.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was collected from a donor who reported having tender lymph nodes under
the arm.
PRODUCT
Platelets.
CODE
Unit
#18P42435.
MANUFACTURER
American Red Cross, Lansing,
Michigan.
DISTRIBUTION
Michigan.
QUANTITY
1 unit
was distributed.
REASON
The
blood product contained a small fibrin clot in the container.
PRODUCT
Tisseal VH Kit, Fibrin
Sealant.
CODE
Lot
#K05499J.
MANUFACTURER
Baxter
Healthcare Corporation, Vienna, Australia.
RECALLED
BY Baxter Healthcare
Corporation, Glendale, California
DISTRIBUTION
Nationwide.
QUANTITY
1,707
kits were distributed.
REASON
The
product was subjected to shipping temperatures that were below the freezing
point of one of the kit components.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#2330189.
MANUFACTURER
LifeShare, Incorporated,
Elyria, Ohio.
DISTRIBUTION
New
Jersey.
QUANTITY
1 unit
was distributed.
REASON
Unlicensed blood product was
distributed in interstate commerce.
PRODUCT
Fresh
Frozen Plasma.
CODE
Unit
#26FF28541.
MANUFACTURER
The
American National Red Cross, Mobile, Alabama.
DISTRIBUTION
North
Carolina.
QUANTITY
1 unit
was distributed.
REASON
Unlicensed blood product was
distributed in intrastate commerce.
PRODUCT
Platelets, Pheresis,
Leukoreduced.
CODE
Unit
#09FP18569.
MANUFACTURER
American Red Cross Blood
Services, Omaha, Nebraska.
DISTRIBUTION
Arizona.
QUANTITY
1 unit
was distributed.
REASON
Unlicensed blood product was
distributed in interstate commerce.
PRODUCT
Platelets, Pheresis,
Leukoreduced.
CODE
Unit
#LS62039.
MANUFACTURER
Mid-South Regional Blood
Center, Memphis, Tennessee.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit
was distributed.
REASON
Blood
product was not quarantined after receiving information concerning a post
donation illness.
PRODUCT
Platelets, Pheresis.
CODE
Unit
#27P47477.
MANUFACTURER
The
American National Red Cross, Johnstown, Pennsylvania.
DISTRIBUTION
Maryland.
QUANTITY
1 unit
was distributed.
REASON
Platelets Pheresis were not
properly agitated during storage.
PRODUCT
Red
Blood Cells.
CODE
Unit
numbers: 18GH58030 and 18GH58074.
MANUFACTURER
American Red Cross, Lansing,
Michigan.
DISTRIBUTION
Michigan.
QUANTITY
2
units were distributed.
REASON
Blood
products exceeded acceptable storage temperatures.
WEEK ENDING JANUARY 26
PRODUCT: a)Allergenic Extract
Hormodendrum cladosporioides, b)Allergenic Extract Aspergillus niger;
c)Allergenic Extract White Potato; d)Allergenic Extract Lambsquarter;
e)Allergenic Extract Penicillium notatum; f)Allergenic Extract Timothy
Grass.
CODE: a)Lot #6253; b) Lot #6392;
c) Lot #6493; d) Lot #6526; e) Lot #6575; f) Lot #6600.
MANUFACTURER: Allergy Laboratories,
Inc., Oklahoma City, OK.
DISTRIBUTION:
Nationwide.
QUANTITY: a) 199/50 ml vials, 31/30
ml vials, 40/10 ml vials and 6/5 ml vials; b) 4/50 ml vials; c) 2/50 ml vials,
29/10 ml vials, 2/5 ml vials, 15/2 ml vials; d) 112/50 ml vials, 39/30 ml vials,
50/10 ml vials, 25/2 ml vials; e) 66/50 ml vials, 30/30 mlvials, 50/10 ml vials,
6/2 ml vials; f) 44/50 ml vials, 23/30 ml vials, 58/10 ml vials, 4/5 ml vials,
10/2 ml vials.
REASON: Allergenic extracts, that
failed finished product sterility testing, were reprocessed and
distributed.
PRODUCT: a) Saphenous Vein; b)
Medial Meniscus, Bone, Left.
CODE: a) Serial #3758591,
3758605, 3758613; b) 4051173.
MANUFACTURER: CryoLife, Inc., Kennesaw,
GA.
DISTRIBUTION: Arizona, California,
Colorado and Florida.
QUANTITY:
Four.
REASON: Various tissue for
transplants, which were collected from a donor who had not been properly
evaluated, were distributed.
PRODUCT: Red Blood Cells,
Irradiated.
CODE: Unit
09GN47948.
MANUFACTURER: American Red Cross Blood
Services, Grand Island, NE.
RECALLED
BY:
American Red Cross Blood Services, Omaha, NE
DISTRIBUTION:
Nebraska.
QUANTITY: One
unit.
REASON: Blood product,collected
from a donor who reported travel to an area designated as endemic for malaria,
was distributed.
PRODUCT: Source Plasma.
CODE: Units 98AIAB5307,
98AIAB5536, 98AIAB5895, 98AIAB5957.
MANUFACTURER: Community Bio-Resources,
Inc., Ames, IA.
DISTRIBUTION:
Austria.
QUANTITY: 4
units.
REASON: Blood products collected
from a donor whose partner had tested positive for Hepatitis B, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; and c) Recovered Plasma.
CODE: a) Units 18S42122 and
18R53862; b) 18R53862; c) 18S42122 and 18R53862.
MANUFACTURER: American Red Cross,
Lansing, MI.
DISTRIBUTION:
Michigan.
QUANTITY: Five
units.
REASON: Blood product,which were
collected from a donor who had close contact with an individual with hepatitis,
were distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; c) Fresh frozen plasma.
CODE: a)Unit 3443670; b) unit
3443670; c) unit 3443670.
MANUFACTURER: Michigan Community Blood
Centers, Grand Rapids, MI.
DISTRIBUTION:
Michigan.
QUANTITY: Three
units.
REASON: Blood products, which were
collected from a donor who had a history of jaundice, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; c) Cryoprecipitated AHF; d) Recovered Plasma.
CODE: a) Unit 6240871 and
6238468; b) unit 6240871; c) unit 6238468; d) 6240871 and 6238468.
MANUFACTURER: Michigan Community Blood
Centers, Grand Rapids, MI.
DISTRIBUTION: Michigan, Texas and
Switzerland.
QUANTITY: Six
units.
REASON: Blood products, which were
collected from a donor who had a history of jaundice, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; c) Recovered Plasma.
.
CODE: a) Unit 27V70270; b)
Unit 27V70270; c) Unit 27V70270
MANUFACTURER: American Red Cross Blood
Services, Johnstown,
PA.
DISTRIBUTION: West
Virginia.
QUANTITY: Three
units.
REASON: Blood products, collected
from a donor with a history of having tested positive for hepatitis, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; c) Fresh frozen plasma; d) Recovered Plasma.
CODE: a) Unit 27GX00670,
27GW05537, 27GV42240; b) 27GV42240; 27GV42240; d) 27GX00670;
27GW05537.
MANUFACTURER: American Red Cross Blood
Services, Johnstown, PA.
DISTRIBUTION: Pennsylvania and West
Virginia.
QUANTITY: Seven
units.
REASON: Blood product, collected
from a donor who provided post donation information regarding high risk
behaviors, and a positive test for Hepatitis B, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Recovered Plasma.
CODE: a) Unit 27W82103; b)
27W82103, 27GK00294.
MANUFACTURER: American Red Cross Blood
Services, Johnstown, PA.
DISTRIBUTION:
Pennsylvania.
QUANTITY: Three
Units.
REASON: Blood product, collected
from a donor with a history of having tested positive for hepatitis, were
distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets; c) Fresh Frozen Plasma; d) Frozen Plasma.
CODE: a) Units 42FS55887,
42H19005, 42W11875; b) 42FS55887, 42H19005; c) 42FS55887,42H19005; d)
42W11875.
MANUFACTURER: American Red Cross Blood
Services, Cleveland, OH.
DISTRIBUTION:
Ohio.
QUANTITY: Eight
units.
REASON: Blood product, collected
from a donor with a history of having tested positive for Hepatitis B core antigen
(anti-HBc), were distributed.
PRODUCT: a) Red Blood Cells; b)
Recovered Plasma.
CODE: a) Unit 09GN72421; b)
09GN72421.
MANUFACTURER: American Red Cross Blood
Services, Omaha, NE.
DISTRIBUTION:
California.
QUANTITY: Two
units.
REASON: Blood products which
tested negative for all required viral marker tests, but were collected from a
donor who had previously tested
positive for Hepatitis due to mononucleosis, were
distributed.
PRODUCT: a) Red Blood Cells; b)Red
Blood Cells, Irradiated.
CODE: a) Unit 27J51089,
27J51092, and 27J51090; b) unit 27J51095.
MANUFACTURER: American Red Cross Blood
Services, Johstown, PA.
DISTRIBUTION:
Virginia.
QUANTITY: 4
units.
REASON: Blood products,
incorrectly tested for syphilis, were distributed.
PRODUCT: Red Blood Cells.
CODE: Unit
27J14201.
MANUFACTURER: American National Red
Cross, Johstown, PA.
DISTRIBUTION: West
Virginia.
QUANTITY: One
unit.
REASON: Blood products,
manufactured from an overweight unit of Whole Blood, was
distributed.
PRODUCT: Red Blood Cells.
CODE: Unit
27J14201.
MANUFACTURER: American National Red
Cross, Johstown, PA.
DISTRIBUTION: West
Virginia.
QUANTITY: One
unit.
REASON: Blood products,
manufactured from an overweight unit of Whole Blood, was
distributed.
PRODUCT: Red Blood Cells.
CODE: Unit 27GS20999.
MANUFACTURER: American National Red
Cross, Johstown, PA.
DISTRIBUTION:
Pennsylvania.
QUANTITY: One
unit.
REASON: Blood product, untested
for Cytomegalovirus (CVM), but labeled as CMV negative, was
distributed.
PRODUCT: a) Red Blood Cells; b)
Recovered Plasma.
CODE: a) Unit 27R53339; b) unit
27R53339.
MANUFACTURER: American National Red
Cross, Johstown, PA.
DISTRIBUTION: West Virginia and
California.
QUANTITY: Two
units.
REASON: Blood products, that
tested negative for antibodies to human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor that previously tested repeatedly
reactive for anti-HIV-1, were distributed.
PRODUCT: Red Blood Cells,
Leukocytes Reduced.
CODE: Unit
0903847.
MANUFACTURER: West Tennessee Regional
Blood Center, Inc., Jackson, TN.
DISTRIBUTION:
Tennessee.
QUANTITY: One
Unit.
REASON: Blood Product, labeled
with an extended expiration date, was distributed.
PRODUCT: Plasma Cryoprecipitate
Reduced.
CODE: Units 12Y11099, 12FS91794,
12R95156, 12Y11129, 12Y11121,12R91070, 12R91067, 12R91073, 12Y11113, 12F08069,
12FF96824,12GY26848, 12GY26851, 12GY26856, 12R93726, 12R91048,
12R91065,
12R91066, 12R91069,
12R91072, 12R91078, 12R91083, 12R91085, 12Y11103,12Y11105, 12Y11109, 12Y11110,
12Y11112, 12Y11115, 12Y11118, 12Y11119,12Y11123, 12Y11124, 12RY11126, 12Y11128,
12Z28177, 12Z28189, and 12R1074.
MANUFACTURER: American Red Cross Blood
Services, Charlotte, NC.
DISTRIBUTION: South Carolina, North
Carolina, and Massachusetts.
QUANTITY: 38
units.
REASON: Blood Products, which were
labeled with an extended expiration
date, were distributed.
PRODUCT: a) Red Blood Cells; b)
Platelets.
CODE: a) Unit G43242; b) Unit
G43242.
MANUFACTURER: Mid-South Regional Blood
Center, Memphis, TN.
DISTRIBUTION:
Tennessee.
QUANTITY: Two
units.
REASON: Blood products, that was not quarantined after
receiving information concerning a post donation illness, were
distributed.