OCTOBER 2006
WEEK ENDING OCTOBER 7
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Fresh Frozen Plasma,
d) Recovered Plasma,
CODE
a) Unit: 6802184;
b) Units: 6840564,
4683768, 4700389;
c) Unit: 4683768;
d) Units: 6840564,
4700389
RECALLING FIRM/MANUFACTURER W. E. & Lela I. Stewart
Blood Center, Tyler, TX,
REASON Blood products,
collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 7 units
DISTRIBUTION TX and Switzerland
PRODUCT Medi-Temp III, Blood and
Fluid Warmer, Model Number FW600, Model Number FW601, Model Number FW603
CODE
Model Number FW600:
A20001, A20002, A20003,
A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013,
A20014, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30010,
A30011, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020,
A30021, A30022, A30023, A30024, A30025, A30027, A30030, A30031, A40001, A40002,
A40003, A40004, A40005, A40006, A40007, A40008, A40009, B20001, B20002, B20003,
B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013,
B20014, B20015, B20016, B20017, B20018, B20020, B20021, B20022, B20023, B20024,
B20025, B20026, B20027, B20028, B20029, B20030, B20031, B20032, B20033, B20034,
B20035, B20036, B20037, B20038, B20039, B20040, B20043, B20044, B20045, B20046,
B20047, B20048, B20049, B20050, B20051, B20052, B20053, B20054, B20055, B20056,
B20057, B20058, B20059, B20060, B20061, B20062, B20063, B20064, B20065, B20066,
B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010,
B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30019, B30020, B30021,
B30022, B30023, B30024, B30025, B30026, B30027, B30028, B30029, B30030, C20002,
C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012,
C20013, C20014, C20015, C20016, C20017, C20018, C20019, C20020, C20021, C20022,
C20023, C20024, C20025, C20026, C20027, C20028, C20029, C20030, C20031, C20032,
C20033, C20034, C20036, C20037, C20038, C20039, C20041, C20042, C20043, C20044,
C20045, C20046, C20047, C20049, C20050, C20051, C20053, C20054, C20055, C20056,
C20057, C20058, C20059, C20060, C30001, C30002, C30003, C30004, C30005, C30006,
C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016,
C30017, C30018, C30019, C30020, C30021, C30022, C30023, C30024, C30025, C30026,
C30027, C30028, C30029, C30030, C30031, C30032, C30033, C30034, C30035, C30036,
C30037, C30038, C30039, C30040, C30041, C30042, C30043, C30044, C30045, C30046,
C30047, C30048, C30049, C30050, C30051, C30052, C30053, C30054, C30055, C30056,
C30057, C30058, C30059, C30060, C40001, C40002, C40003, C40004, C40005, C40006,
C40007, C40008, C40009, C40010, C40011, C40012, C40013, C40014, C40015, C40016,
C40017, C40018, C40019, C40020, C40021, C40022, C40023, C40024, C40025, C40026,
C40027, C40028, C40029, C40030, C40031, C40032, C40033, C40034, C40035, C40036,
C40037, C40038, C40039, C40040, C40041, C40042, C40043, C40044, C40045, C40046,
C40047, C40048, C40049, C40050, C40051, C40052, C40053, C40054, C40055, C40056,
C40057, C40058, C40059, C40061, C40062, C40063, C40064, C40065, C40066, C40067,
C40068, C40069, C40070, C40071, C40072, C40073, C40074, C40075, C40076, C40077,
C40078, C40079, C40080, C40081, C40082, C40083, C40084, C40085, C40086, C40087,
C40088, C40089, C40090, C40091, C40092, C40093, C40094, C40095, C40096, C40097,
C40098, C40099, C40100, C40101, C40102, C40103, C40104, C40105, C40106, C40107,
C40108, C40109, C40110, C40111, C40112, C40113, C40114, C40115, C40116, C40117,
C40118, C40119, C40120, C40121, C40122, C40123, C40124, C40125, C40126, C40127,
C40128, C40129, D30001, D30002, D30003, D30004, D30005, D30006, D30007, D30008,
D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018,
D30019, D30020, D30021, E20001, E20002, E20004, E20005, E20007, E20008, E20009,
E20010, E20011, E20012, E20017, E20018, E20019, E20020, E20021, E20022, E20024,
E20025, E20027, E20028, E20030, E20031, E20032, E20033, E30002, E30003, E30004,
E30005, E30006, E30007, E30009, E30010, E30011, E30012, E30013, E30014, E30015,
E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004,
F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014,
F20015, F20016, F20017, F20018, F20019, F20020, F20021, F20022, F20023, F20024,
F20025, F20027, F20028, F20029, F20030, F20031, F20032, F20033, F20034, F20035,
F20036, F20037, F20038, F20039, F20040, F20041, F20042, F20043, F20044, F20045,
F20046, F20047, F20048, F20049, F20050, F20051, F20052, F20053, F20054, F20055,
F20056, F20057, F20058, F20059, F20060, F20061, F20062, F20063, F20064, F20065,
F20066, F20067, F20068, F20069, F20070, F20071, F20072, F20073, F20074, F20076,
F20077, F20078, F20080, F20081, F20082, F20083, F20084, F20085, F20086, F20087,
F20088, F20089, F20090, F20091, F20092, F20093, F20094, F20095, F20096, F20097,
F20098, F20099, F20101, F20102, F20103, F30001, F30002, F30003, F30004, F30005,
F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015,
F30016, F30017, F30018, F30020, F30021, F30022, F30023, F30025, F30026, F30027,
F30028, F30029, F30030, F30031, F30032, F30033, F30034, F30035, F30036, F30037,
F30038, F30039, F30040, F30041, F30042, F30043, F30044, F30045, F30047, F30048,
F30050, F30052, F30053, F30054, F30056, F30057, F30058, F30059, F30060, F30061,
F30062, F30063, F30064, F30066, F30067, F30068, F30069, F30070, F30071, F30072,
F30073, F30074, F30076, F30077, F30078, F30079, F30081, F30082, F30083, F30084,
F30086, F30087, F30088, F30089, F30090, F30091, F30092, F30093, F30094, F30095,
F30096, F30097, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008,
G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018,
G20019, G20020, G20021, G20022, G20023, G20024, G20025, G20026, G20027, G20028,
G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010,
G30011, G30012, G30013, G30014, G30015, G30016, G30017, G30018, G30019, G30020,
G30021, G30022, G30023, G30024, G30025, G30026, G30027, G30028, G30029, G30030,
G30031, G30032, G30033, G30034, G30035, G30036, G30037, G30038, G30039, G30040,
G30041, G30042, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008,
H20009, H20010, H20011, H20016, H20017, H20018, H20019, H20020, H20021, H20022,
H20023, H20024, H30001, H30002, H30003, H30004, H30005, H30006, H30007, H30008,
H30010, H30011, H30012, H30013, H30014, H30015, H30016, H30017, H30018, H30019,
H30020, H30022, H30023, H30024, H30025, H30026, H30027, H30028, H30029, H30030,
H30031, H30032, H30033, H30034, H30035, H30036, H30037, H30038, H30039, H30040,
H30041, H30042, H30043, H30044, H30045, H30046, H30047, H30048, H30049, H30050,
H30051, H30052, H30053, H30054, H30055, H30056, H30057, H30058, H30059, H30060,
H30061, H30062, H30063, H30064, H30065, H30066, H30067, H30068, H30069, H30070,
H30071, H30072, H30073, I20001, I20002, I20003, I20005, I20007, I20008, I20009,
I20010, I20011, I20012, I20013, I20014, I20016, I20017, I20018, I20019, I20020,
I20021, I20022, I20023, I20024, I20025, I20026, I20027, I20028, I20029, I20030,
I20031, I20032, I20033, I20035, I20036, I20037, I30001, I30002, I30003, I30004,
I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014,
I30015, I30016, I30017, I30019, I30020, I30021, I30022, I30023, I30024, I30025,
I30026, I30027, J20001, J20002, J20003, J20004, J20005, J20006, J20007, J20008,
J20009, J20010, J20011, J20012, J20013, J20014, J20015, J20016, J20017, J20018,
J20019, J20020, J20021, J20022, J20023, J20024, J20025, J20026, J20027, J20028,
J20029, J20030, J20031, J20032, J20033, J20034, J20035, J20036, J20037, J20038,
J20039, J20040, J20042, J20043, J20044, J20045, J20048, J20049, J20050, J20051,
J20052, J30001, J30002, J30003, J30004, J30006, J30007, J30008, J30009, J30010,
J30011, J30012, J30013, J30014, J30015, J30016, J30017, J30020, J30021, J30022,
J30023, J30024, J30025, J30026, J30027, J30028, J30029, J30030, J30031, J30032,
J30033, J30034, J30035, J30036, J30037, J30038, J30039, J30040, J30041, J30042,
J30043, J30044, J30045, J30046, J30047, J30048, J30049, J30050, J30051, J30052,
J30053, J30054, J30055, J30056, J30057, J30058, J30059, J30060, J30061, J30062,
J30063, J30064, J30065, J30066, J30067, J30068, J30069, J30070, J30071, J30072,
J30073, J30074, J30075, J30076, J30077, J30079, J30080, J30081, J30082, K10003,
L10001, L20001, L20002, L20004, L20005, L20006, L20007, L20008, L20009, L20011,
L20012, L20013, L20014, L20016, L20017, L20018, L20019, L20020, L20021, L20022,
L20023, L20024, L20025, L20026, L20027, L20028, L20029, L20030;
Model Number
FW601:
C40001, C40002, C40003, C40004, C40005, C40006, D40001, D40002,
D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012,
D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020
Model Number
FW603:
A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008,
A20009, A20010, A20011, A20012, A20013, A20014, A20015, A20016, A20017, A20018,
A20019, A20020, A20021, A20022, A20023, A20024, A20025, A20026, A20027, A20028,
A20029, A20030, A20031, A20032, A20033, A20034, A20035, A20036, A20037, A30001,
A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30012, A30013,
A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30026, A30027, A30028,
A30029, A30030, A30031, A30032, A30033, A30034, A30040, A30041, A30042, A30043,
A30044, A30045, A30046, A30047, A30048, A30051, A30052, A30053, A30055, A30056,
A30057, A30058, A30059, A30060, A30061, A30062, A30063, A30064, A40001, A40002,
A40003, A40004, A40005, A40006, A40007, A40008, A40009, A40010, A40011, A40012,
A40013, A40014, A40015, A40016, A40017, A40018, A40019, A40020, A40021, A40022,
A40023, A40024, A40025, A40026, A40027, A40028, A40029, A40030, B20001, B20002,
B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012,
B20013, B20014, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008,
B30009, B30010, B30011, B30012, B30013, B30014, B30015, B30016, B30017, B30018,
B30020, B30021, B30022, C20001, C20002, C20003, C20004, C20005, C20006, C20007,
C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C30001,
C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011,
C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30021, D30001,
D30002, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013,
D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30026, D30027, D40001,
D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011,
D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020, D40021,
D40022, D40023, D40024, D40025, D40026, D40027, E20001, E20002, E20003, E20004,
E30001, E30002, E30003, E30004, E30005, E30006, E30007, E30008, E30009, E30010,
E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020,
E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009,
F20010, F20011, F20012, F20013, F20014, F30001, F30002, F30003, F30004, F30005,
F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015,
F30016, F30017, F30018, F30019, F30020, G20001, G20002, G20003, G20004, G20005,
G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015,
G20016, G20017, G20018, G20019, G20020, G30001, G30002, G30003, G30004, G30005,
G30006, G30007, G30008, G30009, G30010, H20001, H20002, H20003, H20004, H20005,
H20006, H20007, H20008, H20009, H20010, H20011, H20012, H20013, I20001, I20002,
I20003, I20004, I20005, I20006, I20007, I20008, I20009, I20010, I20011, I20012,
I20013, I20014, I20015, I20016, I20017, I20018, I20019, I20020, I20021, I20022,
I20023, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009,
I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30018, I30019,
I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, I30027, I30028,
I30029, I30030, I30031, I30032, I30033, I30034, I30035, I30036, K10001, K10002,
K10003, L20001, L20002, L20003, L20004, L20005, L20006, L20007, L20008, L20009,
L20010, L20011, L20012, L20013, L20014, L20015, L20016, L20017, L20018, L20019,
L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029,
L30001, L30002, L30003, L30004, L30005, L30006, L30007, L30008, L30009, L30010,
L30011, L30012
RECALLING FIRM/MANUFACTURER Gaymar Industries, Inc.,
Orchard Park, NY, REASON Blood and Fluid Warmers, manufactured with a
defective label on the front panel, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 752 units Domestic; 883 units
Foreign
DISTRIBUTION Nationwide and Internationally
WEEK ENDING OCTOBER 21
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
53P98507
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
REASON Platelets
Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Platelets
CODE
Unit: LX15118
RECALLING
FIRM/MANUFACTURER Inova Health Care Services, Sterling, VA, 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 VA
PRODUCT Red Blood Cells
CODE
Unit: KS35337
RECALLING
FIRM/MANUFACTURER Inova Health Care Services, Sterling, VA, 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 VA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
53GV64854
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
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 MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit: 53LT87511 (part
1)
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater
Chesapeake & Potomac Regions, Baltimore, MD
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 MD
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
KZ98374
RECALLING FIRM/MANUFACTURER Blood Center of Southeastern
Wisconsin, Inc., Milwaukee, WI,
REASON Blood product, collected from an
unsuitable donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
53FQ00708
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
REASON Blood product,
collected from a donor for whom documentation of a hematocrit test and body
temperature during the donor screening process was discrepant, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Cryoprecipitated
AHF,
d) Plasma
e) Fresh Frozen Plasma,
CODE
a),
c), d), Unit: H49390;
b), e) Unit: Y10295;
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood
products, collected from a donor with a history of melanoma, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION VA
PRODUCT Source Plasma
CODE
Units: 04NWVA4767, 04NWVA4899, 05NWVA0387,
05NWVA0599, 05NWVA0682, 05NWVA0898, 05NWVA0969, 05NWVA1209, 05NWVA1269,
05NWVA1483, 05NWVA1534, 05NWVA1761, 05NWVA1817, 05NWVA2056, 05NWVA2114,
05NWVA2347, 05NWVA2491, 05NWVA2742, 05NWVA2874, 05NWVA3043,
05NWVA3150
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Nutter Fort, WV,
REASON Blood products, collected from a donor with a
history of brain surgery, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 21 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: LS94522
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
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 WI
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Units: FT08289 and
LN66079
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
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 WI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
GR34535
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI
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 1
unit
DISTRIBUTION WI
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
KM46136
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin,
Inc., Milwaukee, WI,
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 1
unit
DISTRIBUTION WI
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
53F53247
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
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 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: LM00051 (split
unit)
RECALLING FIRM/MANUFACTURER Inova Health Care Services,
Sterling, VA, REASON Blood products, which may have reached an
unacceptable temperature during shipment, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION VA
PRODUCT Plasma, Frozen
CODE
Units: 53FM75530, 53FX09851, 53GE94315,
53H20520
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD,
REASON Blood
products, manufactured from units of Whole Blood with an extended collection
time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION MD and DC
PRODUCT Platelets,
CODE
Unit: 53FQ00708
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake &
Potomac Regions, Baltimore, MD,
REASON Blood product, collected from a donor
for whom documentation of a hematocrit test and body temperature during the
donor screening process was discrepant, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION DC
PRODUCT Source Plasma,
CODE
Units: 04HWVD3111, 04HWVD5176, 04HWVD2288,
04HWVD2631, 04HWVD1007, 04HWVD1366, 04HWVD3173, 04HWVD4921, 04HWVC8972,
04HWVD1887, 04HWVD1702, 04HWVD2034, 04HWVD4286, 04HWVD2174, 04HWVC8913,
04HWVC9264, 04HWVC9650, 04HWVD0434, 04HWVD4175, 04HWVD2764, 04HWVD4334,
04HWVD3536, 04HWVD4584, 04HWVD4520, 04HWVD3966, 04HWVD4278, 04HWVD1082,
04HWVD0112, 04HWVD3564, 04HWVD4425, 04HWVD3512, 04HWVD5019, 04HWVD9567,
04HWVD9224
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., Huntington, WV,
REASON Blood products, collected from donors who were not
asked all of the medical history questions, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 34 units
DISTRIBUTION NC
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Unit:
53GX29113
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Regions, Baltimore, MD
REASON Blood product, collected from a donor with an
elevated body temperature, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION DC
WEEK ENDING OCTOBER 28
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: FW82106
RECALLING
FIRM/MANUFACTURER Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, WI,
REASON Blood products, manufactured from an overweight
unit of Whole Blood, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION WI
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE 53LF82627 (part 1)
RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake
& Potomac Region, Baltimore, MD
REASON Platelets, possibly
contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Source Plasma,
CODE
Units: 03MMNC5465, 03MMNC6361, 03MMNC6801,
03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122,
03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708,
03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268,
03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195,
03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644,
03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876,
03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029,
03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260,
04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646,
04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750,
04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076,
04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285,
04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652,
04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456,
04MMNC0931, 04MMNC1578
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services, L.P., Mankato, MN,
REASON Blood products, collected from a donor who was
at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 89
units
DISTRIBUTION CA and Austria
PRODUCT Red Blood Cells,
CODE
Unit: 1170906
RECALLING
FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN,
REASON Blood product, associated with a unit of Fresh
Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MN
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 53GK37120 (parts
1 and 2)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD
REASON Blood products, which were possibly contaminated
with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 53LF79988 (part
2)
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater
Chesapeake & Potomac Region, Baltimore, MD
REASON Blood product,
corresponding to a unit of Platelets that was possibly contaminated with gram
positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
53LT87457
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD
REASON Platelets, possibly contaminated with Bacillus
species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION D.C.
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced, Irradiated,
c) Fresh Frozen Plasma,
d) Plasma,
Cryoprecipitate Reduced,
e) Platelets,
f) Cryoprecipitated AHF, Pooled,
CODE
a)
Units: 0618126, 0300011, 0435473;
b) Unit: 1056384;
c) Unit:
0618126;
d) Units: 09012518, 9010640;
e) Units: 0300011, 0435473;
f)
Unit: 09012518
RECALLING FIRM/MANUFACTURER Memorial Blood Centers,
Minneapolis, MN,
REASON Blood products, which tested negative
for the antibody to Hepatitis C virus (anti-HCV), but were collected from a
donor who previously tested positive for anti-HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION FL and MN
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated
AHF,
c) Plasma,
Cryoprecipitate Reduced,
CODE
a) Units: 8666007,
0132068, 0523797;
b) Units: 0523797, 0132068, 8666007;
c) Unit:
0523797
RECALLING FIRM/MANUFACTURER Memorial Blood Centers,
Minneapolis, MN,
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 previously tested reactive for the antibody, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION MN
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Cryoprecipitated
AHF,
d) Platelets,
e) Recovered Plasma,
CODE
a)
Units: 53FM34504, 53FM36697, 53GJ19101, 53KK06088, 53KM39316;
b) Units:
53FK68042, 53FK69388;
c) Unit: 53FM36697;
d) Unit: 53GJ19101;
e) Units:
53FK68042, 53FK69388, 53FM34504, 53FM36697, 53GJ19101, 53KK06088,
53KM39316
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Chesapeake & Potomac Region, Baltimore, MD,plete.
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor who was previously deferred for a
history of hepatitis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 16 units
DISTRIBUTION CA, MD, VA, D.C., and
Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit: 53LP52167 (part
1)
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater
Chesapeake & Potomac Region, Baltimore, MD
REASON Blood product,
corresponding to a unit of Platelets that was possibly contaminated with
coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Rad Sure Blood
Irradiation Indicators,
CODE Lot Numbers:
O15811XR, O15816XR, 015811X15, 015814X15, 015819X15, 015823X15
RECALLING
FIRM/MANUFACTURER
Recalling Firm: International Specialty
Products, Inc., Wayne, NJ
Manufacturer: Kent Adhesive Products Company, Kent, OH.
REASON
Radiation stickers, which did
not darken following irradiation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 823 boxes of 200 each
DISTRIBUTION Nationwide and
Japan
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
53FJ02995
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Baltimore, MD,
REASON Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
53GQ25220
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Baltimore, MD
REASON Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
53LF83655
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Baltimore, MD
REASON Blood product, which was
collected from a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit:
LJ90713
RECALLING FIRM/MANUFACTURER Mid-South Regional Blood
Center, Memphis, TN
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
LV13961
RECALLING FIRM/MANUFACTURER Mid-South Regional Blood
Center, Memphis, TN
REASON Blood product,
which was collected from a donor who had traveled to a malarial endemic area,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a) Red Blood Cells,
b) Platelets Irradiated,
CODE
a) Units: KK52283, and KL80518;
b) Unit:
KL80518
RECALLING FIRM/MANUFACTURER Virginia Blood Services,
Richmond, VA, REASON Blood products, which were collected from a donor
who had lived in a malarial endemic area, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION A
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
29FN57848
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Norfolk, VA
REASON Blood product,
which was collected from a donor who had lived in a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE1
unit
DISTRIBUTION NC
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Unit: 2466272
(Part B)
RECALLING FIRM/MANUFACTURER Walter Reed Army Medical
Center, Washington, D.C.,
REASON Blood product, which was incorrectly labeled as
irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION D.C.
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Unit: 2466603
(Part B)
RECALLING FIRM/MANUFACTURER Walter Reed Army Medical
Center, Washington, D.C.
REASON Blood product, which was incorrectly
labeled as irradiated, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit: 5115530
(split)
RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community
Blood Bank, Augusta, GA,
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION GA
PRODUCT Plasma Frozen
Cryoprecipitate Reduced,
CODE Unit:
L67721
RECALLING FIRM/MANUFACTURER Michigan Community Blood
Centers, Grand Rapids, MI,
REASON Blood product, which was collected from a donor
who tested positive for the antibody to the hepatitis C virus (anti-HCV), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Source Plasma,
CODE
Units: RZ013603, RZ014423, RZ014865, RZ014997,
05HINB0760, 05NB0807, 05HINB0970, 05HINB1224, 05HINB1653, 5HINB2116 and
06HINA2400
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc.,
Hammond, IN
REASON Blood products, which were collected from a donor
who had a history of being incarcerated, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 11 units
DISTRIBUTION CA and
Austria
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE
Units: 4033698B 4034060C
4047973A 4047973B 4048215B 4048215C 4051012A
4051667B 4051667C 4059451B
4059451C 4060152A 4060152C 4061755B 4069909A 4070648B 4070648C 4071461B
4071461C 4071619B 4071620A 4071620B 4071620C 4071793C 4071905A 4071905C
4072098B 4072098C 4072121A 4072121B 4072554B 4072806A 4072806B 4073010B
4073010C 4073555A 4073617A 4073872A 4073872B 4074791B 4075266A 4075286A
4075600B 4075948A 4076612C 4077051A 4077297B 4077400A 4077400B 4077400C
4078386A 4078507C 4078837C 4079819A 4080066B 4080867A 4080867B 4080867C
4081046A 4081434A 4081434B 4081434C 4081564B 4081564C 4082443A 4082443B
4082443C 4082461A 4082461C 4082766B 4082815B 4083259A 4083259B 4083443A
4083443B 4083572A 4083572B 4083572C 4083795A 4083795C 4084199B 4084199C
4084714A 4084714B 4085441A 4085441B 4085515A 4085515B 4085515C 4085740A
4085996B 4085996C 4086302A 4086302B 4086302C 4086496B 4086496C 4086885B
4086891A 4086891B 4086891C 4720230B 4720230C 4720352A 4720352B 4721062A
4721062B 4721062C 4722321A 4722480A 4723181A 4723223B 4726042A 4726042B
4727340A 4727360C 4727414A 4727414C 4727553A 4727553C 4728132B 4728132C
4728343C 4728543C 4728598A 4728598B 4728598C 4728941C 4728993B 4729046C
4729056A 4729056B 4729056C 4729118A 4729118B 4729118C 4729119C 4729341A
4729341C 4729447A 4729509A 4729509C 4729521B 4729586A 4729586B 4729586C
4729618A 4729648C 4729717B 4729798C 4729816A 4729891A 4730113B 4730151A
4730151C 4730216B 4730541C 4730656C 4730771B 4730771C 4730846C 4730926B
4730935A 4730935B 4731043A 4731043C 4731241A 4731443B4731443C 4731448A
4731544C 4731622A 4731622C 4731764B 4731904A 4731904B 4731904C 4731936A
4731936B 4732006C 4732014A 4732038A 4732038C 4732068C 4732092A 4732092B
4732092C 4732115C 4732158A 4732158B 4732159A 4732159B 4732200B 4732224A
4732224B 4732229A 4732377A 4732377B 4732377C 4732378B 4732378C 4732379B
4732379C 4732413B 4732413C 4732435B 4732441A 4732441C 4732467A 4732467C
4732636A 4732636C 4732697B 4732697C 4732805B 4732805C 4732945A 4732945C
4732984B 4732984C 4733134B 4733134C 4733135B 4733135C 4733329A 4733329B
4733408A 4733408B 4905705B 4907537A 4907609A 4908691A 4908691B 4908691C
4912500A 4914345B 4916674A 4916674C 4916925A 4916925B 4916925C 4917026C
4917187A 4917678C 4918622B 4918780B 4918826A 4918826B 4918843A 4918843B
4918845B 4919085C 4919115A 4919124B 4919124C 4919229B 4919229C 4919236B
4919319B 4919319C 4919325C 4919327A 4919347A 4919347B 4919485A 4919567A
4919567C 4919569B 4919570A 4919570B 4919622B 4919642A 4919642B 4919642C
4919702B 4919702C 4919808B 4919971B 4920080B 4920086A 4920230A 4920332A
4920332B 4920332C 4920404C 4920611A 4920611C 4920769B 4920954A 4920956A
4920956C 4921041A 4921041B 4921041C 4921064A 4921064C 4921267B 4921267C
4921286A 4921286B 4921286C 4921312A 4921312C 4921347B 4921366A 4921374A
4921427C 4921445C 4921520A 4921520B 4921520C 4921625A 4921625B 4921625C
4921659B 4921659C 4921844A 4921844B 4921844C 4921935A 4921935B
RECALLING FIRM/MANUFACTURER Northwest Florida Blood Center,
Pensacola, FL
REASON Unlicensed blood
products were distributed in interstate commerce.
VOLUME OF PRODUCT IN
COMMERCE 321 units
DISTRIBUTION AL, IN, MS, TN, and NJ
PRODUCT
a) Red Blood Cells
b) Fresh Frozen Plasma,
CODE
a) and b) Unit: J21587
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA,
REASON
Blood products, possibly
contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION VA
PRODUCT Recovered Plasma
CODE
Unit: 1056384
RECALLING
FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN
REASON Blood
product, which tested negative for the antibody to Hepatitis C virus (anti-HCV),
but were collected from a donor who previously tested positive for anti-HCV, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
PRODUCT Recovered Plasma
CODE
Unit: 0132068
RECALLING
FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN
REASON Blood product which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who previously tested reactive for the antibody, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Copper Sulfate Solution
(8.3% ACS Reagent Grade Copper Sulfate
Pentahydrate in ACS Reagent Grade
Water) 500 mL; Specific Gravity = 1.053 at 25 C, CODE Lot Number: 2508266
RECALLING
FIRM/MANUFACTURER Ricca Chemical Company, Arlington, TX, REASON Copper Sulfate, with a low specific gravity, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 36
DISTRIBUTION NM, NY, PA, GA and NJ
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Units: 12KJ22979 (split)
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Charlotte, NC,
REASON Blood products, which were identified as being
contaminated by the BacT/ALERT system, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2 units
DISTRIBUTION NC
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
12FP90273
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Charlotte, NC,
REASON Blood product, which was not quarantined after
receipt of post donation information that the donor was diagnosed with anemia,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC