APRIL 2005

WEEK ENDING APRIL 9

PRODUCT Human Tissue for Transplantation, Corneas. 
CODE 04121203R and 04121203L.
RECALLING FIRM/MANUFACTURER Center for Organ Recovery & Education, Pittsburgh, PA
REASON Human tissue for transplantation, collected from a donor whose sexual partner tested positive for the hepatitis C virus (HCV) by NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION CA and PA.

PRODUCT Red Blood Cells for further manufacture into non-injectable products. 
CODE Unit: UM007279.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank Inc., Memphis, TN
REASON Blood product, processed from a unit of whole blood that had not been tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells. 
b) Platelets.                 
c) Fresh Frozen Plasma. 
CODE a), b), and c) Unit: KS72484.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood products, processed from a unit of whole blood that tested negative for CMV but was collected from a donor who previously tested CMV positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets. 
c) Fresh Frozen Plasma. 
CODE
a) Units: 53GE69468, 53L60812, 53L51874;
b) and c) Units: 53L60812, 53L51874.
RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD,
REASON Blood products, collected from a donor taking the medical Amiodarone, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION MD, and DC.

PRODUCT Source Plasma. 
CODE Units 0490339933, 0490339693, 0490339050, 0490337817, 0490337351, 0490336375, 0490335521, 0490335373, 0490334545.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Grand Prairie, TX
REASON Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION NC.

PRODUCT Source Plasma. 
CODE Units 12279012, 12276721.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc. of Wisconsin, Madison, WI,
REASON Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Recovered Plasma. 
CODE Units 14F75, 14G37, 41H73, 21I70, 47I19, 65J08, 78K84, 73P26, 77P34, 00Q51, 77W78, 01X12, 12B82, 91U42, 01W21, and 71U91.
RECALLING FIRM/MANUFACTURER Mayo Clinic Rochester, Division of Transfusion Medicine, Rochester, MN
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from donors who previously tested repeatedly reactive for anti-HIV and negative by Western Blot test, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION FL, PA, CA, and MN.

PRODUCT
a) Red Blood Cells. 
b) Recovered Plasma. 
CODE
a) Units 18R33721 and 18W56823;
b) Unit 18W56823.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Lansing, MI
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from a donor who had previous tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI and CA.

PRODUCT Platelets. 
CODE Unit K89107.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit 17FH87764.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Shoreview, MN
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 WI.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma. 
CODE a) and b) unit 11FT02739.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from a donor who had previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL, and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit 19GR48444.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Problem:  Blood product, corresponding to Fresh Frozen Plasma that was possibly contaminated with Staphylococcus and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT
a) Platelets. 
b) Platelets Leukocytes Reduced.
c) Fresh Frozen Plasma. 
CODE
a) Units 19GF48042, 19GH26355, 19GF59069, 19GK30014, 19GZ43875, 19GF63720, 19GF58503, 19GW31786,
19LF09902, 19LF09915, 19GZ38296, 19GF63312, and 19LS00199;
b) Units 19GH32634 and 19GZ54064;
c) Units 19GH25248, 117T30776, and 19GR21359.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Nashville, TN
REASON Blood products, which were manufactured from whole blood units in which the corresponding red blood cells contained clots, were distributed
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION TN, KY, and AL.

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit 27LT27190.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA
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 WV.

PRODUCT Cryoprecipitated AHF. 
CODE Unit GJ98736.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, which was manufactured from whole blood in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit number: 19GK86461.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT
a) Red Blood Cells for further manufacture into non-injectable products. 
b) Human Serum for further manufacture into non-injectable products. 
CODE a) and b) Unit BT104584.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank Inc., Memphis, TN
REASON Blood products, processed from a unit of whole blood that had not been tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL and TX.

PRODUCT Red Blood Cells. 
CODE Units: KJ69674, KJ69632, LF65478, LF65476, LR62167.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood products, with hematocrits potentially above the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA.

PRODUCT Platelet Pheresis, Leukoreduced. 
CODE Unit: 53LP45266.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD
REASON Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT Red Blood Cells (Apheresis). 
CODE Units KC66017 and E96516, and E98394.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA.

PRODUCT Fresh Frozen Plasma, Pheresis. 
CODE Units 26FQ18378, 26FQ18379, 26FQ18419, 26FQ18407, 26FQ18415, 26FR02483.
RECALLING FIRM/MANUFACTURER American National Red Cross, Gulf Coast Region, Mobile, AL
REASON Unlicensed blood products, labeled with the firm's license number, were distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NY and TN.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 12FZ32146.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor whose body temperature was not properly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit 12LW95749.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor with a low body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

WEEK ENDING APRIL 16

PRODUCT FETALSCREEN. 
CODE Lots FS451, FS452, FS453.
RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics, Inc., Raritan, NJ
REASON FETALSCREEN test kits, demonstrating weak or negative reactivity with the positive control, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5,808 kits, 3 lots.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
Human Tissue for Transplantation. 
a) CryoGraft, Achilles Tendon;
b) Semitendinosus/Gracilis Tendons;
c) CryoVein, Saphenous Vein;
d) CryoGraft, Tibialis Tendon;
e) CryGraft, Arotoiliac Artery;
f) CryoVein, Femoral Vein;
g) CryoGraft, Medial Meniscus Bone-Left;
h) CryoGraft, Quadriceps Tendon-Hemi;
i) CryoGraft, Hemi Patellar Tendon;
j) CryoGraft, Pulmonary Artery;
k) CryoGraft, Medial Meniscus Bone-Right;
l) Femoral-Popliteal Artery;
m) CryoGraft, Pulmonary Trunk Patch;
n) CryoGraft, Lateral Meniscus Bone-Left;
o) CryoVein, Femoral Vein with valve;
p) CryoGraft, Patellar Tendon, Whole;
q) CryoGraft, Pulmonary Monocusp Hemi-Artery-SG.
CODE
a) Donor #40205, Serial #4237153, Donor #40205, Serial #4237161, Donor #42334, Serial #4273184, Donor #42743, Serial #4283114, Donor #43376, Serial #4287127, Donor #44078, Serial #4314675, Donor #44161, Serial #4304965, Donor #44874, Serial #6684820, Donor #47377, Serial #6817189, Donor #49840, Serial #6884820, Donor #50007, Serial #7097239, Donor #50491, Serial #7136220;
b) Donor #39486, Serial #4232127, Donor #40205, Serial #4243838, Donor #42334, Serial #4273249, Donor #43543, Serial #4300965, Donor #43921, Serial #4310590, Donor #44161, Serial #6661976, Donor #44343, Serial #4306160, Donor #45620, Serial #6710115, Donor #48046, Serial #6841255, Donor #49840, Serial #6889818, Donor #50007, Serial #7103288, Donor #50505, Serial #7142949, Donor #52822, Serial 7060782, Donor #54197, Serial #7216030, Donor #54197, Serial #7220332, Donor #54756, Serial #7218658, Donor #57383, Serial #7320357;
c) Donor #40205, Serial #6553788, Donor #41907, Serial #6599621, Donor #42357, Serial #6614914, Donor #42539, Serial #6615988, Donor #42822, Serial #6626599, Donor #42898, Serial #6634087, Donor #43276, Serial #6647996, Donor #43276, Serial #6648019, Donor #43543, Serial #4300645, Donor #43543, Serial #4300690, Donor #43921, Serial #4308516, Donor #44385, Serial #6668752, Donor #45564, Serial #6724601, Donor #45879, Serial #6725908, Donor #47396, Serial #6840601, Donor #47563, Serial #6769018, Donor #47563, Serial #6769053, Donor #47810, Serial #6812564, Donor #48551, Serial #6805622, Donor #48923, Serial #6859237, Donor #50731, Serial #7006363, Donor #52050, Serial #7037340, Donor #52101, Serial #7125063, Donor #53358, Serial #7266253, Donor #54213, Serial #7286677, Donor #55139, Serial #7238163, Donor #55551, Serial #7155385, Donor #56156, Serial #7294558, Donor #57045, Serial #7389855, Donor #57383, Serial #7458784;
d) Donor #40482, Serial #4245105, Donor #40658, Serial #4267702, Donor #42334, Serial #4273265, Donor #43531, Serial #4298960, Donor #43531, Serial #4303686, Donor #43541, Serial #4299968, Donor #43543, Serial #4300956, Donor #43921, Serial #4305381, Donor #44727, Serial #6683408, Donor #44908, Serial #6677200, Donor #47377, Serial #6816973, Donor #47377, Serial #6817267, Donor #47563, Serial #6797186, Donor #48038, Serial #6831542, Donor #48038, Serial #6831576, Donor #48046, Serial #6839019, Donor #48923, Serial #6846991, Donor #49840, Serial #6891073, Donor #50491, Serial #7143846, Donor #50505, Serial #7007618, Donor #50505, Serial #7142965, Donor #51119, Serial #7042347, Donor #51818, Serial #7039379, Donor #52543, Serial #7063510, Donor #52822, Serial #7126124, Donor #53545, Serial #7020110, Donor #54056, Serial #7210499, Donor #54056, Serial #7210543, Donor #54068, Serial #7216624, Donor #54080, Serial #7204438, Donor #54471, Serial #7283591, Donor #54474, Serial #7287478, Donor #54474, Serial #7287483, Donor #54676, Serial #7182629, Donor #54756, Serial #7213614, Donor #54756, Serial #7213621, Donor #54756, Serial #7218632, Donor #55299, Serial #7228353, Donor #57412, Serial #7451149, Donor #57412, Serial #7453116, Donor #57538, Serial #7403808;
e) Donor #42048, Serial #6601936, Donor #57045, Serial #7303651;
f) Donor #42048, Serial #6602983, Donor #47396, Serial #6823052, Donor #47810, Serial #6813725, Donor #47946, Serial #6842949, Donor #52318, Serial #7128210, Donor #55551, Serial #7158126, Donor #57123, Serial #7317690, Donor #58134, Serial #7423827;
g) Donor #42285, Serial #4277287, Donor #42926, Serial #6643901, Donor #50505, Serial #7137749, Donor #57045, Serial #7439333;
h) Donor #42285, Serial #4277333, Donor #42334, Serial #4273222, Donor #42926, Serial #6643867, Donor #55551, Serial #7155689;
i) Donor #39803, Serial #4238249, Donor #42285, Serial #4277414, Donor #42334, Serial #4273214, Donor #42743, Serial #4281872, Donor #43531, Serial #4298999, Donor #44161, Serial #4309599, Donor #46162, Serial #6729798, Donor #47042, Serial #6779199, Donor #47377, Serial #6817221, Donor #48046, Serial #6838991, Donor #48673, Serial #6802485, Donor #48923, Serial #6848964, Donor #49063, Serial #6846765, Donor #48940, Serial #6885394, Donor #50505, Serial #7137729, Donor #50608, Serial #7142637, Donor #52213, Serial #7085784, Donor #54474, Serial #7286884, Donor #57436, Serial #7320787;
j) Donor #42409, Serial #6619959, Donor #52796, Serial #7072290, Donor #54197, Serial #7176168;
k) Donor #42539, Serial #4284122, Donor #47042, Serial #6779189, Donor #48797, Serial #6893056, Donor #48923, Serial #6847825, Donor #50608, Serial #7142613, Donor #50703, Serial #7005438, Donor #52822, Serial #7125857, Donor #54056, Serial #7184433, Donor #54197, Serial #7215958, Donor #55621, Serial #7243611, Donor #57383, Serial #7397977, Donor #57656, Serial #7456757; l) Donor #44635, Serial #6692839, Donor #45620, Serial #6734318, Donor #51818, Serial #7032820, Donor #52097, Serial #7037706, Donor #52097, Serial #7037719, Donor #55393, Serial #7247045, Donor #57045, Serial #7316929;
m) Donor #46111, Serial #6723904;
n) Donor #52213, Serial #7037494;
o) Donor #52818, Serial #7120893;
p) Donor #54080, Serial #7204457, Donor #57884, Serial #7432991;
q) Donor #57172, Serial #7310447.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissue, associated with positive microbiological culture results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 165 tissues.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Red Blood Cells. 
b) Red Blood Cells (Apheresis). 
c) Red Blood Cells, Leukocytes Reduced.
d) Red Blood Cells (Apheresis) Leukocytes Reduced.
e) Red Blood Cells, Leukocytes Reduced, Irradiated.
f) Red Blood Cells, Washed. 
g) Red Blood Cells, Leukocytes Reduced, Washed.
h) Red Blood Cells, Deglycerolized, Leukocytes Reduced. 
i) Red Blood Cells, Frozen. Recall # B-0873-5;
j) Platelets Pheresis, Leukocytes Reduced.
k) Platelets Pheresis, Leukocytes Reduced, Irradiated. 
l) Platelets Pheresis Irradiated, 
m) Fresh Frozen Plasma. 
n) Fresh Frozen Plasma (Apheresis).
o) Plasma Frozen. 
p) Recovered Plasma. 
CODE Blood products, collected between May 30, 2002 and March 8, 2004, of the above types:
RECALLING FIRM American Red Cross, New England Region, Dedham, MA
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16,393.
DISTRIBUTION Nationwide.

PRODUCT

a) Red Blood Cells. 
b) Red Blood Cells, Leukocytes Reduced.
c) Red Blood Cells, Leukocytes Reduced, Irradiated. 
d) Platelets. 
e) Platelets, Irradiated. 
f) Fresh Frozen Plasma. 
g) Plasma. 
h) Red Blood Cells for Further Manufacture of Non-injectables. 
CODE Products collected between April 2001 and July 2003, of the above types:
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3,279 units.
DISTRIBUTION PA, WV, OH, MD, KY, VA, SC, MA, NC, and GA.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. 
CODE
a) Units 4383991 (split unit), 4217025 (split unit), 0109018 (split unit);
b) Units 4217025, 0109018.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Removed.
CODE a) and b) Unit number: 19LM18516.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Tennessee Valley Region, Nashville, TN
Manufacturing Firm: American Red Cross, Tennessee Valley Region, Murfreesboro, TN. .
REASON Blood products, possibly contaminated with coagulase-negative, Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN, and KY.

PRODUCT
a) Platelets, Leukocytes Removed.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number: 19LY67676.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, possibly contaminated with coagulase-negative, Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN, and GA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma. 
CODE
a) Unit numbers: 19GM25728, 19GM25730, 19GR52929, 19GR52935, and 19GR52937;
b) Unit numbers: 19GR52929, 19LM23591.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, possibly contaminated with Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION TN, and KY.

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit 93V11382.
RECALLING FIRM/MANUFACTURER The Cooley Hospital Blood Bank, Northampton, MA
REASON Blood product, which was confidentially identified by the donor to be excluded for donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells Apheresis Leukocytes Reduced. 
CODE Unit 02KF01726.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA
REASON Blood product, which did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells Leukocytes Reduced. .
CODE Unit 182357406.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Wyoming and Switzerland

PRODUCT Source Plasma. 
CODE Units 98MWIB7456 and 98MWID2954.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Menasha, WI
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Units 12K95373, 12R41197.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
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 NC.

PRODUCT

a) Red Blood Cells. 
b) Platelets. 
c) Recovered Plasma. 
CODE a), b), and c) Unit 19GW34523.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Nashville, TN
REASON Blood products, which were collected from a donor who provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY, and CA.

 

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit 12M25628.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor with a history of cancer, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT

a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma. 
CODE a) and b) Unit number: 19LM23659.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, possibly contaminated with coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Red Blood Cells. 
CODE Unit number: 12LR15625.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC
REASON Blood product, that was not properly quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Platelets. 
CODE Unit KL11943.
RECALLING FIRM/MANUFACTURER Lancaster Regional Medical Center, Lancaster, PA
REASON Blood product, collected from a donor taking Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Recovered Plasma. 
CODE Unit 182357406.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Wyoming and Switzerland 

WEEK ENDING APRIL 23

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Units 6025228, 6025579, 6025227, 6025097, 6025352, 6025374, 8516466, 6025012, 6025017, 6025288, 6025541, 6025572, 6024976, 8516454, 8516566, 8516582, 6025075, 6025310, 6025048, 6025077, 6025286, 6025320, 6025429, 6025510, 6025564, 6025571, 8516567, 6025243, 6025244, 8516588, 8516551, 6025194, 6025203, 6025255, 6025258, 8516457, 6025550, 6025069, 6025062, 6025092, 6025100, 6025122, 6025123, 6025139, 6025328, 6025329, 8516439, 8516479, 8516504, 6025267, 6025305, 6025422, 6025458, 6025467, 6025129, 6025412, 8516587, 6024926, 6024931, 6024978, 6025039, 6025185, 6025189, 6025191, 6025200, 6025301, 6025418, 6025439, 6025155, 6025434, 6025474, 6024940, 6025018, 6024991, 6025050, 6024939, 6024949, 6025021, 6025058, 6025080, 6025084, 8516420, 8516437, 8516458, 6025379, 6025442, 6025456, 6025459, 6025463, 6025472, 8516536, 8516590, 8516422, 6024951, 6025049, 6025061, 6025160, 6025343, 6025414, 6025516, 6025078, 6025152, 8516424, 6025237, 6024986, 6025000, 6025010, 6025195, 6025256, 8516468, 6025261, 6025268, 6025287, 6025308, 6025332, 6025403, 6025421, 6025465, 6025475, 6025495, 6025534, 6025120, 6025283, 6024958, 6025197, 6025483, 8516417, 8516452, 6025391, 8516515, 8516517, 8516548, 8516598, 6025527, 6025088, 6025112, 6025008, 6025016, 8516499, 6025358, 6024927, 6025154, 6025007, 6025023, 6025158, 6025368, 6025213, 6025105, 6025124, 6025135, 6025151, 8516425, 8516456, 6025264, 6024944, 6024953, 6024977, 6025253, 8516474, 6025270, 6025415, 6025419, 6024946, 8516405, 6025231, 6025171, 6024950, 6025545, 6025114, 6015205, 6025216, 6025246, 6025460, 6024992, 6025103, 6025146, 6025148, 6025453, 6025461, 6025314, 6025386, 6025404, 6025489, and 6025509.
RECALLING FIRM/MANUFACTURER Blood Bank of Delmarva, Inc., Newark, DE
REASON Blood products, collected from donors with unacceptable hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 184 units.
DISTRIBUTION DE, and MD.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit 12Q68077.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Cryoprecipitated AHF. 
CODE Unit 12FX79622.
RECALLING FIRM American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. 
b) Platelets, Leukocytes Reduced. 
CODE
a) Units 19LM13863, 19LQ29403;
b) Unit 19LM13863.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY, and TN.

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.
CODE Unit 04R23619.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Platelets Leukocytes Removed. .
CODE Unit 19GR46019.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, possibly contaminated with Bacillus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit 19GL52888.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Platelet Pheresis, possibly contaminated with coagulase-negative, Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Deglycerolized, Leukocytes Reduced. 
CODE Unit number: 8463338.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA
REASON Blood product, that was not properly quarantined after the receipt of confirmed positive Hepatitis B Surface Antigen (HBsAg) test results, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
LA.

PRODUCT Source Plasma. 
CODE Unit numbers: 00203180, 00225250, 00246453, and 00275514.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lansing, MI
REASON Blood products, which were collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells. 
CODE Unit 04GF41981.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT
a) Red Blood Cells Leukocytes Reduced. 
b) Recovered Plasma. 
CODE
a) and b) Unit 04KL74881.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON Blood products, which were collected from a donor who provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY and CA.

PRODUCT
a) Red Blood Cells. 
b) Red Blood Cells, Leukocytes Reduced. 
c) Red Blood Cells, Washed. 
d) Red Blood Cells, Frozen.
e) Platelets. 
f) Platelets Pheresis, Leukocytes Reduced. 
g) Cryoprecipitated AHF. 
h) Fresh Frozen Plasma. 
i) Plasma, Cryoprecipitate Reduced. 
CODE Blood products, collected between May 2001 and April 2003, of the types listed above.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS
REASON Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 23,364 units
DISTRIBUTION Nationwide.

PRODUCT
a) Platelets Pheresis Leukocytes Reduced, 
b) Platelets Pheresis Leukocytes Reduced Irradiated, 
CODE a) and b) Unit 12W86533.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON Blood product, which was collected from a donor in which a satisfactory arm inspection was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit number: 04GH12559 (Part 1).
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA
REASON Platelets Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Platelets Pheresis Leukocytes Reduced, 
CODE Unit number: 04LP61765 (Parts A, B, and C).
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA
REASON Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Units 19FZ06300, 19LM18507, 19LQ35595, 19GF44527, 19GK69445, 19GH47875, 19GC15959, 19GN04800.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION TN.

WEEK ENDING APRIL 30

PRODUCT Platelets Pheresis, Leukocytes Reduced, Part B. 
CODE Unit 0891463.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson , TN 
REASON Platelets, implicated in a transfusion reaction and contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma. 
CODE Units: 04RMIC4718, 04RMIC4439, 04RMIC4040, 04RMIC3793, 04RMIC3348, 04RMIC3076, 04RMIC2658, 04RMIC2420, 04RMIC0800, 04RMIC0562, 04RMIC0147, 04RMIB9903, 04RMIB9488, 04RMIB9228.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Kentwood , MI 
REASON Problem: Blood products, collected from a donor who reported self-removal of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION NC.

PRODUCT Fresh Frozen Plasma. 
CODE Unit: 19GY15826.
RECALLING FIRM The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, corresponding to a unit of contaminated platelets, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukoreduced. 
CODE Unit: 26FG18421.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Gulf Coast Region, Mobile, AL
REASON Blood product, collected from a donor whose arm preparation was inadequate, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Platelets Pheresis, Leucocytes Reduced. 
CODE Units: 04KE43718-1, 04KE43718-2 ( Split product).
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood Products, collected in a manner that may have compromised sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. 
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. 
CODE
a) Unit numbers: 19GL48123 (part 1 and 2), 19GL47879, 19GL47962 (part 1 and 2), 19GL48179 (part 1), 19GL48095 (part 1 and 2), 19GL47965 (part 2), 19GL47954 (part 1), 19GL47904 (part 1 and 2), 19GL47897 (part 1), 19GL47829 (part 2), 19GL48025 (part 1), 19GL47946 (part 1), 19GL47884 (part 1 and 2), 19GL48132 (part 1), 19GL48069 (part 1), 19GL48042 (part 1 and 2), 19GL48176 (part 1), 19GL48026 (part 1 and 2), 19GL48127 (part 1 and 2), 19GL48148 (part 1), 19GL47936 (part 1), 19GL49045 (part 1), 19GL48205 (part 1 and 2), 19GL48199 (part 1 and 2), 19GL48063 (part 1), 19GL48039 (part 1), 19GL47887 (part 1);
b) Unit numbers: 19GL48139, 19GL47881 (part 1 and 2), 19GL47832, 19GL48190, 19GL48025 (part 2), 19GL47940, 19GL47905, 19GL47829, 19GL48052 (part 1 and 2), 19GL47965 (part 1).
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Platelet Pheresis products, lacking monthly quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 49 units.
DISTRIBUTION TN, and AR.

PRODUCT Human Cornea Tissues for Transplantation. 
CODE Tissues 012-04-183, 012-04-184.
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye Bank, Knoxville , TN 
REASON Human corneas, procured from a donor who tested repeatedly reactive for the antibody to hepatitis B core antigen (anti- HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION TN, and Jordan.

PRODUCT Red Blood Cells. 
CODE Unit number: 008716.
RECALLING FIRM/MANUFACTURER United States Blood Bank, Inc., Miami , FL 
REASON Blood product, possibly contaminated with coagulase-negative, Staphylococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelet Pheresis, Leukoreduced, Irradiated. 
CODE Units: 19GN88031, 19GJ78567, 19GJ78559, 19GF11239, 19GN88016, 19LY56019, 19LY56005, 19LY56026, 19GN88042, 19GJ78558, 19GJ78578, 19LY56033.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, that were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Leukoreduced, Irradiated. 
CODE Units: 19GF29894, 19LW21464, 19LQ31612.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, that were out of controlled storage for more than 30 minutes, were distributed
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TN.

PRODUCT Platelet Pheresis, Leukoreduced, Irradiated. 
CODE Units: 19GL40204, 19GL40209.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, that were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukoreduced. 
CODE Unit: 19LW37687.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells. 
CODE Unit numbers: 12LG21096, 12LG22405.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from an ineligible donor due to a history of spherocytosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 19LT05640.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, which were not properly quarantined after receiving information concerning post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit numbers: 027LC42217, 027LC42226, 027LC42232, 027LC42245, 027LC42247, 027LC42250, 027LC42255, 027LC42258, 027LC42260, 027LC42263, 027LC42264, 027LC42267, 027LC42269, 027LC42270, 027LC42273, 027LC42275, 027LC42283, 027LC42286, 027LC42290, 027LC42294, 027LC42297, 027LC42299.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood products, collected using trip scales that lacked quality control documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 Units.
DISTRIBUTION MD, WV, and PA.

PRODUCT
a) Fresh Frozen Plasma. 

b) Fresh Frozen Plasma Pheresis. 
CODE
a) Units 19GF53293 (Part 1, Part 2, and Part 3);
b) Units 19GL46438, 19GL46443, 19GT32085 ,19LP09584, 19LP09586.
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION AL, KY, and TN.