JANUARY 2008
WEEK ENDING JANUARY 5
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b)
Blood and Blood Products for Reprocessing - Recovered Plasma, CODE
a) and b) Unit:
55S55386
RECALLING FIRM/MANUFACTURER American National
Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR,.
REASON Blood product collected from a donor with a
gender discrepancy on his registration card, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AR and CA
WEEK ENDING JANUARY 19
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 4770940
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan
N Goldman Center, Oklahoma City, OK,
Manufacturer: Southwest Oklahoma Blood Institute, Lawton, OK. REASON
Blood product,
collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION VA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: LC66239
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON
Blood product, collected from a donor
who reported travel to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: FS09662; LC57976;
LC53857
RECALLING FIRM/MANUFACTURER Blood Center of
Wisconsin, Inc., Milwaukee, WI
REASON Blood products, collected from a
donor who visited a malarial endemic area, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION WI
PRODUCT Red
Blood Cells,
CODE Unit:
9847586
RECALLING FIRM/MANUFACTURER Lifesource,
Glenview, IL REASON Blood product, collected from a donor
who emigrated from a malarial endemic area, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT SoftBank
II Software Versions 23.x, 22.x, 21.x, and 19.x. Report Unique Identifier:
1058332-04/10/2006-014C,
CODE Sofware
Versions 23.x, 22.x, 21.x, and 19.x
RECALLING
FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL,
REASON
Software with a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1,059
units
DISTRIBUTION Nationwide and
Canada
PRODUCT Softbank
II Software Version 23.1 with database Management System Interface. Report
Unique Identifier: 1058332-04/07/2006-011-C,
CODE Software Version 23.1
RECALLING
FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL
REASON
Software with a glitch or defect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 76
units
DISTRIBUTION Nationwide and Canada
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 72C417412
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON
Blood product, with a low platelet
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Unit:
2122287
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN,
REASON Blood products,
collected from a donor who reported testing positive for Hepatitis B antibody,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN and
Switzerland
PRODUCT Red Blood Cells,
CODE
Unit: 04K569439
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Huntsville, AL,
REASON Blood product, collected from a donor
who reported testing positive for Hepatitis B antibody, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 1968503
RECALLING
FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON
Blood product, collected from a donor
whose suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red
Blood Cells,
CODE Unit:
0311769
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC
REASON Blood product, collected from
a donor taking the medication Avodart, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
and Switzerland
PRODUCT Source Plasma,
CODE
Units: 350036994;
350039186
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Grifols Biologicals, Inc., Los Angeles, CA,
Manufacturer: Biomat USA, Inc., McAllen, TX.
REASON
Blood products, collected from a donor
who received a tattoo within 12 months of donating, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION Barcelona, Spain
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Units: 2710885; 2710876; 2710882;
2710883
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN,
REASON Blood product,
documented as being out of controlled storage for more than 30 minutes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TN
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 71S393388
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc.,
Birmingham Region, Birmingham, AL,
REASON Blood product, manufactured
without additive solution, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced,
CODE Units: 71S624379 Part A; 71S624379 Part
B
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Montgomery Region, Montgomery, AL
REASON Leukoreduced
products that had WBC counts performed using samples that exceeded time frame
requirements for analysis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Recovered
Plasma,
CODE Unit:
0311769
RECALLING FIRM/MANUFACTURER The Blood Connection,
Inc., Piedmont, SC,
REASON Blood product, collected from
a donor taking the medication Avodart, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
and Switzerland
PRODUCT
Red Blood
Cells (Apheresis) Leukocytes Reduced,
CODE Units: 4452503; 4452486 (split
unit)
RECALLING FIRM/MANUFACTURER Lifesource, Glenview,
IL,
REASON
Blood products, stored at an
unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION IL
WEEK ENDING JANUARY 26
PRODUCT
a)
Buffy Coat,
b) Red Blood Cells,
c)
Platelets,
d) Fresh Frozen Plasma,
e) Recovered Plasma,
CODE
a) FV16707;
b) FV17274, FV16707,
FV16173, FV15720, FV15174, FV14583, KJ85579;
c) FV17274, FV15720, FV15174,
FV14583, KJ85579;
d) FV17274, FV15174, KJ85579;
e) FV16173, FV15720,
FV14583
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA,
REASON Blood products, which tested negative
for Hepatitis C, but were collected from a donor who previously tested positive
for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 19 units
DISTRIBUTION PA and
FL
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49KQ13791
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT, Tulsa,
OK,
REASON Blood product,
collected from a donor who traveled to an area considered endemic for malaria,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated,
CODE
Unit # 49KP05974
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region – HT, Tulsa, OK,
Manufacturer:
American Red Cross Blood Services-SW Region, Farmers Branch, TX.
REASON
Blood product, collected in a
manner that may compromised the sterility of the unit, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT
a)
Platelets,
b) Recovered Plasma,
CODE a) and b) Unit:
2607554
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood products, collected from a donor
for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX and
Switzerland
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit: 6278322 (2
units)
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT
a)
Cryoprecipitated AHF,
b) Red Blood Cells,
c) Recovered Plasma,
CODE
a), b), and c) Unit:
71N65637X
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Inc., Dunwoody, GA,
REASON Blood products, collected from a donor
who was at risk for HIV Group O, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3 units
DISTRIBUTION GA and
Switzerland
PRODUCT Red
Blood Cells, Leukocytes Reduced,
CODE Unit: C77707
RECALLING
FIRM/MANUFACTURER South Bend Medical Foundation, South Bend, IN,
REASON
Blood product, which may have been
contaminated with coagulase negative Staphylococcus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT
a)
Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen
Plasma,
c) Platelets Leukocytes Reduced,
d) Red Blood Cells Leukocytes Reduced Irradiated,
CODE
a) Units: 49GW17421, 49GW17221, 49GW17229,
49GW17397, 49GW16791,
49GW16795, 49GW16807, 49GW17380, 49GW17395, 49GW17412,
49GW17203, 49GW17206, 49GW17207, 49GW17209, 49GW17211, 49GW17215, 49GW17217,
49GW17219, 49GW17225, 49GW17226, 49GW17231, 49GW17235, 49GV21062, 49GL15483,
49GW16794, 49GW16796, 49GW16800, 49GW16801, 49GW16803, 49GW16805, 49GW16809,
49GW16811, 49GW16684, 49GW16686, 49GW16689, 49GW16693, 49GW16695, 49GW16697,
49GW16698, 49GW16661, 49GW16664, 49GW16665, 49GW16669, 49GW16671, 49GW16673,
49GW16676, 49GW16639, 49GW16646, 49GW16649, 49GW16651, 49GL15420, 49GL15421,
49GL15423, 49GL15426, 49GL15427, 49GL15432, 49GL15434, 49GL15439, 49GL15440,
49GL15441, 49GN31362, 49GN31373, 49GN31376, 49GN31379, 49GN31381, 49GN31383,
49GN31385, 49GN31388, 49GN31390, 49GW16520, 49GW16522, 49GW16523, 49GW16524,
49GW16530, 49GW16539, 49GC10805, 49GC10807, 49GC10811, 49GC10817, 49GC10823,
49GM11759, 49GM11761, 49GM11763, 49GM11768, 49GV20575, 49GV20583, 49GV20604,
49GV20622, 49GV20628, 49GV20651, 49GV20490, 49GN30699, 49GN30678;
b)
Units: 49GW17448, 49GW17405, 49GW17409, 49GW17421, 49GW17221, 49GW16791,
49GW17382, 49GW17412, 49GW17428, 49GW17430, 49GW17203, 49GW17206, 49GW17207,
49GW17215, 49GW17217, 49GW17219, 49GW17225, 49GW17226, 49GW17231, 49GW17235,
49GW16794, 49GW16684, 49GW16697, 49GW16698, 49GW16661, 49GW16669, 49GW16673,
49GW16676, 49GW16639, 49GW16646, 49GW16651, 49GL15420, 49GL15421, 49GL15423,
49GL15426, 49GL15427, 49GL15432, 49GL15434, 49GL15439, 49GL15440, 49GL15441,
49GN31362, 49GN31376, 49GN31379, 49GN31381, 49GN31385, 49GN31388, 49GW16520,
49GW16523, 49GW16524, 49GW16527, 49GW16530, 49GW16535, 49GW16537, 49GW16539,
49GC10805, 49GC10807, 49GC10811, 49GC10817, 49GC10823, 49GM11759, 49GM11761,
49GM11763, 49GM11768, 49GV20575, 49GV20583, 49GV20622, 49GV20628, 49GV20490,
49GN30698, 49GN30699, 49GN30678;
c) Units: 49GN32338, 49GN32339,
49GW17405, 49GW17409, 49GW17421, 49GW17221, 49GW17229, 49GM12123, 49GW17386,
49GW17391, 49GW17392, 49GW17403, 49GW17404, 49GW17408, 49GW17412, 49GW17413,
49GW17420, 49GW17424, 49GW17428, 49GW17203, 49GW17206, 49GW17207, 49GW17215,
49GW17217, 49GW17226, 49GW16693, 49GW16695, 49GW16697, 49GW16673, 49GW16639,
49GW16646, 49GL15423, 49GL15426, 49GL15434, 49GL15439, 49GL15440, 49GL15441,
49GN31388, 49GW16520, 49GW16530, 49GW16535, 49GW16537, 49GW16539, 49GC10823,
49GM11759, 49GM11768, 49GV20575, 49GV20583, 49GN30678, 49GW17380, 49GW17219,
49GW16684, 49GW16651;
d) Unit: 49GW16679
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK,
REASON Blood products, collected in a manner
that may have compromised the sterility of the units, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 219
units
DISTRIBUTION OK and
TX
PRODUCT
a) Red
Blood Cells Leukocytes Reduced,
b) Fresh Frozen Plasma,
c) Platelets Leukocytes Reduced,
d) Red Blood Cells Leukocytes Reduced Irradiated,
CODE
a) Units: 49GN36384, 49GN36372,
49GN36369, 49GN36362, 49GN36359, 49GW20980, 49GN36702, 49GN36713, 49GN36715,
49GN36718, 49GN36732, 49GN36737, 49GN36739, 49GN36742, 49GV23212, 49GV23211,
49GV23203, 49GV23202, 49GV23200, 49GV23198, 49GV23197, 49GV23194, 49GV23188,
49GV23182, 49GV23179, 49GN36989, 49GV36980, 49GM13778, 49GM13774, 49GM13771,
49GM13768, 49GW21559, 49GW21558, 49GW21550, 49GW21547, 49GW21545, 49GQ53350,
49GQ53329, 49GQ53315, 49GQ53295, 49GL17490, 49GL17489, 49GL17469, 49GL17465,
49GL17462, 49GW21969, 49GW21967, 49GW21965, 49GW21961, 49GM14305, 49GM14313,
49GM14318, 49GM14320, 49GM14286, 49GM14291, 49GM14295, 49GM14298, 49GV23962,
49GV23975, 49GN38764, 49GN38766, 49GN38818;
b) Units: 49GN36370,
49GN36369, 49GN36362, 49GN36359, 49GW20980, 49GN36702, 49GN36735, 49GN36737,
49GN36742, 49GV23212, 49GV23211, 49GV23203, 49GV23202, 49GV23200, 49GV23198,
49GV23197, 49GV23182, 49GV23179, 49GV36980, 49GM13779, 49GM13778, 49GM13774,
49GM13771, 49GM13768, 49GW21559, 49GW21545, 49GQ53350, 49GL17489, 49GL17490,
49GL17462, 49GW21967, 49GW21963, 49GM14313, 49GM14318, 49GM14921, 49GV23938,
49GV23943, 49GV23966, 49GV23975, 49GN38764;
c) 49GN36370, 49GN36369,
49GN36362, 49GN36359, 49GN36702, 49GN36732, 49GN36735, 49GN36737, 49GN36742,
49GV23212, 49GV23203, 49GV23200, 49GV23182, 49GV23179, 49GW21559, 49GW21550,
49GW21547, 49GW21545, 49GQ53350, 49GQ53315, 49GL17490, 49GL17489, 49GW21969,
49GW21967, 49GW21963, 49GW21961, 49GM14291, 49GM14298, 49GV23975, 49GN38764,
49GN38818;
d) 49GN36370, 49GN36735, 49GV23206, 49GV23938, 49GV23966
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK
REASON Blood products, collected in a manner
that may have compromised the sterility of the units, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 138
units
DISTRIBUTION OK, TX, NV,
UT
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49KM17577
RECALLING
FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW
Region – HT, Tulsa, OK,
Manufacturer: American Red Cross Blood Services-SW Region, Farmers
Branch, TX.
REASON Blood product, collected from a donor for whom
donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red Blood
Cells Leukocytes Reduced,
CODE Unit:
49N57219
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American National Red Cross SW Region – HT, Tulsa, OK,
Manufacturer:
American Red Cross Blood Services-Southwest Region, Harlingen, TX.
REASON
Blood product,
collected from a donor for whom donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit: 49KP10021
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK,
REASON Blood
product, which was inappropriately distributed in a single storage bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit: 8607814 (part
1)
RECALLING FIRM/MANUFACTURER Lifesource, Glenview, IL,
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red
Blood Cells,
CODE Unit:
9422860
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Lifesource, Glenview, IL,
Manufacturer:
Lifesource Portage Park, Chicago, IL.
REASON Blood product, collected from a donor
who lived in an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Platelets,
CODE
Unit:
7567127
RECALLING FIRM/MANUFACTURER Lifesource, Glenview, IL
REASON
Blood product, collected from a donor
who traveled in an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 49GV36784
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK,
REASON Blood product, collected from a donor
for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Crotalidae Polyvalent Immune Fab (Ovine),
CODE
Unit: BN200623
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Protherics Inc.,
Brentwood, TN,
Manufacturer: Protherics
U.K. Limited, Llandysul, Ceredigion, UK.
REASON The product tested subpotent ate the 24-month
time point.
VOLUME OF PRODUCT IN COMMERCE 1877
cartons
DISTRIBUTION Nationwide
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit: 2257864
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington,
KY,
REASON Blood product, which was not quarantined
after receiving post donation information concerning an illness at the time of
donation, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Red
Blood Cells Leukocytes Reduced Irradiated
CODE Units: 5911456,
5933035
RECALLING FIRM/MANUFACTURER Carter BloodCare,
Bedford, TX,
REASON Blood products, which were not returned
to controlled storage within eight hours following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT
a)
Platelets,
b) Platelets Pooled Leukocytes Reduced,
c) Platelets Pheresis Leukocytes Reduced,
d) Red Blood Cells Leukocytes Reduced Irradiated,
e) Red Blood Cells Leukocytes Reduced,
CODE
a) Units: GR44481, GR44484, GR44490,
GR44502, KC15269, and KC15275;
b) Units: GR44489, GR44509,
GR44485, GR44508, GR44506, GR44518, GR44495,
FQ55665,
LE57544, GR44491, GR44507, LJ00379, GR44483, KC15050, GR44364,
GR44379, LE57471, KC15129, LE57455, LE57445, LE57450, and
LE57422;
c) Units: KZ86759, LC35416, FQ55483, and LC35408;
d) Units:
FW60443, FW60443, FW60443, FW60443, FW60443, FW60443, FW60443,
FW60443, FW60443, FR58564, FR58564, FR58564, FR58564,
FR58564, FR58564,
FR58564, FR58564, and FR58564;
e)
Units: FJ95170, J95170, FJ95170, FQ55474, FQ55474, LC35541, LC35541, and
LC35541
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON
Blood products, which may have not met
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 58
units
DISTRIBUTION WI
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Units: 49GG20868, 49KQ14520, 49KQ14522,
49KQ14529
RECALLING FIRM/MANUFACTURER American National
Red Cross SW Region – HT, Tulsa, OK,
REASON Blood products, collected from donors
who did not have a complete health history screening, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION OK and
TX
PRODUCT Recovered
Plasma,
CODE Unit:
49KM17577
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American National Red Cross SW Region – HT, Tulsa, OK,
Manufacturer: American Red Cross
Blood Services-SW Region, Farmers Branch, TX.
REASON
Blood product, collected from a donor
for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Recovered
Plasma,
CODE Unit:
49N57219
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American National Red Cross SW Region – HT, Tulsa, OK,
Manufacturer:
American Red Cross Blood Services-Southwest Region, Harlingen, TX.
REASON
Blood product,
collected from a donor for whom donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red
Blood Cells Leukocytes Reduced,
CODE Unit: 49KQ14131
RECALLING
FIRM/MANUFACTURER American National Red Cross SW Region – HT,
Tulsa, OK,
REASON Blood
product, collected from a donor for whom donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red
Blood Cells (Apheresis) Leukocytes Reduced,
CODE Units: 1642581( Parts 1 and 2), 1669201
(Parts 1 and 2)
RECALLING FIRM/MANUFACTURER Hoxworth
Blood Center UC Medical Center, Cincinnati, OH,
REASON
Blood
products, collected from a donor who was taking the medication Enbrel, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION OH