OCTOBER 2005
WEEK ENDING OCTOBER 8
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit number:
18236-8169
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Cheyenne, WY.
REASON
Blood product, collected from a donor whose
medical history screening was incomplete, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocyte Reduced
CODE Unit numbers.: 200362026,
200362262, 200362207, 200362238, 200362239, 200362256, 200362226, 200369793,
200357198, 200367542, 200367539, 200360336, 200361068, 20361701, 200361107,
200360963, 200359756, 200366820, 200361109, 200367560, 200367564, 200367558,
200367559, 200361541, 200361511, 200367490, 200361529, 200361531, 200361524,
200361542, 200361536, 200361436, 200361446, 200361434, 200361555,
200361552
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Cheyenne, WY.
REASON Blood products, for which were out of
refrigeration for an unspecified time, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 36 units
DISTRIBUTION LA, AZ, and NV
PRODUCT
a) Red Blood Cells,
Leukocyte Reduced,
b) Source Leukocytes
CODE a) and b) Unit number: 4678555
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON
Blood products, collected from an unreliable donor,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX and NJ
PRODUCT Red Blood Cells (Apheresis) Leukocyte
Reduced
CODE Unit number:
4922434 double collection
RECALLING FIRM/MANUFACTURER Gulf Coast
Regional Blood Center, Houston, TX
REASON Blood products, collected from
an ineligible donor, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocyte Reduced
CODE Unit number:
7032269
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
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 CO
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit numbers: 7039795 and
7049672
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocyte Reduced,
CODE
a) Unit number: 6577212;
b) Unit numbers: 6509405
and 6574298
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
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 3
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 0752939
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 PA
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocyte Reduced,
CODE
a) Unit number: 6830384;
b) Unit number:
6832882
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
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 CO and FL
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Irradiated,
c) Red Blood Cells Leukocytes Reduced,
d)
Red Blood Cells Leukocytes Reduced Irradiated
e) Platelets
f) Platelet Pheresis Leukocytes
Reduced,
g) Platelet Pheresis Leukocytes Reduced Irradiated
h) Cryoprecipitated
AHF,
CODE
a)
Unit numbers: 9983181, 9989011, 9983922, 9959964, 9968355, 9959965, 9968354,
9981165, 9960679, 9968360, 9981158, 9973981, 9973986, 9989000, 9989004, 9989012,
9975552, 9975561, 9961716, 9961726, 9960684, 9989038, 9981170, 9981175, 9960695,
9961731, 9970872, 9983904, 9963277, 9981154, 9970870, 9970873, 9970875, 9989003,
9989018, 9975547, 9960683, 9937174, 9961039, 9981176, 9961736, 9975551, 9961037,
9968359, 9968364, 9981177, 9983173, 9970878, 9989008, 9989019, 9975558, 9959950,
9971311, 9971316, 9971324, 9971300, 9983908, 9969641, 9960689, 9989017, 9975562,
9975565, 9975566, 9961044, 9961713, 9983943, 9989026, 9937172, 9971306, 9973976,
9989001, 9975563, 9975568, 9959946, 9961728, 9970871, 9971312, 9960693, 9989015,
9981153, 9981156, 9939180, 9983150, 9960700, 9989007, 9959953, 9961040, 9970877,
9937173, 9908967, 9983936, 9983912, 9989031, 9961730, 9970897, 9969640, 9983152,
9959954, 9959962, 9983941, 9989032, 9989039, 9981178, 9983174, 9970885, 9970890,
9970892, 9975553, 9971309, 9971319, 9983143, 9989035, 9959961, 9970881, 9981157,
9989016, 9975555, 9961042, 9961047, 9961720, 9908964, 9939197, 9981162, 9981168,
9975969;
b) Unit number: 9983144;
c) Unit numbers: 9961727, 9989024,
9981163, 9970894, 9970901, 9939190, 9961712,9971322, 9989020, 3807671, 9971320, 9989022, 9961718, 9960676, 9968363;
d) Unit numbers: 9981171,
9960687, 3807671, 3809775-1, 3809775-2, 3809776, 9961717, 9939194,
9961737;
e) Unit numbers: 9989011, 9961736, 9989019, 9961720, 9981156,
9989018, 9959946, 9989017, 9975562, 9989022, 9973986, 9989001, 9989004,
9989007, 9989012, 9989016, 9975561, 9975563, 9975568, 9961040, 9961042,
9961728, 9970871, 9970872;
f) Unit numbers: 3812867, 3812873, 3812875,
3812620, 3812866, 3812872, 3812875, 3812615, 3812616, 3811240, 3812616,
3812868-1, 3812868-2, 3812619, 3812622, 3812872, 3811243;
g) Unit
numbers: 3811655, 3811243, 3812617, 3811242-1, 3811242-2, 3812867;
h) Unit
number: 9908967
RECALLING FIRM/MANUFACTURER The Blood Center, New
Orleans, LA
REASON Blood products, on which CMV testing was
incorrectly performed, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 198 units
DISTRIBUTION LA, MS and PA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocyte Reduced,
CODE
a) Unit number: 6884692;
b) Unit numbers: 6886512,
6882894
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
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 3
units
DISTRIBUTION CO and MS
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocyte Reduced,
CODE
a) Unit number: 7032144;
b) Unit numbers: 7025800,
7041771
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
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 3
units
DISTRIBUTION CO
PRODUCT Platelet Pheresis
Leukocytes Reduced,
CODE Unit number:
9011270
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc.,
Greenville, SC,
REASON Blood product, with platelet yield below the
specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION SC
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocyte Reduced,
CODE
a) Unit number: 6853032;
b) Unit numbers: 6864520
and 6858378
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 6625176
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 CO
PRODUCT Red Blood Cells
CODE
Unit number: 6636860
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
6623990
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 6579619
and 6577218
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were 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 CO and NY
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocyte Reduced,
c) Platelets Pheresis Leukocytes Reduced,
CODE
a) Unit number: 6941496;
b) Unit numbers: 6944676
and 6449462;
c) Unit number: 6447621
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected from an
unsuitable donor based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 6871288
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 IL
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced,
b) Platelets Pheresis
Leukocyte Reduced,
CODE
a) and b) Unit
numbers: 6946738 and 6944671
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which
were collected from an unsuitable donor based on travel to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 6602961
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 IL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6611790
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 IL
PRODUCT Red Blood Cells
CODE
Unit numbers: 6173181 and 6138140
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which were 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 CO and UT
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6943751
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit number: 6613568;
b) Unit number:
6620387
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood products, which were 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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit number: 6886163;
b) Unit number:
6887956
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which were 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 CO and PA
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit number: 6846710;
b) Unit number: 6948999,
6944229 and 6940971
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which were
collected from an unsuitable donor based on travel to an area considered endemic
for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 7039980,
7034080 and 7028246
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which were
collected from an unsuitable donor based on travel to an area considered endemic
for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO and NY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
B) Cryoprecipitated AHF
CODE a) and b) Unit number: 030GR12543
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Northeastern
Pennsylvania Region, Ashley, PA
REASON Blood
products, collected from an ineligible donor due to history of Melanoma cancer,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA and CT
PRODUCT Platelet Pheresis
Leukocytes Reduced
CODE Unit number:
12KJ99973
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who traveled
to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Platelet Pheresis
Leukocytes Reduced
CODE Unit numbers: KC29462
(2 units from split)
RECALLING FIRM/MANUFACTURER Tri-Counties Blood
Bank, Santa Barbara, CA
REASON Platelets, with insufficient plasma volume to
support the platelet yield, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA
PRODUCT
a)
Level 1 H-31B Air
Detector / Clamping Devices
b) Level 1 H-1200 Fast Flow Fluid Warmers (with
integrated H-31 B Air Detector Clamp),
c) Level 1 H-31B Air Detector/ Clamping Device (US 115v):
d) Level 1 H-31B Air Detector/ Clamping Device
(International 230V):
CODE
a) Level 1 H-1200 Fast Flow Fluid Warmer System with
Integrated H-31B Air Detector/Clamp (US 115v):
20030009 20030033 20040014
20040433 20050003 20050006 20050013 20050034 20050088 20050089 20050090 20050091
20050092 20050093 20050094 20050095 20050096 20050097 20050098 20050099 20050100
20050102 20050104 20050107 20050108 20050109 20050110 20050111 20050112 20050113
20050114 20050115 20050116 20050117 20050118 20050119 20050120 20050128 20050130
20050133 20050134 20050135 20050136 20050137 20050138 20050139 20050140 20050141
20050142 20050143 20050146 20050148 20050150 20050151 20050152 20050154 20050155
20050156 20050158 20050159 20050160 20050161 20050162 20050163 20050164 20050165
20050166 20050168 20050169 20050170 20050171 20050172 20050173 20050174 20050175
20050176 20050178 20050179 20050180 20050181 20050182 20050183 20050184 20050185
20050186 20050187 20050188 20050189 20050190 20050191 20050192 20050193 20050194
20050195 20050196 20050197 20050198 20050199 20050202 20050204 20050206 20050207
20050208 20050209 20050210 20050211 20050212 20050213 20050214 20050215 20050216
20050217 20050218 20050219 20050220 20050221 20050222 20050223 20050224 20050225
20050226 20050227 20050228 20050229 20050230 20050231 20050232 20050233 20050234
20050235 20050236 20050237 20050238 20050239 20050240 20050241 20050242 20050244
20050245 20050246 20050247 20050248 20050249 20050250 20050251 20050252 20050253
20050254 20050255 20050256 20050257 20050258 20050259 20050260 20050261 20050262
20050263 20050264 20050265 20050266 20050267 20050268 20050269 20050270 20050272
20050273 20050275 20050276 20050277 20050278 20050279 20050281 20050283 20050284
20050288 20050289 20050290 20050293 20050294 20050295 20050296 20050298 20050301
20050303 20050305 20050306
b) Level 1 H-1200 Fast Flow Fluid Warmer System
with Integrated H-31B Air Detector/Clamp (International 230v): 20050013
20050014 20050016 20050017 20050018 20050019 20050020 20050023 20050024 20050025
20050026 20050027 20050028 20050029 20050030 20050031 20050032 20050033 20050034
20050035 20050036 20050037 20050038 20050039 20050040 20050041 20050042 20050043
20050044 20050045 20050046 20050047 20050048 20050049 20050050 20050051 20050052
20050053 20050054 20050055 20050056 20050057 20050058 20050059 20050060 20050061
20050062 20050063 20050064 20050065 20050066 20050067 20050068 20050069 20050070
20050071 20050072 20050073 20050074 20050075 20050076 20050077 20050078 20050079
20050080 20050081 20050082 20050083 20050089 20050101 20050121 20050122 20050123
20050124 20050126 20050127 20050129 20050130 20050131 20050132 20050134 20050167
20050177 20050200 20050201 20050203 20050205 20050280 20050282 20050286 20050292
20050302 20050307;
c) Level 1 H-31B Air Detector/ Clamping Device (US
115v):
20040020 20040021 20040022 20040023 20040024 20040025 20040026
20040027 20040042 20050001 20050002 20050003 20050004 20050005 20050006 20050007
20050008 20050009 20050010 20050011 20050012 20050013 20050014 20050015 20050016
20050017 20050018 20050020 20050021 20050022 20050023 20050025 20050026 20050027
20050028 20050029 20050030 20050031 20050032 20050034 20050036 20050037 20050038
20050039 20050040 20050041 20050043 20050044 20050045 20050046 20050047 20050048
20050051 20050052 20050053 20050054 20050055 20050056 20050057 20050058 20050059
20050060 20050061 20050065 20050067 20050068 20050069 20050070 20050071 20050072
20050073 20050075 20050076 20050077 20050078 20050079 20050089 20050090 20050123
20050124 20050125 20050126 20050127 20050128 20050129 20050130 20050131 20050132
20050133 20050134 20050136 20050138 20050159 20050160 20050161 20050162 20050164
20050166 20050169 20050172 20050174 20050177 20050184 20050186 20050192 20050193
20050242 20050243 20050244 20050245 20050246 20050247 20050249 20050250 20050251
20050252 20050253 20050255;
d) Level 1 H-31B Air Detector/ Clamping Device
(International 230V):
20050033 20050035 20050039 20050049 20050050 20050062
20050063 20050064 20050066 20050074 20050080 20050081 20050082 20050083 20050084
20050085 20050086 20050087 20050088 20050091 20050092 20050093 20050094 20050095
20050096 20050097 20050098 20050099 20050100 20050101 20050102 20050103 20050104
20050105 20050106 20050107 20050108 20050109 20050110 20050111 20050112 20050113
20050114 20050115 20050116 20050117 20050118 20050119 20050120 20050121 20050122
20050135 20050137 20050139 20050140 20050141 20050142 20050143 20050144 20050145
20050146 20050147 20050148 20050149 20050150 20050151 20050152 20050153 20050154
20050155 20050156 20050158 20050163 20050165 20050167 20050168 20050170 20050171
20050173 20050176 20050178 20050179 20050180 20050181 20050182 20050183 20050185
20050187 20050188 20050189 20050190 20050191 20050194 20050195 20050196 20050198
20050199 20050200 20050201 20050202 20050203 20050204 20050205 20050206 20050207
20050208 20050209 20050210 20050211 20050212 20050213 20050214 20050216 20050217
20050218 20050219 20050220 20050221 20050222 20050223 20050226 20050227 20050229
20050230 20050231 20050232 20050234 20050235 20050236 20050237 20050238 20050239
20050240 20050241 20050254 20051097
RECALLING
FIRM/MANUFACTURER Smiths Medical ASD, Inc., Rockland, MA
REASON Fluid
warmers, with defective air detector clamping mechanisms, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION Nationwide
PRODUCT Albumin (Human) 25% in
100 mL vials [Albuminar 25%]
CODE Lot numbers:
C934009, C934110, C934210, C934310, C805209, C805309
RECALLING
FIRM/MANUFACTURER ZLB Behring LLC, Bradley, IL
REASON Human Albumin, that may
have been distributed with a stopper that allowed product leakage, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION KY, TN, PA, NB, MO and IN
PRODUCT Fresh Frozen Plasma
CODE
Unit number: 10756-7634
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood
product, collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AZ
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 7036925
and 7032396
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were 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 MS and CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 6885253
and 6883057
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were 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 VA and CO
PRODUCT Red Blood Cells
CODE
Unit number: 6826389
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 CO
PRODUCT Red Blood Cells
CODE
Unit number: 6580595
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit numbers: 7028556 and 6167924;
b) Unit
number: 6412958
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were collected from an
unsuitable donor based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 7037001
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6947305
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit number: 6882484;
b) Unit number: 6885621
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood products, which were 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 VA and IL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6580497
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 FL
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 6832643 (2
units), 6826472 (2 units), 6825463 (3 units)
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected from an
unsuitable donor based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION VA, CO and NY
PRODUCT Red Blood Cells
CODE
Unit numbers: 6885619 and 6882482
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit numbers: 6887413, 6885224 and 6880084;
b)
Unit number: 6883108
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CO, NY and LA
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit number: 6573181;
b) Unit number: 6577321
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood products, which were 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6947423
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
CODE
Unit number: 6883135
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was 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 PA
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 0753426
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 0750503
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
CODE
Unit numbers: 6830736, 6827847 and 6825068
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood products, which were collected from an
unsuitable donor based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CO and PA
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6387230
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: 6387233
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood Cells
CODE
Unit number: 35LW22624
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Appalachian Region,
Roanoke, VA
REASON Blood product, that tested reactive for antibodies
to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION VA
PRODUCT Red Blood Cells
CODE
Unit number: 0067898
RECALLING
FIRM/MANUFACTURER Suncoast Communities Blood Bank, Sarasota, FL
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 FL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number: LZ09188
RECALLING FIRM/MANUFACTURER Tri-Counties Blood Bank, Santa
Barbara, CA
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 CA
PRODUCT Source Plasma
CODE
Unit number: VP-35630
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON
Blood product, collected from a donor whose arm
inspection was not documented, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Austria
PRODUCT Red Blood Cells
CODE
Unit number: 6928798
RECALLING
FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON
Red Cells, collected from an ineligible donor,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Fresh Frozen
Plasma
b) Recovered Plasma
CODE
a) Unit number: 6979796;
b) Unit numbers: 6978796,
6976360, and 6975385
RECALLING FIRM/MANUFACTURER Florida's Blood
Center, Inc, Orlando, FL
REASON Blood product, which were collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4
units
DISTRIBUTION Austria
PRODUCT
a) Fresh Frozen
Plasma
b) Fresh Frozen Plasma Apheresis
c)
Recovered Plasma
CODE
a) Unit number:
1927054;
b) Unit numbers: 9158340, 9158066 (2 units);
c) Unit number:
1926169
RECALLING FIRM/MANUFACTURER Florida's Blood Center, Inc,
Orlando, FL
REASON Blood products, which were collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5
units
DISTRIBUTION FL and Austria
PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced,
c) Platelets Pheresis Leukocytes Reduced,
d) Platelets Pheresis Leukocytes Reduced
Irradiated
CODE
a) Unit number: 6576035;
b) Unit numbers: 6572721
and 6509984;
c) and d) Unit number: 6581243
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected from an
unsuitable donor based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit numbers: 6864235
and 7046749
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO
REASON Blood products, which were 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 CO
PRODUCT Red Blood Cells(Apheresis) Leukocytes
Reduced
CODE Unit
number: 4673523
RECALLING FIRM/MANUFACTURER Gulf Coast Regional
Blood Center, Houston, TX
REASON Blood product, mislabeled as leukocytes
reduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells
b) Red Blood Cells
Leukoreduced,
CODE
a) Unit number: 40GF68498;
b) Unit numbers:
40GF68527, 40GF68533
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Heart of America, Peoria, IL
REASON Blood products, collected
using a trip scale for which daily QC was not recorded, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Recovered Plasma
CODE
Unit number: 030GR12543
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Northeastern
Pennsylvania Region, Ashley, PA
REASON Blood product, collected from an
ineligible donor due to history of Melanoma cancer, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT
a) Red Blood Cells
b) Fresh Frozen
Plasma
CODE a) and b) Unit number: KE00254
RECALLING
FIRM/MANUFACTURER Southern California Permanente Medical Group Blood
Donor Center, Los Angeles, CA
REASON Blood products, collected from
a donor whose temperature had been taken using an unapproved method, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit number: 4850004
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center,
Houston, TX
REASON Blood product, collected from a donor that
previously tested positive for antibodies to red blood cell antigen E (anti-E),
was distributed without labeling to reflect the anti-E positive
results.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
WEEK ENDING OCTOBER 15
PRODUCT Red Blood Cells
CODE
Unit number: 2095651
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON
Blood product, corresponding to a unit of plasma
that was found to contain clots, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit numbers: 2119199,
2103431, 2113323, 2123504, 2119399, 2119384, 2116396, 2109231, and
2124784
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY
REASON Blood products exposed to unacceptable shipping
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION KY
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) Unit numbers: 2104644, 2088188, 2124335, and
2122776;
b) Unit number: 2114761
RECALLING
FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON
Blood products possibly exposed to unacceptable
shipping temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 5 units
DISTRIBUTION KY
PRODUCT Red Blood Cells,
Leukocytes Reduced Irradiated
CODE Unit number:
71J446534
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Gainesville, FL
REASON Blood product, labeled with the
incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Source Plasma
CODE
Unit number CP-110535
RECALLING
FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA
REASON
Blood product, collected from a donor whose arm
inspection was not acceptable, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Austria
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Fresh Frozen Plasma
CODE a) and b) Unit number 10757-0912
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood products, possibly collected in expired
collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ
WEEK ENDING OCTOBER 22
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 6585146 (2
units), 6868574 (2 units), 0757324 (2 units), and 6834350 (2 units)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center,
Denver, CO
REASON Blood products, which did not meet the acceptable
product specifications for release, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8 units
DISTRIBUTION CO, UT, CA, and VA
PRODUCT
a) Red Blood Cells,
Recall # B-2418-5:
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit number: 6388237;
b) Unit number:
6602463
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood products, which were 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 CO and MS
PRODUCT Red Blood Cells (Apheresis) Leukocytes
Reduced
CODE Unit
numbers: 36265-8887 (parts 1&2), 36265-8917 (parts 1&2), 36266-0164
(parts 1&2), 36266-3820
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., dba United Blood Services, Ventura, CA
REASON Red Cells,
collected by pheresis without anticoagulant, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 7 units
DISTRIBUTION CA
WEEK ENDING OCTOBER 29
PRODUCT Human Tissue
for Transplantation
CODE
Donor numbers
for 2004 and 2005:
BM04-A101, BM04-A102, BM04-A103, BM04-A104, BM04-A105,
BM04-A106, BM04-A107, BM04-A108, BM04-A109, BM04-A110, BM04-A111, BM04-A112,
BM04-A113, BM04-A114, BM04-A115, BM04-A116, BM04-B101, BM04-B102, BM04-B103,
BM04-B104, BM04-B105, BM04-B106, BM04-B107, BM04-B108, BM04-B109, BM04-B110,
BM04-B111, BM04-B112, BM04-B113, BM04-B114, BM04-B115, BM04-B116, BM04-B117,
BM04-B118, BM04-B119, BM04-B120, BM04-B121, BM04-B122, BM04-B123, BM04-B124,
BM04-B125, BM04-B126, BM04-B127, BM04-C101, BM04-C102, BM04-C103, BM04-C104,
BM04-C105, BM04-C106, BM04-C107, BM04-C108, BM04-C109, BM04-C110, BM04-C111,
BM04-C112, BM04-C113, BM04-C114, BM04-C115, BM04-C116, BM04-C117, BM04-C118,
BM04-C119, BM04-C120, BM04-C121, BM04-C122, BM04-C123, BM04-C124, BM04-D101,
BM04-D101, BM04-D102, BM04-D102, BM04-D103, BM04-D103, BM04-D104, BM04-D105,
BM04-D105, BM04-D106, BM04-D106, BM04-D107, BM04-D107, BM04-D108, BM04-D108,
BM04-D109, BM04-D109, BM04-D110, BM04-D110, BM04-D111, BM04-D111, BM04-D112,
BM04-D112, BM04-D113, BM04-D113, BM04-D114, BM04-D114, BM04-D115, BM04-D115,
BM04-D116, BM04-D116, BM04-D117, BM04-D117, BM04-D118, BM04-D118, BM04-D119,
BM04-D119, BM04-D120, BM04-D120, BM04-D121, BM04-D121, BM04-D122, BM04-D122,
BM04-D123, BM04-D123, BM04-D124, BM04-D124, BM04-D125, BM04-D125, BM04-D126,
BM04-D126, BM04-D127, BM04-D127, BM04-D128, BM04-D128, BM04-D129, BM04-D129,
BM04-E101, BM04-E101, BM04-E102, BM04-E102, BM04-E103, BM04-E103, BM04-E104,
BM04-E104, BM04-E105, BM04-E106, BM04-E106, BM04-E107, BM04-E107, BM04-E108,
BM04-E109, BM04-E109, BM04-E110, BM04-E110, BM04-E111, BM04-E111, BM04-E112,
BM04-E112, BM04-E113, BM04-E113, BM04-E114, BM04-E114, BM04-E115, BM04-E115,
BM04-E116, BM04-E116, BM04-E117, BM04-E117, BM04-E118, BM04-E118, BM04-E119,
BM04-E119, BM04-E120, BM04-E120, BM04-E121, BM04-E121, BM04-E122, BM04-E122,
BM04-F016, BM04-F101, BM04-F102, BM04-F103, BM04-F104, BM04-F105, BM04-F107,
BM04-F108, BM04-F109, BM04-F110, BM04-F111, BM04-F112, BM04-F113, BM04-F114,
BM04-F115, BM04-F116, BM04-F117, BM04-F118, BM04-F119, BM04-F120, BM04-F121,
BM04-F122, BM04-F123, BM04-F124, BM04-F125, BM04-F126, BM04-F127, BM04-F128,
BM04-F129, BM04-F130, BM04-F131, BM04-F132, BM04-F133, BM04-F134, BM04-F135,
BM04-F136, BM04-F137, BM04-F138, BM04-F139, BM04-F140, BM04-F141, BM04-F142,
BM04-F143, BM04-F145, BM04-G101, BM04-G102, BM04-G103, BM04-G104, BM04-G105,
BM04-G106, BM04-G107, BM04-G108, BM04-G109, BM04-G110, BM04-G111, BM04-G112,
BM04-G113, BM04-G114, BM04-G115, BM04-G116, BM04-G117, BM04-G118, BM04-G119,
BM04-G120, BM04-G121, BM04-G122, BM04-G123, BM04-G124, BM04-G125, BM04-G126,
BM04-G127, BM04-G128, BM04-G129, BM04-G130, BM04-G131, BM04-G132, BM04-G133,
BM04-G134, BM04-G135, BM04-G136, BM04-G137, BM04-G138, BM04-G139, BM04-G140,
BM04-G141, BM04-G142, BM04-G143, BM04-H101, BM04-H102, BM04-H103, BM04-H104,
BM04-H105, BM04-H106, BM04-H107, BM04-H108, BM04-H109, BM04-H110, BM04-H111,
BM04-H112, BM04-H113, BM04-H114, BM04-H115, BM04-H116, BM04-H117, BM04-H118,
BM04-H119, BM04-H120, BM04-H121, BM04-H122, BM04-H123, BM04-H124, BM04-H125,
BM04-H126, BM04-H127, BM04-H128, BM04-H129, BM04-H130, BM04-H131, BM04-H132,
BM04-H133, BM04-H134, BM04-H135, BM04-H136, BM04-I101, BM04-I102, BM04-I103,
BM04-I104, BM04-I105, BM04-I106, BM04-I107, BM04-I108, BM04-I109, BM04-I110,
BM04-I111, BM04-I112, BM04-I113, BM04-I114, BM04-I115, BM04-I116, BM04-I117,
BM04-I118, BM04-I119, BM04-I120, BM04-I121, BM04-I121, BM04-I122, BM04-I123,
BM04-I124, BM04-I125, BM04-I126, BM04-I127, BM04-I128, BM04-I129, BM04-I129,
BM04-I130, BM04-I131, BM04-I132, BM04-I133, BM04-I134, BM04-I135, BM04-I136,
BM04-I137, BM04-J117, BM04-J121, BM04-J131, BM04-J132, BM04-J133, BM04-J134,
BM04-J135, BM04-J136, BM04-J137, BM04-J138, BM04-J139, BM04-J140, BM04-J141,
BM04-J142, BM04-J143, BM04-K101, BM04-K102, BM04-K103, BM04-K104, BM04-K105,
BM04-K106, BM04-K107, BM04-K108, BM04-K109, BM04-K110, BM04-K111, BM04-K112,
BM04-K113, BM04-K114, BM04-K115, BM04-K116, BM04-K117, BM04-K118, BM04-K119,
BM04-K120, BM04-K121, BM04-K122, BM04-K123, BM04-K124, BM04-K125, BM04-K126,
BM04-K127, BM04-K128, BM04-L101, BM04-L102, BM04-L103, BM04-L104, BM04-L105,
BM04-L106, BM04-L107, BM04-L108, BM04-L109, BM04-L110, BM04-L111, BM04-L112,
BM04-L113, BM04-L114, BM04-L115, BM04-L116, BM04-L117, BM04-L118, BM04-L119,
BM04-L120, BM04-L121, BM04-L122, BM04-L123, BM04-L124, BM04-L125, BM04-L126,
BM04-L127, BM04-L128, BM04-L129, BM04-L130, BM04-L131, BM04-L132, BM04-L133,
BM05-A101, BM05-A102, BM05-A103, BM05-A104, BM05-A105, BM05-A106, BM05-A107,
BM05-A108, BM05-A109, BM05-A110, BM05-A111, BM05-A112, BM05-A113, BM05-A114,
BM05-A115, BM05-A117, BM05-A118, BM05-A119, BM05-A120, BM05-A121, BM05-A122,
BM05-A123, BM05-A124, BM05-A125, BM05-A126, BM05-A127, BM05-A128, BM05-A129,
BM05-A130, BM05-A131, BM05-A132, BM05-A133, BM05-A134, BM05-B101, BM05-B102,
BM05-B103, BM05-B104, BM05-B105, BM05-B106, BM05-B107, BM05-B108, BM05-B109,
BM05-B110, BM05-B111, BM05-B112, BM05-B113, BM05-B114, BM05-B115, BM05-B116,
BM05-B117, BM05-B118, BM05-B119, BM05-B120, BM05-B121, BM05-B122, BM05-B123,
BM05-B124, BM05-B125, BM05-B126, BM05-B127, BM05-B128, BM05-B129, BM05-B130,
BM05-B131, BM05-B132, BM05-B133, BM05-B134, BM05-B135, BM05-B136, BM05-B137,
BM05-B138, BM05-B139, BM05-B140, BM05-B141, BM05-B142, BM05-B143, BM05-B144,
BM05-B145, BM05-B146, BM05-B147, BM05-B148, BM05-B149, BM05-B150, BM05-B151,
BM05-B152, BM05-C101, BM05-C102, BM05-C103, BM05-C104, BM05-C105, BM05-C106,
BM05-C107, BM05-C108, BM05-C109, BM05-C110, BM05-C111, BM05-C112, BM05-C113,
BM05-C114, BM05-C115, BM05-C116, BM05-C117, BM05-C118, BM05-C119, BM05-C120,
BM05-C121, BM05-C122, BM05-C123, BM05-C124, BM05-C125, BM05-C126, BM05-C127,
BM05-C128, BM05-C129, BM05-C130, BM05-C131, BM05-C132, BM05-C133, BM05-C134,
BM05-C135, BM05-C136, BM05-C137, BM05-C138, BM05-C139, BM05-C140, BM05-C141,
BM05-C142, BM05-C143, BM05-C144, BM05-C145, BM05-C146, BM05-C147, BM05-C148,
BM05-C149, BM05-C150, BM05-C151, BM05-C152, BM05-C153, BM05-D101, BM05-D102,
BM05-D103, BM05-D104, BM05-D105, BM05-D106, BM05-D107, BM05-D108, BM05-D109,
BM05-D110, BM05-D111, BM05-D112, BM05-D113, BM05-D114, BM05-D115, BM05-D116,
BM05-D117, BM05-D118, BM05-D119, BM05-D120, BM05-D121, BM05-D122, BM05-D123,
BM05-D124, BM05-D125, BM05-D126, BM05-D127, BM05-D128, BM05-D129, BM05-D130,
BM05-D131, BM05-D132, BM05-D133, BM05-D134, BM05-D135, BM05-D136, BM05-D137,
BM05-D138, BM05-D139, BM05-D140, BM05-E101, BM05-E102, BM05-E103, BM05-E104,
BM05-E105, BM05-E106, BM05-E107, BM05-E108, BM05-E109, BM05-E110, BM05-E111,
BM05-E112, BM05-E113, BM05-E114, BM05-E115, BM05-E116, BM05-E117, BM05-E118,
BM05-E119, BM05-E120, BM05-E121, BM05-E122, BM05-E123, BM05-E124, BM05-E125,
BM05-E126, BM05-E127, BM05-E128, BM05-E129, BM05-E130, BM05-E131, BM05-E132,
BM05-E133, BM05-E134, BM05-E135, BM05-E136, BM05-E137, BM05-E138, BM05-E139,
BM05-E140, BM05-E141, BM05-E142, BM05-F101, BM05-F102, BM05-F103, BM05-F104,
BM05-F105, BM05-F106, BM05-F107, BM05-F108, BM05-F109, BM05-F110, BM05-F111,
BM05-F112, BM05-F113, BM05-F114, BM05-F115, BM05-F116, BM05-F117, BM05-F118,
BM05-F119, BM05-F120, BM05-F121, BM05-F122, BM05-F123, BM05-F124, BM05-F125,
BM05-F126, BM05-F127, BM05-F128, BM05-F129, BM05-F130, BM05-F131, BM05-F132,
BM05-F133, BM05-F134, BM05-F135, BM05-F136, BM05-F137, BM05-F138, BM05-F139,
BM05-F140, BM05-F141, BM05-F142, BM05-F143, BM05-G101, BM05-G102, BM05-G103,
BM05-G104, BM05-G105, BM05-G106, BM05-G107, BM05-G108, BM05-G109, BM05-G110,
BM05-G111, BM05-G112, BM05-G113, BM05-G114, BM05-G115, BM05-G116, BM05-G117,
BM05-G118, BM05-G119, BM05-G120, BM05-G121, BM05-G122, BM05-G123, BM05-G124,
BM05-G125, BM05-G126, BM05-G127, BM05-G128, BM05-G129, BM05-G130, BM05-G131,
BM05-G132, BM05-G133, BM05-G134, BM05-G135, BM05-G136, BM05-G137, BM05-G138,
BM05-G139, BM05-G140, BM05-G141, BM05-G142, BM05-G143, BM05-G144, BM05-G145,
BM05-G146, BM05-G147, BM05-H101, BM05-H102, BM05-H103, BM05-H104, BM05-H105,
BM05-H106, BM05-H107, BM05-H108, BM05-H109, BM05-H110, BM05-H111, BM05-H112,
BM05-H113, BM05-H114, BM05-H115, BM05-H116, BM05-H117, BM05-H118, BM05-H119,
BM05-H120, BM05-H121, BM05-H122, BM05-H123, BM05-H124, BM05-H125, BM05-H126,
BM05-H127, BM05-H128, BM05-H129, BM05-H130, BM05-H131, BM05-H132, BM05-H133,
BM05-H134, BM05-H135, BM05-H136, BM05-H137, BM05-H138, BM05-H139, BM05-H140,
BM05-H141, BM05-H142, BM05-H143, BM05-H144, BM05-H145, BM05-H148
RECALLING FIRM/MANUFACTURER BioMedical Tissue Services,
LTD, Fort Lee, NJ
REASON Human
Tissues, procured from donors without adequate donor eligibility determinations,
were distributed.
VOLUME OF PRODUCT IN COMMERCE Human
Tissue Collected from 761 donors
DISTRIBUTION NJ, FL,
AL, TX, and GA
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit number: 6605344;
b) Unit
numbers: 6635693 and 7035841
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO and PA
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6419282 and 6613102
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6417437
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit number: 7020814;
b) Unit
numbers: 7040969 and 7030236
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO
PRODUCT
a) Red Blood
Cells;
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit number: 6574718;
b) Unit number:
6622166
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood products,
which were 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6843802 and 6841057
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6910785
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6586552
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which was
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 7049574
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which was
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced Irradiated
CODE Unit numbers: 0753213 and
0748414
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood products, which were
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 CO
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit numbers: 7014526 and 7008695;
b)
Unit number: 7004547
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood products,
which were collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3 units
DISTRIBUTION CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6863510
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood product,
which was 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 AL
PRODUCT Red Blood
Cells
CODE Unit number: 6883569
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which was 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6602842
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood product,
which was 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6414545 and 7015446
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO and MS
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6415163
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit number: 6827554;
b) Unit number:
6829645
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood products,
which were 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 CO and
IL
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6829646 and 6827555
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT Red Blood
Cells
CODE Unit number:
7024098
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6829277, 6825895, 6823674 and 6820450
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION CO and FL
PRODUCT Red Blood
Cells
CODE Unit numbers:
6884654
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT
a) Red Blood
Cells Leukocytes Reduced
b) Fresh Frozen Plasma
CODE
a) Unit numbers: 100400606, 100400612,
100400613, 100400614, 100400615, 100400616, 100400618, 100400619, 100400621, 100400623, 100400624, 100400626;
b) Unit numbers: 100400606, 100400612,
100400613, 100400614, 100400615, 100400616, 100400618,
100400619,
100400620, 100400621, 100400623, 100400626
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON
Blood products, which were untested
for viral markers, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 24 units
DISTRIBUTION AZ, ND, and
SD
PRODUCT
a) Red Blood
Cells Leukocytes Reduced
b) Platelet, Leukocytes Reduced
CODE
a) and b) Unit number: 13FV49860
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
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 MI
PRODUCT Platelet
Pheresis, Leukocytes Reduced
CODE Unit
numbers: 0751728 part 1 & 2
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit numbers: 6948703 and 7035863;
b)
Unit number: 6950646
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
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 3 units
DISTRIBUTION CO, IL, and
VA
PRODUCT Red Blood
Cells
CODE Unit number:
6627474
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6950715
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells
CODE Unit number:
7028811
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6887065
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 0759240
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6873256
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells
CODE Unit number:
6632179
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
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
CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6824561
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT Red Blood
Cells
CODE Unit number:
6151399
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 CO
PRODUCT Red Blood
Cells
CODE Unit number:
7012674
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 IL
PRODUCT Platelets
Pheresis Leukocytes Reduced
CODE Unit
numbers: 6825432 and 6570732 (2 parts)
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were collected
from an unsuitable donor based on travel to an area considered endemic for
malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6176778 and 7005754
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, which were 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 CO
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit numbers: 6165886 and 6145166;
b)
Unit number: 6151057
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood products,
which were collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3 units
DISTRIBUTION CO and
FL
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
number: 6175171
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product, which
was 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 MS
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit numbers: 6826765 and 6328772;
b)
Unit number: 6820967
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
REASON Blood products,
which were collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3 units
DISTRIBUTION CO
PRODUCT
a) Red Blood
Cells Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit number:
6880248
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood products, which were
collected from a donor with a history of hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY and Switzerland
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit
number: 0749169
RECALLING FIRM/MANUFACTURER Belle
Bonfils Memorial Blood Center, Denver, CO
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 CO
PRODUCT Red Blood
Cells Leukocytes Reduced
CODE Unit
numbers: 6316110 and 6324307
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO
PRODUCT Source Plasma
CODE
Unit numbers: 04OUTB3489,
04OUTB3721, and 04OUTB4252
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., Ogden, UT
REASON
Blood products, which were collected
from a donor who reportedly had engaged in multiple high risk behavior
activities, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CA
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
c) Red Blood Cells Leukocytes Reduced Irradiated,
d) Red Blood Cells
(Apheresis)
e) Fresh
Frozen Plasma
f) Plasma
CODE
a) Unit numbers: 004GF48097, 004GF48113,
004GF48307, 004GF48308, 004GF48525, 004GF48770, 004GF48793, 004GF48824,
004R29554, 004R29561, 004R30169, and 004S71044;
b) Units 004GF47660,
004GF47661, 004GF47665, 004GF47666, 004GF47754, 004GF47755, 004GF47757,
004GF47760, 004GF47765, 004GF47778, 004GF47782, 004GF47783, 004GF47786,
004GF47788, 004GF47964, 004GF47969, 004GF47971, 004GF47974, 004GF47978, 004GF47987, 004GF47988, 004GF47989, 004GF47993, 004GF48006,
004GF48012,
004GF48074, 004GF48096, 004GF48101, 004GF48104, 004GF48105, 004GF48285,
004GF48298, 004GF48301, 004GF48303, 004GF48312, 004GF48317, 004GF48324,
004GF48386, 004GF48387, 004GF48448, 004GF48449, 004GF48451, 004GF48453,
004GF48454, 004GF48513, 004GF48527, 004GF48681, 004GF48683, 004GF48684, 004GF48687, 004GF48784, 004GF48786, 004GF48788, 004GF48790,
004GF48797,
004GF48801, 004GF48803, 004GF48805, 004GF48807, 004GF48820, 004GF49449,
004GF49450, 004GF49456, 004GF49457, 004GF49459, 004GF49460, 004GF49533,
004GF49543, 004GF49545, 004GF49549, 004GF49551, 004GF49554, 004R29145,
004R29147, 004R29149, 004R29150, 004R29153, 004R29310, 004R29349, 004R29354, 004R29523, 004R29526, 004R29530, 004R29542,
004R29551,
004R29556, 004R29566, 004R29569, 004R29572, 004R29576, 004R29577, 004R29581,
004R29619, 004R29623, 004R29648, 004R29652, 004R30040, 004R30057, 004R30062, 004R30067, 004R30068, 004R30073, 004R30074, 004R30075,
004R30077,
004R30092, 004R30093, 004R30096, 004R30171, 004R30175, 004R30190, 004R30194,
004R30198, 004R30207, 004R30211, 004R30217, 004R30231, 004R30235, 004R30306, 004R30310, 004R30316, 004R30320, 004R30329, 004R30332,
004R30336,
004R30338, 004R30348, 004R30349, 004R30351, 004R30507, 004R30509, 004R30514,
004R30516, 004R30532, 004R30534, 004R30535, 004R30538, 004R30539, 004R30541, 004R30544, 004R30571, 004R30573, 004R30592, 004R30595,
004R30598,
004R30600, 004R30662, 004R30665, 004R30671, 004R30693, 004R30696, 004R30706,
004R30709, 004R30721, 004R30732, 004R30735, 004R30746, 004R30748, 004R30750, 004R30751, 004R30757, 004R30762, 004R30764, 004R30770,
004R30779,
004R30852, 004R30855, 004R30856, 004R30867, 004R30869, 004R30871, 004R30872,
004R31089, 004R31091, 004R31118, 004R31121, 004R31124, 004R31125, 004R31128, 004R31231, 004R31234, 004R31236, 004R31251, 004R31253,
004R31282,
004R31284, 004R31287, 004R31316, 004R31318, 004R31339, 004R31341, 004R31344,
004R31347, 004R31359, 004R31360, 004R31363, 004R31366, 004R31367, 004R31368, 004R31369, 004R31670, 004R31683, 004R31709, 004R31711,
004R31727,
004R31737, 004R31750, 004R31752, 004R31756, 004R31760, 004R31763, 004R31773,
004R31777, 004R31780, 004R31783, 004R31789, 004R31809, 004R31812,
004R31821, 004R31826, 004R31828, 004R31832, 004R31835, 004R31908, 004R31914, 004R31925, 004R31952, 004R31955, 004R31962,
004R31966,
004R31969, 004R31973, 004R31977, 004R31984, 004R31987, 004R32009, 004R32010,
004R32324, 004R32327, 004R32328, 004R32330, 004R32331, 004R32336, 004R32342, 004R32345, 004R32347, 004R32349, 004R32355, 004R32356,
004R32358,
004R32363, 004R32378, 004R32402, 004R32405, 004R32408, 004R32412, 004S70449,
004S70451, 004S70453, 004S70458, 004S70488, 004S70505, 004S70507, 004S70511, 004S70611, 004S70625, 004S70626, 004S70643, 004S70646,
004S70648,
004S71035, 004S71053, 004S71054, 004S71069, 004S71077, 004S71080, 004S71096,
004S71100, 004S71103, 004S71106, 004S71123, 004S71127, 004S71134, 004S71142, 004S71156, 004S71166, 004S71486, 004S71490, 004S71967,
004S71974,
004S71978, 004S71980, 004S72009, 004S72013, 004S72015, 004S72018, 004S72021,
004S72158, 004S72176, 004S72177, 004S72181, 004S72184, 004S72187,
004S72489, 004S72494, 004S72511, 004S72543, 004S72548, 004S72551, 004S72582, 004S72586, 004S72589, 004S72592, 004S72594,
004S72596,
004S72612, 004S72616, 004S72619, 004S72625, 004S72626, 004S72630, 004S72632,
004S72637, 004S72640,
004S72833, 004S72836, 004S72845, 004S72850, 004S72851,
004S72858, 004S72861, 004S72884, 004S72890, 004T40548, and
004T40550;
c) Units 004GF47967, 004GF47984, 004GF48102, 004GF48385, 004R29345, 004R29559, 004R30195, 004R30754, 004R30766,
004R30768,
004R30774, 004R30777, 004R30782, 004R30859, 004R31248, 004R31314, 004R31658,
004R31793, 004R31959, 004R32011, 004R32014, 004S71030, 004S71480, 004S72590, 004S72623, 004S72882, 004S72886;
d) Units 004GX07429R2, 004GX07429R1,
004GY06608, 004GY06762R1, and 004GY06762R2;
e) Units 004GF47964,
004GF47969, 004GF47971, 004GF47974, 004GF47978, 004GF47984, 004R30507,
004R30509, 004R30514, 004R30516, 004R30532, 004R30534, 004R30535, 004R30538, 004R30539, 004R30541, 004R30544, 004R31229, 004R31231,
004R31234,
004R31236, 004R31248, 004R31251, 004R31253, 004R31344, 004R31347, 004R31359,
004R31360, 004R31363, 004R31366, 004R31369, 004S70507, 004S72158, 004S72176, 004S72177, 004S72184, and 004S72873;
f) Units 004GF48386, 004GF48387,
004GF48807, 004GF48817, 004R30040, 004R30057, 004R30062, 004R30067,
004R30068, 004R30073, 004R30074, 004R30075, 004R30077, 004R30092, 004R30093, and 004R30096
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON
Blood products, which were collected
from donors in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 432
units
DISTRIBUTION CA, MA, ME, NH, NY, PA and
Switzerland
PRODUCT Platelets Pheresis, Leukocytes
Reduced
CODE Unit
6837223 part 1, 2, and 3
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood products, mislabeled as leukocytes
reduced, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit
0758826
RECALLING FIRM/MANUFACTURER Belle Bonfils
Memorial Blood Center, Denver, CO
REASON Blood product,
mislabeled as leukocytes reduced, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit
number: 4280084
RECALLING FIRM/MANUFACTURER Blood Centers
of the Pacific, San Francisco, CA
REASON Blood
product, which was shipped at potentially unacceptable shipping temperatures,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit
number: 3423284
RECALLING FIRM/MANUFACTURER Central
Indiana Regional Blood Center, Indianapolis, IN
REASON Blood product, which may not have met
product specifications for release, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT Recovered
Plasma
CODE Unit numbers: 004GF47660,
004GF47661, 004GF47665, 004GF47666, 004GF47754, 004GF47755, 004GF47757,
004GF47760, 004GF47765, 004GF47778, 004GF47782, 004GF47783, 004GF47786,
004GF47788, 004GF47967, 004GF47987, 004GF47988, 004GF47989, 004GF47993,
004GF48006, 004GF48012, 004GF48074, 004GF48096, 004GF48097, 004GF48101,
004GF48102, 004GF48104, 004GF48105, 004GF48285, 004GF48298, 004GF48301,
004GF48303, 004GF48307, 004GF48308, 004GF48312, 004GF48317, 004GF48324,
004GF48448, 004GF48449, 004GF48451, 004GF48453, 004GF48454, 004GF48513,
004GF48521, 004GF48527, 004GF48681, 004GF48683, 004GF48684, 004GF48687,
004GF48784, 004GF48786, 004GF48788, 004GF48790, 004GF48797, 004GF48801,
004GF48803, 004GF48805, 004R29145, 004R29147, 004R29149, 004R29150, 004R29153,
004R29310, 004R29345, 004R29349, 004R29354, 004R29522, 004R29523, 004R29526,
004R29530, 004R29542, 004R29551, 004R29556, 004R29559, 004R29566, 004R29569,
004R29572, 004R29576, 004R29577, 004R29581, 004R29619, 004R29623, 004R29648,
004R29652, 004R30171, 004R30175, 004R30190, 004R30194, 004R30195, 004R30198,
004R30204, 004R30207, 004R30211, 004R30217, 004R30231, 004R30235, 004R30306,
004R30310, 004R30316, 004R30320, 004R30329, 004R30332, 004R30336, 004R30338,
004R30348, 004R30349, 004R30351, 004R30571, 004R30573, 004R30592, 004R30595,
004R30598, 004R30600, 004R30662, 004R30665, 004R30671, 004R30693, 004R30696,
004R30706, 004R30709, 004R30721, 004R30732, 004R30735, 004R30746, 004R30748,
004R30750, 004R30751, 004R30754, 004R30757, 004R30762, 004R30764, 004R30766,
004R30768, 004R30770, 004R30774, 004R30777, 004R30779, 004R30782, 004R30852,
004R30855, 004R30856, 004R30859, 004R30867, 004R30869, 004R30871, 004R30872,
004R31089, 004R31091, 004R31118, 004R31121, 004R31124, 004R31125, 004R31128,
004R31282, 004R31284, 004R31287, 004R31314, 004R31316, 004R31318, 004R31367,
004R31658, 004R31670, 004R31683, 004R31709, 004R31711, 004R31727, 004R31737,
004R31750, 004R31752, 004R31756, 004R31760, 004R31763, 004R31773, 004R31777,
004R31780, 004R31783, 004R31789, 004R31793, 004R31809, 004R31812, 004R31821,
004R31826, 004R31828, 004R31832, 004R31835, 004R31908, 004R31914, 004R31925,
004R31928, 004R31952, 004R31955, 004R31959, 004R31962, 004R31966, 004R31969,
004R31973, 004R31977, 004R31984, 004R31987, 004R32009, 004R32010, 004R32011,
004R32014, 004R59549, 004S70449, 004S70451, 004S70453, 004S70458, 004S70488,
004S70505, 004S70511, 004S70611, 004S70625, 004S70626, 004S70643, 004S70646,
004S70648, 004S71030, 004S71035, 004S71053, 004S71054, 004S71069, 004S71077,
004S71080, 004S71096, 004S71100, 004S71103, 004S71106, 004S71123, 004S71127,
004S71134, 004S71135, 004S71135, 004S71142, 004S71156, 004S71166, 004S71480,
004S71486, 004S71490, 004S71507, 004S71967, 004S71974, 004S71978, 004S71980,
004S72009, 004S72013, 004S72015, 004S72018, 004S72021, 004S72187, 004S72489,
004S72494, 004S72511, 004S72543, 004S72548, 004S72551, 004S72582, 004S72586,
004S72589, 004S72590, 004S72592, 004S72594, 004S72596, 004S72612, 004S72616,
004S72619, 004S72622, 004S72623, 004S72625, 004S72626, 004S72630, 004S72632,
004S72637, 004S72640, 004T40548, and 004T40550
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON
Blood products, which were collected
from donors in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 277
units
DISTRIBUTION CA, MA, ME, NH, NY, PA and
Switzerland