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U.S. Department of Health and Human Services

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Enforcement Report for June 1, 2005

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

June 1, 2005
05-22

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

______________________________
PRODUCT
a) Frozen Threadfin Bream Black and white label with orange
and green pineapple insignia on clear plastic packaging
labeled in part: "Pineapple Brand Frozen Threadfin
Bream***Ca Dong Muoi Xa Ot***Net Wt 1 lb". Recall # F-
386-5;
b) Frozen Featherback Fish Meat Pink, yellow, black and
blue product label on clear plastic packaging with
styrafoam plate is labeled in part: "Frozen Featherback
Meat***Cha Ca That Lat***14 oz". Recall # F-387-5.
CODE
Unknown
RECALLING FIRM/MANUFACTURER
Vincent Seafood and Trading Co, South El Monte, CA, by telephone and letters on October 7, 2004. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
229 cartons.
DISTRIBUTION 
CA and TX.

______________________________
PRODUCT
20 oz. Lander original Lubricating Skin Lotion, item #5020. Helps soothe & moisturize dry skin***. Dry Skin Treatment***. Ingredients: Water, Stearic Acid, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Triethanolamine, Tocopheryl Acetate, Methylparaben, Hydrolyzed Collegen, Fragrane, Propylparaben, Petrolatum, Retinyl palmitate, Dimethicone, Propylene Glycol, Algae Extract, Lanolin, Sorbital***. Recall # F-389-5.
CODE
Item #5020 Lot 32551714.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lander Co. Inc, Lawrenceville, NJ, by on February 22, 2005.
Manufacturer: Lander Company Inc, Binghamton, NY. Firm initiated recall is ongoing.
REASON
One lot of Original Lubricating Skin Lotion was tested and found to be contaminated with Enterobacter cloacae.
VOLUME OF PRODUCT IN COMMERCE
213/12 per case plastic bottles.
DISTRIBUTION 
PR, CA, AL, PA, and Panama.

______________________________
PRODUCT
Kids brand Sour Max candy in 5.3 oz bags, Product of Canada, UWG, Mississauga, Ontario. Recall # F-390-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Great Lakes Wholesale Company, Grand Rapids, MI, by email, fax and/or telephone on or about April 6, 2005. Firm initiated recall is ongoing.
REASON
The product contains the undeclared colors yellow 5, red 40 and blue 1.
VOLUME OF PRODUCT IN COMMERCE
1825 cases of 24.
DISTRIBUTION 
Nationwide and Bahamas.

______________________________
PRODUCT
a) Blackberry Gelato Paste, Product Code F232, Net Wt
105.82 Oz (6.61 Lb). Recall # F-391-5;
b) Green Apple Gelato Paste, Product Code 019.1 and F226,
Net Wt 105.82 oz (6.61 lb). Recall # F-392-5;
c) Italian Classic Cream Gelato Paste, Product Code 020,
Net Wt 105.8 oz (6.61 lb). Recall # F-393-5;
d) Italian Custard Cream Gelato Paste, Product Code 466,
Net Wt 105.8 oz (6.61 lb). Recall # F-394-5;
e) Kiwi Gelato Paste, Product Code T/1003, Net Wt 105.82 oz
(6.61 lb). Recall # F-395-5;
f) Mango Gleato Paste, Product Code 388, Net Wt 105.82 oz
(6.61 lb). Recall # F-396-5;
g) Cantaloupe Gelato Paste, Product Code 018, Net Wt 105.82
oz (6.61 lb). Recall # F-397-5;
h) Mint Gelato Paste, Product Code 015, Net Wt 105.8 oz
(6.61 lb). Recall # F-398-5;
i) Peach Gelato Paste, Product Code 054 and F238, Net Wt
105.8 oz (6.61 lb). Recall # F-399-5;
j) Peach Mango Gelato Paste, Product Code 195, Net Wt 105.8
oz (6.61 lb). Recall # F-400-5;
k) Pineapple Gelato Paste, Product Code 418 and F202, Net
Wt 105.8 oz (6.61 lb). Recall # F-401-5;
l) Pink Grapefruit Gelato Paste, Product Code T/1003, Net
Wt 105.8 oz (6.61 lb). Recall # F-402-5;
m) Pistachio Gelato Paste, Product Code 329, Net Wt 88.35
oz (5.52 lb) and Product Code F070, Net Wt 105.8 oz
(6.61 lb). Recall # F-403-5;
n) Pure 100% Pistachio Gelato Paste, Product Code T/1022,
Net Wt 105.8 oz (6.61 lb). Recall # F-404-5;
o) Raspberry Gelato Paste, Product Code T/1016 and F218,
Net Wt 105.8 oz (6.61 lb). Recall # F-405-5;
p) Trifle Zuppa Inglese Gelato Paste, Product Code 237,
F089 and 56, Net Wt 105.8 oz (6.61 lb).
Recall # F-406-5;
q) Strawberries Gelato Paste, Product Code 326, Net Wt
105.8 oz (6.61 lb). Recall # F-407-5;
r) Wild Berries Gelato Paste, Product Code 306, Net Wt
105.8 oz (6.61 lb). Recall # F-408-5;
s) Cherry Gelato Topping, Product Code 390, Net Wt 38.80 oz
(2.42 lb). Recall # F-409-5;
t) Raspberry Gelato Topping, Product Code 437, Net Wt 38.80
oz (2.42 lb). Recall # F-410-5;
u) Strawberry Gelato Topping, Product Code 437, Net Wt
38.80 oz (2.42 lb). Recall # F-411-5;
v) Cherry Variegating Sauce, Product Code 317, Net Wt
105.82oz (6.61lb). Recall # F-412-5;
w) Cherry Amareno (Whole Cherries), Product Code 038.1 and
F303, Net Wt 105.82oz (6.61lb). Recall # F-413-5;
x) Pineapple Variegating Sauce, Product Code 427, Net Wt
88.35 oz (5.51lb). Recall # F-414-5;
y) Wild Berries Variegating Sauce, Product Codes 421 (Net
Wt 88.35 oz) and F316 (Net Wt 105.82 oz).
Recall # F-415-5;
z) Wild Strawberries Variegating Sauce, Product Code 420,
Net Wt 88.35 oz (5.52lb). Recall # F-416-5;
CODE
All codes on the market.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ital-Tex Ice Cream Technologies, Carrollton, TX, by letter on March 18, 2005.
Manufacturer: Name Prodotti Rubicone s.r.l., Bertinoro, Italy. Firm initiated recall is ongoing.
REASON
a) Unapproved colors E122 and E131;
b), e), h), m), and n) Unapproved colors, E102 and E131;
c), d), g), k), p), and x) Unapproved colors, E102 and
E124;
f) Unapproved colors, E102, E110, and E124;
i) and j) Unapproved colors, E102 and E110;
l), o), q), and u) Unapproved colors, E122 and E124;
r) and y)Unapproved colors, E122, E131, and E124;
s) Unapproved colors, E122, E151, E102 and E124;
t) Unapproved colors, E122, E163, and E124;
V), w) Unapproved colors, E122, E102, E151, and E124;
z) Unapproved colors, E102, E124, E163, and E129.
VOLUME OF PRODUCT IN COMMERCE
Approximately 1055 containers.
DISTRIBUTION 
Nationwide and Canada.
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

_______________________________
PRODUCT
Kourtney?s Best Jumbo Lump Crabmeat, 1 lb, packaged in plastic tubs with snap on lids. Recall # F-385-5.
CODE
207, 208.
RECALLING FIRM/MANUFACTURER
B&G Seafood, Inc, Des Allemands, LA, by telephone beginning August 19, 2004. Firm initiated recall is complete.
REASON
The product was contaminated with Escherichia coli.
VOLUME OF PRODUCT IN COMMERCE
654 lbs.
DISTRIBUTION 
LA, FL, MD, NJ, and PS.

______________________________
PRODUCT
Frozen Crab Meat Clear plastic packaging with black, blue and red writing and orange and green pineapple insignia labeled in part: "Crab Meat***Thit Cua". Recall # F-388-5.
CODE
Unknown
RECALLING FIRM/MANUFACTURER
Vincent Seafood and Trading Co, South El Monte, CA, by telephone and letters on October 7, 2004. Firm initiated recall is ongoing.
REASON
The product is decomposed.
VOLUME OF PRODUCT IN COMMERCE
7,838 one pound retail packages.
DISTRIBUTION 
CA and TX.

______________________________
PRODUCT
a) FAGE brand Total 0% Authentic Greek Yogurt, FAT-FREE
STRAINED YOGURT, GRADE A, ALL NATURAL, Net Wt. 5.3 oz.
(150g) and 17.6 oz. (500g). --- The yogurt is packaged
in a plastic cup. Barcode # for 5.3 oz. yogurt: 6 89544
08000 8; barcode # for 17.6 oz. yogurt: 6 89544 00173 7.
Plant No. 36-GR-9114 Recall # F-417-5;
b) FAGE brand Total Authentic Greek Yogurt, STRAINED YOGURT
with Greek Honey, GRADE A, ALL NATURAL, Net Wt. 5.3 oz.
(150g). The yogurt is packaged in a plastic cup.
Barcode # 6 89544 08120 3. Plant No. 36-GR-9114. Recall
# F-418-5.
CODE
a), and b) "USE BY" dates ranging from 4/1/05 - 4/22/05.
RECALLING FIRM
Recalling Firm: Fage USA Corp., Woodside, NY, by telephone and letter on/about February 26, 2005.
Manufacturer: Fage Dairy Industry S.A., Greece. Firm initiated recall is complete.
REASON
FAGE yogurt may potentially be contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
7961 cases (79,356 individual cups) in total.
DISTRIBUTION 
CA.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Famotidine Injection, 20mg/2mL, 10x2mL Single dose vials, Each mL contains 10mg of famotidine, for the Preparation of IV Solutions, Rx Only. NDC 55390-029-10. Recall # D-229-5.
CODE
Lot #609336, exp. 04/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH, by letters, dated April 19, 2005.
Manufacturer: Ben Venue Laboratories Inc, Bedford, OH. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
146,660 vials.
DISTRIBUTION 
Nationwide.

______________________________
PRODUCT
Paxil (Paroxetine HCl) Tablets, 10mg, scored Tablets, Rx only, NDC 0029-3210-1330. Recall # D-233-5.
CODE
Lots: 64-4B10 & F64-4B10.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smithkline Beecham Pharmaceuticals Co. Cidra, PR, by telephone on April 28, 2005.
Manufacturer: Sb Pharmco Puerto Rico Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Superpotent: These lots are being recalled because they contain a low incidence of tablets with elevated weights and assay.
VOLUME OF PRODUCT IN COMMERCE
78,097 units.
DISTRIBUTION 
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Oxycodone and Acetaminophen Capsules, USP* 5 mg/500mg * Each capsule contains: Oxycodone Hydrochloride USP and Acetaminophen, USP * 100 Capsules * Rx only. NDC 0603-4997-21. Recall # D-161-5.
CODE
C1180603A.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals Inc, Charlotte, NC, by letter on April 21, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
2,752 bottles.
DISTRIBUTION 
AL.

_______________________________
PRODUCT
a) Armour Thyroid (thyroid tablets, USP), 30 mg., Rx only,
packaged in 100 tablet bottle containers. Product label
contains NDC 0456-0458-01 (FOREST). Recall # D-217-5;
b) Armour Thyroid (thyroid tablets, USP), 60 mg., Rx only,
packaged in 100 tablet bottle containers. Product label
contains NDC 0456-0459-01 (FOREST). Recall # D-218-5;
c) Armour Thyroid (thyroid tablets, USP), 120 mg., Rx only,
packaged in 100 tablet bottle containers. Product label
contains NDC 0456-0461-01 (FOREST). Recall # D-219-5.
CODE
a) Lots 034052, 035064, 035066, 036171, and 036456;
b) Lots 034053, 034488, 035065, 035997, 036500, 040423;
c) Lots 034051, 035067, 035995, 035996, 036499, 042018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letter on April 12, 2005.
Manufacturer: Forest Pharmaceuticals, Inc., Earth City, MO. Firm initiated recall is ongoing.
REASON
Subpotent: Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
58,544/100 tablet bottles.
DISTRIBUTION 
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0935-5.
CODE
Unit number: 4586774.
RECALLING FIRM/MANUFACTURER
Recalling firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on April 15, 2003.
Manufacturer: Oklahoma Blood Institute, Ardmore, OK. Firm initiated recall is complete.
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 
OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1060-5.
CODE
Unit J10702.
RECALLING FIRM/MANUFACTURER
Costal Bend Blood Center, Corpus Christi, TX, by telephone and facsimile on September 19, 2002. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with gram-positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1066-5.
CODE
Unit: 390005380.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by fax on December 11, 2003. Firm initiated recall is complete.
REASON
Blood product, released with incomplete testing but later found to have an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1074-5.
CODE
Unit: 18236-8849.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone and fax on February 16, 2005.
Manufacturer: Blood Systems Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
WY.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-1084-5.
CODE
Unit: 246320206 (split unit).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on January 8, 2004.
Manufacturer: Blood Systems Inc., Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
SD and MS.

_______________________________
PRODUCT
Platelets, Pheresis , split product. Recall # B-1087-5.
CODE
Unit: 19GL14515.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter dated August 6, 1997. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Immucor-Gamma?s Alsever?s Solution, 250 mL (Modified by Gamma for Suspending and Preserving Red Blood Cells). Recall # B-1144-5.
CODE
Lot # ALS843-2, Expiration 9/16/2005.
RECALLING FIRM/MANUFACTURER
Gamma Biologicals, Inc., Houston, TX, by letter and facsimile dated January 25, 2005. Firm initiated recall is ongoing.
REASON
Alsever?s Solution, possibly contaminated with mold species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
482 bottles.
DISTRIBUTION 
Nationwide and Japan.

_______________________________
PRODUCT
Sorvall Cellwasher 2 (DA-12 rotor arm assembly); Model Number 04500. Recall # B-1145-5.
CODE
Serial numbers: R28O-155736-SO, S11O-155794-SO, S11O-155795-SO, S17O-155835-SO, S24O-155869-SO, S24O-155870-SO, T07O-155911-TO, T14O-155953-TO, T14O-155954-TO, U12O-156092-UO, U19O-156114-UO, U19O-156115-UO, U26O-156156-UO, U26O-156157-UO, V03O-156216-VO, V03O-156218-VO, V09O-156247-VO, V09O-156253-VO, V09O-156254-VO, V09O-156261-VO, V09O-156262-VO, V09O-156263-VO, V09O-156264-VO, V09O-156265-VO, V09O-156266-VO, V16O-156330-VO, W140-156453-WO, W14O-156447-WO, W14O-156451-WO, W23O-156496-WO, W23O-156506-WO, and X14N-109222-XN.
RECALLING FIRM/MANUFACTURER
Kendro Laboratory Products, Asheville, NC, by letter dated February 18, 2005. Firm initiated recall is ongoing.
REASON
Blood Bank cellwashers, containing an out of specification rotor arm assembly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________
PRODUCT
Source Plasma. Recall # B-1146-5.
CODE
Unit numbers ST257873, ST257015, ST256794, ST254334, ST253699, ST253096, ST252706, ST251877, ST251064, ST250725, ST244231, ST243848, ST243198, ST232355, ST231966, ST230734, ST229955, ST229479, ST228537, ST228167, ST226338, ST226046, ST224666, ST214759, ST214422, ST213858, ST213604, ST212969, ST212635, ST211772, ST211236, ST210739, ST210129, ST209822, ST209076, ST208557, ST208172, ST207555, ST204946, ST204370, ST203654, ST202367, ST201361, ST201134, ST200216, ST200072, ST198752, ST198099, ST197677, ST197093, ST196573, ST196082, ST195518, ST195008, ST194027, ST193318, ST192837, ST191478, ST190745, ST182325, ST180913, ST174141, ST173781, ST172858, ST172468, ST171752, ST170665, ST170151, ST169744, ST169240, ST168773, ST166650, ST163819, ST163237, ST162468, ST161778, ST160923, ST160392, ST159817, ST158962, ST158152, ST157885, ST157131, ST156231, ST155668, ST154557, ST154241, ST153565, ST152904, ST152416, ST151525, ST151116, ST150302, ST189958, ST189103, ST186491, and ST183949.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on February 14, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
97 units.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1152-5;
b) Platelets. Recall # B-1153-5.
CODE
a) and b) Unit number 4661784.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 12 and 13, 2003. Firm initiated recall is complete.
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 
OK and TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1154-5.
CODE
Unit numbers 01SMNB9766 and 01SMNC0321.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., St. Cloud, MN, by facsimile on June 5, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-1155-5.
CODE
Unit numbers 00SMNC1623, 00SMNB9630, 00SMNC7533, and 00SMNC1229.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., St. Cloud, MN, by facsimile on July 25 and 31, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION 
MI and Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-1156-5.
CODE
Unit numbers 00PWIB5991, 00PWIB6289, 00PWIB4557, 00PWIB4197, and 00PWIB3586.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Stevens Point, WI, by facsimile on July 26, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION 
MI and Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-1158-5.
CODE
Unit numbers SX064773, SX064445, SX064289, SX063463, SX063291, AND SX063023.     
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., San Marcos, TX, by facsimile on June 30, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-1159-5.
CODE
Unit numbers SX009379, SX008942, SX008487, SX008087, SX007611, SX007312, SX007164, SX006951, SX006636, SX006440, SX006213, SX005815, SX005711, SX005461, SX005352, SX005121, SX005036, SX004854, and SX004750.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Marcos, TX, by facsimile on June 29, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION 
MA

_______________________________
PRODUCT
Source Plasma. Recall # B-1160-5.
CODE
Unit number 330020328.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Seattle, WA, by facsimile on December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of deferral information related to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Spain.

_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-1162-5;
b)Plasma, Cryoprecipitate Reduced. Recall # B-1163-5.
CODE
a) and b) Unit number 1377521.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on May 21, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
NC

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1164-5.
CODE
Unit number 1407113.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on July 2, 2003. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Austria

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1165-5.
CODE
Unit number 8476060.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on August 15, 2001. Firm initiated recall is complete.
REASON
Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that subsequently reported a previous reactive test for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1167-5.
CODE
Unit number 4917527A.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc. Orlando, FL, by facsimile on June 9, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1168-5.
CODE
Unit number 2269211.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers Inc., Orlando, FL, by letter on April 27, 2001. Firm initiated recall is complete.
REASON
Blood product tested positive for antibodies to red blood cell antigen D (anti-D) but was not labeled anti-D positive.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1170-5.
CODE
Unit number 3022277.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers Inc., Orlando, FL, by telephone on March 1, 1999. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received Human Chorionic Gonadatropin (HCG) injections, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1171-5.
CODE
Unit numbers 00JWIB3650, 00JWIB4063.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P. Janesville, WI, by facsimile on August 23, 2000. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1172-5.
CODE
Unit number 4617514.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 22 and 30, 2003. Firm initiated recall is complete.
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 
OK.

_______________________________
PRODUCT
Platelets. Recall # B-1173-5.
CODE
Unit number 3926998.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone on August 6, 1999, and by facsimile on August 10, 1999, and September 22, 1999. Firm initiated recall is complete.
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 
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1174-5;
b) Platelets, Recall # B-1175-5.
CODE
a) and b) Unit number 4674432.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 6, 2003. Firm initiated recall is complete.
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 
OK and TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1176-5;
b) Platelets, Recall # B-1177-5.
CODE
a) and b) Unit number 4558173.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, by facsimile on February 18, 2003, and July 21, 2003. Firm initiated recall is complete.
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 
OK and TX.

_______________________________
PRODUCT
Platelets. Recall # B-1178-5.
CODE
Unit number: KK75374.        
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, facsimile on December 30, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet the specifications for manufacturing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-1179-5;
b) Platelets. Recall # B-1180-5;
c) Recovered Plasma. Recall # B,1181-5.
CODE
a), b), and c) Unit number 4191363.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 17, 2001. Firm initiated recall is complete.
REASON
Blood products collected a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
OK, TX and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1182-5;
b) Recovered Plasma. Recall # B-1183-5.
CODE
a) and b) Unit number 11LV27257.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone and electronic mail message on May 11, 2004, and by letter on May 17, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
MO and CA.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1184-5.
CODE
Unit number 5317426.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc. Orlando, FL, by telephone on June 22, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to a history of possible blood and body fluid exposure, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1191-5.
CODE
Unit number E17710.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone and facsimile on March 25, 2005. Firm initiated recall is complete.
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 
IL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1192-5.
CODE
Unit number T04153.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone and facsimile on February 24, 2005. Firm initiated recall is complete.
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 
IL.

_______________________________
PRODUCT
a) Platelets. Recall # B-1193-5;
b) Fresh Frozen Plasma. Recall # B-1194-5.
CODE
a) and b) Unit number L88116.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by telephone on March 2, 2005, and by facsimile on March 10, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1198-5;
b) Fresh Frozen Plasma. Recall # B-1199-5.
CODE
a) and b) Unit number S81045.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by telephone on March 1, 2005. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Platelets that tested positive for Staphylococcus epidermidis bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1201-5.
CODE
Unit number: 12KE81932     
RECALLING FIRM/MANUFACTURER
American Red Cross , Carolinas Region, Charlotte, NC, by telephone on September 2, 2003. Firm initiated recall is complete.
REASON
Blood product, untested for human immunodeficiency virus (HIV) and hepatitits C virus (HCV) by the nucleic acid test (NAT) method, was distributed.     
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1202-5.
CODE
Unit numbers: 9033166 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on March 16, 2004. Firm initiated recall is complete.
REASON
Platelets, collected on an instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION 
SC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1203-5.
CODE
Unit number 4666179.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 19, 2003. Firm initiated recall is complete.
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 
MS

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1204-5;          
b) Recovered Plasma. Recall # B-1205-5.
CODE
a)and b) Unit number 4616567.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 14, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
OK and Switzerland.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1206-5
b) Platelets. Recall # B-1207-5.
c) Recovered Plasma. Recall # B-1208-5.
CODE
a), b) and c) Unit number 4705045.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on August 22, 25, and 28, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
OK, TX and Switzerland.

______________________________
PRODUCT
Red Blood Cells. Recall # B-1209-5.
Recovered Plasma. Recall # B-1210-5.
CODE
a) and b) Unit number 6530948
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on March 31, 2005. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
FL and Switzerland.

______________________________
PRODUCT
Source Plasma. Recall # B-1212-5.
CODE
Unit number HP120496.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Chicago, Chicago, IL, by telephone and electronic mail on January 3, 2005. Firm initiated recall is complete.
REASON
Blood product, that tested elevated for alanine aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
NY

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1213-5;
b)Recovered Plasma. Recall # B-1214-5.
CODE
a) and b) Unit numbers 3452773 and 3451520.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource Blood Services, Glenview, IL, by telephone on October 29 and 31, 2004.
Manufacturer: LifeSource, Gurnee Donor Center, Gurnee, IL. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
IL.

______________________________
PRODUCT
Fresh Frozen Plasma [Apheresis]. Recall # B-1215-5.
CODE
Unit number T17375.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by telephone on February 3, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using automated equipment that had not been validated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
MI.

______________________________
PRODUCT
Red Blood Cells. Recall # B-1216-5.
CODE
Unit number 01KK98700.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, by telephone on March 8, 2004, and by letter on March 9, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that tested positive for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
NY.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1217-5.
b) Plasma. Recall # B-1218-5.
CODE
a) Unit numbers 01FW19307, 01KX80274, 01Q71880, and 01Y52914.
b) Unit numbers 01FW19307, 01FW19319, 01KX80274, 01Q71880, and 01Y52914.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, by telephone and letter on January 8 and 9, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Platelets that were pooled and possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION 
NY.

______________________________
PRODUCT
Red Blood Cells. Recall # B-1219.
CODE
Unit number 6035916.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK,, by letter on February 23, 2004. Firm initiated recall is complete.
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 
AK.

______________________________
PRODUCT
Red Blood Cells. Recall # B-1220-5.
CODE
Unit number 6705129.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter on October 10, 2003. Firm initiated recall is complete.
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 
AK.

______________________________
PRODUCT
Red Blood Cells. Recall # B-1221-5.
CODE
Unit number 6705310.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter on December 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
AK.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1224-5.
b) Recovered Plasma. Recall # B-1225-5.
CODE
a) and b) Unit number 4467500.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 4, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
OK and Switzerland.

______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1226-5.
CODE
Unit numbers 22GE79947, 22GE79957, 22GE79963, 22GE79966, 22GE79967, 22GH04791, 22GH04794, 22GH04800, 22GH04813, and 22KW58769.
RECALLING FIRM
The American National Red Cross,Penn-Jersey Region, Philadelphia, PA, by telephone and letter on August 5, 2004. Firm initiated recall is complete.
REASON
Blood products were manufactured in bags that may have contained leaks.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION 
PA.

______________________________
PRODUCT
Source Plasma. Recall # B-1227-5.
CODE
Unit numbers DZMMBT and DZMMJB.
RECALLING FIRM
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on October 3, 2003.
Manufacturer: International BioResources, LLC, Eugene, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
IN.

______________________________
PRODUCT
Source Plasma. Recall # B-1228-5.
CODE
Unit numbers FQDQHJ and FQDQCL.
RECALLING FIRM
Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on May 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
IN.

______________________________
PRODUCT
Source Plasma. Recall # B-1229-5.
CODE
Unit number FQDVRL.
RECALLING FIRM
Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on April 24, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not tested for syphilis, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IN.

______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1230.
CODE
Unit number 22KV74611.
RECALLING FIRM
The American National Red Cross,Penn-Jersey Region, Philadelphia, PA, by telephone on February 1, 2005, and by letter on February 22, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that tested positive for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
PA.

______________________________
PRODUCT
Source Plasma. Recall # B-1231.
CODE
Unit number 02BMTC2170.
RECALLING FIRM
Biolife Plasma Services L.P., Deerfield, IL, by facsimile on March 19, 2003. Firm initiated recall is complete.
REASON
Blood product collected from an ineligible donor due to recent dental surgery.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
MI.

______________________________
PRODUCT
Source Plasma. Recall # B-1233-5.
CODE
Unit number FQDMQW.
RECALLING FIRM
Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on April 16, 2003.
International Bio-Resources, LLC, Salem, OR. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IN.

______________________________
PRODUCT
Source Plasma. Recall # B-1234-5.
CODE
Unit number FQDKYH.
RECALLING FIRM
Aventis Bio-Resources, Inc. Knoxville, TN, by facsimile on April 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IN.

______________________________
PRODUCT
Source Plasma. Recall # B-1235-5.
CODE
Units 92020610, 91484918, 91484956, 91484222, 91484017.
RECALLING FIRM
Biomat USA, Inc., Colorado Springs, CA, by facsimile on July 11, 2003 and December 26, 2003. Firm initiated recall is complete.
REASON
Blood products, which were untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION 
CA and Spain.

______________________________
PRODUCT
Source Plasma. Recall # B-1236-5.
CODE
Units 330021509, 330021712, 330022059, 330022272, 330022697, 330022922, 330023312, 330023676, 330024154, 330024391, 330024767, 330024976, 330025347, 330025593, 330025974.
RECALLING FIRM
Biomat USA, Inc., Colorado Springs, CA, by facsimile December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for being an unreliable historian, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION 
Spain.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1237-5;
b) Platelets, Leukocytes Removed. Recall # B-1238-5;
c) Fresh Frozen Plasma. Recall # B-1239-5;
d) Recovered Plasma. Recall # B-1240-5.
CODE
a), b) and c) Unit numbers: 33GR68578, 33GJ66433.          
d) Unit numbers: 33GE75845, 33GT23988.
RECALLING FIRM
American Red Cross, Connecticut Region, Farmington, CT, by letter, dated January 13, 2005, and electronically on January 11, 2005. Firm initiated recall completed.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.      
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION 
CA and CT.

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1242-5.
CODE
Unit number 231467988.
RECALLING FIRM
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ, by telephone on March 29, 2004 and by letters dated November 21, 2002 and March 29, 2004.
Manufacturer: Blood Systems, Inc, Billings, MT. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Methadone HCL, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
MT.

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1243-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1244-5.
CODE
a) Unit numbers: 4635622 (Part 1), 4627584 (Part1), 4654056
(Parts 1 & 2);
b) Unit numbers: 4627584 (Part 2), 4635622 (Part 2).
RECALLING FIRM
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on April 2, 18, and July 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that who was taking Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION 
OK, TX, and AR.

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1251-5.
b) Cryoprecipitated AHF. Recall # B-1252-5;
c) Recovered Plasma. Recall B-1253-5.
CODE
a), b), and c) Unit number FV02486.
RECALLING FIRM
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on February 25, 2005.. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had undergone surgery and had received blood transfusions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
CT, MA, and Switzerland.

______________________________
PRODUCT
Recovered Plasma. Recall # B-1258-5
CODE
Unit number 5734369.
RECALLING FIRM
Florida?s Blood Centers, Inc, Orlando, FL, by facsimile on December 29, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Austria.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1260-5.
CODE
Unit LG12219.
RECALLING FIRM
Healthcare Provider Services, dba Rhode Island Blood Center, Providence, RI, by letter on March 8, 2005. Firm initiated recall is complete.
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 
MA.

______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-1271-5.
CODE
Unit 3042021.
RECALLING FIRM
Ogden Medical Center, Inc., Ogden, UT, by telephone on January 24, 2003 and by letter dated January 24, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a therapeutic donor with a history of polycythemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
UT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1272-5;
b) Recovered Plasma, for manufacturing injectable
products. Recall # B-1273-5.
CODE
a) and b) Unit number: 4508467.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimiles on August 21, 22, and 28, 2003, and by letter dated September 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
NY and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1275-5;
b) Fresh Frozen Plasma. Recall # B-1276-5.
CODE
a) and b) Unit number: 4483825.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 3, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
OK, and Austria.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1277-5;
b) Platelets. Recall # B-1278-5;
c) Fresh Frozen Plasma. Recall # B-1279-5.
CODE
a), b) and c) Unit number: 4685689.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously made a therapeutic donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
AR, OK, and TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1280-5.
CODE
Unit number: 4582546.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimiles on January 28, and February 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
OK.

______________________________
PRODUCT
Platelets. Recall # B-1290-5.
CODE
Unit 4804882.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 11 and 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin within 3 days of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
TX.

______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-1291-5;
b) Recovered Plasma. Recall # B-1292-5.
CODE
a) and b) Unit 4350370.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by telephone on September 3, 2003, and facsimile dated September 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who admitted to risk factors for variant Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
FL and Austria.

______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-1306-5.
CODE
Unit number: 4506318.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had an elevated alanine aminotransferease (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
OK.

_______________________________
PRODUCT
Baxter Fenwal Amicus Separator Apheresis Device. Recall # B-1307-5.
CODE
Product Codes: 4R4580 and 4R4580R. All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Fenwal Division, Deerfield, IL, by letter dated March 16, 2005.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON
Apheresis Devices, in which the polycarbonate window on the centrifuge door may develop cracks and fissures if ammonia or ammonia based cleaners are used on it, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,221 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________
PRODUCT
Leukotrap RC - Whole Blood Collection, Filtration and Storage System with the New Pall RC2D Leukocyte Reduction Filter. Recall # B-1309-5.
CODE
Affected Leukotrap RC Systems Lot Numbers: 0400198, 0400161, 0301733, 0301615, 0300039, 0300898, 0300038, RE 1827, 0400317, 0400232, 0400278, 0400234, 0400200, 0400199, 0400282;
Affected RC2D Filter Lot Numbers: 231517, 231917, 232217, 303617, 304917, 330717, 330817, 331417, 402220, 402420, 402620, 402720, 403320.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pall Biomedical Products Corp., East Hills, NY, by telephone on March 17, 2004, and by letter dated March 19, 2004.
Filter Manufacturer:   Pall Biomedical, Inc., Fajardo, PR.
System Manufacturer: Pall Medical, Covina, CA. Firm initiated recall is ongoing.
REASON
Leukoreduction Filters, associated with reports of air down stream of the filter and quality control failures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30,888 units.
DISTRIBUTION 
IA, FL, TX, and MD.

_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1311-5.
CODE
Numbers NY-05-04-017-R1 and NY-05-04-017-L1.
RECALLING FIRM/MANUFACTURER
Sight Society of Northeastern New York, Albany, NY, by telephone on April 22, 2005. Firm initiated recall is complete.
REASON
Human Tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION 
PA and SD.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1315-5;
b) Platelets. Recall # B-1316-5.
CODE
a) and b) Unit number 0063204.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on December 7, 2001. Firm initiated recall is complete.
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 
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1319-5.
CODE
Unit numbers 87346237, 87344066, 87338089, 87334494, 87329667, 87326307, 87320916, 87318029, 87311501, 87309249, 87303667, 87301144, 87295726, 87293463, 87288131, 87285369, 87280005, 87276978, 87265903, 87263299, 87256277, 87248746, 87246612, 87241785, 87238648, 87233506, 87231939, 87226195, 87216219, 87213782, 87208795, 87204674, 87201635, 87197945, 87193657, 87287922, 87185041, 87179613, 87176520, 87171556, 87168129, 87162226, 87153811, 87152630, 70439915, 70437386, 70432190, 70427929, 70422429, 70420333, 70412109, 70408317, 70402643, 70399455, 70393859, 70390957, 70385922, 70382716, 70377200, 70374247, 70368796, 70365832, 70361483, 70357424, 70352238, 70349528, 70341584, 70338669, 70333008, 70330359, 70624983, 70322545, 70317558, 70314977, 70310771, 70307566, 70301090, 70298468, 70292695, 70290134, 70284911, and 70281781.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dallas, TX, by facsimile on July 17, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
82 units.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1320-5.
CODE
Unit number 04DILD3390.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., DeKalb, IL, by facsimile on March 10, 2005. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1321-5.
CODE
Unit numbers 65931R and 01347T.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lakeland, FL, by facsimile on February 14, 1998. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1322-5;
b) Fresh Frozen Plasma. Recall # B-1323-5.
CODE
a) and b) Unit number B169359.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on August 7, 2002.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
WA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-1324-5;
b) Platelets, Pooled. Recall # B-1325-5.
CODE
a) Unit number E166030;
b) Pool number HP10816.
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on September 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit; 1 pool.
DISTRIBUTION 
WA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1326-5.
CODE
Unit number FG02482.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated April 4, 2005.
Manufacturer: Heartland Blood Centers, Elgin Donor Center, Elgin, IL. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distribted.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IL.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1327-5;
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1328-5.
CODE
a) and b) Unit number 40P03881.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on February21, 2005, and by letter on March 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
IL.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0937-5.
CODE
Unit: 18235-4611.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by electronic notification on July 13, 2004.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1011-5;  
b) Recovered Plasma. Recall # B-1012-5.
CODE
a) and b) Unit number: 7833910.
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by facsimile and by letter, dated December 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to the use of erythromycin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
FL, and Switzerland.

_______________________________
PRODUCT
Baxter Fenwal Sepacell PLS-5A Leukocyte Reduction Administration Set For Platelet Transfusion. Product Code 4C2496. Recall # B-1026-5.
CODE
Lot Number A04I08265.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Fenwal Division, Deerfield, IL, by letter dated March 15, 2005.
Manufacturer: Baxter Healthcare Corporation, Parque Industrial Itabo, Haina, Dominican Republic. Firm initiated recall is ongoing.
REASON
Platelet Bedside Filters, containing an inverted pre-filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
493
DISTRIBUTION 
VA, WA, HA, D.C.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1027-5.
CODE
Unit numbers 33GV65820, 33GV65882, 33GV65783, 33GV65784, 33GV65799, 33GV65790, 33GV65809, 33GV65819, 33GV65832, 33GV65805, 33GV65850, 33GV65862, 33GV65749, 33GY89268, 33GY89247, 33GY89248, 33GV65787, 33GV65789, 33GV65771, 33GV65768, 33GV65775, 33GL44543, 33GL44517, 33GY89294, 33GV65837, 33GV65879, 33GL44548, 33GL44515, 33GV65875, 33GV65877, 33GR76215, 33GV65773, 33GV65778, 33GV65842, 33GV65848, 33GL44547, 33GV65828, 33GY89301, 33GY89281, 33GY89289, 33GV65884, 33GV65769, 33GV65776, 33GV65774, 33GV65838, 33GV65847, 33GL44540, 33GY89239, 33GL44561, 33GL44550, 33GL44555, 33GR76210, 33GV65878, 33GY89302, 33GY89306, 33GR76208, 33GR76218, 33GR76238, 33GV65804, 33GV65797, 33GV65801, 33GY89323, 33GL44534, 33GV65826, 33GV65830, 33GY89308, 33GY89275, 33GV65885, 33GV65883, 33GV65786, 33GV65785, 33GV65792, 33GV65793, 33GV65791, 33GV65767, 33GV65788, 33GV65777, 33GV65835, 33GV65839, 33GV65843, 33GL44546, 33GL44523, 33GY89266, 33GY89256, 33GY89307, 33GY89309, 33GL44514, 33GY89312, 33GL44531, 33GY89322, 33GR76199, 33GL44516, 33GY89349, 33GY89246, 33GV65833, 33GL44507, 33GL44505, 33GL44541, 33GL44519, 33GL44549, 33GY89346, 33GY89347, 33GY89343, 33GY89331, 33GY89332, 33GY89314, 33GY89324, 33GY89244, 33GY89321, 33GR76227, 33GY89290, 33GY89292, 33GY89252, 33GY89253, 33GY89251, 33GY89304, 33GY89257, 33GY89259, 33GY89262, 33GV65881, 33GY89313, 33GV65861, 33GY89320, 33GY89264, 33GY89240, 33GL44510, 33GL44560, 33GV65831, 33GL44512, 33GL44532, 33GV65858, 33GV65752, 33GV65755, 33GV65765, 33GY89296, 33GV65823, 33GV65870, 33GV65866, 33GV65864, 33GY89274, 33GR76231, 33GV65867, 33GR76202, 33GR76196, 33GR76236, 33GV65796, 33GY89241, 33GV65757, 33GV65876, 33GR76206, 33GY89276, 33GR76230, 33GV65800, 33GY89329, 33GV65871, 33GV65872, 33GR76200, 33GR76213, 33GL44539, 33GV65816, 33GV65868, 33GV65865, 33GV65753, 33GV65873, 33GV65762, 33GR76201, 33GV65760, 33GR76216, 33GV65886, 33GR76232, 33GR76229, 33GR76233, 33GR76237, 33GV65811, 33GV65825, 33GV65798, 33GV65803 33GV65802 33GV65807 33GV65845, and 33GV65860.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and facsimile on March 10, 2005. Firm initiated recall is complete.
REASON
Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
181 units.
DISTRIBUTION 
CT, and MA.

_______________________________
PRODUCT
Fresh Frozen Plasma, Irradiated. Recall # B-1036-5.
CODE
Unit number: 0058515.
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Lauderhill, FL, by telephone on September 2, 1999, Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1053-5;
b) Red Blood Cells Pheresis, Leukocytes Reduced.
Recall # B-1054-5;
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1055-5;
d) Red Blood Cells Pheresis, Leukocytes Reduced,
Irradiated. Recall # B-1056-5;
e) Red Blood Cells, Leukocytes Reduced, Washed.
Recall # B-1057-5;
f) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1058-5;
g) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1059-5.
CODE
Units 6158665, 6280982, 2936980, 6173056, 6157828,
6149107, 6283062, 2879340, 0172683, 6227592,
6233165, 6165618, 6161628, 2936979, 2884028,
6150003, 2917063, 2917061, 6146654, 6157827,
6215115, 6258946, 6260317, 6260316, 6250216,
6283012, 2923046, 0096640, 6215114, 0099358, 6249123,
6258961, 0176452, 0166294, 2976917, 6150002, 6237643,
6227594, 6270548, 2906478, 6207506, 0088076, 6162020,
6162019, 6161630, 6161626, 6161624, 6161204, 6161203,
2904669, 6283133, 6263378, 6177155, 2917062, 5460852,
2978760, 6191779, 6157045, 6245621, 6238501, 2940567,
6158666, 6276236, 6165608, 6161629, 2936982, 2936976,
6215667, 6258948, 5461811, 6209918, 6245628, 6215120,
6283063, 0096985, 0095730, 2949151, 6215121, 6215118,
6244382, 0089927, 2081778, 2916555, 6245203, 6265714,
6139302, 0095480, 6140482, 6149428, 6139303, 6196672,
6238833, 2929494, 6196786, 6245202, 6173751, 6182666,
6149429, 0146605, 2906220, 6167275, 6160579, 6156241,
2906839, 6174692, 6213577, 6195084, 6201425, 6165297,
6142891 (2 splits), 0100223, 5451155, 6172091, 2905693,
2896543, 2914517, 2860747, 2958346, 2898210, 6145855,
6264243, 6138325, 2863720, 2917438, 2914217, 2906697,
2905095, 6143215, 6204602, 6213581, 6218343, 6218699,
6165946, 6228094, 0094742, 2926563, 6164804, 6140310,
2907775, 6168635, 6147114, 6230329, 2937219, 2929444,
6151090, 6242715, 2864095, 2877141, 2863666, 2861679,
2979707, 6150863, 6149232, 6139026, 6136621, 6161200,
6167274, 6153690, 6143479, 6179242, 6242716, 6228087,
6201393, 6237932, 2083686, 0115630, 0112327, 6235464,
5446817, 5454886, 0185871, 0178793, 2875678, 2872637,
0142866, 2878153, 0179697, 2940840, 2861676, 2889543,
2910417, 2862328, 2906385, 6164957, 6164851, 6150489,
2906652, 6163637, 6141404, 2939378, 2905094, 6176129,
6168630, 6151374, 6172090, 6154505, 6146707, 6145170,
6142774, 6157604, 2927019, 6167272, 6160576, 6153697,
2906838, 6182330, 6168185, 6211724, 6245697, 6165844,
6254363, 6270729, 6283973, 6168633, 5451154, 2949154,
2961617, 6235471, 6283131, 0175302, 0176454, 2931633,
2957478, 2895962, 0186435, 6152715, 6284758, 6279530,
6265472, 6255178, 0096989, 2867366, 0185879, 0185241,
0179763, 0165439, 0132046, 2909693, 2904929, 6139120,
2908106, 6164846, 2906643, 2906642, 2927094, 6149081,
6146254, 6142737, 6141144, 6143471, 6157830, 6157829,
6214470, 6218695, 6228093, 6265670, 6235465, 5458009,
0133930, 0186716, 0179046, 2875682, 2931634, 6197318,
2905489, 2895971, 2925476, 2909698, 2906219, 2906218,
2904914, 2896630, 6149872, 6164914, 6164911, 2914176,
6157717, 6144210, 6172096, 6172092, 6168632, 6178433,
6178432, 6178424, 6171603, 6171600, 6207237, 6241971,
2080617, 0127172, 0087059, 6136293, 6172094, 6223328,
6200483, 5461797, 0164306, 2914216, 6157602, 6153694,
6147141, 2927034, 2905692, 2869512, 6164960, 6145456,
6142773, 6143714, 6160203, 6143418, 6256629, 2860788,
5443398, 5456940, 0186440, 0178799, 2913725, 2953228,
2993348, 2858677, 2895974, 6156883, 6154090, 6151161,
6142250, 6142219, 6141335, 2904670, 6156995, 6149073,
6149072, 6157614, 6171672, 6160315, 2961630, 2867369,
0185878, 2966463, 6178427, 6216922, 5438558, 6148608,
2934239, 2975833, 2925640, 6164807, 6270051, 6274085,
0085548, 5451016, 2884057, 2916951, 6146610, 6228049,
0185874, 2869514, 2967524, 6164216, 6262354, 0098156,
2080343, 2875680, 2875679, 2875675, 0179044, 0179043,
6151135, 6151250, 0186443, 0175301, 0179041, 2963814,
6165046, 6141399, 6162016, 6151262, 6145204, 6142247,
6141337, 6140672, 6176824, 6143475, 6143474, 6143461,
6165846, 6249668, 6279732, 6272740, 0149185, 2867403,
2867370, 2867365, 0185882, 0185880, 0185877, 0185872,
0185869, 2871358, 2886448, 2981919, 6150896, 2934087,
2934083, 2929314, 2908104, 6154088, 6142221, 6137395,
2914195, 6146938, 6223257, 6250781, 6276301, 6237929,
5436285, 2945523, 6260814, 6225790, 0185883, 6186695,
6247267, 6247266, 6241214, 0143457, 6172089, 6148604,
6149229, 2934090, 2934086, 6150889, 2917457, 5445501,
0185366, 2858691, 0157927, 0109765, 2921024, 5443452,
5446794, 0147707, 0186441, 0185876, 2881413, 0142594,
0170919, 2931643, 2955586, 2897035, 2934348, 2919313,
2896545, 6153696, 6143473, 6273494, 2867972, 2889550,
2940074, 2940065, 2963807, 6164910, 6164853, 2914174,
6146547, 6143809, 6154138, 2882527, 2867402, 2869507,
0185365, 2859475, 2863783, 2982406, 2961861, 2916952,
2898072, 6164849, 6154086, 6140627, 6137715, 6136912,
2939357, 6178423, 6171426, 5466757, 2895973, 2895969,
2925461, 2909699, 2934322, 2909700, 2885676, 6164918,
6146590, 0097730, 0098241, 2925639, 2915743, 6168132,
0112316, 6248326, 5457685, 2982403, 2973942, 6160427,
6138567, 6202102, 5443451, 2876806, 0185460, 6257235,
6180063, 6151354, 6160202, 6160200, 6153691, 2993879,
2897494, 6146939, 6160577, 6172921, 2966925, 2961628,
2924851, 2876666, 2907546, 5431346, 2988291, 2979622,
2974507, 2895970, 2914175, 2906650, 6165058, 6161206,
6141403, 6136282, 2904665, 2904664, 6160429, 6252408,
2084306, 0096796, 0127012, 0098155
b) Units 6152011, 6265790, 6152001, 6136973, 6278267,
6232344, 6245203, 6225710, 6225707, 6171964, 2090736,
6152014, 6240240, 2939410, 6152013, 0122872, 6255545,
6272734, 6178145, 6272547, 6178666;
c) Units 0096984, 0088078, 5443397, 6164847, 2925464,
2937994, 6144313, 2895672, 6153628;
d) Unit 6245201;
e) Units 0158718, 2895961, 6238506, 6215113, 2938748;
f) Units 6182923 (8 splits), 0102301, 6272174, 0155141,
0107804 (2 splits), 6232304, 0171418, 2958942, 2979100
(2 splits), 6264155 (3 splits), 0162199, 0152046,
2894267, 0155167, 6191146, 6182954 (2 splits), 6244681,
5437558, 0133268, 2960124, 2862628 (2 splits), 2957930,
2969659, 6191324, 6219913, 5466665, 2892668, 2951670,
6182961, 6183021, 6262504, 0147517 (2 splits), 2860181
(2 splits), 2983819, 2984030, 6200605, 6247557,
6193028 (2 splits), 0084750 (3 splits), 0139898,
5456811, 2867774 (2 splits), 0142454, 2964840, 0155003
(2 splits), 6229846, 0086047, 2084874, 0107789
(2 splits), 2991366, 2964816 (2 splits), 0158192
(2 splits), 2869647 (2 splits), 7426717 (3 splits),
6185456, 6193079, 0124953, 5437560, 0183441, 0160173
(3 splits), 2923849, 2980937, 6144436, 6154435
(2 splits), 6210980, 6263851 (3 splits), 0102672,
0107781 (2 splits), 0150466, 2921933, 2975301,
2934958, 0155186, 6236023, 6244713, 6232317 (3 splits),
6262595, 2922041, 6211081, 2921887, 0149416, 0139891,
5465962, 0180195, 2877895, 2943681 (2 splits), 2935344,
6181476 (2 splits), 6252223, 6266043, 5454984, 2921999,
0177684, 5437459, 2867687, 0150445, 6235331, 5442653,
0177856, 6240129, 6235586, 0084277, 6206579, 2921912,
2979595, 2948975, 0098923 (3 splits), 5437410, 0181161,
6264200 (2 splits), 0084077 (2 splits), 2942386, 0115810
(3 splits), 6266369, 0107733 (3 splits);
g) Units 6210918, 7426372, 6229846, 6220357, 6266369,
6247517, 0148502 (2 splits), 2923878, 2921912,
6191472, 2085507, 2854321, 0084277, 0187747,
2970754, 6264200, 6262595, 0162199, 0189390
(2 splits), 2921999, 2867774, 6244681, 0124953,
2942386, 0181161.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by letters dated October 10, 2003 and December 1, 2003. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
767 units.
DISTRIBUTION 
CA, FL, GA, IL, MS, NC, NJ, NY, TN, and TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1065-5.
CODE
Units: 21609-6076, 21609-6083, 21609-6084, 21609-6275.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on November 8, 2002.
Manufacturer: Blood Systems Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION 
SD.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1075-5.
CODE
Unit: 18236-8849.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone and fax on February 16, 2005.
Manufacturer: Blood Systems Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Irradiated. Recall # B-1086-5.
CODE
Unit number: 4705192.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone on June 30, 2005 and fax on July 1, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled as "Leukocyte Reduced" but which failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
OK.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1135-5;
b) Recovered Plasma. Recall # B-1136-5.
CODE
a) Unit number 9144974;
b) Unit number 1368467.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by facsimile on October 26, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Aricept, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1157-5.
CODE
Unit numbers 00PWIA4592, 00PWIA4939, 00PWIA5590, 00PWIA5973, 00PWIA6671, 00PWIA7072, and 00PWIA7746.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Stevens Point, WI, by facsimile on September 21, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a recent measles vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION 
Austria.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1161-5.
CODE
Unit number: 8462882.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by facsimile on May 27, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to use of the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
Austria.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1166-5.
CODE
Unit number: 4921392A.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by telephone and letter beginning September 7, 2001. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1185-5.
CODE
Unit number: 6723076.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by telephone on Autust 21, 2001. Firm initiated recall is complete.
REASON
Blood product tested positive for antibodies to red blood cell antigen D and C (anti-D and anti-C) but was not labeled anti-D and anti-C positive.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1186-5.
CODE
Unit number 6537982.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on April 1, 2005. Firm initiated recall is complete.
REASON
A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1187-5.
CODE
Unit number 6515203.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on April 1, 2005. Firm initiated recall is complete.
REASON
A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1188-5.
CODE
Unit number 6542349.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by facsimile on April 1, 2005. Firm initiated recall is complete.
REASON
A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1190-5.
CODE
Unit number 6525316.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on April 1, 2005. Firm initiated recall is complete.
REASON
A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1195-5;
b) Platelets. Recall # B-1196-5;
c) Fresh Frozen Plasma. Recall # B-1197-5.
CODE
a), b), and c) Unit number N11806.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on December 31, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-1211-5.
CODE
Unit number FQDQKX.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on April 16, 2003.
Manufacturer: International Bio-Resources, LLC, Salem, OR. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1222-5.
CODE
Unit number 5019232.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter on November 25, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
AK.

_______________________________
PRODUCT
Source Plasma. Recall # B-1223-5.
CODE
Unit number FQCZNL.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on April 16, 2003.
Manufacturer: International Bio-Resources, LLC, Salem, OR. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1232-5.
CODE
Unit number FQDLYZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN, by facsimile on April 16, 2003.
Manufacturer: International Bio-Resources, LLC, Salem, OR. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability determination was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
IN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1245-5.
CODE
Unit number: 92710412.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on April 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1246-5.
CODE
Unit numbers 04974468, 04849803, 04841777, 04840824, 05821426, 04489771, and 04488828.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1247-5.
CODE
Unit number: 1150250.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated April 3, 2003. Firm initiated recall is complete.
REASON
Blood product, which remained out of controlled storage for more than 30minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1254-5.
CODE
Unit numbers 05828715, 05824496, and 04489795.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1255-5.
CODE
Unit numbers 04847090 and 05822249.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1256-5.
CODE
Unit numbers 04850267, 05827782, 05821860, and 04489252.
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1257-5.
CODE
Unit number 3867695.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by telephone on November 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of a human tissue transplant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1259-5.
CODE
Unit number 8310540 (distributed as two split units.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by telephone and letter beginning August 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
FL.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1261-5.
CODE
Unit numbers: 6818791, 6817789, 3362390.
RECALLING FIRM/MANUFACTURER
Florida?s Blood Centers, Inc., Orlando, FL, by facsimile on December 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who gave a history of ulcerative colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
Austria and Switzerland.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1262-5.
CODE
Units: 4460247, 4615317.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and fax on March 17, 2003 and June 27, 2003. Firm initiated recall is complete.
REASON
Blood products, prepared from plasma that was not frozen within 6 hours of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
OK.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1267-5;
b) Platelets. Recall # B-1268-5;
c) Recovered Plasma. Recall # B-1269-5.
CODE
a), b), and c) Unit 4191475.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
NY, TX, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1270-5.
CODE
Unit 04LE57305.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone and facsimile on February 15, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an autologous donor with a history of seizures, but not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
MA.

_______________________________
PRODUCT
Recovered Plasma, for manufacturing non-injectable products. Recall # B-1274-5.
CODE
Unit number: 4508467.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on August 21, 22, and 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1295-5.
CODE
Unit number 027GM98403.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on November 28, 2004, and by letter on December 2, 2004. Firm initiated recall is complete.
REASON
Blood product exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
PA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1296-5.
CODE
Unit number 5285064.
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Columbia Ogden Medical Center, Ogden, UT, by telephone on December 3, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
UT.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1298-5.
CODE
Unit numbers: 4584729 and 4560714.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 16, 2003. Firm initiated recall is complete.
REASON
Blood products, whose freeze time exceeded the firm?s specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
OK.

_______________________________
PRODUCT
Baxter Fenwal Blood-Pack Unit, Product Code 4R1247MC.
Recall # B-1308-5.
CODE
Lots M02I26046, M02I26046A, M02J10064, M02J10064A, M02K18032, M02K30029, M03A31067, M03B14038, M03B14038A, M03B28053, M03C21056, M03E28056, M03K06051, M04A17032, M04C26039 and M04E07034.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letter dated March 16, 2005.       
Manufacturer: Baxter Healthcare Corporation, Transfusion Therapies Division, Maricao, PR. Firm initiated recall is ongoing.
REASON
The Samplink access device included in the cases with the Blood-Pack Units may be expired while the Blood-Pack Units are still within expiration.
VOLUME OF PRODUCT IN COMMERCE
16 lots, 1,991 cases.
DISTRIBUTION 
Nationwide and Germany.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1312-5;
b) Recovered Plasma. Recall # B-1313-5.
CODE
a) Unit number 4543571;
b) Unit number 4543571 (two units distributed).
RECALLING FIRM/MANUFACTURER
Recalling firm: Oklahoma Blood Institute, Sylvan N. Goldman Center), Oklahoma City, OK, by facsimile on January 23, 2003, March 26, 2003, and April 3, 2003.
Manufacturer: Oklahoma Blood Institute, Northwest Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION 
OK, FL, and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1314-5.
CODE
Unit numbers 15796929, 15795687, 15793966, 15793058, 15791238, 14560217, 14558429, 14557422, 14555756, 14554513, 14552557, 14551802, 15469496 and 15468758.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Clearwater, FL, by facsimile on July 19, 1999. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION 
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1317-5.
CODE
Unit number 26173-6759.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 5, 2002. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but failed quality control testing due to as elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION 
AR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1318-5.
CODE
Unit numbers 26173-2206, 26173-2200, 26173-2192, 26173-2191, 26173-2188, 26173-2187, 26173-2195, and 26173-2196.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on August 8, 2002, and by letter on August 30, 2002. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION 
AR.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails. Recall # Z-0850-05.
CODE
Pre-paks Lot CR10-P115-14, exp. 10/2006, and
5-gallon pail Lot CR09-P115-30, exp. 9/2006.
RECALLING FIRM/MANUFACTURER
Darex Container Products, Division of W.R. Grace & Co., Chicago, IL, by letters dated March 30, 2005. Firm initiated recall is ongoing.
REASON
Both lots were found to be out of specification due to an elevated level of small particles (fines).
VOLUME OF PRODUCT IN COMMERCE
360 pre-packs and 18 5-gallon pails.
DISTRIBUTION 
Nationwide.

_______________________________
PRODUCT
Style 363 Saline-Filled BIOCELL textured Breast Implants. Recall # Z-0851-05.
CODE
UF6328, UF6330, UF6331, UM5056, UM5057, UM5059.
RECALLING FIRM
Recalling Firm: Inamed Corp, Goleta, CA, by letter on May 5, 2005 and follow-up telephone calls.
Manufacturer: McGhan Medico, SA, Barreal de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
Wrong size Implant was mislabeled with the wrong size.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION 
WI, TN, TX, NY, and AR.

 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES - CLASS III

_______________________________
PRODUCT
Osborn Gallimycin 36 (Erythromycin), 36-Hour Milk Out for Lactating Cows, each 6-mL single dose syringe contains 300 mg. Erythromycin (Gallimycin), 12/6 mL (0.2 Fl Oz) syringes per carton, manufactured by a non-sterilizing process. Recall # V-083-5.
CODE
Lot 5A009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bimeda Inc, Kansas City, MO, by letter dated March 30, 2005.
Manufacturer: Bimeda MTC Animal Health Inc, Cambridge, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Leaking prefilled syringes.
VOLUME OF PRODUCT IN COMMERCE
104,220 syringes.
DISTRIBUTION 
Nationwide.

_______________________________
PRODUCT
Spectinomycin Hydrochloride, USP, Non-Sterile for Veterinary Use Only, for Manufacturing, Processing or Repacking; an Rx antibiotic for veterinary use. Recall # V-084-5.
CODE
List No. 06066-04-01, lots 03252CD00, 03253CD00, 03267CD00, 03268CD00, 03269CD00, 03270CD00, 14951CD00, 14952CD00, 14964CD00, 14974CD00, 14975CD00, 14976CD00, 14985CD00, 14986CD00, 15017CD00, 15018CD00, 15020CD00, 15021CD00, 15995CD00, 15996CD00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Chicago, IL, by telephone on March 10, 2005 and by letters dated April 12, 2005. Firm initiated recall is ongoing.
REASON
The product was labeled with a 60-month expiration date, but the stability data only supports a 24-month expiration date.
VOLUME OF PRODUCT IN COMMERCE
12,217.46 KA.
DISTRIBUTION 
MN, MO and Egypt.

_______________________________
PRODUCT
ResiPROX Leave-On Lotion for Dogs and Cats, Pramoxine HCL 1.5% Oatmeal, 8 oz bottle. Available only through licensed veterinarians. Recall # V-085-5.
CODE
Lot Number WJ433.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by fax on May 11, 2005. Firm initiated recall is ongoing.
REASON
At the 6-month test point, the test lot for the product was found to be out of specification for Total Aerobic Plate Count.
VOLUME OF PRODUCT IN COMMERCE
3,672 units.
DISTRIBUTION 
Nationwide.

END OF ENFORCEMENT REPORT FOR June 1, 2005

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