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U.S. Department of Health and Human Services

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Enforcement Report for October 5, 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.

October 5, 2005
05-40

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

______________________________
PRODUCT
Pasteurized liquid whole eggs, Recall # F-653-5
CODE
Lots 116-5 and 117-5
RECALLING FIRM/MANUFACTURER
Crystal Lake, Llc, Warsaw, IN, by telephone on May 4, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella based on the USDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
53,016 pounds
DISTRIBUTION
IL, MI, OH and Canada

______________________________
PRODUCT
Spiced apple almonds - whole almonds coated with a confectionary spice mixture sold retail and as an item in gift baskets. Retail bags are 8 oz clear cello bags, with a stick on label stating Harry and David SPICED APPLE ALMONDS cinnamon apple candy coated almonds. Bags are tied at the top with a ribbon. Bags that are placed into the Harvest Home Collection Basket are 6 oz. clear cello bags and sealed at the top. Both bags contain the ingredient statement, nutritional labeling, Recall # F-659-5
CODE
Best if used by 07/28/06 on 8 oz. retail bags, Lot # 1815SF on 6 oz. gift basket bags
RECALLING FIRM/MANUFACTURER
Harry and David, Medford, OR, by telephone on August 30, 2005, by press release and telephone on September 1, 2005, and by letters on September 2, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk and FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
4,512 - 8 oz. retail packages and 60 - 6 oz. packages in gift baskets
DISTRIBUTION
Nationwide

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PRODUCT
HOME SPECIAL brand SOUP MIX, Net Wt. 4 OZ. --- Serving Size 30 g --- Servings Per Container 15 --- The product is packaged in a heat-sealed flexible plastic bag. UPC bar code # 6 64460 11505 8, Recall # F-661-5
CODE
All products on the market at the time the recall was initiated
RECALLING FIRM/MANUFACTURER
Recalling Firm: HO's Trading, Inc., Brooklyn, NY, by press release and letter on April 21, 2005.
Manufacturer: Sinojet Development Ltd, Hong Kong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
8 cases (100 packages per case)
DISTRIBUTION
NY, NJ, MA, TX and GA
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

_______________________________
PRODUCT
a) Basil Leaf, Rubbed, Recall # F-656-5;
b) Original Italian Seasoning, 2.59 lbs (41.5 oz)
packages, Recall # F-657-5
CODE
a) Code:3-1017; lot number P30500;
b) Code: C2225; Lot numbers W17485 and W18556
RECALLING FIRM/MANUFACTURER
WIBERG of California, Brea, CA, by telephone on August 26, 2005. Firm initiated recall is ongoing.
REASON
Fancy whole basil received from distributor, was found to be contaminated with Salmonella Blockley.
VOLUME OF PRODUCT IN COMMERCE
372.82 lbs.
DISTRIBUTION
CA

_______________________________
PRODUCT
Peachy Paterno Ice Cream sold in 1/2 gallon carton, Recall # F-658-5
CODE
Code Date 12/10/05
RECALLING FIRM/MANUFACTURER
University Creamery, University Park, PA, by telephone on July 28, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared FD&C Yellow #5 color.
VOLUME OF PRODUCT IN COMMERCE
16 cartons
DISTRIBUTION
The product is sold in the firm's retail store.

_______________________________
PRODUCT
a) Islands Blend By Healthy Choice, ORANGE***JUICE***
Pasteurize, Recall # F-663-5;
b) Islands Blend By Healthy Choice, APPLE***JUICE***
Pasteurize, Recall # F-664-5;
c) Islands Blend By Healthy Choice, Grapefruit***JUICE***
Pasteurize, Recall # F-665-5;
d) Islands Blend By Healthy Choice, Carrot***JUICE***
Pasteurize, Recall # F-666-5;
e) Islands Blend By Healthy Choice, Lemonade***JUICE***
Pasteurize, Recall # F-667-5;
f) Islands Blend By Healthy Choice, Watermelon***JUICE***
Fresh, Recall # F-668-5
CODE
Production date codes ranging from August 7, 2005 through September 1, 2005
RECALLING FIRM/MANUFACTURER
Healthy Choice Islands Blend Inc, DBA Island Blends, Los Angeles, CA, by telephone and letter beginning on September 5, 2005. Firm initiated recall is ongoing.
REASON
Manufacturer failed to produce juice under requirements of Hazard Analysis and Critical Control Point (HACCP) 21 CFR Part 120.
VOLUME OF PRODUCT IN COMMERCE
a) 800 gallons, 278 quarts, 4 pints;
b) 14 gallons, 41 half gallons, 24 pints;
c) 45 gallons, 2 quarts;
d) 2 gallons, 4 half gallons, 4 pints;
e) 51 gallons;
f) 4 gallons
DISTRIBUTION
CA

_______________________________
PRODUCT
Maple walnut cheesecake - Harry and David bake shop frozen maple walnut cheesecake, net wt. 2 lbs. The product is a cheesecake with walnuts on the rim, packaged in a shrink wrapped plastic film, inside a white paperboard box, Recall # F-670-5
CODE
Best if used by: 09/30/06 lot code 2355BC and 2365BC
RECALLING FIRM/MANUFACTURER
Harry and David, Medford, OR, by letter and telephone on September 16, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
1,644 cheesecakes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Cran brand Face Paint, 5 colors; UPC 7-08820-45951-9, Made in Taiwan, Recall # F-671-5
CODE
All units
RECALLING FIRM/MANUFACTURER
Wholesale Merchandisers, Inc., Grand Rapids, MI, by posting a notice in the stores and on the website, on June 17, 2005. Firm initiated recall is complete.
REASON
Face paints contain unapproved colors and may have been manufactured under conditions whereby they were contaminated with pathogens.
VOLUME OF PRODUCT IN COMMERCE
38 packages
DISTRIBUTION
OH

_______________________________
PRODUCT
Frozen Mahi Mahi fillets ranging in size from 3 - 4 lb each. Fillets are placed into a plastic bag then into a corrugated box with gel packs on top of fillets. There was no labeling associated with the fillets except hand written product code on box, Recall # F-672-5
CODE
Item no. 51711950. Product code on box: 0695, 0745, 0765, 0825, 0875, 0965, 1045, 1105, 1165, 1255 or 1305
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Fish & Seafood, Inc., Minnetonka, MN, by telephone beginning May 20, 2005.
Manufacturer: Chun Cheng USA, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
FDA samples of raw frozen Mahi Mahi fillets were found to contain levels of histamine above 50 ppm.
VOLUME OF PRODUCT IN COMMERCE
133.30 lbs
DISTRIBUTION
MN and WI
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

_______________________________
PRODUCT
a) "Baby Wipe" brands come in either scented or unscented
packaged in a flexible plastic container. Labeled in
part: Alcohol-Free Baby Wipes are soft, thick,
convenient wipes moistened with a gentle cleansing
solution that will clean any part of baby's delicate
skin. Sizes: Triad 80 -7.25" x 8, AmeriNet Choice 40 -
7.25" x 8". Product Code: 10-6810, AC-6710, 10-6710,
10-6700, 10-6610 and AC-6700, Recall # F-654-5;
b) Triad "Cleansing Wipes" packaged in a plastic flexible
container. Labeled in part: Triad Cleansing Wipes,
Hypoallergeenic, Unscented, Alcohol-Free, Deodorizing
Formula (40 - 7.25" x 8" Wipes), Product Code: 10-6610,
Recall # F-655-5
CODE
a) Lot #'s, 4G80, 4G79, 4H99, 4H83, 4H84, 4J59, 4J61,
4J01, 4J60, 4J55, 4J58, 4K73, 4K76,
4K75, 4K113, 4K74;
b) Lot numbers 4J59, 4J64, 4K73
RECALLING FIRM/MANUFACTURER
Recalling Firm: H & P Industries, Inc., Brookfield, WI, by letters dated January 17, 2005 and February 18, 2005.
Manufacturer: H & P Industries, Inc., Pewaukee, WI. Firm initiated recall is ongoing.
REASON
Products are contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
105,348 units
DISTRIBUTION
Nationwide
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Gemzar (Gemcitabine HCl for Injection) 1 g equivalent to base, for I.V. use only, Sterile Single Use Vial, Rx, Vial No. 7502, NDC 0002-7502-01. Recall # D-489-5
CODE
Lots 8RJ10R, 8RX43M, 8SE75M, 8RX45MA (France) and 8RU85MA (Italy).
RECALLING FIRM/MANUFACTURER
Eli Lilly and Company, Indianapolis, IN, by letter dated September 15, 2005. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
48,208
DISTRIBUTION
Nationwide, France and Italy

_______________________________
PRODUCT
Gabapentin Tablets, 600 mg, 100 tablet bottles, NDC 0093-7173-01, Recall # D-500-5
CODE
Lot #: G04043 Exp. 01/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA, by letter dated August 3, 2005.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Dissolution failure at 3 month test point.
VOLUME OF PRODUCT IN COMMERCE
6,946 bottles
DISTRIBUTION
TN

_______________________________
PRODUCT
Demulen 1/35 - 28 Tablets (Ethynodiol Diacetate & Ethinyl Estradiol), Each Demulen 1/35 tablet contains: ethynodiol diacetate 1mg, ethinyl estradiol 35 mcg, 6 units of 28 tablets, Each Compack contains: 21 Demulen 1/35 (white) tablets 7 placebo (blue) tablets, Rx only, NDC 0025-0161-09, Recall # D-501-5
CODE
Lot # C401110, C400392 and C400827 expiration date in all of them 01/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on August 5, 2005.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
Subpotent; Ethinyl Estradiol.
VOLUME OF PRODUCT IN COMMERCE
32,649 units
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Lotrimin AF, Antifungal (Miconazole Nitrate 2%), Net wt. 100g (3.5 oz) and 133g (4.6oz), OTC, NDC 11523-1272-1, Recall # D-481-5
CODE
3B03CC, exp Feb 2006; 4B09CC, exp Feb 2007; 4G03CC, June 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering-Plough HealthCare Products, Inc., Memphis, TN, by letter on August 29, 2005.
Manufacturer: Kik Custom Mfg, Cumberland, RI. Firm initiated recall is ongoing.
REASON
Subpotency: The analytical results for Miconazole Nitrate were below specification for the 12 month stability point.
VOLUME OF PRODUCT IN COMMERCE
479,148 units
DISTRIBUTION
Nationwide and Panama

_______________________________
PRODUCT
MESALAMINE RECTAL SUSPENSION, USP, ENEMA, 4g/60 mL, For Rectal Use Only, Rx only. Distributed under the Clay Park Labs (CPL) label. NDC 45802-098-51: 7 x 60 mL Unit-Dose Bottles, NDC 45802-098-28: 28 x 60 mL Unit-Dose bottles, Recall # D-490-5
CODE
104 batches are being recalled: ML027, ML028, ML029, ML030, ML031, ML032, ML033, ML034, ML035, ML036, ML037, ML038, ML039, ML040, ML041, ML042, ML043, ML044, ML045, ML046, ML047, ML048, ML049, ML050, ML051, ML052, ML053, ML054, ML055, ML056, ML057, ML058, ML059, ML060, ML061, ML062, ML063, ML064, ML065, ML066, ML067, ML068, ML069, ML070, ML071, ML072, ML073, ML074, ML075, ML076, ML077, ML078, ML079, ML080, ML081, ML082, ML083, ML084, ML085, ML086, ML087, ML088, ML089, ML090, ML091, ML092, ML093, ML094, ML095, ML096, ML097, ML098, ML099, ML100, ML101, ML103, ML104, ML105, ML106, ML107, ML108, ML109, ML110, ML111, ML112, ML113, ML114, ML117, ML119, ML120, ML121, ML122, ML123, ML124, ML125, ML127, ML128, ML129, ML132, ML133, ML134, ML135, ML136, ML137. NDC 45802-098-51: UPC bar code # 3 45802-098-51 1; NDC 45802-098-28: UPC bar code # 3 45802-098-28 3. Firm Product Number: 098-51 and 098-28
RECALLING FIRM/MANUFACTURER
Recalling Firm: Clay Park Labs, Inc., Bronx, NY, by letters on September 16 - 19, 2005.
Manufacturer: Agis Industries (1983) Ltd., Bnei Brak, Israel. Firm initiated recall is ongoing. Note: Contract manufacturer of the container Solonolite Plastic Corp, Gloucester, MA was responsible for the problem.
REASON
Container Leakage: leaking bottles.
VOLUME OF PRODUCT IN COMMERCE
200,000 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Peroxyl, 35% CG (Cosmetic Grade), 35% Hydrogen Peroxide by weight, meets USP specifications when properly diluted, Recall # D-491-5
CODE
Lot No. 04E46
RECALLING FIRM/MANUFACTURER
Arkema, Inc., Memphis, TN, by telephone on August 11, 2004. Firm initiated recall is complete.
REASON
Failed pH specifications: The firm received a consumer complaint stating that the pH of the product was 2.9 which is above the specification of 2.3-2.8.
VOLUME OF PRODUCT IN COMMERCE
83,700 pounds
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Gladase Papain-Urea Debriding Ointment. Labeled in part as "For topical use only, Store in a cool place. Rx only, Product code is 5048410030, NDC 59366-2879-3, Recall # D-492-5
CODE
Lot numbers: S0403 and S0432
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith and Nephew, Inc., Wound Management Division, Largo, FL, by letters on August 19, 2005.
Manufacturer: Stiefel Laboratories Inc., Oak Hill, NY. Firm initiated recall is ongoing.
REASON
Mislabeling: Incorrect primary tube labeling with respect to the owner of the product. There are no quality or dosing issues involved.
VOLUME OF PRODUCT IN COMMERCE
2,916 tubes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Agua De Alibour (zinc sulfate and copper
sulfate) Astringent-Antiseptic liquid packaged
in 4 oz. white HDPE cylinder bottle, OTC,
UPC code: 758537051049, Recall # D-493-5;
b) Alcohol Boricado (Boric Acid Alcohol) liquid
packaged in either 2 or 4 oz. amber PET
Boston round bottles, OTC, Recall # D-494-5;
c) Alcohol Mentolado (Mentholated Alcohol) liquid
packaged in 2 oz. amber PET Boston round bottle,
OTC, Recall # D-495-5;
d) Tincture of Arnica liquid packaged in either
1 oz. or 2 oz. amber PET Boston round bottles,
OTC, Recall # D-496-5;
e) Boric Acid Powder NF Topical Antifungal Agent,
2 oz., 4 oz., and 8 oz. sizes packaged in 4 oz,
225 cc, and 500 cc, respectively, white HDPE
Boston round bottles, OTC, Recall # D-497-5;
f) Eucalyptus Oil Aromatic NF liquid packaged in
a 1 oz. amber PET Boston round bottle. OTC,
Recall # D-498-5;
g) Sodium Bicarbonate USP powder, 4 oz., 8 oz.,
and 16 oz. sizes packaged in 150 cc, 225 cc,
and 500 cc, respectively, white HDPE Boston
round bottles. OTC, Recall # D-499-5
CODE
All unexpired lots are affected. Products have a six digit lot number with the first two digits representing the year of production, the next two representing the month of production, and the last two being a sequential production number.
RECALLING FIRM/MANUFACTURER
Lex, Inc, Medley, FL, by letters on August 29/30, 2005. Firm initiated recall is ongoing.
REASON
Misbranding: Non-compliance with FDA requirements OTC labeling and monograph requirements.
VOLUME OF PRODUCT IN COMMERCE
25,682 cases
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-1082-5
CODE
Unit number: 18236-8169
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on March 17, 2005.
Manufacturer: Blood Systems Inc., Cheyenne, WY. Firm initiated recall is ongoing.
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, Recall # B-2208-5
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, by letter on December 31, 2003.
Manufacturer: Blood Systems Inc., Cheyenne, WY. Firm initiated recall is ongoing.
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,
Recall # B-2210-5;
b) Source Leukocytes, Recall # B-2211-5
CODE
a) and b) Unit number: 4678555
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated March 4, 2004. Firm initiated recall is ongoing.
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, Recall # B-2212-5;
CODE
Unit number: 4922434 double collection
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated February 26, 2005. Firm initiated recall is complete.
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, Recall # B-2278-5
CODE
Unit number: 7032269
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 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
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-2279-5
CODE
Unit numbers: 7039795 and 7049672
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 7, 2004. 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
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2280-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2281-5
CODE
a) Unit number: 6577212;
b) Unit numbers: 6509405 and 6574298
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 2004. 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
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2282-5
CODE
Unit number: 0752939
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 6, 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
PA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2283-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2284-5
CODE
a) Unit number: 6830384;
b) Unit number: 6832882
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. 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
CO and FL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2308-5;
b) Red Blood Cells Irradiated,
Recall # B-2309-5;
c) Red Blood Cells Leukocytes Reduced,
Recall # B-2310-5;
d) Red Blood Cells Leukocytes Reduced
Irradiated, Recall # B-2311-5;
e) Platelets, Recall # B-2312-5;
f) Platelet Pheresis Leukocytes Reduced,
Recall # B-2313-5;
g) Platelet Pheresis Leukocytes Reduced
Irradiated, Recall #           B-2314-5;
h) Cryoprecipitated AHF, Recall # B-2315-5
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, by telephone and fax on July 14, 2004. Firm initiated recall is complete.
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, Recall # B-2317-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2318-5
CODE
a) Unit number: 6884692;
b) Unit numbers: 6886512, 6882894
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 10, 2004. 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
3 units
DISTRIBUTION
CO and MS

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2320-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2321-5
CODE
a) Unit number: 7032144;
b) Unit numbers: 7025800, 7041771
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 13, 2004. 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
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-2328-5
CODE
Unit number: 9011270
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by letter on September 5, 2000. Firm initiated recall is complete.
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, Recall # B-2343-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2344-5
CODE
a) Unit number: 6853032;
b) Unit numbers: 6864520 and 6858378
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 2004. Firm initiated recall is complete.
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, Recall # B-2345-5
CODE
Unit number: 6625176
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on Mach 17, 2004. Firm initiated recall is complete.
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, Recall # B-2346-5
CODE
Unit number: 6636860
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 17, 2004. Firm initiated recall is complete.
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, Recall # B-2347-5
CODE
Unit number: 6623990
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 12, 2004. Firm initiated recall is complete.
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, Recall # B-2348-5
CODE
Unit numbers: 6579619 and 6577218
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 10, 2003. Firm initiated recall is complete.
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, Recall # B-2349-5;
b) Red Blood Cells, Leukocyte Reduced,
Recall # B-2350-5;
c) Platelets Pheresis Leukocytes Reduced,
Recall # B-2351-5
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, by facsimile on February 6, 2004. Firm initiated recall is complete.
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, Recall # B-2352-5;
CODE
Unit number: 6871288
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 12, 2004. Firm initiated recall is complete.
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,
Recall # B-2353-5;
b) Platelets Pheresis Leukocyte Reduced,
Recall # B-2354-5
CODE
a) and b) Unit numbers: 6946738 and 6944671
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 2004. Firm initiated recall is complete.
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, Recall # B-2355-5
CODE
Unit number: 6602961
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 2004. Firm initiated recall is complete.
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, Recall # B-2356-5
CODE
Unit number: 6611790
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 13, 2004. Firm initiated recall is complete.
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, Recall # B-2357-5
CODE
Unit numbers: 6173181 and 6138140
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 17, 2004. Firm initiated recall is complete.
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, Recall # B-2358-5
CODE
Unit number: 6943751
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recall # B-2359-5;
b) Red Blood Cells Leukocytes Reduced,
Recall # B-2360-5
CODE
a) Unit number: 6613568;
b) Unit number: 6620387
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 10, 2003. Firm initiated recall is complete.
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, Recall # B-2361-5;
b) Red Blood Cells Leukocytes Reduced,
Recall # B-2362-5
CODE
a) Unit number: 6886163;
b) Unit number: 6887956
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 31, 2003. Firm initiated recall is complete.
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, Recall # B-2363-5;
b) Red Blood Cells Leukocytes Reduced,
Recall # B-2364-5
CODE
a) Unit number: 6846710;
b) Unit number: 6948999, 6944229 and 6940971
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 30, 2003. Firm initiated recall is complete.
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, Recall # B-2365-5
CODE
Unit numbers: 7039980, 7034080 and 7028246
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 5, 2004. Firm initiated recall is complete.
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, Recall # B-2375-5;
B) Cryoprecipitated AHF, Recall # B-2376-5
CODE
a) and b) Unit number: 030GR12543
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on May 26, 2005 and by letter on June 9, 2005. Firm initiated recall is complete.
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, Recall # B-2381-5
CODE
Unit number: 12KJ99973
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on June 20, 2003 and by letter on July 2, 2003. Firm initiated recall is complete.
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, Recall # B-2385-5
CODE
Unit numbers: KC29462 (2 units from split)
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by telephone on November 11, 2003 and by letter on December 31, 2003. Firm initiated recall is complete.
REASON
Platelets, with insufficient plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Level 1 H-31B Air Detector / Clamping Devices
Level 1 H-1200 Fast Flow Fluid Warmers (with integrated H-31 B Air Detector Clamp),
Recall # B-2386-5
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, by letter dated June 20, 2005. Firm initiated recall is ongoing.
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%], Recall # B-2387-5
CODE
Lot numbers: C934009, C934110, C934210, C934310, C805209, C805309
RECALLING FIRM/MANUFACTURER
ZLB Behring LLC, Bradley, IL, by telephone and letters dated August 26, 2005 and by fax or e-mails and letters dated August 29, 2005. Firm initiated recall is ongoing.
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, Recall # B-2388-5
CODE
Unit number: 10756-7634
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on December 1, 2003. Firm initiated recall is complete.
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, Recall # B-2397-5
CODE
Unit numbers: 7036925 and 7032396
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 22, 2003. Firm initiated recall is complete.
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, Recall # B-2398-5
CODE
Unit numbers: 6885253 and 6883057
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 22, 2003. Firm initiated recall is complete.
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, Recall # B-2399-5
CODE
Unit number: 6826389
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 17, 2004. Firm initiated recall is complete.
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, Recall # B-2400-5
CODE
Unit number: 6580595
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 25, 2004. Firm initiated recall is complete.
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, Recall # B-2401-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2402-5
CODE
a) Unit numbers: 7028556 and 6167924;
b) Unit number: 6412958
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recall # B-2403-5
CODE
Unit number: 7037001
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 25, 2004. Firm initiated recall is complete.
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, Recall # B-2404-5
CODE
Unit number: 6947305
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recal # B-2405-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2406-5
CODE
a) Unit number: 6882484;
b) Unit number: 6885621
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recall # B-2407-5
CODE
Unit number: 6580497
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. Firm initiated recall is complete.
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, Recall # B-2408-5
CODE
Unit numbers: 6832643 (2 units), 6826472 (2 units), 6825463 (3 units)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 25, 2004. Firm initiated recall is complete.
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, Recall # B-2409-5
CODE
Unit numbers: 6885619 and 6882482
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recall # B-2410-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2411-5
CODE
a) Unit numbers: 6887413, 6885224 and 6880084;
b) Unit number: 6883108
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. Firm initiated recall is complete.
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, Recall # B-2413-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-2414-5
CODE
a) Unit number: 6573181;
b) Unit number: 6577321
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 20, 2004. Firm initiated recall is complete.
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, Recall # B-2412-5
CODE
Unit number: 6947423
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 1, 2004. Firm initiated recall is complete.
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, Recall # B-2415-5
CODE
Unit number: 6883135
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 5, 2004. Firm initiated recall is complete.
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, Recall # B-2416-5
CODE
Unit number: 0753426
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 5, 2004. Firm initiated recall is complete.
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, Recall # B-2417-5
CODE
Unit number: 0750503
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 5, 2004. Firm initiated recall is complete.
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, Recall # B-2420-5
CODE
Unit numbers: 6830736, 6827847 and 6825068
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 5, 2004. Firm initiated recall is complete.
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, Recall # B-2421-5
CODE
Unit number: 6387230
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. Firm initiated recall is complete.
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, Recall # B-2422-5
CODE
Unit number: 6387233
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. Firm initiated recall is complete.
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, Recall # B-2423-5
CODE
Unit number: 35LW22624
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by telephone on October 13, 2004. Firm initiated recall is complete.
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, Recall # B-2430-5
CODE
Unit number: 0067898
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by facsimile on November 12, 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
FL

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2431-5
CODE
Unit number: LZ09188
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by letter dated October 31, 2002. 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
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-2432-5
CODE
Unit number: VP-35630
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter on February 12, 2003. 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
Austria

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2436-5
CODE
Unit number: 6928798
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile dated March 28, 2003. Firm initiated recall is complete.
REASON
Red Cells, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-2438-5;
b) Recovered Plasma, Recall # B-2439-5
CODE
a) Unit number: 6979796;
b) Unit numbers: 6978796, 6976360, and 6975385
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc, Orlando, FL, by facsimile on August 12, 2004. Firm initiated recall is complete.
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, Recall # B-2440-5;
b) Fresh Frozen Plasma Apheresis, Recall # B-2441-5;
c) Recovered Plasma, Recall # B-2442-5
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, by facsimile on August 4, 2004. Firm initiated recall is complete.
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, Recall # B-2446-5;
b) Red Blood Cells Leukocytes Reduced,
Recall # B-2447-5;
c) Platelets Pheresis Leukocytes Reduced,
Recall # B-2448-5;
d) Platelets Pheresis Leukocytes Reduced
Irradiated, Recall # B-2449-5
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, by facsimile on November 10, 2003. Firm initiated recall is complete.
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, Recall # B-2450-5
CODE
Unit numbers: 6864235 and 7046749
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 10, 2004. Firm initiated recall is complete.
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
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells(Apheresis) Leukocytes Reduced, Recall # B-2209-5
CODE
Unit number: 4673523
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, telephone on January 21, 2004. Firm initiated recall is complete.
REASON
Blood product, mislabeled as leukocytes reduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2226-5;
b) Red Blood Cells Leukoreduced, Recall # B-2227-5
CODE
a) Unit number: 40GF68498;
b) Unit numbers: 40GF68527, 40GF68533
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America, Peoria, IL, by telephone on May 4, 2005. Firm initiated recall is complete.
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, Recall # B-2377-5
CODE
Unit number: 030GR12543
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by facsimile on May 26, 2005. Firm initiated recall is complete.
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, Recall # B-2389-5;
b) Fresh Frozen Plasma, Recall # B-2390-5
CODE
a) and b) Unit number: KE00254
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group Blood Donor Center, Los Angeles, CA, by telephone and letter on October 18, 2002. Firm initiated recall is complete.
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, Recall # B-2424-5
CODE
Unit number: 4850004
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on September 27, 2004. Firm initiated recall is complete.
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
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

______________________________
PRODUCT
Hemashield Vantage Vascular Graft. Vascular graft prosthesis. Recall # Z-1459-05
CODE
Catalog Number, Product Description, Lot Number: M002023750060, HVVG 6mm x 100cm, 5649003; M002023750060, HVVG 6mm x 100cm, 5948031; M002023750060, HVVG 6mm x 100cm, 6639821; M002023750060, HVVG 6mm x 100cm, 6647296; M002023750060, HVVG 6mm x 100cm, 7030066; M002023750070, HVVG 7mm x 100cm, 5669601; M002023750070, HVVG 7mm x 100cm, 5728283; M002023750070, HVVG 7mm x 100cm, 5821740; M002023750070, HVVG 7mm x 100cm, 6032950; M002023750070, HVVG 7mm x 100cm, 6962284; M002023750080, HVVG 8mm x 100cm, 6007978; M002023750080, HVVG 8mm x 100cm, 6279546; M002023750080, HVVG 8mm x 100cm,6722180; M002023750080, HVVG 8mm x 100cm, 6919131; M002023750080, HVVG 8mm x 100cm, 7161034; M002023750080, HVVG 8mm x 100cm, 7249926; M002023750080, HVVG 8mm x 100cm, 7402224; M002023750100, HVVG 10mm x 100cm, 6876321; M002023750100, HVVG 10mm x 100cm, 6962286; M002023754060, HVVG 6mm x 40cm, 5721446; M002023754060, HVVG 6mm x 40cm, 5728284; M002023754060, HVVG 6mm x 40cm, 5780318; M002023754060, HVVG 6mm x 40cm, 5860237; M002023754060, HVVG 6mm x 40cm, 5899944; M002023754060, HVVG 6mm x 40cm, 6011811; M002023754060, HVVG 6mm x 40cm, 6239445; M002023754060, HVVG 6mm x 40cm, 6268215; M002023754060, HVVG 6mm x 40cm, 6304504; M002023754060, HVVG 6mm x 40cm, 6320785; M002023754060, HVVG 6mm x 40cm, 6364795; M002023754060, HVVG 6mm x 40cm, 6440114; M002023754060, HVVG 6mm x 40cm, 6615660; M002023754060, HVVG 6mm x 40cm, 6628696; M002023754060, HVVG 6mm x 40cm, 6647104; M002023754060, HVVG 6mm x 40cm, 6696492; M002023754060, HVVG 6mm x 40cm, 6807737; M002023754060, HVVG 6mm x 40cm, 6917823; M002023754060, HVVG 6mm x 40cm, 6979854; M002023754060, HVVG 6mm x 40cm, 7000352; M002023754060, HVVG 6mm x 40cm, 7071546; M002023754060, HVVG 6mm x 40cm, 7200982; M002023754070, HVVG 7mm x 40cm, 5691792; M002023754070, HVVG 7mm x 40cm, 5726049; M002023754070, HVVG 7mm x 40cm, 5779847; M002023754070, HVVG 7mm x 40cm, 5797094; M002023754070, HVVG 7mm x 40cm, 5955887; M002023754070, HVVG 7mm x 40cm, 6011812; M002023754070, HVVG 7mm x 40cm, 6037086; M002023754070, HVVG 7mm x 40cm, 6136721; M002023754070, HVVG 7mm x 40cm, 6611338; M002023754070, HVVG 7mm x 40cm, 6657664; M002023754070, HVVG 7mm x 40cm, 6691603; M002023754070, HVVG 7mm x 40cm, 6851214; M002023754070, HVVG 7mm x 40cm, 7161578; M002023754070, HVVG 7mm x 40cm, 7175592; M002023754070, HVVG 7mm x 40cm, 7249015; M002023754070, HVVG 7mm x 40cm, 7402368; M002023754070, HVVG 7mm x 40cm, 7403197; M002023754070, HVVG 7mm x 40cm, 7535410; M002023754070, HVVG 7mm x 40cm, 7565108; M002023754070, HVVG 7mm x 40cm, 7631134; M002023754080, HVVG 8mm x 40cm, 5669605; M002023754080, HVVG 8mm x 40cm, 5728288; M002023754080, HVVG 8mm x 40cm, 5783271; M002023754080, HVVG 8mm x 40cm, 5797165; M002023754080, HVVG 8mm x 40cm, 5841181; M002023754080, HVVG 8mm x 40cm, 5912738; M002023754080, HVVG 8mm x 40cm, 5976346; M002023754080, HVVG 8mm x 40cm, 6008050; M002023754080, HVVG 8mm x 40cm, 6107641; M002023754080, HVVG 8mm x 40cm, 6138907; M002023754080, HVVG 8mm x 40cm, 6238549; M002023754080, HVVG 8mm x 40cm, 6320790; M002023754080, HVVG 8mm x 40cm, 6361655; M002023754080, HVVG 8mm x 40cm, 6427209; M002023754080, HVVG 8mm x 40cm, 6598660; M002023754080, HVVG 8mm x 40cm, 6617325; M002023754080, HVVG 8mm x 40cm, 6646329; M002023754080, HVVG 8mm x 40cm, 6647152; M002023754080, HVVG 8mm x 40cm, 6691608; M002023754080, HVVG 8mm x 40cm, 6876382; M002023754080, HVVG 8mm x 40cm, 7114368; M002023754080, HVVG 8mm x 40cm, 7138064; M002023754080, HVVG 8mm x 40cm, 7161580; M002023754080, HVVG 8mm x 40cm, 7175587; M002023754080, HVVG 8mm x 40cm, 7276583; M002023754080, HVVG 8mm x 40cm, 7402360; M002023754080, HVVG 8mm x 40cm, 7535409; M002023754100, HVVG 10mm x 40cm, 5691791; M002023754100, HVVG 10mm x 40cm, 5731519; M002023754100, HVVG 10mm x 40cm, 5891897; M002023754100, HVVG 10mm x 40cm, 6052007; M002023754100, HVVG 10mm x 40cm, 6418381; M002023754100, HVVG 10mm x 40cm, 6926326; M002023754100, HVVG 10mm x 40cm, 7000766; M002023754100, HVVG 10mm x 40cm, 7504489; M002023756060, HVVG 6mm x 60cm, 5707200; M002023756060, HVVG 6mm x 60cm, 5724793; M002023756060, HVVG 6mm x 60cm, 5745982; M002023756060, HVVG 6mm x 60cm, 5767491; M002023756060, HVVG 6mm x 60cm, 5767495; M002023756060, HVVG 6mm x 60cm, 5852837; M002023756060, HVVG 6mm x 60cm, 5853224; M002023756060, HVVG 6mm x 60cm, 5891798; M002023756060, HVVG 6mm x 60cm, 5947960; M002023756060, HVVG 6mm x 60cm, 5968420; M002023756060, HVVG 6mm x 60cm, 5988577; M002023756060, HVVG 6mm x 60cm, 6050593; M002023756060, HVVG 6mm x 60cm, 6096033; M002023756060, HVVG 6mm x 60cm, 6268220; M002023756060, HVVG 6mm x 60cm, 6347541; M002023756060, HVVG 6mm x 60cm, 6388858; M002023756060, HVVG 6mm x 60cm, 6418565; M002023756060, HVVG 6mm x 60cm, 6611350; M002023756060, HVVG 6mm x 60cm, 6628703; M002023756060, HVVG 6mm x 60cm, 6654862; M002023756060, HVVG 6mm x 60cm, 6655453; M002023756060, HVVG 6mm x 60cm, 6770384; M002023756060, HVVG 6mm x 60cm, 6807126; M002023756060, HVVG 6mm x 60cm, 6850094; M002023756060, HVVG 6mm x 60cm, 6919450; M002023756060, HVVG 6mm x 60cm, 7010071; M002023756060, HVVG 6mm x 60cm, 7057154; M002023756060, HVVG 6mm x 60cm, 7075488; M002023756060, HVVG 6mm x 60cm, 7161035; M002023756060, HVVG 6mm x 60cm, 7173034; M002023756060, HVVG 6mm x 60cm, 7230491; M002023756060, HVVG 6mm x 60cm, 7259726; M002023756060, HVVG 6mm x 60cm, 7528090; M002023756070, HVVG 7mm x 60cm, 5633991; M002023756070, HVVG 7mm x 60cm, 5691790; M002023756070, HVVG 7mm x 60cm, 5745981; M002023756070, HVVG 7mm x 60cm, 5773786; M002023756070, HVVG 7mm x 60cm, 5793283; M002023756070, HVVG 7mm x 60cm, 5853511; M002023756070, HVVG 7mm x 60cm, 5903684; M002023756070, HVVG 7mm x 60cm, 5988575; M002023756070, HVVG 7mm x 60cm, 6011813; M002023756070, HVVG 7mm x 60cm, 6037090; M002023756070, HVVG 7mm x 60cm, 6109301; M002023756070, HVVG 7mm x 60cm, 6282450; M002023756070, HVVG 7mm x 60cm, 6383841; M002023756070, HVVG 7mm x 60cm, 6440361; M002023756070, HVVG 7mm x 60cm, 6611337; M002023756070, HVVG 7mm x 60cm, 6667242; M002023756070, HVVG 7mm x 60cm, 6754019; M002023756070, HVVG 7mm x 60cm, 6930145; M002023756070, HVVG 7mm x 60cm, 7137399; M002023756070, HVVG 7mm x 60cm, 7276579; M002023756070, HVVG 7mm x 60cm, 7403200; M002023756070, HVVG 7mm x 60cm, 7545048; M002023756070, HVVG 7mm x 60cm, 7545052; M002023756070, HVVG 7mm x 60cm, 7579389; M002023756080, HVVG 8mm x 60cm, 5633990; M002023756080, HVVG 8mm x 60cm, 5726141; M002023756080, HVVG 8mm x 60cm, 5856535; M002023756080, HVVG 8mm x 60cm, 5891889; M002023756080, HVVG 8mm x 60cm, 5948034; M002023756080, HVVG 8mm x 60cm, 6073565; M002023756080, HVVG 8mm x 60cm, 6185146; M002023756080, HVVG 8mm x 60cm, 6339117; M002023756080, HVVG 8mm x 60cm, 6388288; M002023756080, HVVG 8mm x 60cm, 6415673; M002023756080, HVVG 8mm x 60cm, 6598671; M002023756080, HVVG 8mm x 60cm, 6610550; M002023756080, HVVG 8mm x 60cm, 6628701; M002023756080, HVVG 8mm x 60cm, 6722144; M002023756080, HVVG 8mm x 60cm, 6754031; M002023756080, HVVG 8mm x 60cm, 6820115; M002023756080, HVVG 8mm x 60cm, 6861408; M002023756080, HVVG 8mm x 60cm, 6926327; M002023756080, HVVG 8mm x 60cm, 6948142; M002023756080, HVVG 8mm x 60cm, 7008949; M002023756080, HVVG 8mm x 60cm, 7071547; M002023756080, HVVG 8mm x 60cm, 7115438; M002023756080, HVVG 8mm x 60cm, 7528226; M002023756100, HVVG 10mm x 60cm, 5856641; M002023756100, HVVG 10mm x 60cm, 6051871; M002023756100, HVVG 10mm x 60cm, 6193600; M002023756100, HVVG 10mm x 60cm, 6524295; M002023756100, HVVG 10mm x 60cm, 6620113; M002023756100, HVVG 10mm x 60cm, 6691596; M002023756100, HVVG 10mm x 60cm, 6960306; M002023756100, HVVG 10mm x 60cm, 6961911; M002023758060, HVVG 6mm x 80cm, 5669380; M002023758060, HVVG 6mm x 80cm, 5779844; M002023758060, HVVG 6mm x 80cm, 5922480; M002023758060, HVVG 6mm x 80cm, 5964495; M002023758060, HVVG 6mm x 80cm, 6032948; M002023758060, HVVG 6mm x 80cm, 6216685; M002023758060, HVVG 6mm x 80cm, 6304505; M002023758060, HVVG 6mm x 80cm, 6347707; M002023758060, HVVG 6mm x 80cm, 6364796; M002023758060, HVVG 6mm x 80cm, 6388362; M002023758060, HVVG 6mm x 80cm, 6416301; M002023758060, HVVG 6mm x 80cm, 6615663; M002023758060, HVVG 6mm x 80cm, 6628554; M002023758060, HVVG 6mm x 80cm, 6646521; M002023758060, HVVG 6mm x 80cm, 6654376; M002023758060, HVVG 6mm x 80cm, 6696487; M002023758060, HVVG 6mm x 80cm, 6722189; M002023758060, HVVG 6mm x 80cm, 6774183; M002023758060, HVVG 6mm x 80cm, 6816154; M002023758060, HVVG 6mm x 80cm, 6930142; M002023758060, HVVG 6mm x 80cm, 7000351; M002023758060, HVVG 6mm x 80cm, 7010061; M002023758060, HVVG 6mm x 80cm, 7161036; M002023758060, HVVG 6mm x 80cm, 7230490; M002023758060, HVVG 6mm x 80cm, 7630848; M002023758070, HVVG 7mm x 80cm, 5724827; M002023758070, HVVG 7mm x 80cm, 5728287; M002023758070, HVVG 7mm x 80cm, 5955888; M002023758070, HVVG 7mm x 80cm, 6050597; M002023758070, HVVG 7mm x 80cm, 6230257; M002023758070, HVVG 7mm x 80cm, 6288273; M002023758070, HVVG 7mm x 80cm, 6440359; M002023758070, HVVG 7mm x 80cm, 6691602; M002023758070, HVVG 7mm x 80cm, 6770192; M002023758070, HVVG 7mm x 80cm, 6851207; M002023758070, HVVG 7mm x 80cm, 7161577; M002023758070, HVVG 7mm x 80cm, 7175590; M002023758070, HVVG 7mm x 80cm, 7248691; M002023758070, HVVG 7mm x 80cm, 7402229; M002023758070, HVVG 7mm x 80cm, 7402371; M002023758070, HVVG 7mm x 80cm, 7631133; M002023758080, HVVG 8mm x 80cm, 5700634; M002023758080, HVVG 8mm x 80cm, 5765239; M002023758080, HVVG 8mm x 80cm, 5815016; M002023758080, HVVG 8mm x 80cm, 5911567; M002023758080, HVVG 8mm x 80cm, 5972377; M002023758080, HVVG 8mm x 80cm, 6068815; M002023758080, HVVG 8mm x 80cm, 6238548; M002023758080, HVVG 8mm x 80cm, 6256385; M002023758080, HVVG 8mm x 80cm, 6320652; M002023758080, HVVG 8mm x 80cm, 6347706; M002023758080, HVVG 8mm x 80cm, 6416627; M002023758080, HVVG 8mm x 80cm, 6598409; M002023758080, HVVG 8mm x 80cm, 6617271; M002023758080, HVVG 8mm x 80cm, 6647222; M002023758080, HVVG 8mm x 80cm, 6691605; M002023758080, HVVG 8mm x 80cm, 6876377; M002023758080, HVVG 8mm x 80cm, 6962282; M002023758080, HVVG 8mm x 80cm, 7114366; M002023758080, HVVG 8mm x 80cm, 7138066; M002023758080, HVVG 8mm x 80cm, 7161579; M002023758080, HVVG 8mm x 80cm, 7220186; M002023758080, HVVG 8mm x 80cm, 7276584; M002023758080, HVVG 8mm x 80cm, 7317245; M002023758080, HVVG 8mm x 80cm, 7402219; M002023758100, HVVG 10mm x 80cm, 5783268; M002023758100, HVVG 10mm x 80cm, 5891786; M002023758100, HVVG 10mm x 80cm, 6165924; M002023758100, HVVG 10mm x 80cm, 6524301; M002023758100, HVVG 10mm x 80cm, 6598574; M002023758100, HVVG 10mm x 80cm, 7031876; M002023758100, HVVG 10mm x 80cm, 7317854; M002023758100, HVVG 10mm x 80cm, 7504480.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick MA, by letters on June 27, 2005.
Manufacturer: Boston Scientific Corporation, Wayne, NJ. Firm initiated recall is ongoing.
REASON
During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
VOLUME OF PRODUCT IN COMMERCE
3,487 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
LifeScan brand OneTouch Ultra Meter - Owner's Booklet, Recall # Z-1596-05. This is an extension of Z-0821-05
CODE
All System Kits shipped during June 2003 until December 2003
RECALLING FIRM/MANUFACTURER
Lifescan Inc., Milpitas, CA, by letters on November 21, 2003, February 4, 2004, February 17, 2004 and February 9-10, 2004. Firm initiated recall is complete.
REASON
LifeScan brand One Touch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)-mg/dL versus mmol/L. This error has the postential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
VOLUME OF PRODUCT IN COMMERCE
572,000 units
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
a) Baxter Lock Box for 100 mL or 250 mL
Bag Set, for use with 6060 Pump Family;
Baxter product code 2L9354 and previously
marketed by Sabratek under product code
606194, Recall # Z-1569-05;
b) Baxter Lock Box for 250 mL Container,
for use with 6060 Pump Family; Baxter
product code 2L9363 and previously marketed
by Sabratek under product code 606160;
Product code 2L9363 is sold separately and
as a component of the 6060 Pain kit, product
code 2M9832P, Recall # Z-1570-05
CODE
a) All lot numbers/serial numbers of
product codes 2L9354 and 606194;
b) All lot numbers/serial numbers of
product codes 2L9363, 606160 and 2M9832P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 1, 2004.
Manufacturer: Baxter Healthcare Corp., Andover, MA. Firm initiated recall is ongoing.
REASON
The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm "Door Open", but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
VOLUME OF PRODUCT IN COMMERCE
1,486 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 8 mm x 60 mm
Catalog Number: LXB08060, Recall # Z-1577-05;
b) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 8 mm x 80 mm
Catalog Number: LXB08080, Recall # Z-1578-05;
c) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 8 mm x 100 mm
Catalog Number: LXB080100, Recall # Z-1579-05;
d) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 10 mm x 40 mm
Catalog Number: LXB10040, Recall # Z-1580-05;
e) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 10 mm x 60 mm
Catalog Number: LXB10060, Recall # Z-1581-05;
f) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 10 mm x 80 mm
Catalog Number: LXB10080, Recall # Z-1582-05;
g) Bard® Luminexx® Endoscopic Biliary Stent
and Delivery System, 7.5 FR, 10 mm x 100 mm
Catalog Number: LXB10100, Recall # Z-1583-05
CODE
a) Lot Number: 96CP1992;
b) Lot Number: 96CP1385;
c) Lot Number: 96CP2406;
d) Lot Numbers: 96CP1388, 96CP1389, 96CP2244;
e) Lot Numbers: 96CP1390, 96CP1391, 96CP1392,
96CP1393, 96CP1988, 96CP2497, 96CP2498, 96CP1996;
f) Lot Numbers: 96CP1394, 96CP1395, 96CP1396,
96CP1397, 96CP1995;
g) Lot Number: 96CP2508
RECALLING FIRM/MANUFACTURER
Angiomed Gmbh, Karlsruhe, Germany, Federal Republic of, by telephone and letter on July 26, 2005 and by letters dated July 28, 2005. Firm initiated recall is ongoing.
REASON
Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.
VOLUME OF PRODUCT IN COMMERCE
204 units
DISTRIBUTION
Nationwide

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PRODUCT
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx only, Ref G14191; Catalog No. 0073710, Recall # Z-1584-05
CODE
Lots 15-U1320351 and 15-U1320349
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc., Spencer, IN, by telephone on July 6, 1935. Firm initiated recall is complete.
REASON
Mislabeled as to size.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and FL

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PRODUCT
Bard Luminexx 3 Biliary Stent and Delivery System, Recall # Z-1585-05
CODE
Catalog # Lot # LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060 96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937; LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 & 96DP2321
RECALLING FIRM/MANUFACTURER
Recalling Firm: Brad Peripheral Vascular Inc., Tempe, AZ, by letter dated July 21, 2005.
Manufacturer: Angiomed Gmbh, Karlsruhe, Germany, Federal Republic. Firm initiated recall is ongoing.
REASON
Broken stent struts of nitinol stents were noted in manufacturing.
VOLUME OF PRODUCT IN COMMERCE
102 units
DISTRIBUTION
Nationwide

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PRODUCT
Guidant OTW OMNILINK.018 & .035 Biliary Stent Systems, Recall # Z-1586-05
CODE
Model number of the device and manufacturing lots involved: OTW OmniLink 18 1007942-18 OTW OMNI 18 5.0MMX18MMX135CM 1007944-18 OTW OMNI 18 6.0MMX18MMX135CM 1007946-18 OTW OMNI 18 7.0MMX18MMX135CM 1007948-18 OTW OMNI 18 8.0MMX18MMX135CM 1007949-18 OTW OMNI 18 9.0MMX18MMX135CM 1007950-18 OTW OMNI 18 10.0MMX18MMX135CM 1007980-18 OTW OMNI 18 5.0MMX18MMX80CM 1007982-18 OTW OMNI 18 6.0MMX18MMX80CM 1007984-18 OTW OMNI 18 7.0MMX18MMX80CM 1007986-18 OTW OMNI 18 8.0MMX18MMX80CM 1007987-18 OTW OMNI 18 9.0MMX18MMX80CM 1007988-18 OTW OMNI 18 10.0MMX18MMX80CM 1007942-28 OTW OMNI 18 5.0MMX28MMX135CM 1007944-28 OTW OMNI 18 6.0MMX28MMX135CM 1007946-28 OTW OMNI 18 7.0MMX28MMX135CM 1007948-28 OTW OMNI 18 8.0MMX28MMX135CM 1007949-28 OTW OMNI 18 9.0MMX28MMX135CM 1007950-28 OTW OMNI 18 10.0MMX28MMX135CM 1007980-28 OTW OMNI 18 5.0MMX28MMX80CM 1007982-28 OTW OMNI 18 6.0MMX28MMX80CM 1007984-28 OTW OMNI 18 7.0MMX28MMX80CM 1007986-28 OTW OMNI 18 8.0MMX28MMX80CM 1007987-28 OTW OMNI 18 9.0MMX28MMX80CM 1007988-28 OTW OMNI 18 10.0MMX28MMX80CM 1007942-38 OTW OMNI 18 5.0MMX38MMX135CM 1007944-38 OTW OMNI 18 6.0MMX38MMX135CM 1007946-38 OTW OMNI 18 7.0MMX38MMX135CM 1007948-38 OTW OMNI 18 8.0MMX38MMX135CM 1007949-38 OTW OMNI 18 9.0MMX38MMX135CM 1007950-38 OTW OMNI 18 10.0MMX38MMX135CM 1007980-38 OTW OMNI 18 5.0MMX38MMX80CM 1007982-38 OTW OMNI 18 6.0MMX38MMX80CM 1007984-38 OTW OMNI 18 7.0MMX38MMX80CM 1007986-38 OTW OMNI 18 8.0MMX38MMX80CM 1007987-38 OTW OMNI 18 9.0MMX38MMX80CM 1007988-38 OTW OMNI 18 10.0MMX38MMX80CM 1007942-58 OTW OMNI 18 5.0MMX58MMX135CM 1007944-58 OTW OMNI 18 6.0MMX58MMX135CM 1007946-58 OTW OMNI 18 7.0MMX58MMX135CM 1007948-58 OTW OMNI 18 8.0MMX58MMX135CM 1007949-58 OTW OMNI 18 9.0MMX58MMX135CM 1007950-58 OTW OMNI 18 10.0MMX58MMX135CM 1007980-58 OTW OMNI 18 5.0MMX58MMX80CM 1007982-58 OTW OMNI 18 6.0MMX58MMX80CM 1007984-58 OTW OMNI 18 7.0MMX58MMX80CM 1007986-58 OTW OMNI 18 8.0MMX58MMX80CM 1007987-58 OTW OMNI 18 9.0MMX58MMX80CM 1007988-58 OTW OMNI 18 10.0MMX58MMX80CM 1007940-12 OTW OMNI 18 4.0MMX12MMX135CM 1007942-12 OTW OMNI 18 5.0MMX12MMX135CM 1007944-12 OTW OMNI 18 6.0MMX12MMX135CM 1007946-12 OTW OMNI 18 7.0MMX12MMX135CM 1007978-12 OTW OMNI 18 4.0MMX12MMX80CM 1007980-12 OTW OMNI 18 5.0MMX12MMX80CM 1007982-12 OTW OMNI 18 6.0MMX12MMX80CM 1007984-12 OTW OMNI 18 7.0MMX12MMX80CM 1007940-16 OTW OMNI 18 4.0MMX16MMX135CM 1007942-16 OTW OMNI 18 5.0MMX16MMX135CM 1007944-16 OTW OMNI 18 6.0MMX16MMX135CM 1007946-16 OTW OMNI 18 7.0MMX16MMX135CM 1007978-16 OTW OMNI 18 4.0MMX16MMX80CM 1007980-16 OTW OMNI 18 5.0MMX16MMX80CM 1007982-16 OTW OMNI 18 6.0MMX16MMX80CM 1007984-16 OTW OMNI 18 7.0MMX16MMX80CM 1007978-18 OTW OMNI 18 4.0MMX18MMX80CM 1007940-18 OTW OMNI 18 4.0MMX18MMX135CM US Part Numbers Omnilink .035 1008159-18 OTW OMNI 35 4.0MMX18MMX135CM 1008161-18 OTW OMNI 35 5.0MMX18MMX135CM 1008163-18 OTW OMNI 35 6.0MMX18MMX135CM 1008165-18 OTW OMNI 35 7.0MMX18MMX135CM 1008167-18 OTW OMNI 35 8.0MMX18MMX135CM 1008168-18 OTW OMNI 35 9.0MMX18MMX135CM 1008169-18 OTW OMNI 35 10.0MMX18MMX135CM 1008174-18 OTW OMNI 35 4.0MMX18MMX80CM 1008176-18 OTW OMNI 35 5.0MMX18MMX80CM 1008178-18 OTW OMNI 35 6.0MMX18MMX80CM 1008180-18 OTW OMNI 35 7.0MMX18MMX80CM 1008182-18 OTW OMNI 35 8.0MMX18MMX80CM 1008183-18 OTW OMNI 35 9.0MMX18MMX80CM 1008184-18 OTW OMNI 35 10.0MMX18MMX80CM 1008161-28 OTW OMNI 35 5.0MMX28MMX135CM 1008163-28 OTW OMNI 35 6.0MMX28MMX135CM 1008165-28 OTW OMNI 35 7.0MMX28MMX135CM 1008167-28 OTW OMNI 35 8.0MMX28MMX135CM 1008168-28 OTW OMNI 35 9.0MMX28MMX135CM 1008169-28 OTW OMNI 35 10.0MMX28MMX135CM 1008176-28 OTW OMNI 35 5.0MMX28MMX80CM 1008178-28 OTW OMNI 35 6.0MMX28MMX80CM 1008180-28 OTW OMNI 35 7.0MMX28MMX80CM 1008182-28 OTW OMNI 35 8.0MMX28MMX80CM 1008183-28 OTW OMNI 35 9.0MMX28MMX80CM 1008184-28 OTW OMNI 35 10.0MMX28MMX80CM 1008161-38 OTW OMNI 35 5.0MMX38MMX135CM 1008163-38 OTW OMNI 35 6.0MMX38MMX135CM 1008165-38 OTW OMNI 35 7.0MMX38MMX135CM 1008167-38 OTW OMNI 35 8.0MMX38MMX135CM 1008168-38 OTW OMNI 35 9.0MMX38MMX135CM 1008169-38 OTW OMNI 35 10.0MMX38MMX135CM 1008176-38 OTW OMNI 35 5.0MMX38MMX80CM 1008178-38 OTW OMNI 35 6.0MMX38MMX80CM 1008180-38 OTW OMNI 35 7.0MMX38MMX80CM 1008182-38 OTW OMNI 35 8.0MMX38MMX80CM 1008183-38 OTW OMNI 35 9.0MMX38MMX80CM 1008184-38 OTW OMNI 35 10.0MMX38MMX80CM 1008161-58 OTW OMNI 35 5.0MMX58MMX135CM 1008163-58 OTW OMNI 35 6.0MMX58MMX135CM 1008165-58 OTW OMNI 35 7.0MMX58MMX135CM 1008167-58 OTW OMNI 35 8.0MMX58MMX135CM 1008168-58 OTW OMNI 35 9.0MMX58MMX135CM 1008169-58 OTW OMNI 35 10.0MMX58MMX135CM 1008176-58 OTW OMNI 35 5.0MMX58MMX80CM 1008178-58 OTW OMNI 35 6.0MMX58MMX80CM 1008180-58 OTW OMNI 35 7.0MMX58MMX80CM 1008182-58 OTW OMNI 35 8.0MMX58MMX80CM 1008183-58 OTW OMNI 35 9.0MMX58MMX80CM 1008184-58 OTW OMNI 35 10.0MMX58MMX80CM 1008159-12 OTW OMNI 35 4.0MMX12MMX135CM 1008161-12 OTW OMNI 35 5.0MMX12MMX135CM 1008163-12 OTW OMNI 35 6.0MMX12MMX135CM 1008165-12 OTW OMNI 35 7.0MMX12MMX135CM 1008174-12 OTW OMNI 35 4.0MMX12MMX80CM 1008176-12 OTW OMNI 35 5.0MMX12MMX80CM 1008178-12 OTW OMNI 35 6.0MMX12MMX80CM 1008180-12 OTW OMNI 35 7.0MMX12MMX80CM 1008159-16 OTW OMNI 35 4.0MMX16MMX135CM 1008161-16 OTW OMNI 35 5.0MMX16MMX135CM 1008163-16 OTW OMNI 35 6.0MMX16MMX135CM 1008165-16 OTW OMNI 35 7.0MMX16MMX135CM 1008174-16 OTW OMNI 35 4.0MMX16MMX80CM 1008176-16 OTW OMNI 35 5.0MMX16MMX80CM 1008178-16 OTW OMNI 35 6.0MMX16MMX80CM 1008180-16 OTW OMNI 35 7.0MMX16MMX80CM
RECALLING FIRM/MANUFACTURER
Guidant Endovascular Solutions, Inc., Temecula, CA, by letter on September 22, 2005. Firm initiated recall is ongoing.
REASON
Stents may become loose or dislodged from the delivery catheter.
VOLUME OF PRODUCT IN COMMERCE
69,700 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) CryoValve, Pulmonary Valve & Conduit,
Model # PV00, Recall # Z-1589-05;
b) CryoValve, Aortic Valve & Conduit SG,
Model # SGAV00, Recall # Z-1590-05;
c) CryoValve, Pulmonary Valve & Conduit SG,
Model # SGPPV00, Recall # Z-1591-05
CODE
a) Donor #58842, Serial #7426089;
b) Donor #65389, Serial #7943760;
c) Donor #62963, Serial #7819366
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone and letter on April 19, 2004. Firm initiated recall is ongoing.
REASON
Tissues associated with complaints of alleged recipient infection.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
MO, TX and Australia

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PRODUCT
CryoValve, Pulmonary Valve & Conduit, Donor #68538, Model # PV00, Recall # Z-1593-05
CODE
Serial #8045214
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on January 26, 2004. Firm initiated recall is complete.
REASON
Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
CA
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Elx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall # Z-1576-05
CODE
Version 12 and older software
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letters dated March 8, 2004.
Manufacturer: Ortho Clinical Diagnostics, Inc., Raritan, NJ. Firm initiated recall is ongoing.
REASON
An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek Elx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
VOLUME OF PRODUCT IN COMMERCE
128
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR OCTOBER 5, 2005

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