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U.S. Department of Health and Human Services

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Enforcement Report for March 24, 2004

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.


March 24, 2004
04-12

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

______________________________
PRODUCT
a) Wisconsin Cheesecake Co. Candy Bar Cheesecake made with
butterfinger, Net Weight 28 oz. Recall # F-147-4;
b) Wisconsin Cheesecake Co. Candy Bar Cheesecake made with
Reeses pieces, Net Weight 28 oz. Recall # F-148-4;
c) Wisconsin Cheesecake Co. Candy Bar Cheesecake made with
snickers, Net Weight 28 oz. Recall # F-149-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Wisconsin Cheesecake Co., Inc., Schofield, WI, by telephone and letter on December 8, 2003. Firm initiated recall is complete.
REASON
The products contain undeclared peanut ingredients.
VOLUME OF PRODUCT IN COMMERCE
15,853 cheesecakes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Old Fashioned Cheese Cheddar Cheese Snack Spread, Garlic
& Herb, Net wt. 16 oz. (This product is a cold pack
cheese food); and Vern's Colored Garlic & Herb Cold Pack
Cheese Food, Net wt. 12 oz; and Laack's White Garlic &
Herb Cold Pack Cheese Food, Net wt. 16 oz.
Recall # F-150-4.
b) Vern's Sharp Cheddar Cold Pack Cheese Food, Net. Wt. 216
oz; and Laack's Sharp Cheddar Cold Pack Cheese Food, Net
wt. 16 oz. Recall # F-151-4.
CODE
a) "Code 6X 01 May 2005 037" and "31 OCT 2004";
b) "31 OCT 2004".
RECALLING FIRM/MANUFACTURER
Old Fashioned Foods, Inc., Mayville, WI, by letters dated November 9, 2003. FDA initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
180 cases (12/16 oz. per case) 64 cases (12/12 oz per case).
DISTRIBUTION
IL, MN and WI.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) A) Winn Dixie brand Creamy Peanut Butter, Net wt 12 oz.
(340g) and Net wt 18 oz. (1 lb 2 oz) 510g.
B) Deep South brand Creamy Peanut Butter, Net wt. 18 oz
(1 lb 2 oz) 510g, 28 oz (1 lb 12 oz) 793g, and 40 oz.
(2 lb. 8 oz.) 1.13kg. Product is packed in clear
rigid plastic jars closed with Red unlabeled plastic
screw lids. Recall # F-143-4;
b) A) Winn Dixie brand Crunchy Peanut Butter, Net wt 12 oz.
(340g).
B) Deep South brand Crunchy Peanut Butter, Net wt. 28 oz
(1 lb. 12 oz.) 793g and and 40 oz. (2 lb. 8 oz.)
1.13kg. Product is packed in clear
rigid plastic jars with Blue plastic unlabeled screw
lids. Recall # F-144-4.
CODE
a) A) WD Creamy, 12oz, Code: 50020, UPC#21140-60935, Best
if used by date; 12/05/2003 and WD, Creamy, 18oz,
Code: 2206, UPC#21140-60941, Best if used by date:
12/05/2003,
DS, Creamy, 18oz, Code: 2839, UPC#211450-60940, Best
if used by date: 01/05/2004, DS, Creamy, 40oz, Code:
2847, UPC#21140-60952, Best if used by date:
11/13/2003 and DS, Creamy, 28oz, Code: 2843,
UPC#21140-60948, Best if used by date: 11/14/2003;
b) A) Code: 50021, UPC#21140-60937, Best if used by date:
11/05/2003,
DS, Crunchy, 40oz., Code: 2845, UPC#21140-60953, Best
if used by date: 10/13/2003, DS, Crunchy, 40oz, Code:
2845, UPC#21140-60953, Best if used by date
10/14/2003 and DS, Crunchy, 28oz, Code: 2841,
UPC#21140-60946, Best if used by date: 10/14/2003.
RECALLING FIRM/MANUFACTURER
Winn Dixie Stores, Inc, Jacksonville, FL, by e-mail on May 8, 2003. Firm initiated recall is complete.
REASON
Product may contain elevated levels of Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
12,615 cases (12 jars per case).
DISTRIBUTION
AL, FL, GA, LA, KY, and NC.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
HOKAN brand Lite Coconut Milk, 13/5 oz. can. Product of Thailand. Recall # F-140-4.
CODE
All codes that fail to declare potassium metabisulfite in the ingredient statement, including "PROD 050203" and "PROD 110203".
RECALLING FIRM/MANUFACTURER
Novalia Ltd., Tuxedo Park, NY, by letter dated February 6, 2004. Georgia State initiated recall is complete.
REASON
Coconut milk contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
5,831 cases x 12 cans.
DISTRIBUTION
GA and FL.

______________________________
PRODUCT
Giant brand Ranglers Barbeque Corn Chips, 10 oz plastic
bag, distributed in cases, 12 bags per case, Recall # F-
145-4.
CODE
SEPT0903B, SEPT1603B, SEPT2303B, OCT1403B, DEC0203B, or DEC0903B.
RECALLING FIRM/MANUFACTURER
Wise Foods, Inc., Berwick, PA, by letter on November 3, 2003. Firm initiated recall is complete.
REASON
Corn chips contain undeclared ingredients including color additive, Red #40 Lake, monosodium glutamate, and sulfating agents.
VOLUME OF PRODUCT IN COMMERCE
1,730 cases.
DISTRIBUTION
MD, PA, VA, DE, and D.C.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles,
Rx only, Recall # D-118-4;
b) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles,
Rx only. Recall# D-119-4.
CODE
a) Lot Number/Expiration Date: Lot 7EF27A (8/1/05),
Lot 7EF28A(8/1/05);
b) Lot Number/Expiration Date: Lot 7ED87A (7/1/05);
Lot 7EE34A (7/1/05).
RECALLING FIRM/MANUFACTURER
FPP Inc, Cincinnati, OH, by letter on February 18, 2004. FDA initiated recall is ongoing.
REASON
Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
67 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Dakin's Solution 0.25% By Century Half Strength, (0.25%
sodium hypochlorite), 473 mL 16 Fl. OZ. Recall # D-122-4.
CODE
Lot Number: 871/Expiration Date: 10/27/2004.
RECALLING FIRM/MANUFACTURER
Century Pharmaceuticals, Inc, Indianapolis, IN, by letter and fax on January 15, and January 23, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: Stability assay failed to meet specification limits.
VOLUME OF PRODUCT IN COMMERCE
1,200.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Butalbital, Aspirin & Caffeine Tablets,USP,
50mg-Butalbital/325mg-Aspirin/40mg-Caffeine, CIII,
100 count bottles, Rx only. Recall # D-116-4.
CODE
Lot Number/Expiration Date: 539C21, 04/2004;
541C21, 04/2004; 743D21, 05/2004; 744D21, 05/2004;
745D21, 05/2004; 746D21, 05/2004; 281F21, 07/2004;
284F21, 07/2004; 285F21, 08/2004.
RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on January 13, 2004. FDA initiated recall is ongoing.
REASON
Stability Failure: Product lacks stability for Butalbital drug ingredient.
VOLUME OF PRODUCT IN COMMERCE
96,113.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Aspirin and Codeine Phosphate Tablets, USP, 325 mg/60 mg,
100 count bottles, Rx only. Recall # D-120-4.
CODE
Lot Number 101304A/Expiration Date: 3/2004.
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami, FL, by letter on November 11, 2003. Firm initiated recall is ongoing.
REASON
Stability Failure: Product is exceeding the stability specification for free Salicylic Acid.
VOLUME OF PRODUCT IN COMMERCE
4,392 bottles.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
MGP Promethazine with Codeine Cough Syrup; (Promethazine
Hydrochloride 6.25 mg/5mL and Codeine Phosphate 10 mg/5mL;
4 oz. Bottles. Rx Only. Recall # D-121-4.
CODE
Lot numbers: 25016A, 25091A, 25103A, 25408A, 25409A,25457A, 25525A.
RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letters dated February 17, 2004. Firm initiated recall is ongoing.
REASON
Discoloration, (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
149,505 bottles.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Questran Powder (Cholestyramine for Oral Suspension, USP) 4
grams cholestyramine resin, USP per scoopful, 378 G (168 G
anhydrous cholestyramine) Cans, Rx Only. Recall # D-123-4.
CODE
Lot 3A63688.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Co., New Brunswick, NJ, by email on November 10, 2003. Firm initiated recall is ongoing.
REASON
Superpotent (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
18,571 cans.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0374-4;
b) Platelets Pheresis, Leukocytes Reduced. Recall # B-
0375-4.
CODE
a) Unit number LE30532 (distributed as two split products);
b) Unit number LE47395.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on July 15, 2003, and by letter on July 16, 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
3 units.
DISTRIBUTION
MA and RI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0376-4;
b) Platelets. Recall # B-0377-4;
c) Fresh Frozen Plasma. Recall # B-0378-4;
d) Recovered Plasma. Recall # B-0379-4.
CODE
a) and b) Unit numbers 13FQ08979 and 13T92433;
c) Unit number 13T92433;
d) Unit number 13FQ08979.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by facsimile on July 7, 2003, telephone on July 25, 2003, and by letter on July 28, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MI and CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0853-4.
CODE
Unit number: 15391-7336.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on June 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking Isosorbide Mononitrate at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0890-4.
CODE
Unit 0680168.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on June 17, 2002. Firm initiated recall is complete.
REASON
Blood Products, which were negative for all viral markers, but were collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA and Switzerland.

_______________________________
PRODUCT
Human Cornea Tissue. Recall # B-0911-4.
CODE
Tissue 01-1320.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX, by letter dated January 6, 2004. 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 the hepatitis B surface antigen (HBsAg) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0920-4;
b) Platelets, Leukocytes Reduced. Recall # B-0921-4.
CODE
a) and b) Unit 33GS41637.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by e-mail on October 30, 2003, and by letter dated October 31, 2003. 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
2 units.
DISTRIBUTION
CA and CT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0923-4;
b) Platelets, Leukocytes Reduced. Recall # B-0924-4.
CODE
a) and b) Unit 33GS41641.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by e-mail on October 30, 2003, and by letter dated October 31, 2003. 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
2 units.
DISTRIBUTION
CA and CT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0926-4.
CODE
Unit number 8350055.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on April 9, 2002, and by letter, dated May 3, 2002. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0927-4.
CODE
Unit 18233-5020.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc. Cheyenne, WY, by phone and fax on November 25, 2003. 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 and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0930-4.
CODE
Unit number: 8239861.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on October 1, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor who was previously deferred for body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0931-4;
b) Red Blood Cells, Leukocytes Removed, Irradiated.
Recall # B-0932-4;
c) Recovered Plasma. Recall # B-0933-4.
CODE
a) Unit numbers: 8103966, 8103968, 8124908, 8124909,
8124914, 8124917, 8111126, 8111127, 8111128, 8111129,
8111130, 8111131, 8111133, 8111134, 8111135, 8111136,
8111137, 8111138, 8111141, 8111143, 8111144, 8111145,
8111167, 8111169, 8111170, 8132006, 8132007, 8103983,
8103937, 8103938, 8103942, 6590493, 6590529, 6590530,
8103970, 8103971, 8103976, 8103977, 8103978, 8103979,
8103980, 8103943, 8103945, 8103947, 8103948, 8103949,
8103954, 8103955, 8103958, 8103960, 8103961, 8103963,
6586947, 6586948, 6580882, 6580884, 6580885, and
6580494;
b) Unit number: 8103967;
c) Unit numbers: 8103964, 8103966, 8103967, 8103968,
8124908, 8124909, 8124914, 8124917, 8111126, 8111127,
8111128, 8111129, 8111130, 8111131, 8111133, 8111134,
8111135, 8111136, 8111137, 8111138, 8111141, 8111143,
8111144, 8111145, 8111167, 8111169, 8111170, 8132006,
8132007, 8103983, 8103937, 8103938, 8103942, 6590493,
6590529, 6590530, 8103970, 8103971, 8103976, 8103977,
8103978, 8103979, 8103980, 8103943, 8103945, 8103947,
8103948, 8103949, 8103954, 8103955, 8103958, 8103960,
8103961, 8103963, 6586947, 6586948, 6580882, 6580884,
6580885, and 6580494.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated November 15, 2001. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
119 units.
DISTRIBUTION
LA, TX, and Switzerland.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0935-4.
CODE
Unit number 7790422 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN,
by telephone on September 29, 2003, and by letter on November 13, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0939-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0940-4;
c) Platelets. Recall # B-0941-4.
CODE
a) Unit number T11160;
b) Unit number T10314;
c) Unit numbers T11160 and T10314.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by facsimile on October 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
4 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0942-4.
CODE
Unit number 0933836.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter and facsimile on September 12, 2003, and January 8, 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
KY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0943-4.
CODE
Unit number 0924469.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter and facsimile on June 6, 2003, and January 7, 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
OH.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0944-4.
CODE
Unit number 8446151.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on October 1, 2003. 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
LA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0945-4.
CODE
Unit number 6942917 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on March 18, 2002. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells, Pheresis, Leukoreduced, Recall # B-0948-4.
CODE
Units: 18233-5842 (component 04761), 18233-5842 (component 04741).
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Cheyenne, WY, by phone on December 18, 2003. 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
WY.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0949-4;
b) Recovered Plasma. Recall # B-0950-4.
CODE
a) and b) Units 18GN10295, 18GN09949.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, fax, e-mail, or letter dated December 10, 2003. 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
4 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0952-4;
b) Platelets. Recall # B-0953-4.
CODE
a) and b) Unit number 8226541.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on July 20, 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
LA and MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0954-4;
b) Platelets. Recall # B-0955-4.
CODE
a) and b) Unit number 8226542.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on July 20, 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
LA and MI.

_______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
Recall # B-0956-4;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0957-4.
CODE
a) and b) Unit number FG81581.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on December 11, 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
MA.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0958-4.
CODE
Unit number FG75316.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on November 4, 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
RI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0959-4.
CODE
Unit number 5477083.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc. Eastern Maine Medical Center, Bangor, ME, by telephone on November 21, 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
ME.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0960-4;
b) Platelets. Recall # B-0961-4.
CODE
a) and b) Unit number 8502965.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone and letter on October 14, 2002. 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
LA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0962-4.
CODE
Unit numbers 8508987 and 8351272.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by letter on December 24, 2002. 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
LA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0963-4.
CODE
Unit numbers 8351307 and 8149893.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone and letter on December 4, 2002. 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
LA and TX.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-0966-4;
b) Cryoprecipitated AHF. Recall # B-0967-4;
c) Cryoprecipitated AHF, Pooled. Recall # B-0968-4.
CODE
a) Unit numbers: 18FJ64991, 18FV53677;
b) Unit numbers: 18FY08852, 18N88603;
c) Unit number: 18GC13058.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI, by telephone on October 20, 2003 and by letter, dated October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AK and MI.

_______________________________
PRODUCT
Platelets. Recall # B-0983-4.
CODE
Unit number: T77028.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on December 10, 2003, and by letter, dated December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0985-4;
b) Platelets. Recall # B-0986-4.
CODE
a) and b) Unit L84633.
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated January 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0989-4.
CODE
Unit number 004GK46858.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile on July 17, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0990-4;
Platelets. Recall # B-0991-4.
CODE
a) and b) Unit number S49714.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on December 29, 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
MI.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0992-4.
CODE
Unit number 71H98074-5.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on October 3, 2003. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall #B-0891-4.
CODE
Unit 0680168.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on June 17, 2002. Firm initiated recall is complete.
REASON
Blood Products, which were negative for all viral markers, but were collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA and Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0922-4.
CODE
Unit 33GS41637.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by e-mail on October 30, 2003, and by letter dated October 31, 2003. 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
1 unit.
DISTRIBUTION
CA and CT.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0925-4.
CODE
Unit 33GS41641.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by e-mail on October 30, 2003, and by letter dated October 31, 2003. 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
1 unit.
DISTRIBUTION
CA and CT.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0928-4.
CODE
Unit 18233-5020.
RECALLING FIRM/MANUFACTURER
Blood Systems Inc. Cheyenne, WY, by phone and fax on November 25, 2003. 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 and Switzerland.
_________________________________________________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0929-4.
CODE
Unit number: LE71662.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on December 19, 2003. Firm initiated recall is complete.
REASON
Blood product, that did not have the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0936-4;
b) Platelets. Recall # B-0937-4;
c) Fresh Frozen Plasma. Recall # B-0938-4.
CODE
a), b), and c) Unit number T11538.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by facsimile on November 20 and 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI, and TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-0946-4.
CODE
Unit number: H63292.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on September 5, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Washed, Irradiated. Recall # B-0947-4.
CODE
Units V00478, S42242.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated September 3, 2002. Firm initiated recall is complete.
REASON
Blood products, washed using expired processing sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets, For Further Manufacturing. Recall # B-0951-4.
CODE
Unit 18GN09949.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, fax, e-mail, or letter dated December 10, 2003. 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
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0964-4;
b) Platelets Recall # B-0965-4.
CODE
a) and b) Unit 26115-7302.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. Fort Smith, AR, by letter dated March 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0987-4.
CODE
Unit numbers 8118448 and 8118436.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on August 20, 2001. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but failed quality control testing due to an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0988-4.
CODE
Unit numbers 004FF39194, 004FF39178, 004FF39190, 004FF39201, and 004FF39205.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on September 25, 2003. Firm initiated recall is complete.
REASON
Blood products, that were leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MA.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Faaborg patient lift/hoist, battery operated
lifts. The PL series lifts have electric parallel
base widening, with a weight capacity of 365 lbs.
to 550 lbs. depending on the base model. The Users
Guide refers to the lift as a "Faaborghoist".
Recall # Z-0551-04;
b) Faaborg patient lift/hoist, battery operated
lifts. The VL series lifts have electric V-shape
base widening, with a weight capacity of 365 lbs.
to 550 lbs. depending on the base model.
Recall # Z-0552-04;
c) Faaborg patient lift/hoist, battery operated
lifts. The Solution/Nordic series lifts have
electric V-shape base widening, with a weight
capacity of 210 lbs. to 365 lbs. depending on the
base model. Recall # Z-0553-04
CODE
a) All PL series models, all serial numbers;
b) All VL series models, all serial numbers;
c) All Solution/Nordic series models, all serial numbers.
RECALLING FIRM/MANUFACTURER
Moving Solutions, Inc., Downers Grove, IL, by letters on November 29, 2001, January 24, 2004 and March 11, 2004. FDA initiated recall is ongoing.
REASON
Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
VOLUME OF PRODUCT IN COMMERCE
856 lifts.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Laser system, DUO System, Class IV laser diode
material processing machine. Recall # Z-0360-04.
CODE
None noted.
RECALLING FIRM/MANUFACTURER
Coherent, Inc., Santa Clara, CA., by service representative visit beginning on January 21, 2004. Firm initiated recall is ongoing.
REASON
Unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
70 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Statscan digital radiographic system for Diagnostic Radiography. Recall # Z-0389-04.
CODE
None supplied.
RECALLING FIRM/MANUFACTURER
Lodox Systems, South Lyon, Mi, by service technician visit beginning on March 16, 2004. Firm initiated recall is ongoing.
REASON
The units are defective under 21 CFR 1010.2 in that the identification and certification labels were inadequate or missing. In addition there was inadequate testing and quality control procedures to establish certification. This can result in misleading the purchasers and manufacturers about requirements for certification of products introduced into commerce. The required tracking for components may not be followed and thus a loss of traceability.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and IL.

______________________________
PRODUCT
Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04.
CODE
Serial Numbers/Model Numbers: TFAP0004P-TFAP00048.
RECALLING FIRM/MANUFACTURER
Coherent Inc Laser Group, Santa Clara, CA, by letter and on-site visit on November 7, 2003. Firm initiated recall is ongoing.
REASON
Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
VOLUME OF PRODUCT IN COMMERCE
52 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 21mm 80 cm
.018" REF PMB 8-7-21-80. Recall # Z-0597-04;
b) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 18mm 80 cm
.018" REF PMB 8-7-18-80. Recall # Z-0598-04;
c) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 14mm 80 cm
.018" REF PMB 8-7-14-80. Recall # Z-0599-04;
d) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 21mm 80 cm
.018" REF PMB 8-6-21-80. Recall # Z-0600-04;
e) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 18mm 80 cm
.018" REF PMB 8-6-18-80. Recall # Z-0601-04;
f) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 14mm 80 cm
.018" REF PMB 8-6-14-80. Recall # Z-0602-04;
g) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 21mm 80 cm
.018" REF PMB 8-5-21-80. Recall # Z-0603-04;
h) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 18mm 80 cm
.018" REF PMB 8-5-18-80. Recall # Z-0604-04;
i) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 14mm 80 cm
.018" REF PMB 8-5-14-80. Recall # Z-0605-04;
j) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 21mm 80 cm
.014" REF PMB 4-7-21-80. Recall # Z-0606-04;
k) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 18mm 80 cm
.014" REF PMB 4-7-18-80. Recall # Z-0607-04;
l) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 7mm x 14mm 80 cm
.014" REF PMB 4-7-14-80. Recall # Z-0608-04;
m) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 21mm 80 cm
.014" REF PMB 4-6-21-80. Recall # Z-0609-04;
n) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 18mm 80 cm
.014" REF PMB 4-6-18-80. Recall # Z-0610-04;
o) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 6mm x 14mm 80 cm
.014" REF PMB 4-6-14-80. Recall # Z-0611-04;
p) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 21mm 80 cm
.014" REF PMB 4-5-21-80. Recall # Z-0612-04;
q) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 18mm 80 cm
.014" REF PMB 4-5-18-80. Recall # Z-0613-04;
r) ParaMount Mini GPS Biliary Stent System, Balloon
Expandable Stent and Delivery System, 5mm x 14mm 80 cm
.014" REF PMB 4-5-14-80. Recall # Z-0614-04;
s) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 21mm
80 cm .018" REF PMP 8-7-21-80. Recall # Z-615-04;
t) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 18mm
80 cm .018" REF PMP 8-7-18-80. Recall # Z-616-04;
u) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 14mm
80 cm .018" REF PMP 8-7-14-80. Recall # Z-617-04;
v) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 21mm
80 cm .018" REF PMP 8-6-21-80. Recall # Z-618-04;
w) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 18mm
80 cm .018" REF PMP 8-6-18-80. Recall # Z-619-04;
x) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 14mm
80 cm .018" REF PMP 8-6-14-80. Recall # Z-620-04;
y) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 21mm
80 cm .018" REF PMP 8-5-21-80. Recall # Z-621-04;
z) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 18mm
80 cm .018" REF PMP 8-5-18-80. Recall # Z-622-04;
aa) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 14mm
80 cm .018" REF PMP 8-5-14-80. Recall # Z-623-04;
bb) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 21mm
80 cm .014" REF PMP 4-7-21-80. Recall # Z-624-04;
cc) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 18mm
80 cm .014" REF PMP 4-7-18-80. Recall # Z-625-04;
dd) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 7mm x 14mm
80 cm .014" REF PMP 4-7-14-80. Recall # Z-626-04;
ee) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 21mm
80 cm .014 REF PMP 4-6-21-80. Recall # Z-627-04;
ff) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 18mm
80 cm .014" REF PMP 4-6-18-80. Recall # Z-628-04;
gg) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 6mm x 14mm
80 cm .014" REF PMP 4-6-14-80. Recall # Z-629-04;
hh) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 21mm
80 cm .014" REF PMP 4-5-21-80. Recall # Z-630-04;
ii) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 18mm
80 cm .014" REF PMP 4-5-18-80. Recall # Z-631-04;
jj) ParaMount Mini GPS Stent System, Peripheral System,
Balloon Expandable Stent and Delivery System, 5mm x 14mm
80 cm .014" REF PMP 4-5-14-80. Recall # Z-632-04.
CODE
Lots 262849 through 445216.
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Saint Paul, MN, by letter on January 30, 2004. Firm initiated recall is ongoing.
REASON
After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
VOLUME OF PRODUCT IN COMMERCE
446 units.
DISTRIBUTION
Nationwide, China and Ireland.

______________________________
PRODUCT
ATS Open Pivot Mechanical Heart Valve. Recall # Z-0634-04.
CODE
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
RECALLING FIRM/MANUFACTURER
ATS Medical, Inc, Minneapolis, MN, by letters dated February 18, 2004. Firm initiated recall is ongoing.
REASON
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
VOLUME OF PRODUCT IN COMMERCE
56,266.
DISTRIBUTION
Nationwide and Internationally.

______________________________
PRODUCT
a) CXP software, Part No. 623560. Recall # Z-0635-04;
b) Cytomics MXP Software, Part No. 623688.
Recall # Z-036-04;
c) Cytomics RXP Software, Part Numbers: 175488, 6418489,
175260, 175261, 175262, 175263, 175264, 175265.
Recall # Z-0637-04.
CODE
a), b) and c) Version 1.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, by modified operating instructions on February 13, 2004. Firm initiated recall is ongoing.
REASON
Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
VOLUME OF PRODUCT IN COMMERCE
418.
DISTRIBUTION
Nationwide and Canada.

______________________________
PRODUCT
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT. Recall # Z-0638-04.
CODE
Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
RECALLING FIRM/MANUFACTURER
Datascope Corporation, Montvale, NJ, by letters on December 30, 2003. Firm initiated recall is ongoing.
REASON
Water permeability of the patch is out of specification.
VOLUME OF PRODUCT IN COMMERCE
710 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue Flex Tip Arrowgard Blue Curved Catheter for high Volume Ifusions. Recall # Z-0639-04.
CODE
Product number AK-22142-CF Lot numbers RF2035008, RF2067620, RF2100365, RF3023691, RF3045916, RF3078012, RF3089042, RF3099786, RF3121691, and RF3122085. Product number AK-22142-CFSP Lot numbers RF2046619, RF2046669, RF3099895, and RF3111053. Product number AK-22142-F Lot numbers RF1105891, RF2100885, RF3088793, RF3089028, RF3089202, RF3099359, RF3100354, RF4012646. Product number AK-25142-CF Lot number RF1080802, RF1094019, RF2010218, RF2067624, RF2100633, RF2100886, RF3067453, RF3088794, RF3099633, RF3100446, and RF3121805. Product number AK-25142-CFSP Lot numbers RF2010219, RF2046670, RF3100573, and RF3111264. Product number AK-25142-F Lot numbers RF1104566, RF3024351, RF3034977, RF3056501, RF3088861, RF3089029, RF3099313, and RF3100355. Product number CS-22142-CF Lot numbers RF1028262, RF1033063, RF1105890, RF2099516, RF2111093, RF3013358, RF3077978, RF3088513, RF3099272, and RF3100452. Product number CS-22142-F Lot numbers RF1033064, RF2100484, RF3045575, RF3088456, and RF3051547. Product number CS-25142-CF Lot numbers RF1082563, RF1104918, RF1105889, RF2089343, RF2100890, RF2111125, RF3056376, RF3067264, and RF3099410. Product number CS-25142-F Lot numbers RF1104919, RF2111094, RF2111192, RF2111673, RF3023765, RF3035176, RF3045410, RF3056617, RF3099369, RF3121572, and RF4012292.Product number CS-26142-F Lot numbers RF2111134, RF2111290, RF3078240, RF3088795, RF3099586, RF3100056, RF3100272, RF3111001, RF3111434, and RF3121623.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated February 18, 2004. Firm initiated recall is ongoing.
REASON
Catheter slips out of the suture wing during use.
VOLUME OF PRODUCT IN COMMERCE
6,610 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and
55602. Recall # Z-0642-04;
b) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 1.0 cm length, Item Numbers: 53128 and
55604. Recall # Z-0643-04;
c) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 1.2 cm length, Item Numbers: 53130 and
55606. Recall # Z-0644-04;
d) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 1.5 cm length, Item Numbers: 53132 and
55608. Recall # Z-0645-04;
e) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 1.7 cm length, Item Numbers: 53134 and
55610. Recall # Z-0646-04;
f) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 2.0 cm length, Item Numbers: 53136 and
55612. Recall # Z-0647-04;
g) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 2.3 cm length, Item Numbers: 53138 and
55614. Recall # Z-0648-04;
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
h) Kit, 14 Fr., 2.5 cm length, Item Numbers: 53140 and
55616. Recall # Z-0649-04;
i) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 2.7 cm length, Item Numbers: 53142 and
55618. Recall # Z-0650-04;
j) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 3.0 cm length, Item Numbers: 53144 and
55620. Recall # Z-0651-04;
k) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 3.5 cm length, Item Number: 55622. Recall #
Z-0652-04;
l) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 4.0 cm length, Item Number: 55624. Recall #
Z-0653-04;
m) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 14 Fr., 4.5 cm length, Item Number: 55626. Recall #
Z-0654-04;
n) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 0.8 cm length, Item Numbers: 54146 and
55628. Recall # Z-0655-04;
o) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 1.0 cm length, Item Numbers: 54148 and
55630. Recall # Z-0656-04;
p) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 1.2 cm length, Item Numbers: 54150, 55275,
55632. Recall # Z-0657-04;
q) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 1.5 cm length, Item Numbers: 54152 and
55634. Recall # Z-0658-04;
r) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 1.7 cm length, Item Numbers: 54154, 55636.
Recall # Z-0659-04;
s) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 2.0 cm length, Item Numbers: 54156 and
55638. Recall # Z-0660-04;
t) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 2.3 cm length, Item Numbers: 54158 and
55640. Recall # Z-0661-04;
u) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 2.5 cm length, Item Numbers: 54160 and
55642. Recall # Z-0662-04;
v) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 2.7 cm length, Item Number: 55644. Recall #
Z-0663-04;
w) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 3.0 cm length, Item Number: 55646. Recall #
Z-0664-04;
x) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 3.5 cm length, Item Numbers: 54166 and
55648. Recall # Z-0665-04;
y) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 4.0 cm length, Item Number: 55650. Recall #
Z-0666-04;
z) Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 16 Fr., 4.5 cm length, Item Number: 55652. Recall #
Z-0667-04;
aa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 0.8 cm length, Item Number: 55654. Recall #
Z-0668-04;
bb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 1.0 cm length, Item Numbers: 54240 and
55656. Recall # Z-0669-04;
cc)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 1.2 cm length, Item Numbers: 54242 and
55658. Recall # Z-0670-04;
dd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 1.5 cm length, Item Numbers: 54244 and
55660. Recall # Z-0671-04;
ee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 1.7 cm length, Item Numbers: 54246 and
55662. Recall # Z-0672-04;
ff)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 2.0 cm length, Item Numbers: 54248 and
55664. Recall # Z-0673-04;
gg)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 2.3 cm length, Item Numbers: 54250 and
55666. Recall # Z-0674-04;
hh)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 2.5 cm length, Item Numbers: 54252 and
55668. Recall # Z-0675-04;
ii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 2.7 cm length, Item Number: 55670.
Recall # Z-0676-04;
jj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 3.0 cm length, Item Numbers: 54256 and
55672. Recall # Z-0677-04;
kk)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 3.5 cm length, Item Numbers: 54258 and
55674. Recall # Z-0678-04;
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
ll)Kit, 18 Fr., 4.0 cm length, Item Numbers: 54260 and
55676. Recall # Z-0679-04;
mm)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 18 Fr., 4.5 cm length, Item Numbers: 54262 and
55678. Recall # Z-0680-04;
nn)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 0.8 cm length, Item Numbers: 54186 and
55680. Recall # Z-0681-04;
oo)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 1.0 cm length, Item Number: 55682. Recall
# Z-0682-04;
pp)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 1.2 cm length, Item Numbers: 54190 and
55684. Recall # Z-0683-04;
qq)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 1.5 cm length, Item Numbers: 54192 and
55684. Recall # Z-0684-04;
rr)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 1.7 cm length, Item Numbers: 54194 and
55688. Recall # Z-0685-04;
ss)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 2.0 cm length, Item Numbers: 54196 and
55690. Recall # Z-0686-04;
tt)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 2.3 cm length, Item Number: 55692.
Recall # Z-0687-04;
uu)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 2.5 cm length, Item Numbers: 54200 and
55694. Recall # Z-0688-04;
vv)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 2.7 cm length, Item Numbers: 54202 and
55696. Recall # Z-0689-04;
ww)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 3.0 cm length, Item Numbers: 54204 and
55698. Recall # Z-0690-04;
xx)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 3.5 cm length, Item Numbers: 54206 and
55700. Recall # Z=0691-04;
yy)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 4.0 cm length, Item Numbers: 54208 and
55702. Recall # Z-0692-04;
zz)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 20 Fr., 4.5 cm length, Item Numbers: 54210 and
55704. Recall # Z-0693-04;
aaa)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 1.5 cm length, Item Number: 55706.
Recall # Z-0694-04;
bbb)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 1.7 cm length, Item Numbers: 54214 and
55708.Recall # Z-0695-04;
ccc)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 2.0 cm length, Item Number: 55711.
Recall # Z-0696-04;
ddd)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 2.3 cm length, Item Numbers: 54218 and
55713. Recall # Z-0697-04;
eee)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 2.5 cm length, Item Numbers: 54220 and
55715. Recall # Z-0698-04;
fff)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 2.7 cm length, Item Numbers: 54222 and
55717. Recall # Z-0699-04;
ggg)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 3.0 cm length, Item Numbers: 54224 and
55719. Recall # Z-0700-04;
hhh)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 3.5 cm length, Item Numbers: 54226 and
55721. Recall # Z-0701-04;
iii)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 4.0 cm length, Item Number: 55723.
Recall # Z-0702-04;
jjj)Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube
Kit, 24 Fr., 4.5 cm length, Item Numbers: 54230 and
55725. Recall # Z-0703-04.
CODE
a) Lot Numbers: 73088GZ00, 75182GZ00, 78309GZ00, 72040GZ00,
75183GZ00, 77269GZ00, 79340GZ00, 79365GZ00;
b) Lot Numbers: 73089GZ00, 74144GZ00, 75198GZ00, 79364GZ00,
80424GZ00, 80425GZ00, 73083GZ00, 74134GZ00, 75199GZ00,
77283GZ00, 79367GZ00, 80426GZ00;
c) Lot Numbers: 71030GZ00, 73102GZ00, 74135GZ00, 75184GZ00,
79363GZ00, 80423GZ00, 72065GZ00, 74112GZ00, 75164GZ00,
76240GZ00, 80421GZ00;
d) Lot Numbers: 72064GZ00, 77284GZ00, 78328GZ00, 80422GZ00,
71031GZ00, 74109GZ00, 76230GZ00, 79357GZ00, 80427GZ00;
e) Lot Numbers: 74136GZ00, 77286GZ00, 79342GZ00, 82505GZ00;
f) Lot Numbers: 82460GZ00, 82474GZ00;
g) Lot Numbers: 73095GZ00, 78311GZ00, 76231GZ00, 78312GZ00;
h) Lot Numbers: 73096GZ00, 74137GZ00, 76217GZ00, 77256GZ00,
80385GZ00, 72062GZ00, 76218GZ00, 78313GZ00;
i) Lot Numbers: 71032GZ00, 73090GZ00, 77272GZ00, 74157GZ00,
78302GZ00;
j) Lot Numbers: 77271GZ00 and 74113GZ00;
k) Lot Number: 79376GZ00;
l) Lot Number: 82529GZ00;
m) Lot Numbers: 73084GZ00 and 78326GZ00;
n) Lot Numbers: 72038GZ00, 78315GZ00, 80399GZ00, 75201GZ00,
78308GZ00, 79358GZ00;
o) Lot Numbers: 72039GZ00, 74158GZ00, 77257GZ00, 80404GZ00,
76219GZ00, 79359GZ00;
p) Lot Numbers: 74148GZ00, 72060GZ00, 74149GZ00, 75187GZ00,
77287GZ00, 75202GZ00, 80420GZ00;
q) Lot Numbers: 74138GZ00, 75200GZ00, 73092GZ00 76232GZ00;
r) Lot Numbers: 74150GZ00, 79374GZ00;
s) Lot Numbers: 78304GZ00, 73085GZ00, 74151GZ00;
t) Lot Numbers: 76241GZ00, 74111GZ00, 75203GZ00, 78316GZ00,
80387GZ00;
u) Lot Numbers: 75165GZ00, 78305GZ00, 71016GZ00, 73103GZ00,
75185GZ00, 76233GZ00, 79360GZ00, 80382GZ00;
v) Lot Numbers: 74139GZ00, 75186GZ00, 76242GZ00, 80383GZ00;
w) Lot Numbers: 76243GZ00, 78327GZ00, 79361GZ00;
x) Lot Numbers: 77258GZ00, 72061GZ00, 74140GZ00, 75204GZ00,
76244GZ00, 79362GZ00;
y) Lot Numbers: 74110GZ00, 75167GZ00, 75197GZ00, 78317GZ00,
80384GZ00;
z) Lot Numbers: 75188GZ00, 76245GZ00, 82476GZ00;
aa)Lot Numbers: 82525GZ00, 85665GZ00, 90020GZ00, 91086GZ00,
91151GZ00, 92207GZ00, 93303GZ00;
bb)Lot Numbers: 74114GZ00, 75168GZ00, 75196GZ00, 79375GZ00,
84570GZ00, 85666GZ00, 88816GZ00, 91116GZ00, 92204GZ00,
95383GZ00;
cc)Lot Numbers: 76220GZ00, 82475GZ00, 83539GZ00, 86696GZ00,
88819GZ00, 89937GZ00, 90022GZ00, 92218GZ00;
dd)Lot Numbers: 73091GZ00, 84610GZ00, 88823GZ00, 92208GZ00;
ee)Lot Numbers: 02567GZ00, 03609GZ00, 82466GZ00, 83558GZ00,
85682GZ00, 86705GZ00, 87761GZ00, 88821GZ00, 89934GZ00,
91091GZ00, 92239GZ00, 94343GZ00, 95412GZ00, 84604GZ00,
89879GZ00, 91162GZ00;
ff)Lot Numbers: 81443GZ00, 82480GZ00, 84580GZ00, 84619GZ00,
85663GZ00, 87800GZ00, 88820GZ00, 89935GZ00, 90005GZ00,
91113GZ00, 91150GZ00, 94326GZ00, 84604GZ00, 89879GZ00,
91162GZ00;
gg)Lot Numbers: 82497GZ00, 82523GZ00, 84620GZ00, 85645GZ00,
86702GZ00, 87765GZ00, 89917GZ00, 90017GZ00, 90988GZ00,
91084GZ00, 92229GZ00, 92246GZ00, 84572GZ00, 87772GZ00,
89938GZ00, 91079GZ00;
hh)Lot Numbers: 82481GZ00, 82498GZ00, 84621GZ00, 85664GZ00,
86694GZ00, 87801GZ00, 88817GZ00, 89971GZ00, 91067GZ00,
92180GZ00, 93276GZ00, 94341GZ00, 82486GZ00, 85648GZ00,
85674GZ00, 88850GZ00, 89958GZ00, 94314GZ00;
ii)Lot Numbers: 81439GZ00, 82483GZ00, 85639GZ00, 86703GZ00,
87773GZ00, 88846GZ00, 89916GZ00, 90021GZ00, 91087GZ00,
92205GZ00;
jj)Lot Numbers: 82499GZ00, 84578GZ00, 85638GZ00, 87762GZ00,
88818GZ00, 89936GZ00, 90018GZ00, 91085GZ00, 91132GZ00,
92223GZ00, 93295GZ00, 94339GZ00, 82500GZ00, 82524GZ00,
84573GZ00, 85667GZ00, 86735GZ00, 89910GZ00, 90987GZ00,
91133GZ00, 94353GZ00;
kk)Lot Numbers: 83553GZ00, 85646GZ00, 87763GZ00, 88849GZ00,
89878GZ00, 89918GZ00, 90032GZ00, 90989GZ00, 92193GZ00,
93262GZ00, 94324GZ00, 82526GZ00, 85640GZ00, 86704GZ00,
87779GZ00, 89880GZ00, 90986GZ00, 91080GZ00, 93305GZ00;
ll)Lot Numbers: 12905GZ00, 83554GZ00, 84609GZ00, 87769GZ00,
88811GZ00, 89968GZ00, 91114GZ00, 92202GZ00, 93302GZ00,
01516GZ00, 10819GZ00, 82484GZ00, 86706GZ00, 89919GZ00,
92206GZ00, 94370GZ00;
mm)Lot Numbers: 81438GZ00, 82470GZ00, 83540GZ00, 85647GZ00,
86734GZ00, 88812GZ00, 89939GZ00, 90019GZ00, 91115GZ00,
92203GZ00, 92247GZ00, 93292GZ00, 95382GZ00, 10808GZ00,
82501GZ00, 84593GZ00, 86707GZ00, 89920GZ00, 90033GZ00,
91134GZ00, 92243GZ00;
nn)Lot Numbers: 84605GZ00, 88859GZ00, 91167GZ00, 81446GZ00,
83543GZ00, 85650GZ00, 86740GZ00, 89888GZ00, 91061GZ00,
91159GZ00, 94354GZ00;
oo)Lot Numbers: 81448GZ00, 82465GZ00, 83544GZ00, 84611GZ00,
85673GZ00, 86741GZ00, 88847GZ00, 89912GZ00, 90037GZ00,
91140GZ00, 93264GZ00, 94325GZ00;
pp)Lot Numbers: 02568GZ00, 83556GZ00, 88860GZ00, 96452GZ00,
10809GZ00, 84612GZ00, 86730GZ00, 88839GZ00, 89889GZ00,
91065GZ00, 92224GZ00, 94355GZ00;
qq)Lot Numbers: 01517GZ00, 81444GZ00, 82471GZ00, 87760GZ00,
93277GZ00, 81448GZ00, 82465GZ00, 83544GZ00, 84611GZ00,
85673GZ00, 86741GZ00, 88847GZ00, 89912GZ00, 90037GZ00,
91140GZ00, 93264GZ00, 94325GZ00;
rr)Lot Numbers: 01496GZ00, 10807GZ00, 84606GZ00, 84613GZ00,
86744GZ00, 89891GZ00, 90038GZ00, 91082GZ00, 93265GZ00,
96436GZ00, 96474GZ00;
ss)Lot Numbers: 84583GZ00, 85668GZ00, 94337GZ00, 01508GZ00,
03604GZ00, 84595GZ00, 86710GZ00, 88840GZ00, 91139GZ00,
94342GZ00;
tt)Lot Numbers: 84614GZ00, 88851GZ00, 91066GZ00, 91136GZ00,
94371GZ00;
uu)Lot NumbersL 84618GZ00, 89881GZ00, 89966GZ00, 84615GZ00.
vv)Lot Numbers: 82456GZ00, 85641GZ00, 86709GZ00, 89922GZ00,
91088GZ00, 84616GZ00, 89913GZ00;
ww)Lot Numbers: 81445GZ00, 84594GZ00, 85669GZ00, 86736GZ00,
87774GZ00, 89882GZ00, 90034GZ00, 90985GZ00, 91149GZ00,
84615GZ00;
xx)Lot Numbers: 82502GZ00, 83541GZ00, 84584GZ00, 86737GZ00,
87785GZ00, 88861GZ00, 89883GZ00, 89969GZ00, 90035GZ00,
91152GZ00, 93301GZ00, 84596GZ00, 88841GZ00, 89893GZ00,
91062GZ00;
yy)Lot Numbers: 02553GZ00, 82455GZ00, 83534GZ00, 84574GZ00,
85649GZ00, 86738GZ00, 87780GZ00, 87786GZ00, 89923GZ00,
90036GZ00, 90991GZ00, 91173GZ00, 92222GZ00, 82482GZ00,
83557GZ00, 87764GZ00, 93304GZ00;
zz)Lot Numbers: 82468GZ00, 83542GZ00, 86728GZ00, 86739GZ00,
89887GZ00, 89911GZ00, 90023GZ00, 91068GZ00, 91158GZ00,
92219GZ00, 93307GZ00, 95384GZ00, 83537GZ00, 85681GZ00,
86711GZ00, 89970GZ00, 91160GZ00, 95404GZ00;
aaa)Lot Numbers: 84622GZ00, 87776GZ00, 88852GZ00,
92200GZ00, 95385GZ00;
bbb)Lot Numbers: 83535GZ00, 87775GZ00, 88842GZ00,
90039GZ00, 94340GZ00, 02554GZ00, 84623GZ00, 86745GZ00,
89927GZ00, 91166GZ00, 92241GZ00;
ccc)Lot Numbers: 12903GZ00, 85633GZ00, 86731GZ00,
87777GZ00, 90041GZ00, 92220GZ00;
ddd)Lot Numbers: 03605GZ00, 10811GZ00, 82503GZ00,
84579GZ00, 85683GZ00, 88830GZ00, 89924GZ00, 90040GZ00,
91168GZ00, 93275GZ00, 96437GZ00, 85634GZ00, 86732GZ00,
88843GZ00, 91154GZ00;
eee)Lot Numbers: 84571GZ00, 88831GZ00, 89894GZ00,
91137GZ00, 02576GZ00, 83547GZ00, 84608GZ00, 86692GZ00,
88809GZ00, 89940GZ00, 89950GZ00;
fff)Lot Numbers: 02544GZ00, 84581GZ00, 84607GZ00,
89925GZ00, 91161GZ00, 94338GZ00, 83536GZ00, 86713GZ00,
89895GZ00, 92232GZ00, 95386GZ00;
ggg)Lot Numbers: 84597GZ00, 86712GZ00, 88829GZ00,
91063GZ00, 94356GZ00, 01509GZ00, 83546GZ00, 85675GZ00,
86746GZ00, 88844GZ00, 91089GZ00, 92242GZ00;
hhh)Lot Numbers: 02545GZ00, 84582GZ00, 87788GZ00,
88848GZ00, 91090GZ00, 91153GZ00, 82487GZ00, 84598GZ00,
86693GZ00, 88862GZ00, 92178GZ00, 95405GZ00;
iii)Lot Numbers: 85635GZ00, 85670GZ00, 91064GZ00,
94320GZ00;
jjj)Lot Numbers: 03620GZ00, 83545GZ00, 85651GZ00,
87789GZ00, 89926GZ00, 92196GZ00, 92221GZ00, 85636GZ00,
89896GZ00, 91138GZ00.
RECALLING FIRM/MANUFACTURER
Ross Products Division Abbott Laboratories, Columbus, OH, by telephone, fax, and FedEx on March 1, 2004. Firm initiated recall is ongoing.
REASON
The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.
VOLUME OF PRODUCT IN COMMERCE
61,160 kits.
DISTRIBUTION
Nationwide, Australia, New Zealand, and Italy.

_______________________________
PRODUCT
a) Endocoupler, C-Mount 30 mm Focal Length Catalog Number:
7204823, 7204823S. Part No: 7204823. Recall # Z-0704-04.
b) Endocoupler C-Mount 35 mmFocal Length Catalog Number:
6900398. Recall # Z-0705-04;
c) Endocoupler 18 M M F.L, Autoclavable Catalog Number:
7207905, 7207905S. Recall # Z-0706-04;
d) Endocoupler , C-Mount 35 mm Focal Length Catalog Number:
7204614, 7204614M, 7204614S. Recall # Z-0707-04;
e) Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number:
7205461. Recall # Z-0708-04.
CODE
a) Serial #s: SR 8433 SR 8472 SR 8504 SR 8562 SR 8391
SR 8506 SR 8538 SR 8555 SR 8392 SR 8395 SR 8489
SR 8494 SR 8554 SR 8471 SR 8485 SR 8477 SR 8568
SR 8513 SR 8514 SR 8394 SR 8520 SR 8493 SR 8567
SR 8569 SR 8396 SR 8533 SR 8561 SR 8534 7204823S
SR 8623 SR 8422 SR 8563 SR 8590 SR 8577 SR 8591
SR 8628 SR 8495 SR 8576 SR 8627 SR 8426 SR 8490
SR 8499 SR 8587 SR 8573 SR 8428 SR 8574 SR 8578
SR 8580 SR 8589 SR 8565 SR 8566 SR 8498 SR 8564 SR 8620.
b) Serial #s: 50001621-2, 50001621-1.
c) Part No: 7207095 Serial #s: XF 819 XF 922 XF 951 XF 955
XF 960 XF 962 XF 963 XF 967 XF 968 XF 990 XF 1033 XF 974
XF 976 XF 952 XF 835 XF 878 XF 1012 XF 1013 XF 1017
XF 1029 XF 1036 XF 1039 XF 1042 XF 811 XF 817 XF 820
XF 920 XF 965 XF 971 XF 977 XF 980 XF 988 XF 991 XF 992
XF 996 XF 1002 XF 1004 XF 1020 XF 1025 XF 1026 XF 1030
XF 1032 XF 1045 XF 1046 XF 957 XF 203 XF 704 XF 954
XF 959 XF 969 XF 970 XF 987 XF 1001 XF 801 XF 816 XF 712
XF 301 XF 909 XF 917 XF 848 XF 863 XF 864 XF 894 XF 904
XF 910 XF 918 XF 865 XF 868 XF 829 XF 800 XF 806 XF 888
XF 892 XF 953 XF 964 XF 966 XF 851 XF 858 XF 879 XF 807
XF 808 XF 897 XF 925 XF 935 XF 956 XF 958 XF 961 XF 716
XF 818 XF 994 XF 1009 XF 1037
Part No: 7207905S Serial #s: XF 144 XF 456 XF 709 XF 779
XF 884 XF 699 XF 748 XF 529 XF 669 XF 850;
d) Part No: 7204614 Serial #s: QW 17251 QW 17264 QW 17064
QW 17301 QW 17240 QW 17312 QW 17271 QW 17311 QW 17236
QW 17274 QW 17256 QW 17266 QW 16939 QW 17296 QW 17187
QW 17306 QW 17062 QW 17235 QW 17063 QW 17304 QW 17245
QW 17309 QW 17299 QW 17182 QW 17061 QW 17241 QW 17065
QW 17246 QW 17316 QW 17250 QW 16979 QW 17294 QW 16984
QW 17269 QW 17058 QW 17276 QW 17186 QW 17281 QW 17279
QW 17286 QW 17307 QW 17290 QW 16945 QW 17291 QW 17314
QW 17317 QW 17255 QW 17320 QW 16946 QW 16944 QW 16949
QW 16960 QW 17059 QW 16963 QW 17060 QW 17057 QW 17066
Part No: 7204614M Serial #s: QW 14735 QW 5709 QW 7623
QW 14560 QW 2701 QW 13306 QW 10665 QW 15180 QW 15114
QW 16358 QW 6058 QW 7968 QW 10807 Part No: 7204614S
Serial #s: QW 12364 QW 15063 QW 18182 QW 17009 QW 18017
QW 18011 QW 6103 QW 14098 QW 18016 QW 17037 QW 11192
QW 18183 QW 17007 QW 16545 QW 14024 QW 16291 QW 9983
QW 17035 QW 12988 QW 17031 QW 18180 QW 15194 QW 11626
QW 17000 QW 15987 QW 16068 QW 16360 QW 18004 QW 15852
QW 16111 QW 16581 QW 11689 QW 15148 QW 18173 QW 13125
QW 17033 QW 15878 QW 15895 QW 17039 QW 18005 QW 17036
QW 10883 QW 10101 QW 14937 QW 12600 QW 18195 QW 17014
QW 12172 QW 13286 QW 14804 QW 15494 QW 16591 QW 18197
QW 12065 QW 17038 QW 11699 QW 15091 QW 13797 QW 15941
QW 18009 QW 6327 QW 12382 QW 16160 QW 13645 QW 14801
QW 16723 QW 17011 QW 18014 QW 15446 QW 17016 QW 13867
QW 13994 QW 9574 QW 15607 QW 15352 QW 16296 QW 13203
QW 14232 QW 11717 QW 14071 QW 15111 QW 18027;
e) Part No: 7205461 Serial #s: UE 1130 UE 1234 UE 1142
UE 127 UE 1143 UE 1212 UE 1216 UE 1222 UE 1226 UE 1217
UE 1145 UE 1227.
RECALLING FIRM/MANUFACTURER
Smith And Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated February 19, 2004. Firm initiated recall is ongoing.
REASON
Endocouplers assembled with screws that cannot be effectively sterilized .
VOLUME OF PRODUCT IN COMMERCE
305 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Xact(tm) Drop Seat Base, a plastic seat support in Xact(tm) Integrated and Xact Individual w/Drop seat Base Wheelchair cushions. Recall # Z-0709-04.
CODE
Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
RECALLING FIRM/MANUFACTURER
Action Products Inc, Hagerstown, MD, by letter on January 19, 2003. Firm initiated recall is ongoing.
REASON
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
VOLUME OF PRODUCT IN COMMERCE
819 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel-4 cm length, catalog No. 06506803. Recall # Z-0711-04.
CODE
Lot W24005, Use By 2005-03.
RECALLING FIRM/MANUFACTURER
Empath Medical, Inc., Plymouth, MN, by telephone and fax on February 26, 2004. Firm initiated recall is ongoing.
REASON
The product is labeled as sterile product but had not been sterilized.
VOLUME OF PRODUCT IN COMMERCE
20/ten-pack kits.
DISTRIBUTION
NY.

_______________________________
PRODUCT
DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures. Recall # Z-0712-04.
CODE
Model DCTM, serial numbers 00182-0303, 00337-0303, 00901-0503, 00948-0503, 02082-0703, 02083-0703, 02152-0703, 02153-0703, 02187-0703, 02188-0703, 02289-0703, 02460-0803, 02492-0803, 02493-0803, 02581-0803, 02730-0803, 02805-0803, 02809-0903, 02810-0903, 02811-0903, 02812-0903, 02866-0903, 02918-0903, 02989-0903, 02990-0903, 02991-0903, 03147-0903, 03148-0903, 03149-0903, 03457-1003, 03458-1003, 03544-1003, 03545-1003, 03624-1003, 03625-1003, 03756-1003, 03757-1003, 03888-1103, 03956-1103, 04085-1103, 04122-1103, 04154-1103, 04236-1103, 04248-1103, 04264-1103, 04371-1203, 04433-1203, 04439-1203, 04480-1203, 04529-1203, 04572-1203, 04634-1203, 04659-1203, 04709-1203, 00032-0104, 00085-0104, WG0031-0102-R.
RECALLING FIRM/MANUFACTURER
Del Medical Systems Group, Franklin Park, IL, by letter dated February 13, 2004 and February 19, 2004. Firm initiated recall is ongoing.
REASON
There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units.
VOLUME OF PRODUCT IN COMMERCE
57 units.
DISTRIBUTION
Nationwide, Canada, Panama and Pakistan.

______________________________
PRODUCT
a) Apex Pilot Shaft, 10mm, catalog number: 690110. Recall
# Z-0713-04;
b) Apex Pilot Shaft, 11.5mm, catalog number: 69011. Recall
# Z-0714-04;
c) Apex Pilot Shaft, 13mm, catalog number: 690113. Recall
# Z-0715-04;
d) Apex Pilot Shaft, 14.4mm, catalog number: 690114.
Recall # Z-0716-04;
e) Apex Pilot Shaft, 16mm, catalog number: 690116. Recall
# Z-0717-04;
f) Apex Pilot Shaft, 17.5mm, catalog number: 690117.
Recall # Z-0718-04.
CODE
a) Lot numbers: 128, 214;
b), c), d), e), and f) Lot numbers: 052, 113, 214.
RECALLING FIRM/MANUFACTURER
Apex Surgical, LLC, Lakeville, MA, by letter on January 17, 2003. Firm initiated recall is complete.
REASON
Pilot shaft may break during reaming or broaching of the femur.
VOLUME OF PRODUCT IN COMMERCE
172.
DISTRIBUTION
CT, OH, FL, OK, TX, RI, NV, and SC.

______________________________
PRODUCT
Restoration Hip system Cylindrical Distal Extension. Catalog numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions. Recall # Z-0719-04.
CODE
Lots: 96910501, 96949401, 96940901, 96950901.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters on February 10, 2004. Firm initiated recall is ongoing.
REASON
The Cylindrical Distal Extensions were incorrectly coded and packaged.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
GA, MN, and Sweden.

______________________________
PRODUCT
3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, in boxes of 50 per box. Recall # Z-0720-04.
CODE
Lot # 2006-01 AN.
RECALLING FIRM/MANUFACTURER
3M Company/Medical Division, St Paul, MN, by Product Recall Notice on February 27, 2004. Firm initiated recall is ongoing.
REASON
The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout as 3 hours.
VOLUME OF PRODUCT IN COMMERCE
90,000 ampoules.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Medtronic Bravo pH Monitoring System Receiver.
Recall # Z-0633-04.
CODE
All serial numbers less than 400,000 are involved.
RECALLING FIRM/MANUFACTURER
Medtronic Gastroenterology / Urology, Shoreview, MN, by letters dated February 6, 2004. Firm initiated recall is ongoing.
REASON
The product's rear panel label could smear during use causing the serial number to be unreadable. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
1468.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ProbeChek Vysis UroVysion Control Slides, for
Fluorescence in situ Hybridization (FISH) using Vysis
UroVysion Bladder Recurrence Kit; an invitro
diagnostic; fixed, cultured normal human male
lymphoblast cell line (negative target) and fixed
culture human bladder carcinoma cell line specimens
(positive), applied to glass microscope slides,
catalog #30-805070, 3 slides per kit. Recall # Z-
0640-04.
CODE
Lot 47228, exp. 05/04 and lot 49023, exp. 08/04.
RECALLING FIRM/MANUFACTURER
Vysis, Downers Grove, IL, by telephone beginning on February 18, 2004. FDA initiated recall is ongoing.
REASON
Some of the control slides did not have adequate cells deposited upon their surface.
VOLUME OF PRODUCT IN COMMERCE
234 kits.
DISTRIBUTION
Nationwide, Germany and Japan.

_______________________________
PRODUCT
Salvart Oral Moisturizer, 2.5 fl oz. aerosol cans.
OTC, Item number 0386-0009-75. Recall # Z-0641-04.
CODE
Lots: #031751F09, #031761F10, #031771F11, Expiration date for all lots: June 2005.
RECALLING FIRM/MANUFACTURER
Gebauer Co., Cleveland, OH, by letter on February 23, 2004. Firm initiated recall is ongoing.
REASON
The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.
VOLUME OF PRODUCT IN COMMERCE
25,561.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Calf Primer II-R (Monensin) sold in bulk. Recall # V-113-4.
CODE
93125 (1-7-04).
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, La Vergne, TN, by telephone on January 9, 2004. Firm initiated recall is complete.
REASON
Calf feed, which had a medicated swine feed inadvertently mixed into it, was distributed.
VOLUME OF PRODUCT IN COMMERCE
28,040 pounds.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Consolidated Nutrition Metabalance 25/45 10485APY
Medicated, A Complete Feed for Starting Pigs, containing
0.0055% Carbadox, packaged in 50-lb Bags. Recall # V-114-4.
CODE
Lot #G114303.
RECALLING FIRM/MANUFACTURER
ADM Alliance Nutrition, Inc., Quincy, IL, by telephone on October 28, 2003. Nebraska State initiated recall is complete.
REASON
Product was subpotent.
VOLUME OF PRODUCT IN COMMERCE
121/50 lb. Bags.
DISTRIBUTION
NE.

_______________________________
PRODUCT
ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
Recall # V-115-4.
CODE
6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA initiated recall is complete.
REASON
LACF Feiline Diet for non-domestic carnivores does not carry the BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
1,620 cases.
DISTRIBUTION
KS.

_______________________________
PRODUCT
Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in
part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate
27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed
27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint
supplement containing Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM". Recall # V-116-4.
CODE
All codes without the required cautionary statement are under recall.
RECALLING FIRM/MANUFACTURER
Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA initiated recall is ongoing.
REASON
This animal feed product does not contain the required BSE cautionary statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 cases 4-5 lb. Containers per case.
DISTRIBUTION
Venezuela, Nicaragua and Guatemala.

END OF ENFORCEMENT REPORT FOR MARCH 24, 2004

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