FDA

Enforcement Report

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 12, 2003
03-11

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

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PRODUCT
Country Club Deluxe Cookies N' Cream Ice Cream, packed in one-half gallon cartons. The product is packaged under the Inter-American Products label, and distributed by Inter-American Products, Inc., Cincinnati, Ohio.
Recall # F-164-3.
CODE
198213-870 UPC. 11110-51883.
RECALLING FIRM/MANUFACTURER
Kroger Co., Cincinnati, OH, by fax and press release on November 22, 2002. Firm initiated recall is complete.
REASON
The product is misbranded because cartons may actually contain Country Club Deluxe Nutty Caramel Ice Cream, which is made with peanuts. The Cookies N'Cream label does not list peanuts.
VOLUME OF PRODUCT IN COMMERCE
6,208 one-half gallon containers.
DISTRIBUTION
AL, FL, GA, MS, PR and TN.

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PRODUCT
Biochem brand Ultimate Lo Carb Bar, Chocolate Brownie Nut, wrapped in flexible foil-like film, Net wt. 60 g (2.1 oz.).
Recall # F-235-3.
CODE
UPC #15794-18809 with the following lot numbers. APR1803S1, APR1803S6, APR1803W6, APR1803W1, APR1803H7, APR1803N6, APR1903S7, APR1903N7 and APR1903W7.
RECALLING FIRM/MANUFACTURER
Elan Nutrition, L.L.C., Grand Rapids, MI, by press release, telephone and letter on January 17, 2003. FDA initiated recall is ongoing.
REASON
Product may contain undeclared peanut butter.
VOLUME OF PRODUCT IN COMMERCE
158,496 bars.
DISTRIBUTION
Nationwide.

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PRODUCT
A cake mix sold under the two brand names, Baker Girl brand White Cake mix in 18.5 oz. carton, distributed by Purity Foods, Inc., Clayton, OH. and County Fare brand White Cake mix, Ultra Moist, in 18.5 oz. Carton. Recall # F-236-3.
CODE
Products with expiration dates 9/20/02 through 12/31/03.
RECALLING FIRM/MANUFACTURER
Amendt Corporation, Monroe, MI, by press release and recall notification on January 13, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared egg whites and non-fat dry milk.
VOLUME OF PRODUCT IN COMMERCE
298,150 units.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Dudek brand Kapusniak (cabbage soup), 32 fl. oz. (1 QT),
Keep refrigerated. Recall # F-237-3;
b) Dudek brand:
1. Pierogi Mushroom (dumplings), Net Wt. 16 oz., keep
refrigerated. Recall # F-238-3.
2. Pierogi Potato (dumplings), Net Wt. 16 oz., keep
refrigerated. Recall # F-239-3;
3. Pierogi Potato Chive (dumplings), Net Wt. 16 oz.,
keep refrigerated. Recall # F-240-3;
4. Pierogi Potato Cheddar (dumplings), Net Wt. 16 oz.,
keep refrigerated. Recall # F-241-3.
CODE
a) Expiration date of before and including 12/29/02;
b) Expiration date of before and including 5/15/03.
RECALLING FIRM/MANUFACTURER
Dudek Foods, Inc. Hamtramck, MI, by a press release, telephone and letters dated May 23, 2002. FDA initiated recall is complete.
REASON
a) Undeclared whey and wheat;
b) Undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
a) MI;
b) IN, MI, and OH.

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PRODUCT
Glace Winter Melon packed in a clear, heat-sealed, plastic bag in a cardboard box, NET WT. 12 oz. Product of China/Hong Kong/Japan. Recall # F-242-3.
CODE
"Consume Before: AUG 1 2002".
RECALLING FIRM/MANUFACTURER
Recalling Firm: 282 International Trading, Inc., Brooklyn, NY, by telephone on/about June 27, 2002 and followed up with onsite visits.
Manufacturer: Tuong Song Hong Hong Kong, China. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
129 cases (60 - 12 oz. Packages per case).
DISTRIBUTION
NY.

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PRODUCT
Frozen Biscuit Sandwiches:
a) Deli Pride Egg Sausage and Cheese Biscuit. 4.4 oz.
Recall # F-243-3;
b) Breakfast in a Minit Egg, Sausage, & Cheese Biscuit.
5.1 oz. Recall # F-244-3;
c) Breakfast in a Minit Sausage & Biscuit. 3.8 oz.
Recall # F-245-3;
d) Smiley's Egg, Sausage & Cheese Biscuit. 5.1 oz.
Recall # F-246-3;
e) Marketfare All Stars Country Sausage & Biscuit. 3.7 oz.
Recall # F-247-3;
f) Marketfare All Stars Egg, Sausage & Cheese Buttermilk
Biscuit. 5.6 oz. Recall # F-248-3;
g) Wil's Kitchen Egg, Sausage & Cheese Biscuit. 5.1 oz.
Recall # F-249-3.
CODE
All sandwiches coded 345143 through 365143 and 001243 through 080243.
RECALLING FIRM/MANUFACTURER
MarketFare Foods, Phoenix, AZ, by press releases on March 22, 2002, and April 5, 2002 and recall letters dated March 21, 2002 and April 9, 2002. State initiated recall is complete.
REASON
The products may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Nationwide.
DISTRIBUTION
Undetermined.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

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PRODUCT
LAT CHIU PRODUCTS brand RED CHERRIES Spicy, 3.5 oz., 100 gm, packaged in a flexible plastic bag. Est., Serving Size: 100 g, Servings per Container: 1 Barcode # 05847 54121. Recall # F-233-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Tai Pan Industries, U.S.A., Brooklyn, NY, by visit on/about June 13, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
8 cases (96 packages per case).
DISTRIBUTION
NY.

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PRODUCT
Hale's Blue Boy brand SALA syrup, net wt 24 oz, packaged in glass bottle with metal screw-on cap, 12 bottles per carton and labeled, in part, "Product of Thailand". Recall # F-234-3.
CODE
05-2545-151.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastland Food Corporation, Columbia, MD, by letter on February 7, 2003.
Manufacturer: Hale's Trading, Thailand. Firm initiated recall is ongoing.
REASON
The product contained an unapproved color additive, carmoisine (formerly Ext. D&C Red No. 10).
VOLUME OF PRODUCT IN COMMERCE
675 cartons.
DISTRIBUTION
MS.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Rhinaris, Lubricating Nasal Mist, non-medicated, Mixture of polyethylene glycol 15%, and propylene glycol 5% in a solution containing 0.02% benzalkonium chloride as a preservative. 33 FL. OZ. (10 mL) and 1 FL. OZ. (30 mL) bottles. NDC 51817-071-01(.33 fl oz), NDC 51817-071-02
(1 fl oz). Recall # D-160-3.
CODE
209281, Exp. MA 07 (MA = May)-----.33 fl oz. bottles; 209280, Exp. MA 07 (MA=May)-------1 fl. oz bottles.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmascience, Inc., Tonawanda, NY, by letters on February 5, 2003 and February 11, 2003.
Manufacturer: Pharmascience¸ Inc., Montreal, Canada. Firm initiated recall is ongoing.
REASON
Microbial Contamination: Pseudomonas fluorescens.
VOLUME OF PRODUCT IN COMMERCE
10,000 bottles (.33);
1,345 bottles (1 fl. Oz.).
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg, unit dose packages of 100, and bottles of 1,000 count, Rx only. NDC numbers: 0046-0867-95 (bottles of 1000) and 0046-0967-99 (unit dose packages). Recall # D-158-3.
CODE
1,000 tablet bottles: LOT #1A03925, EXP 12/02;
100 unit dose tablets: LOT #1A03960, EXP 05/05;
LOT #1B00084, EXP 05/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Corp. Columbus, OH, by mail and faxed recall notices on January 20, 2003 and February 25, 2003.
Manufacturer: Ayerst Laboratories Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall ongoing.
REASON
Dissolution Failure: by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
26 packages and 3,870 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

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PRODUCT
Human Tissue for Transplantation, Cornea. Recall # B-0534-3.
CODE
Number 2002-11-6042.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Columbia, MO, by telephone on November 21, 2002. Firm initiated recall is complete.
REASON
Cornea, collected from a donor whose serum tested repeatedly reactive for antibody to Hepatitis C Virus (Anti-HCV), and Recombinant Immunoblot Assay (RIBA) positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Platelets. Recall # B-0417-3.
CODE
Unit R70544.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on September 27, 2002, and by letter dated October 18, 2002. Firm initiated recall is complete.
REASON
Platelets, corresponding to a unit of Red Blood Cells that were positive for Klebsiella pneumonia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

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PRODUCT
Red Blood Cells, Leukocytes Reduced Unit (1 unit). Recall # B-0434-3.
CODE
Unit 740-1644.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 11, 2002. Firm initiated recall is complete.
REASON
Blood product, that was not quality control tested, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

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PRODUCT
Fresh Frozen Plasma. Recall B-0491-3.
CODE
Unit 3418916.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

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PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0496-3.
CODE
Unit C41781 - Part B.
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Pal Alto, CA, by facsimile dated March 31, 2002. Firm initiated recall is complete.
REASON
Platelets, that may have had a decreased plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Source Plasma. Recall # B-0497-3.
CODE
G-34705-118, G-34505-118, G-34303-118, G-34003-118, G-32971-118,
G-32765-118, G-32059-118, G-31802-118, G-30385-118, G-30146-118,
G-29898-118, G-29670-118, G-29401-118, G-29123-118, G-28886-118,
G-28611-118, G-27351-118, G-27102-118, G-25435-118, G-25147-118,
G-24377-118, G-24130-118, G-23881-118, G-23642-118, G22758-118,
G-19237-118, G-18975-118, G-15159-118, G-14934-118.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile dated October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of tattoo application within the prior 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
NC and Switzerland.

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PRODUCT
Source Plasma. Recall # B-0554-3.
CODE
units 01GMIA7860, 01GMIA8157, 01GMIA8938, 01GMIA9230, 01GMIA9961, 01GMIB0273, 01GMIB1037, 01GMIB1354, 01GMIB2108, and 01GMIB2425.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by letter dated July 5, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who admitted to engaging in multiple high risk behaviors,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
AL.

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PRODUCT
a) Red Blood Cells. Recall # B-0578-3;
b) Platelets. Recall # B-0579-3;
c) Fresh Frozen Plasma. Recall # B-0580-3.
CODE
a); b) and c) Unit 66213555.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL. by telephone on September 5, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who had a sexual partner who lived in a HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.

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PRODUCT
Misys Blood Bank System. Recall # B-0581-3.
CODE
Version 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson, AZ, by a Product Safety Notification, dated April 2, 2002. Firm initiated recall ongoing.
REASON
Defect in the design of blood bank software programs could result in the release of unsuitable blood product.
VOLUME OF PRODUCT IN COMMERCE
3 Versions.
DISTRIBUTION
Nationwide, Canada, United Kingdom, Bermuda and Saudi Arabia.

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PRODUCT
a) Red Blood Cells. Recall # B-0590-3;
b) Platelets. Recall # B-0591-3;
c) Fresh Frozen Plasma. Recall # B-0592-3.
CODE
a); b) and c) Units 8082260, 8080030, 6320672.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on October 9, 10, and November 27, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
IL.

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PRODUCT
Fresh Frozen Plasma. Recall # B-0593-3.
CODE
Unit 53GR43504.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated April 2, 2002. Firm initiated recall complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was implicated in a transfusion reaction and found to be contaminated with Bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

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PRODUCT
Fresh Frozen Plasma. Recall # B-0594-3.
CODE
Unit 8725624.
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital, Baltimore, MD, by telephone on November 11, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0599-3.
CODE
Unit 29FF49956.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on June 26, 2002 and letter on July 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but was collected from an ineligible donor due to a subsequent disclosure of previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0600-3.
CODE
Unit number 29FN42246.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated April 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0601-3.
CODE
Unit number 29KH33786.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters dated September 23, 2002 and October 23, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0492-3.
CODE
Unit 3418916.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
X-Cel MB-700 A/C Podiatry X-Ray System. Recall #Z-0424-03.
CODE
Model MB-700 A/C, serial numbers 622686, 622687,622688, 622689, 320367, and 325120.
RECALLING FIRM/MANUFACTURER
X-Cel X-Ray Corp., Crystal Lake, IL, by telephone on November 19, 2002 and letters dated February 27, 2003. Firm initiated recall is complete.
REASON
The X-Ray system contained a defective X-Ray tube shield.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.

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PRODUCT
a) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC.
Recall # Z-0425-03;
b) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC-NT.
Recall # Z-0426-03;
c) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC-NT-U.
Recall # Z-0427-03;
d) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-15.0-SC-NT.
Recall # Z-0428-03.
e) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-20.0-SC-NT-UA-082900.
Recall # Z-0429-03;
f) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC.
Recall # Z-0430-03;
g) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-LONDON-062593.
Recall # Z-0431-03;
h) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-NT.
Recall # Z-0432-03;
i) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-NT-U.
Recall # Z-0433-03;
j) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-U.
Recall # Z-0434-03;
k) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC.
Recall # Z-0435-03;
l) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC-NT.
Recall # Z-0436-03;
m) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC-NT-MKDT-090600.
Recall # Z-0437-03;
CODE
All lots on the market as of November 25, 2002.
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letters on November 26, 2002. Firm initiated recall is ongoing.
REASON
The tip of the stiffened cannula might break during use and remain in the patient.
VOLUME OF PRODUCT IN COMMERCE
39,906.
DISTRIBUTION
Nationwide, Brazil, Canada, Dominican Republic and Israel.
___________________________
PRODUCT
a) Megadyne Mega Tip, E-Z Clean Non Stick Cautery Tip,
Single Use Only, STERILE. Recall # Z-0468-3;
b) Megadyne Mega Tip, Modified E-Z Clean Non Stick Cautery
Tip, Single Use Only, STERILE. Recall # Z-0469-3.
CODE
a) Catalog Number 0600. Lots 00664, 00845, 10038, 10190,
10541, 10669, 10703, 10766, 10951, 11110, 11356, 20046,
20219, 20520, 20592, 20757, 20777, 20856, 20997,21075;
b) Catalog Number 0600M. Lots 00994, 01880, 01181, 01112,
10156, 10670, 11008, 11388, 20260, 20814.
RECALLING FIRM/MANUFACTURER
Megadyne Medical Products, Inc., Draper, UT, by letter on December 20, 2002. Firm initiated recall ongoing.
REASON
The metal substrate cautery tip may break during use.
VOLUME OF PRODUCT IN COMMERCE
a) 19464;
b) 4,855.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only. Recall # Z-0556-03.
CODE
M00023, M00024, M00029, M00031, M00033R, M00034, M00035.
RECALLING FIRM/MANUFACTURER
Thermage, Hayward, CA, by faxed recall notification on December 8, 2002 with a follow-up letter on December 9, 2002. Firm initiated recall is ongoing.
REASON
The product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
VOLUME OF PRODUCT IN COMMERCE
1,326 units.
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
MultiDiagnost 4 - x-ray system, multi functional/universal system for general use. Recall # Z-0586-03.
CODE
Serial numbers include (but are not limited to): 4584520996, 4594911196, 4595090397, 4595290697, 4594871196, 4594841196, 4595130197, 4615641197, 4595240797, 459500197, 4615511097, 4615581097, 4584570996, 4615320897, 459516497, 4595070197, 4584320996, 4584721096, 4615661197, 4594980197 Part numbers: 9896 000 58511, 9896 000 58512,
9896 000 58521, 9896 000 58522.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter dated January 10, 2003. Firm initiated recall is ongoing.
REASON
Internal short circuit - May allow for stand and table to move spontaneously in upward or downward movement.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
a) Modular femoral and proximal tibial replacement system
consisting of femoral head/neck, body, stem and condyle
components. Also proximal tibial body rotating hinge-
type knee and stem components. Recall # Z-0587-03;
b) Modular Replacement System with Extra-Cortical Porous
Coating, Femoral Module Stem and Tibial Module Stem.
Recall # Z-0588-03.
CODE
Catalog No. Lot No. Description
6485-3-000 D6MR MRS SML FEM STEM 10 X 102;
6485-3-011 D6CEB MRS 11MM X 127MM FEMORAL STEM;
6485-3-013 D6CFB MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6CFG MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6CFE MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6GZE MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6GZC MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6HAB MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6HAC MRS 13MM X 127MM FEMORAL STEM;
6485-3-013 D6HAD MRS 13MM X 127MM FEMORAL STEM;
6485-3-015 D6CHD MRS 15MM X 127MM FEMORAL STEM;
6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM;
6485-3-017 D6GPA MRS 17MM X 127MM FEMORAL STEM;
6485-3-017 D6GPD MRS 17MM X 127MM FEMORAL STEM;
6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM;
6485-3-311 D6CAA MRS 11MM X 203MM FEMORAL STEM;
6485-3-311 D6GTA MRS 11MM X 203MM FEMORAL STEM;
6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM;
6485-3-313 D6CBC MRS 13MM X 203MM FEMORAL STEM;
6485-3-313 D6CBD MRS 13MM X 203MM FEMORAL STEM;
6485-3-313 D6CBB MRS 13MM X 203MM FEMORAL STEM;
6485-3-313 D6GWB MRS 13MM X 203MM FEMORAL STEM;
6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM;
6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM;
6485-6-409 D6HMA MRS 9MM TIBIAL STEM;
6485-6-411 D5XWB MRS 11MM TIBIAL STEM;
6485-6-411 D6HNA MRS 11MM TIBIAL STEM;
b) Catalog No. Lot No. Description
6485-3-008 D6JC SMALL FEMORAL STEM SECTION 8MM X 102MM;
6485-3-011 D6CDA FEMORAL MODULE STEM SECTION 11MM X
127MM;
6485-3-011 D6CDE FEMORAL MODULE STEM SECTION 11MM X
127MM;
6485-3-011 D6CDF FEMORAL MODULE STEM SECTION 11MM X
127MM;
6485-3-011 D6CEA FEMORAL MODULE STEM SECTION 11MM X
127MM;
6485-3-013 D6ADA FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6ADB FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6ADC FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CFA FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CFD FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CFF FEMORAL MODULE STEM SECTION 13MM
X 127MM;
6485-3-013 D6CFH FEMORAL MODULE STEM SECTION
13MM X 127MM;
6485-3-013 D6CFI FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CFJ FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CFK FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CGA FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6CGF FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6NJA FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6NKB FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-013 D6NKC FEMORAL MODULE STEM SECTION 13MM
X 127MM;
6485-3-013 D6NKD FEMORAL MODULE STEM SECTION 13MM X
127MM;
6485-3-015 D6CHA FEMORAL MODULE STEM SECTION 15MM X
127MM;
6485-3-015 D6CHC FEMORAL MODULE STEM SECTION 15MM
X 127MM;
6485-3-015 D6CHE FEMORAL MODULE STEM SECTION 15MM
X 127MM;
6485-3-015 D6CHF FEMORAL MODULE STEM SECTION 15MM
D6GRB FEMORAL MODULE STEM SECTION 15MM X 127MM;
6485-3-015 D6GRC FEMORAL MODULE STEM SECTION 15MM X
127MM;
6485-3-015 D6GRD FEMORAL MODULE STEM SECTION 15MM
X 127MM;
6485-3-015 D6GRE FEMORAL MODULE STEM SECTION 15MM X
127MM;
6485-3-017 D5YEF FEMORAL MODULE STEM SECTION 17MM X
127MM;
6485-3-311 D5YKAA FEMORAL MODULE 11MM X 203MM CURVED
LONGSTEM;
6485-3-311 D5YKAB FEMORAL MODULE 11MM X 203MM CURVED
LONGSTEM;
6485-3-311 D5YKAC FEMORAL MODULE 11MM X 203MM CURVED
LONGSTEM;
6485-3-313 D6CBA FEMORAL MODULE 13MM X 203MM CURVED
LONGSTEM;
6485-6-409 D5GBE TIBIAL MODULE STEM SECTION 9MM X 127MM;
6485-6-411 D5XWA TIBIAL MODULE STEM SECTION 11MM X
127MM.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters on January 7, 2003 and February 12, 2003. Firm initiated recall is ongoing.
REASON
Some components have disassociated post-operatively resulting in additional surgery to the patient.
VOLUME OF PRODUCT IN COMMERCE
a) 136; b) 311.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** Single use, sterile, disposable intravascular catheters with an traumatic tip. Recall # Z-0593-03.
CODE
Lot Number 41340.
RECALLING FIRM/MANUFACTURER
Jomed Catheters, Inc., Queensbury, NY, via e-mail on November 21, 2002. Firm initiated recall is complete.
REASON
6 Fr. Catheters packaged and labeled as 5 Fr.
VOLUME OF PRODUCT IN COMMERCE
50 catheters.
DISTRIBUTION
Germany, Hungary and Italy.
___________________________
PRODUCT
a) Viridia/Agilent Information Center Model: M3150A#C01.
Recall # Z-0594-03;
b) Viridia/Agilent Information Center Model: M3151A#C01.
Recall # Z-0595-03;
c) Intellivue Information Center Model: M3150B#C01.
Recall # Z-0596-03;
d) Intellivue Information Center Model: M3150BU#C01.
Recall # Z-0597-03;
CODE
a) Serial 4102A02856 4102A10464 4102A10465 4102A10466 4102A10467 4102A10468 4102A10470 4102A10473 4102A10483 4102A10488 4102A10491 4102A10492 4102A10498 4102A10499 4102A10506 4102A10509 4102A10520 4102A10523 4102A10524 4102A10525 4102A10526 4102A10527 4102A10531 4102A10534 4102A10535 4102A10536 4102A10537 4102A10539 4102A10540 4102A10546 4102A10549 4102A10550 4102A10554 4102A10555 4102A10556 4102A10557 4102A10558 4102A10567 4102A10568 4102A10573 4102A10574 4102A10576 4102A10578 4102A10587 4102A10589 4102A10591 4102A10597 4102A10599 4102A10624 4102A10625 4102A10628 4102A10633 4102A10634 4102A10637 4102A10653 4102A10656 4102A10659 4102A10660 4102A10662 4102A10663 4102A10664 4102A10679 4102A10688 4102A10689 4102A10692 4102A10695 4102A10707 4102A10709 4102A10710 4102A10712 4102A10721 4102A10723 4102A10726 4102A10727 4102A10728 4102A10729 4102A10730 4102A10731 4102A10732 4102A10738 4102A10743 4102A10744 4102A10746 4102A10749 4102A10752 4102A10753 4102A10756 4102A10757 4102A10758 4102A10759 4102A10760 4102A10766 4102A10768 4102A10769 4102A10771 4102A10774 4102A10775 4102A10777 4102A10780 4102A10781 4102A10782 4102A10793 4102A10818 4102A10821 4102A10825 4102A10827 4102A10828 4102A10854 4102A10858 4102A10862 4102A10863 4102A10864 4102A10874 4102A10875 4102A10876 4102A10890 4102A10893 4102A10900 4102A10901 4102A10908 4102A10909 4102A10910 4102A10911 4102A10926 4102A10928 4102A10931 4102A10933 4102A10934 4102A10936 4102A10942 4102A10943 4102A10954 4102A10957 4102A10960 4102A10966 4102A10967 4102A10968 4102A10970 4102A10972 4102A10974 4102A10981 4102A10982 4102A11000 4102A11003 4102A11004 4102A11008 4102A11009 4102A11010 4102A11014 4102A11018 4102A11019 4102A11023 4102A11030 4102A11031 4102A11039 4102A11042 4102A11043 4102A11053 4102A11054 4102A11058 4102A11059 4102A11060 4102A11061 4102A11063 4102A11067 4102A11072 4102A11073 4102A11079 4102A11081 4102A11082 4102A11083 4102A11084 4102A11086 4102A11103 4102A11106 4102A11108 4102A11122 4102A11125 4102A11126 4102A11127 4102A11146 4102A11147 4102A11148 4102A11154 4102A11158 4102A11172 4102A11173 4102A11174 4102A11175 4102A11176 4102A11182 4102A11183 4102A11184 4102A11186 4102A11189 4102A11194 4102A11195 4102A11196 4102A11208 4102A11214 4102A11215 4102A11216 4102A11217 4102A11227 4102A11233 4102A11236 4102A11237 4102A11247 4102A11248 4102A11249 4102A11253 4102A11256 4102A11257 4102A11258 4102A11259 4102A11260 4102A11262 4102A11263 4102A11264 4102A11265 4102A11266 4102A11268 4102A11269 4102A11270 4102A11271 4102A11274 4102A11278 4102A11282 4102A11283 4102A11288 4102A11302 4102A11303 4102A11305 4102A11306 4102A11307 4102A11308 4102A11314 4102A11315 4102A11327 4102A11330 4102A11334 4102A11336 4102A11337 4102A11338 4102A11348 4102A11349 4102A11350 4102A11351 4102A11352 4102A11353 4102A11356 4102A11357 4102A11359 4102A11363 4102A11371 4102A11382 4102A11386 4102A11387 4102A11388 4102A11397 4102A11398 4102A11399 4102A11400 4102A11404 4102A11405 4102A11411 4102A11412 4102A11413 4102A11416 4102A11422 4102A11424 4102A11429 4102A11430 4102A11433 4102A11436 4102A11451 4102A11453 4102A11454 4102A11456 4102A11458 4102A11463 4102A11467 4102A11471 4102A11472 4102A11473 4102A11481 4102A11482 4102A11493 4102A11495 4102A11496 4102A11500 4102A11501 4102A11507 4102A11511 4102A11516 4102A11517 4102A11518 4102A11520 4102A11530 4102A11531 4102A11532 4102A11536 4102A11537 4102A11543 4102A11544 4102A11545 4102A11549 4102A11552 4102A11561 4102A11562 4102A11564 4102A11565 4102A11566 4102A11567 4102A11568 4102A11569 4102A11576 4102A11577 4102A11578 4102A11579 4102A11588 4102A11590 4102A11591 4102A11592 4102A11593 4102A11595 4102A11598 4102A11600 4102A11606 4102A11607 4102A11608 4102A11613 4102A11614 4102A11618 4102A11619 4102A11631 4102A11632 4126A11603 4126A11604 4126A11624 4126A11625 4126A11629 4126A11633 4126A11639 4126A11642 4126A11645 4126A11663 4126A11664 4126A11666 4126A11667 4126A11668 4126A11670 4126A11676 4126A11677 4126A11680 4126A11681 4126A11682 4126A11693 4126A11694 4126A11700 4126A11701 4126A11703 4126A11719 4126A11721 4126A11727 4126A11728 4126A11729 4126A11731 4126A11733 4126A11735 4126A11740 4126A11741 4126A11742 4126A11757 4126A11758 4126A11759 4126A11760 4126A11765 4126A11771 4126A11772 4126A11773 4126A11774 4126A11775 4126A11776 4126A11777 4126A11778 4126A11784 4126A11798 4126A11800 4136A11801 4136A11802 4136A11804 4136A11805 4136A11806 4136A11807 4136A11808 4136A11809 4136A11810 4136A11814 4136A11815 4136A11817 4136A11818 4136A11821 4136A11823 4136A11824 4136A11825 4136A11826 4136A11827 4136A11851 4136A11854 4136A11855 4136A11856 4136A11863 4136A11864 4136A11865 4136A11866 4136A11867 4136A11868 4136A11869 4136A11871 4136A11872 4136A11873 4136A11874 4136A11879 4136A11880 4136A11881 4136A11885 4136A11886 4136A11887 4136A11888 4136A11889 4136A11890 4136A11891 4136A11893 4136A11896 4136A11902 4136A11908 4136A11909 4136A11919 4136A11932 4136A11938 4136A11939 4136A11941 4136A11942 4136A11943 4136A11944 4136A11947 4136A11948 4136A11949 4136A11958 4136A11959 4136A11960 4136A11962 4136A11963 4136A11964 4136A11970 4136A11971 4136A11973 4136A11974 4136A11975 4136A11980 4136A11989 4136A11990 4136A11991 4136A11992 4136A11993 4136A11996 4136A12005 4136A12007 4136A12008 4136A12009 4136A12015 4136A12016 4136A12017 4136A12023 4136A12024 4136A12026 4136A12027 4136A12028 4136A12029 4136A12034 4136A12035 4136A12036 4136A12037 4136A12044 4136A12057 4136A12065 4136A12066 4136A12067 4136A12068 4136A12069 4136A12070 4136A12090 4136A12096 4136A12097 4136A12099 4136A12100 4136A12101 4136A12103 4136A12104 4136A12105 4136A12107 4136A12109 4136A12110 4136A12111 4136A12112 4136A12124 4136A12125 4136A12126 4136A12128 4136A12133 4136A12134 4136A12139 4136A12140 4136A12143 4143A03606 4143A11919 4143A12153 4143A12158 4143A12159 4143A12164 4143A12167 4143A12169 4143A12190 4143A12191 4143A12192 4143A12193 4143A12195 4143A12197 4143A12200 4143A12204 4143A12218 4143A12219 4143A12223 4143A12230 4143A12231 4143A12246 4143A12249 4143A12254 4143A12258 4143A12266 4143A12267 4143A12271 4143A12272 4143A12274 4143A12275 4143A12276 4143A12277 4143A12281 4143A12287 4143A12288 4143A12293 4143A12294 4143A12316 4143A12323 4143A12332 4143A12342 4143A12351 4143A12355 4143A12356 4143A12366 4143A12377 4143A12379 4143A12383 4143A12384 4143A12385 4143A12388 4143A12389 4143A12390 4143A12392 4143A12393 4143A12394 4143A12395 4143A12396 4143A12397 4143A12398 4143A12402 4143A12421 4143A12422 4143A12427 4143A12428 4143A12436 4143A12439 4143A12446 4143A12447 4143A12460 4143A12469 4143A12472 4143A12473 4143A12491 4143A12492 4143A12493 4143A12498 4143A12501 4143A12504 4143A12515 4143A12516 4143A12532 4143A12537 4143A12549 4143A12550 4143A12554 4143A12555 4143A12559 4143A12560 4143A12561 4143A12562 4143A12563 4143A12571 4143A12573 4143A12576 4143A12579 4143A12580 4143A12583 4143A12584 4143A12593 4143A12594 4143A12595 4143A12596 4143A12597 4143A12598 4143A12602 4143A12609 4143A12614 4143A12626 4143A12628 4143A12633 4143A12637 4143A12638 4143A12646 4143A12647 4143A12648 4143A12649 4143A12650 4143A12651 4143A12652 4143A12653 4143A12654 4143A12657 4143A12658 4143A12659 4143A12660 4143A12676 4143A12682 4143A12683 4143A12684 4143A12685 4143A12694 4143A12695 4143A12699 4143A12701 4143A12702 4143A12704 4143A12708 4143A12709 4143A12711 4143A12712 4143A12722 4143A12728 4143A12730 4143A12731 4143A12732 4143A12735 4143A12736 4143A12738 4143A12739 4143A12740 4143A12743 4143A12746 4143A12749 4143A12750 4143A12751 4143A12752 4143A12756 4143A12758 4143A12761 4143A12762 4143A12763 4143A12764 4143A12765 4143A12768 4143A12769 4143A12772 4143A12773 4143A12774 4143A12775 4143A12776 4143A12778 4143A12780 4143A12781 4143A12783 4143A12784 4143A12792 4143A12802 4143A12803 4143A12806 4143A12807 4143A12808 4143A12813 4143A12815 4143A12816 4143A12824 4143A12827 4143A12839 4143A12843 4143A12857 4143A12858 4143A12864 4143A12867 4143A12868 4143A12871 4143A12876 4143A12877 4143A12885 4143A12886 4143A12896 4143A12897 4143A12898 4143A12907 4143A12913 4143A12922 4143A12930 4212A12809 4212A12810 4212A12811 4212A12916 4212A12917 4212A12918 4212A12919 4212A12923 4212A12931 4212A12935 4212A12937 4213A01418 4213A12875 4213A12948 4213A12949 4213A12951 4213A12954 4213A12956 4213A12961 4213A12964 4213A12965 4213A12968 4213A12973 4213A12975 4213A12976 4213A12991 4213A12992 4213A12994 4213A12995 4213A12996 4213A12997 4213A13000 4213A13001 4213A13002 4213A13008 4213A13015 4213A13023 4213A13046 4213A13048 4213A13049 4213A13051 4213A13052 4213A13057 4213A13063 4213A13064 4213A13065 4213A13080 4213A13081 4213A13086 4213A13087 4213A13097 4213A13098 4213A13099 4213A13104 4213A13105 4213A13106 4213A13107 4213A13109 4213A13110 4213A13111 4213A13112 4213A13123 4213A13130 4213A13131 4213A13132 4213A13136 4213A13137 4213A13145 4213A13148 4213A13153 4213A13154 4213A13155 4213A13168 4213A13169 4213A13171 4213A13180 4213A13182 4213A13185 4213A13186 4213A13187 4213A13188 4213A13191 4213A13198 4213A13215 4213A13216 4213A13222 4213A13225 4213A13226 4213A13229 4213A13230 4213A13231 4213A13232 4213A13233 4213A13234 4213A13235 4213A13236 4213A13237 4213A13238 4213A13242 4213A13243 4213A13250 4213A13252 4213A13267 4213A13268 4213A13269 4213A13273 4213A13274 4213A13276 4213A13278 4213A13282 4213A13284 4213A13295 4213A13296 4213A13297 4213A13298 4213A13306 4213A13313 4213A13317 4213A13318 4213A13320 4213A13325 4213A13326 4213A13327 4213A13328 4213A13340 4213A13343 4213A13345 4213A13350 4213A13351 4213A13352 4213A13353 4213A13354 4213A13358 4213A13359 4213A13360 4213A13361 4213A13364 4213A13379 4213A13382 4213A13386 4213A13387 4213A13389 4213A13390 4213A13397 4213A13402 4213A13407 4213A13409 4213A13410 4213A13416 4213A13422 4213A13423 4213A13431 4213A13434 4213A13436 4213A13437 4213A13439 4213A13446 4213A13449 4213A13450 4213A13451 4213A13453 4213A13455 4213A13456 4213A13457 4213A13460 4213A13461 4213A13463 4213A13474 4213A13479 4213A13480 4213A13481 4213A13482 4213A13483 4213A13489 4213A13490 4213A13493 4213A13494 4213A13500 4213A13501 4213A13502 4213A13504 4213A13505 4213A13507 4213A13521 4213A13522 4213A13523 4213A13528 4213A13529 4213A13530 4213A13531 4213A13532 4213A13534 4213A13535 4213A13536 4213A13544 4213A13567 4213A13568 4213A13570 4213A13583 4213A13586 4213A13587 4213A13588 4213A13589 4213A13590 4213A13591 4213A13592 4213A13593 4213A13594 4213A13595 4213A13597 4213A13598 4213A13599 4213A13601 4213A13602 4213A13604 4213A13608 4213A13609 4213A13610 4213A13611 4213A13617 4213A13619 4213A13621 4213A13622 4213A13626 4213A13628 4213A13629 4213A13630 4213A13639 4213A13640 4213A13641 4213A13648 4213A13648 4213A13660 4213A13661 4213A13662 4213A13663 4213A13670 4213A13673 4213A13676 4213A13678 4213A13679 4213A13685 4213A13686 4213A13687 4213A13697 4213A13698 4213A13699 4213A13700 4213A13711 4213A13712 4213A13714;

b) Serial# 4102A00874 4102A00889 4102A00890 4102A00894 4102A00905 4102A00920 4102A00945 4102A00957 4102A00971 4102A00972 4102A00984 4102A01011 4102A01029 4102A01030 4102A01031 4102A01032 4136A01100 4136A01101 4136A01102 4136A01103 4136A01104 4136A01105 4136A01106 4136A01116 4136A01117 4143A01190 4143A01191 4143A01192 4143A01213 4143A01227 4143A01244 4143A01289 4143A01290 4143A01291 4143A01292 4143A01311 4143A01312 4213A01338 4213A01345 4213A01346 4213A01383 4213A01386 4213A01398 4213A01399 4213A01400 4213A01401 4213A01402 4213A01403 4213A01404 4213A01405 4213A01406 4213A01407 4213A01412 4213A01416 4213A01420 4213A01421 4213A01425 4213A01442 4213A01452 4213A01468 4213A01472 4213A01479 4213A01481 4213A01482 4213A01483 4213A01484 4213A01485 4213A01486 4213A01490 4213A01491 4143A01175 4143A01249 4143A01250 4143A01251 4143A01252 4143A01253 4213A01347 4143A01178 4213A01469 4102A00903 4102A00904 4102A00892;

c) Serial 4225A00106 4225A00107 4225A00108 4225A00111 4225A00112 4225A00113 4225A00114 4225A00116 4225A00117 4225A00118 4225A00119 4225A00127 4225A00145 4225A00149 4225A00150 4225A00151 4225A00152 4225A00164 4225A00165 4225A00166 4225A00167 4225A00169 4225A00188 4225A00189 4213A13698 4213A13700 4225A00122 4225A00136 4225A00138 4225A00137 4225A00139 4225A00140 4225A00142 4225A00143 4225A00144 4225A00101 4225A00102 4225A00103 4225A00104;

d) 4225A00169 4225A00171 4225A00181 4225A00182 4213A13456
4131A13457.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc. Cardiac & Monitoring Systems,
Andover, MA, by letter on/about February 19, 2003. Firm initiated recall is ongoing.
REASON
Central Station Monitoring Information Centers may experience screen freeze, i.e. loss of display, keyboard or mouse lock up.
VOLUME OF PRODUCT IN COMMERCE
a) 972 units;
b) 82 units;
c) 39 units;
d) 6 units.
DISTRIBUTION
Nationwide and Canada, Europe, Asia, Latin America.
___________________________
PRODUCT
a) Bard Stinger Ablation Catheter: Item Numbers 210001
218501 L210001 210002 218502 L210002 210003 218503
L210003 210004 218504 L210004 210005 218505 L210005
210006 218506 L210006 210007 218507 L210007 210015
218516 L210008 210016 218518 L210009 210017 218519
L210010 210018 218520 L210011 210019 218521 L210012
210020 218523 L210013 210023 218524 L210014 210024
218525 L210015 210025 218526 L210016 210026 218527
L210017 210027 218528 L210018 210028 218529 210029
210030. Recall # Z-0598-03;
b) Bard Stinger M Ablation Catheters: Item Numbers 210001M
218501M 210002M 218502M 210003M 218503M 210004M 218504M
210005M 218505M 210006M 218506M 210007M 218507M 210015M
218516M 210016M 218518M 210017M 218519M 210018M 218520M
210019M 218521M 210020M 218523M 210023M 218524M 210024M
218525M 210025M 218526M 210026M 218527M 210027M 218528M
210028M 218529M 210029M 210030M. Recall # Z-0599-03;
c) Bard Stinger S Ablation Catheter: Item Numbers 210001S
218501S 6210015S 210002S 218502S 6210016S 210003S
218503S 6210017S 210004S 218504S 6210018S 210005S
218505S 6210019S 210006S 218506S 6210020S 210007S
218507S 210015S 218516S 210016S 218518S 210017S 18519S
210018S 218520S 210019S 218521S 210020S 218523S 210023S
218524S 210024S 218525S 210025S 218526S 210026S 218527S
210027S 218528S 210028S 218529S 210029S 210030S.
Recall # Z-0600-03;
d) Bard Stinger SM Ablation Catheter Item Numbers 210001SM
218501SM 210002SM 218502SM 210003SM 218503SM 210004SM
218504SM 210005SM 218505SM 210006SM 218506SM 210007SM
218507SM 210015SM 218516SM 210016SM 218518SM 210017SM
218519SM 210018SM 218520SM 210019SM 218521SM 210020SM
218523SM 210023SM 218524SM 210024SM 218525SM 210025SM
218526SM 210026SM 218527SM 210027SM 218528SM 210028SM
218529SM 210029SM 210030SM. Recall # Z-0601-03;
e) Bard Orbiter ST Artrial Mapping Steerable Catheter Item
Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B
7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B
7FAM0018B 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B
7FAM0019B 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B
7FAM0020B 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B
320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B 320007
7FAM00007 7FAM00016 7FAM0005B 7FAM0014B 320008 7FAM00008
7FAM00017 7FAM0006B 7FAM0015B 320009 7FAM00009 7FAM00018
7FAM0007B 7FAM0016B. Recall # Z-0602-03;
f) Bard Orbiter PV Steerable Catheter Item #: 320100
(Marketed in Europe Only). Recall # Z-0603-03.
CODE
All lot numbers where the 4th digit contains the letter A
through M. Ex. 07A"A"1234.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc. Electrophysiology Division, Billerica, MA, by letter on January 8, 2003. Firm initiated recall is ongoing.
REASON
Sterile barrier maybe perforated compromising sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
25,502 units;
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A. Recall # Z-0606-03.
CODE
The External Drainage Sets lot numbers: 60300370, 60306608, 60306609, 60321387, 60300373, and 60376191. These lots of EDS may be included in the following set configurations:
Catalog #: 910-109
Lot#: 0118080; 0118369; 0118572;
0118981; 0119845; 0117525.
Catalog# 910-110A
Lot #: 60300370; 60300373; 60306608;
60300370-1; 60321387; 60306608-1;
60306609; 60321387-1; 60306609-1;
60321387-2; 60376191; 60321387-3.
Catalog # 910-112A
Lot #: 0117569; 0117609; 0117834;
0117478; 0117833; 0117957;
0118062; 0118175; 0118420;
0118421; 0118573; 0118693.
Catalog #910-118A
Lot #: 0117570; 0117479; 0118023;
0118489; 0119150; 0119505.
Catalog #910-120A
Lot #: 0117536; 0117371; 0117453;
0117537; 0117902; 0117948;
0118047; 0118161; 0118422;
0118543; 0118616; 0118744;
0118808; 0118912; 0118955;
0119020; 0119081; 0119348;
0119500; 0119582.
Catalog #910-123A
Lot #: 0117805; 0118576; 0118845;
0118957.
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ, by letter and reply form on December 16, 2002. Firm initiated recall ongoing.
REASON
The check valve in the patient line may stick in the closed position.
VOLUME OF PRODUCT IN COMMERCE
8952.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
a) Compat Enteral Delivery Pump Set with Piercing Spike.
Recall # Z-0607-03;
b) Compat 500 mL Baggle Top Fill Enteral Feeding Container
with Preattached Enteral Delivery Pump Set.
Recall # Z-0608-03.
c) Compat DualFlo Enteral Delivery Pump Set with 1000-mL
Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water
Bag. Recall # Z-0609-03.
CODE
a) Item number 19930700, lot 3092D;
b) Item number 19931200, lots 3152A and 3182A;
c) Item number 19944700, lot 3232E.
RECALLING FIRM/MANUFACTURER
Novartis Nutrition Corp., St Louis Park, MN, by letter dated January 31, 2003. Firm initiated recall ongoing.
REASON
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
VOLUME OF PRODUCT IN COMMERCE
930 administration sets.
DISTRIBUTION
Nationwide and Canada.
___________________________
PRODUCT
a) Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT).
Recall # Z-0610-03;
b) Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT
SpO2 measurement option. Recall # Z-0611-03.
CODE
a) All serial numbers of the units distributed prior to the
recall. September 16, 2002.
b) All units with N-XOSAT SpO2 measurement option
distributed prior to the recall. September 16, 2002.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Madison, WI, by letters dated September 16, 2002. Firm initiated recall ongoing.
REASON
Falsely high blood oxygen saturation readings in some circumstances, which could result in no alarm in a critical life-threatening situation.
VOLUME OF PRODUCT IN COMMERCE
a) 1019;
b) 85.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________
PRODUCT
Scimed ChoICE PT "J" Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assemblies are packaged in a five-pack product box.
Recall # Z-0589-03.
CODE
Pouch codes are: Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01.
The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.
RECALLING FIRM/MANUFACTURER
Symbiosis Corp., Miami, FL, by letter on July 16, 2002. Firm initiated recall is complete.
REASON
Labeled as J tip but may be straight tip.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
FL, KS, NH, IA, PA, MI and CA.

___________________________
PRODUCT
a) Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE
Hydrophilic Coating, 300 cm length. Recall Z-0590-03.
b) Scimed PT Graphix Intermediate PTCA Guide Wire with ICE
Hydrophilic Coating, 300 cm length. Recall Z-0591-03.
CODE
a) Individual Devices in Pouches with Catalog No. 12155-01,
UPN H74912155011, Lot Number 4773987, exp. Date 2004-5.
These pouches were packaged in two lots of five-pack
boxes with the following codes: Catalog 12155-01, lot
4791304 Catalog 12155-011, lot 4798294.
b) Individual devices in pouches as follows: Catalog No.
14914-01 UPN H74914914011 Lot Number Expiration Date
4772607 2004-0 4772610 " 4762379 " 4762384 " 4772618 "
4766619 " 4758393 " 4758432 " 4753775 " 4758389 "
4758427 " 4756521 " 4762390 " 4756485 " 4753781 "
4758397 " 4758423 " 4753783 " 4753785 " 4740328
2004-4 4753779 2004-5 4753759 " 4753769 " 4756534 "
4756536 " 4756531 " 4724690 2004-4 4740329 " 4736552 "
The above PT Graphix(tm) guide wire pouch lots were
packaged in 18 lots of five-pack boxes with the
following codes: Catalog No. 1215T UPN H74914914012
Lot Number Expiration Date 4789558 2004-05 4791600 "
4789558 " 4791126 " 4785009 " 4787988 " 4786427 "
4783177 " 4780051 " 4780186 " 4783316 " 4780190 "
4782079 " 4780939 " 4771889 " 4777410 " 4775761 "
4776272 " 4766792 "
RECALLING FIRM/MANUFACTURER
Symbiosis, Corp., Miami, FL, by letters on August 22, 2002. Firm initiated recall is ongoing.
REASON
Product labeled as Scimed Choice PT Extra Support PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm.
VOLUME OF PRODUCT IN COMMERCE
a) 27/5 pack boxes.
b) 228/5 pack boxes.
DISTRIBUTION
Nationwide and Internationally.

___________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument. The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultra filtration controller to prevent excessive loss of water from the patient's blood, an extra corporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument include a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultra filtration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates. Recall # Z-0605-03.
CODE
Product codes 5M5576, 5M5576R,
serial numbers 200000 through 202864.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp., Round Lake, IL, by letter dated November 15, 2002. Firm initiated recall ongoing.
REASON
Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
VOLUME OF PRODUCT IN COMMERCE
2,864 units.
DISTRIBUTION
Nationwide, Mexico, China, South Korea, Hong Kong.

END OF ENFORCEMENT REPORT FOR MARCH 12, 2003

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