FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________

PRODUCT

Chef's brand Pickled Egg-Plant, in 16-ounce jars.
Recall #F-420-0.

None.

Bright Time Intertrade L.P., Bangkok, Thailand.

Vasinee Food Corporation, Brooklyn, New York, by letter and allergy alert on December 23, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

New York.

200 cases (24 jars per case) were distributed.

Pickled Egg-Plant contained undeclared sulfites and sodium benzoate.

Babcock Hall brand Ice Cream:

a) Brownies and Raspberry Swirl Ice Cream, in bulk 3-gallon containers, 1/2 gallon, quarts, and pints
b) Vanilla Chocolate Cake Ice Cream, in bulk 3-gallon containers
c) Pumpkin Cream Pie Ice Cream, in bulk 3-gallon containers, and 1/2 gallon containers
d) Chocolate Marshmallow Ice Cream, in bulk 3-gallon containers
e) Grasshopper Ice Cream, in bulk 3-gallon containers.
Recall #F-423/427-0.

All product on the market at time recall initiation.

Babcock Hall Dairy Plant, University of Wisconsin-Madison Department of Food Science, Madison, Wisconsin.

Manufacturer, by letter on March 16, 2000, followed by visit to relabel product on March 17, 2000. Firm-initiated field correction (relabeling) complete.

Wisconsin.

Undetermined.

a-d) Products contain undeclared egg ingredients; e) Product contains an undeclared egg ingredient and FD&C Yellow

No. 5.

Wing Kee Lung brand Dried Lotus Root, packaged in 6-ounce flexible plastic bags. Recall #F-419-0.

None.

Xinhu Cereals & Oils & Export Company of Guang-Dong, Xinhui, Guangdong, China.

Tai Wing Hong Importer, Inc., Brooklyn, New York, by allergy alert and letter November 30, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

New York, Maryland, Pennsylvania others undetermined.

50 cases (100 packages per case) were distributed.

Product contained undeclared sulfites.

Stop & Shop brand Plain Pound Creme Cake, 15 ounces,

UPC Code 0200-05254. Recall #F-435-0.

All cakes sold on or before April 7, 2000.

Pennant Foods, Lisle, Illinois.

The Stop & Shop Supermarket Company, Boston, Massachusetts, by E-mail and press release on April 7, 2000. Firm-initiated recall complete.

Connecticut, Massachusetts, New York, Rhode Island.

Approximately 500 units.

Product contained undeclared eggs.

Betty Crocker Super Moist Cherry Chip Cerisette Cake Mix, in 510g boxes. Recall #F-438-0.

F923T, F924T, K015T, K016T.

General Mills, Inc., Toledo, Ohio.

General Mills, Inc., Minneapolis, Minnesota, by letter on March 23, 2000. The Canadian government issued a press release on March 23, 2000. Firm-initiated recall ongoing.

Canada.

12,136 cases (12 boxes per case) were distributed.

Product contains undeclared egg whites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________

PRODUCT

Tortilla Chips and Cheese Dip Snack Kits containing a 1-7/8 ounce package of tortilla chips and a 4-1/2 ounce container of cheese dip. Recall #F-306-0.

No lot coding. Pull Date: Sell by - 30 May 00

Plant Code: 322205420.

Frito-Lay, Inc., Dallas, Texas.

Frito-Lay, Inc., Plano, Texas, by E-mail on March 17, 2000. Firm-initiated recall ongoing.

Louisiana, Mississippi, Alabama, Georgia, Florida, North Carolina, South Carolina, Tennessee, Arkansas, Kentucky, Illinois, Michigan, Indiana, Missouri, Minnesota, Wisconsin, Iowa.

6,006 kits were distributed; firm estimated that 1,000 to 3,200 kits remained on market at time of recall initiation.

Product contains undeclared dairy ingredients, FD&C Yellow No. 5 and FD&C Yellow No. 6.

Penne Pasta Salad: a) 5-ounce plastic cup; b) 4-pound food service plastic tub (brand name on 5-ounce plastic cup only: WaWa Express). Recall #F-421-0.

a) 0362 EXP 1/12/00, 0365 EXP 1/15/00;

b) 0354 EXP 1/11/00, 0362 EXP 1/19/00.

Missa Bay, Inc., Swedesboro, New Jersey.

Manufacturer, by telephone on or before January 7, 2000, and by visit on or before January 19, 2000. Firm-initiated recall complete.

New Jersey, Pennsylvania, Delaware, Maryland, Virginia.

a) 1,844 cups; b) 210 tubs were distributed.

Product contained undeclared sulfites.

Babcock Hall brand Ice Cream and Sherbet:

a) Mint Ice Cream, in bulk 3-gallon, 1/2 gallon, and quarts
b) Mint Chocolate Chip Ice Cream, in bulk 3-gallon containers, 1/2 gallons, and quarts
c) Butter Pecan Ice Cream, in bulk 3-gallon containers, 1/2 gallons, quarts, and pints
d) Chocolate Chip Cookie Dough Ice Cream, in bulk 3-gallon containers, 1/2 gallons, quarts, and pints
>e) Banana Fudge Marble Ice Cream, in bulk 3-gallon containers, 1/2 gallons, quarts, and pints
f) Lemon Sherbet, in bulk 3-gallon containers, 1/2 gallons, and quarts
g) Lime Sherbet, in bulk 3-gallon containers, 1/2 gallons, quarts, and pints. Recall #F-428/435-0.

All product on the market at time recall initiation.

Babcock Hall Dairy Plant, University of Wisconsin-Madison Department of Food Science, Madison, Wisconsin.

Manufacturer, by letter on March 16, 2000, followed by visit to relabel product on March 17, 2000. Firm-initiated field correction complete.

Wisconsin.

Undetermined.

Products contained undeclared FD&C Yellow No. 5.

Yellowfin Tuna Loins, frozen (row) vacuumed packaged in various weights. Recall #F-437-0.

Lot #23300; Production Dates: 12/04/98; 02/03/99; 6/08/99; 7/24/99; 8/14/99; 9/03/99; 9/06/99; 9/09/99; and 9/10/99. (Note: there may be other production dates that were already sold to customers).

Sea Pack, Piti, Guam.

Garden and Valley Isle Seafood, Inc., Honolulu, Hawaii (distributor), by memorandum February 23 and 24, 2000, and by telephone. Firm-initiated recall ongoing.

Hawaii.

2,262.20 pounds were distributed.

Product contained high levels of histamine and was associated with histamine poisoning.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________

PRODUCT

Sangria Senorial Natural and Artificial Flavor Sangria Flavored Carbonated Beverage, in 11.16 fluid ounce (330mL) bottles. Recall #F-422-0.

J13B92 02:47.

Novamex de Mexico, Cd. Juarez Chih., Mexico.

Tipp Enterprises, doing business as Novamex, El Paso, Texas, by telephone and fax on or about April 30, 1999. Firm-initiated recall complete.

Nationwide.

100,000 cases (24 per case) were distributed.

Product failed to bear an ingredient statement.

Tuv Taam brand Cole Slaw, in 14-ounce rigid plastic containers. Recall #F-436-0.

All codes.

Tuv Taam Corporation, Brooklyn, New York.

Manufacturer, by visit starting on December 8, 1999. Completed recall resulted from sample analysis and follow by the New York State Department of Agriculture and Markets.

New York and New Jersey.

Approximately 15,000 packages were distributed.

Product contained undeclared potassium sorbate.

________

PRODUCT

Cypress Medical Products Sterile Procedure Kits and Tray containing antiseptic products recalled by Clinipad Corporation. Recall #Z-522-0.

a) Kits containing Clinidine Ointment, Sterile, 1.0 gram

I.V. Start Kits:

Reorder #82-03, Economy, 50 kits/case, lot 80410, and all lots starting with "9" or "0"

Reorder #82-05, Deluxe, 50 kits/case, all lots starting with "9" or "0"

Reorder #82-06, Latex-free, 50 kits/case, all lots starting with "9" or "0"

Reorder #82-07, Premium, 50 kits/case, lots 71103, 71104, 80409, all lots starting with "9" or "0".

Daily Catheter Care Trays, 20 trays/case, reorder #86-101, lot 71205, 71208, 90403, 90225.

b) Kits containing Clinidine Ointment - 4339SC, Clinguard

Protective Dressing Prep Pad - 8133S-B, Cliniswab

Isopropyl Alcohol Antiseptic Swabsticks - 1245SB, and Clinipad Alcohol Prep - 0110:

Omnicare Central Line Dressing Kit, reorder #84-117, lots 71215 and 80404;

c) Kits containing Clinipad Alcohol Prep - 0110:

Sharp Debridement Package, 20 kits/case, order number SDP, reorder #84-160, lots 70812 and 70813;

d) Kits containing Clinipad Iodophor PVP Iodine USP Prep Pads - 9153:

Skin Staple Remover kits:

Reorder #82-15, Premium, 50 kits/case, lot 71016

Reorder #1295-815, Starline, 50 kits/case, lot 70903

Reorder #241, PSS Select, 50 kits/case, lot 80214

Suture Removal Kit, reorder #81-213, lot 80305.

Cypress Medical Products, Ltd., McHenry, Illinois.

Manufacturer, by letter on March 22, 2000. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide.

96,736 kits/trays were distributed.

The antiseptic products may be contaminated with bacteria.

________

Various Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation:

ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with

T-Fasteners, Complete Kit, 14 French (List #00227);

ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with

T-Fasteners, Complete Kit, 18 French (List #00238);

ROSS Flexiflo Introducer Gastrostomy Kit with Brown/Mueller

T-Fastener Set, Complete Kit, 18 French (List #50190);

Ross Inverta-PEG Pull Technique Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #52002);

Ross Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #52354);

ROSS Flexiflow Versa-PEG Gastrostomy Kit, Complete Kit, 22 French (list #50520);

ROSS Flexiflo Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #51492) [Obsolete]. Recall #Z-523-0.

All lot numbers beginning with 25 through 62.

Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.

Manufacturer, by letters dated March 20 and 27, 2000, and providing stickers to be placed on kits advising users not to use the Clinipad products and to destroy them. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide, Chile, Hungary, Korea, Mexico, Netherlands, Singapore, Turkey.

77,492 (including the Class II portion).

Kits contain Clinipad antiseptic products which may be contaminated with bacteria.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________

PRODUCT

Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation:

ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 16 French (List #50724); ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 20 French (List #50738). Recall #Z-523-0.

All lot numbers beginning with 25 through 62.

Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.

Manufacturer, by letters dated March 20 and 27, 2000, and providing stickers to be placed on kits advising the users not to use the Clinipad products and to destroy them. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide, Chile, Hungary, Korea, Mexico, Netherlands, Singapore, Turkey.

77,492 (including the Class I portion).

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

________

Heart Valve Allograft Models AVOO, PVOO, AVO5.

Recall #Z-628/631-0.

Serial Numbers: 3887502, 3887391, 6100597, 6276377.

Cryolife, Inc., Kennesaw, Georgia.

Manufacturer, by letter on March 23 and 27, 2000. Firm-initiated recall complete.

Tennessee, Oklahoma, Michigan.

4 valves.

Donor did not meet current guidelines regarding serodilution of plasma.

Hemodialysis/Apheresis Trays containing recalled Clinipad products.

Recall #Z-632-0.

All items listed below are Vas-Cath products.

Bard Access Systems, Inc., Salt Lake City, Utah.

Manufacturer, by letters on March 20 and 22, 2000. Customers were given the option of returning any affected product for credit or removing the Clinipad components. Firm-initiated recall ongoing.

Clinipad, Corporation, Rocky Hill, Connecticut.

Nationwide.

108,347 kits/trays were distributed.

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

LSL Sterile Mid-Stream Urine Specimen Kit, 120 ml, containing recalled Clinipad product. Recall #Z-633-0.

Kit Reorder #LSL1030, All lots beginning with 7, 8, 9, and 0A3006, 0B3007.

LSL Industries, Inc., Chicago, Illinois.

Manufacturer, by letters dated March 20, 1000, and April 6, 2000, instructing users to hold kits in quarantine until stickers were provided to be placed on the kits advising the user not to use the Clinipad product and to destroy it. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Tennessee, Kansas, Vermont, Texas, Michigan, Pennsylvania, New York, Oklahoma, Massachusetts, Indiana, Florida, New Jersey, Oregon, Arizona, Alaska.

64,400 kits were distributed.

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

Deltec Procedural Tray (containing recalled Clinipad products) for use with CliniCath Peripherally Inserted Catheters, Product Numbers 21-2501-01 and 21-2515-01; Deltec CliniCath Peripherally Inserted Catheters, with Tray, Product Numbers 21-2508-01, 21-2509-01, 21-2510-01, 21-2511-01, 21-2512-01, and 21-2513-01. Recall #Z-634-0.

All lots distributed since 1/1/97.

Sims Deltec, Inc., St. Paul, Minnesota.

Manufacturer, by letter dated April 5, 2000. Firm stated that consignees could keep CliniCath products needed for urgent patient needs and return the rest. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide and international.

3,512 trays were distributed.

Trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

Zipprep Electrode Starter Kits containing Clinipad Alcohol Antiseptic Swabsticks, intended for use with EEG monitoring Systems. Recall #Z-635-0.

Aspect Product #185-0043; Aspect Lot Numbers: 418442, 413659, 423659, 417506.

Aspect Medical Systems, Inc., Natick, Massachusetts.

Manufacturer, by notifying customers on March 29, 2000 to discontinues and destroy any products on hand. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Washington state, Florida, West Virginia, California, Ohio, Massachusetts, Pennsylvania, Louisiana, Kentucky, and international.

81 kits (all past expiration dating).

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

General Procedure Kit. Recall #Z-637-0.

Catalog DYNJTS0300, Lot 9904007

DYNJTS4302, Lot 9904002

DYNJTS0400, Lot 9903041

DYNJTS4306, Lot 9903037

DYNJTS7025, Lot 9903035

DYNJTS4301, Lot 9904001

DYNJTS4303, Lot 9903036.

Physician Industries Manufacturing, West Valley City, Utah.

Manufacturer, by telephone on May 6, 1999. Firm-initiated recall complete.

Georgia, Illinois, Nevada, Pennsylvania, Texas.

2,880 kits were distributed.

Distributed kits had positive bioburden test results after EtO sterilization.

Allograft Heart Valve, Model AVOO and PVOO.

Recall #Z-638/639-0.

Serial Numbers: 3887693, 3887707, 3895343, 3895351, 6004946, 6004954, 6262155, 6268331, 6297846.

Cryolife, Inc., Kennesaw, Georgia.

Manufacturer, by letters on April 3 and 6, 2000. Firm-initiated recall complete.

New York, Colorado, Tennessee, Florida, Michigan, Maryland, Ohio, California.

9 valves.

Donor did not meet current guideline regarding serodilution of plasma.

Hermitage Eye Pads, Sterile 2 1/8" X 2 5/8", Product of China. Sterilized in the U.S.A, for use as a bandage over the eye for protection or absorption of secretions: a) Item No. EP-1600; b) Item No. EP-2000. Recall #Z-640/641-0.

Lot #5588.

Shaoxing Life Surgical Dressing Company, Ltd., Zhejiang Prov. Shaoxing County, China.

Hermitage Hospital Products, Inc., Niantic, Connecticut, by telephone on April 19, 2000, followed by fax. Firm-initiated recall ongoing.

Arkansas, California, Oklahoma, Puerto Rico.

a) 33 cases (600 per case); b) 33 cases (2000 per case).

Product was not sterilized and incorrectly transferred to released inventory without being gamma sterilized.

Allograft Heart Valve, Models PV00, AV00, AV40, MV10 PV05.

Recall #Z-642/646-0.

Serial Numbers: 3889149, 3911446, 3911454, 6965792, 6965768, 6313744.

Cryolife, Inc., Kennesaw, Georgia.

Manufacturer, by letters on April 7, 12, and 13, 2000. Firm-initiated recall complete.

New York, Pennsylvania, Louisiana, California, North Carolina, Canada.

6 valves.

Donors did not meet current guidelines regarding serodilution of plasma.

Disposable Coronary Control Syringe, 20mL,

Catalog #K01-04072. Recall #Z-647-0.

Lot #A140030.

Merit Medical Systems, Inc., South Jordan, Utah.

Manufacturer, by telephone on January 21, 2000. Firm-initiated recall complete.

South Carolina.

25 syringes.

Syringes were shipped to customer prior to terminal sterilization processing.

Flo-Rester Sizer Pack (of blood vessel sizers), used to determine the internal diameters of arteries and veins:

Catalog Numbers: a) FRSZPK05; b) FRSZ400; c) FRSZ300;

d) FRSZ250; e) FRSZ200; f) FRSZ150. Recall #Z-648/653-0.

Lot Numbers: a) 526069, 525165, 523878, 522704, 521864, 518549, and 515997; b) 526067, 525588, 524943, 520805, and 516003;

c) lot number 516002; d) 516001; e) 516000; f) 515999.

Bio-Vascular, Inc., St. Paul, Minnesota.

Manufacturer, by letter dated April 19, 2000. Firm-initiated recall ongoing.

Nationwide, Brazil, Canada, Denmark, Germany, United Kingdom.

107 sizers were distributed.

The bulb of the device may loosen and become detached from the shaft.

VACUTAINER Urine Collection Kit for Midstream Specimens containing recalled Clinipad products.

Recall #Z-659-0.

Catalog Number 364952 Vacutainer Urine Collection kit with

sterile cup, 5ml preservative tube, and Clinipad Rantex

Wipe, Lot 9E165, 9F229, 9H142, 9J205, 9J206;

Catalog Number 364972 Vacutainer Urine Collection kit with

sterile cup, 12 ml conical urinalysis tube, 5 ml

preservative tube, and Clinical Rantex Wipe, Lot 9E170,

9E171, 9F233, 9G085, 9H147, 9J201.

Becton Dickinson & Company, Broken Bow, Nebraska.

Becton Dickinson & Company, Franklin Lakes, New Jersey, by letter dated April 7, 2000, instructing customers to place warning stickers on kits. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide.

1,428,050 kits were distributed.

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

FLOW-20, used as a gastrointestinal feeding tube:

a) Flow-20-Push; b) Flow-20-Pull; c) Flow-20-Pull-S.

Recall #Z-660/662-0.

Lot Numbers: a) 1276176 and 1280434; b) 1276560;

c) 1277439 and 1278396.

Wilson-Cook Medical, Inc., Winston-Salem, North Carolina.

Manufacturer, by telephone, fax and mail beginning November 10, 1999. Firm-initiated recall complete.

Alabama, Arizona, California, Connecticut, Florida, Louisiana, Massachusetts, Missouri, New Hampshire, New York, North Dakota, Ohio, Pennsylvania, Texas, Vermont, Wisconsin, Australia, Hungary, Jordan, Singapore.

246 units were distributed.

Kits may contain a larger external bumper, which may not properly secure the feeding tube.

Magnetom 42 SP Magnetic Resonance Imaging System with

Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body:

a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A);

b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall #Z-664/665-0.

Each unit is identified with a unique serial number. Those units sold (194 units) in the USA with the software version 2A2.7B are listed as follows:

Siemens AG, Erlangen, Germany.

Siemens Medical Systems, Inc., Iselin, New Jersey, by letter dated February 24, 2000. Firm-initiated field correction ongoing.

Nationwide and international.

Approximately 387 units.

Patients who are registered on the MRI systems with birth dates of January 1, 2000 or later will be misinterpreted by the software to have been born in 1900.

Product insert for Acetaminophen (Enzymatic Rate) Reagent, used for the quantitative determination of Acetaminophen in serum, Catalog #502-13. Recall #Z-667-0.

Catalog No. 502-13.

Diagnostic Chemicals Ltd., Charlottestown, PE, Canada.

Manufacturer, by letters dated March 15 and 21, 2000. Firm-initiated recall ongoing.

Nationwide and Canada

310 units were distributed.

The "Product Insert" does not contain information on interference from N-acetylcysteine (NAC), the drug of choice for treating acetaminophen overdose.

Abbott ARCHITECT i System with Software Version 1.0 Processing Module, List No. 08C89-00-1, designed to perform automated immunoassay tests bassed on the use of Chemiluminescent Microparticle Immunoassay (CMIA) detection technology. Recall #Z-611-0, which appeared in the May 3, 2000 Enforcement Report should read: RECALLED BY: Manufacturer, by telephone on February 25, 1999.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

GAP IgG Helicobacter Pylori Enzyme Immunoassay Kit, for the qualitative detection of IgG specific antibodies to helicobacter pylori in human serum. Recall #Z-610-0.

Catalog #404 2050, Lot #0426753-1/2 EXP 11/00.

Biomerica, Inc., Newport Beach, California.

Manufacturer, by telephone on or about March 17, 2000. Firm-initiated recall ongoing.

California.

252 kits were distributed.

The stability parameters were starting to draft and would be out-of-specification before the expiration date.

Endoscopic Blunt Dissecting Instrument, used to probe or move organs during surgery. Recall #Z-636-0.

KJJU02, KJJU03, BKJU01, BKJU02.

Manufacturas Frontera Norte SA de CV, CD Juarez, Mexico.

Eagle Endoscopic, Inc., Bartonville, Texas, by telephone on April 14, 2000, and by telephone followed by fax on April 17, 2000. Firm-initiated recall ongoing.

Illinois and Tennessee.

473 cases (20 units per case) were distributed.

Tip separated from body while in use.

Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers: 006-04100-00, 006-04100-01, 006-04100-00S, 006-04100-01S, and 006-04100-02. Recall #Z-654/658-0.

All units shipped prior to March 30, 2000.

Nicolet, Madison, Wisconsin.

Merge Technologies, Inc., West Allis, Wisconsin, by "Important Customer Product Advisory" dated April 21, 2000. Firm-initiated field correction ongoing.

California, Connecticut, Kansas, Minnesota, Missouri, Nebraska, Ohio, Oregon, Virginia, Wisconsin, Brazil, Netherlands, Sweden.

103 units were distributed.

There is a potential for horizontal banding to appear on video screen images and images printed on laser film.

Kodak Oncology Film, identified as ECFLM film, 35 x 43 cm, Catalog No. 8715757. Recall #Z-663-0.

Emulsion Numbers: 0116-022-12, 0116-022-14, 0116-022-16.

Eastman Kodak Company, Windsor, Colorado.

Eastman Kodak Company, Rochester, New York, by telephone on March 24, 2000, and letters dated April 13, 2000. Firm-initiated recall ongoing.

California, Missouri, North Carolina, Pennsylvania, Texas, Wisconsin.

26 boxes (100 sheets per box) were distributed.

Graphic Arts film was slit, chopped, and packaged as Oncology X-ray Film.

Ampicillin/Sulbactam 10/10 mcg Antimicrobial Susceptibility Test Disk, packaged 50 disks per box, intended for use in the standardized disk susceptibility test and is the recommended method of performing antimicrobial disk diffusion testing. Recall #Z-666-0.

Product #33-135, Lot #216785 EXP 4/02.

Oxoid Ltd., Basingstoke Hants RG248PW, United Kingdom.

Remel Inc., Lenexa, Kansas, by telephone during March 13 - 15, 2000. Firm-initiated recall complete.

Nationwide.

100 packages were distributed.

The zones of inhibition obtained were below the acceptable zone diameter of the NCCLS Standard for Antimicrobial Disk Susceptibility Tests.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________

Bovine mastitis treatment kits containing Clinipad alcohol pads:

a) U.S. Vet Masti-Clear Penicillin G Procaine in Sesame Oil Lactating Cow Mastitis treatment. GC Hanford - firm on label.

b) U.S. Vet go-dry. Penicillin G Procaine in Sesame Oil Dry Cow Mastitis Treatment - GC Hanford - firm on label

c) First Choice Dry Cow Mastitis Treatment, Penicillin G Procaine in Sesame Oil - KenAG Inc., Ashland , O H- firm on label

d) Aqua-Mast II Lactating Cow Mastitis Treatment Penicillin G Procaine in Sesame Oil. KenAG, Inc., Ashland, OH - firm on label

e) Amoxi-Mist Lactating Cow Formula - Rx veterinary product - Pfizer Animal Health, Exton, PA - firm on label

f) Dariclox Lactating Cow Formula - Rx veterinary product - Pfizer Animal Health Exton, PA - firm on label

g) Orbenin Quick Release Cloxacillin Sodium Intramammary Infusion USP.Veterinary product - Canadian market - SmithKline Beecham Animal Health, Mississauga, Ontario - firm on label.

h) Orbenin-DC Dry Cow Intramammary Infusion - Rx veterinary product - Pfizer Animal Health, Exton, PA firm on label.

Recall #V-082/089-0.

All lots produced from 3/7/97 to 3/9/2000 - Kits produced AFTER 3/9/2000 will have Webcol Alcohol Preps.

G.C. Hanford Manufacturing Company, Syracuse, New York.

Manufacturer, by letter mailed on March 29, 2000, requesting consignees to remove and destroy all Clinipad alcohol preps packaged with the kits. Firm-initiated recall ongoing.

Clinipad Corporation, Rocky Hill, Connecticut.

Nationwide.

619,820 cartons were distributed.

Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

a) Albadry Plus Suspension Kits - Penicillin G procaine and novobiocin sodium dry cow formula. 12-10 ml syringes and clinipad alcohol pads for intramammary infusion for treatment of mastitis;

b) Albadry Plus Suspension Kits - Penicillin G procaine and novobiocin sodium dry cow formula. 144-10 ml syringes and clinipad alcohol pads for intramammary infusion for treatment of mastitis. Recall #V-090/091-0.

All lots - Clinipad lot numbers packaged in kits - 705751, 801134, 803577, 803755.

Pharmacia & Upjohn, Kalamazoo, Michigan.

Manufacturer, by letter mailed on April 6, 2000. Firm-initiated recall ongoing.

Clinipad, Corporation, Rocky Hill, Connecticut.

Nationwide.

176,000 cartons of 12 and 5,850 pails of 144 were distributed.

Kits contain Clinipad Alcohol Pads labeled as sterile. Clinipad is unable to assure sterility.

MEDICAL DEVICE SAFETY ALERTS:

________

Abbott Ambulatory Infusion Manager Plus Single-Channel Infusion Pump, five types of programming options available for TPN, pain management, intermittent, variable time and contiuous delivery of medications and nutritional fluids.

Safety Alert #N-014-0.

List #13967, Serial Numbers 12300001/12320000.

Abbott Laboratories, Inc., San Diego, California.

Abbott Laboratories, Inc., Abbott Park, Illinois, by letter date, by letter on March 2, 2000.

Nationwide.

15,947 units were distributed.

There is a possibility that medication therapy may be missed on March 1, 2000, due to the leap year, if the pumps were not appropriately reprogrammed on March 1, 2000.

END OF ENFORCEMENT REPORT FOR MAY 10, 2000

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