FDA

Enforcement Report

CODE
For tuna salad and seafood salad distributed to Sheetz Convenience Store Chains only, all with a use by date of July 4, 1998; for tuna salad, seafood salad, and coleslaw distributed through Fleming Food Service, all with a use by date of July 9, 1998; for tuna salad, seafood salad and coleslaw distributed to all remaining accounts, all with use by date of July 13, 1998.

MANUFACTURER
JVM Country Products, Inc. (doing business as Meadows Country Products), Altoona, Pennsylvania.

RECALLED BY
Manufacturer, by fax on June 25 and 30, 1998, followed by visit. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania, West Virginia, Virginia, Ohio, Maryland.

QUANTITY
Firm esstimates none remains on the market.

REASON
Products contain undeclared eggs.

PRODUCT
Master Choice Dark Bittersweet Chocolate Bars, 3.5 ounces. Recall #F-575-8.

CODE
All codes that do not bear the corrective stickered ingredient declaration statement "may contain traces of peanuts, hazelnuts, almonds, cream powder, and milk powder."

MANUFACTURER
Wissol Exporting Company, Mulheim a.d. Ruhr, Germany.

RECALLED BY
The Great Atlantic & Pacific Tea Company, Inc., Montvale, New Jersey, by telephone and fax on June 16, 1998, and by press release on June 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 9,422 unstickered bars remained on market at time of recall initiation.

REASON
Product may contain undeclared peanuts, hazelnuts, almonds, cream powder, and milk powder.

PRODUCT
Coffee Supreme Ice Cream, in half gallon cylindrical cartons. Recall #F-576-8.

CODE
13398.

MANUFACTURER
Welsh Farms, West Caldwell, New Jersey.

RECALLED BY
Welsh Farms, Long Valley, New Jersey, by letter on June 15, 1998, fax on June 17, 1998, and by press release on July 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1,368 half gallon cartons were distributed.

REASON
Product may contain undeclared peanut butter.

 PRODUCT
Toasted Oats Cereal, all brands as follows: Acme Toasted Oats Toasted Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by American Procurement & Logistics Co., Salt Lake City, UT

America's Choice Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Compass Foods, Montvale, NJ Bi-Lo Toasted Oats Whole Grain Toasted Oat Cereal, Net Wts. 15 Oz. and 20 Oz. in paper boxes, distributed by Bi-Lo, Inc., Mauldin, SC

Cub Foods Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed for Cub Foods by Preferred Products, Inc., Eden Prairie, MN

Delchamps Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Delchamps, Inc., Mobile, AL Finast Toasted Oats Whole Grain Toasted Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Foodhold U.S.A., Incorporated, Atlanta, GA

Flavorite Toasted Oats Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Preferred Products, Inc., Eden Prairie, MN

Food Club Toasted Oats Toasted Whole Grain Oat Cereal, Net Wts. 15 Oz. and 20 Oz. in paper boxes, distributed by Topco Associates, Inc., Skokie, IL

Foodland Toasted Oats Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Preferred Products, Inc., Eden Prairie, MN Food Services of America Signature Toasted Oats Toasted Whole Grain Oat Cereal, 4/32 Oz. plastic bags within each cardboard box, Net Wt. 8 Lbs., distributed by Food Services of America, Inc., Seattle, WA

Fry's Quality Assured Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Fry's Food and Drug Stores of Arizona, Phoenix, AZ

Hannaford Toasted Oats Cereal, Net Wts. 15 Oz. and 20 Oz. in paper boxes, and Net Wt. 32 Oz. in plastic bags, distributed by HannaFord Bros. Co., Scarborough, ME

Harris Teeter Toasted Oats Toasted Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Harris Teeter, Mathews, NC Hill Country Fare Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by H-E-B, San Antonio, TX

IGA Toasted Oats Toasted Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by IGA, Inc., Chicago, IL Janet Lee Toasted Oats Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Albertson's, Inc., Boise, ID

Jewel Toasted Oats Toasted Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by American Procurement & Logistics Co., Salt Lake City, UT

Kingston Whole Grain Toasted Oats, Net Wts. 15 Oz. and 20 Oz. in paper boxes, packed for Kingston Marketing Co., Skokie, IL Kroger Toasted Oats Whole Grain Oat Cereal, Net Wts. 15 Oz. and 35 Oz. in paper boxes, distributed by The Kroger Co., Cincinnati, OH

Kroger Toasted Oats Cereal, Net Wt. 10 Oz. in plastic bags, distributed by The Kroger Co., Cincinnati, OH

Lady Lee Toasted Oats Toasted Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Milan Distributing Co., Milan, IL

Laura Lynn Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Ingles Markets, Inc., Ashville, NC 28816 Lucky Toasted Oats, Net Wts. 15 Oz. and 35 Oz. in paper boxes, distributed by American Procurement & Logistics Company, Salt Lake City, UT

Malt-O-Meal Foodservice Division Toasty O's Whole Grain Toasted Oat Cereal For Foodservice Sale Only, 4 Bags - 32 Oz. (2 Lbs.) in cardboard boxes with inner plastic bags, distributed by Malt-O-Meal Company, Minneapolis, MN

Malt-O-Meal Toasty O's Toasted Whole Grain Oat Cereal, Net Wts. 10, 15, 32, and 40 Oz. in plastic bags, distributed by Malt-O-Meal Co., Minneapolis, MN

Meijer Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Meijer, Inc., Grand Rapids, MI Millville Toasted Oats Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Aldi, Inc., Batavia, IL Nature's Best Toasted Oats Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Preferred Products, Inc., Eden Prairie, MN Our Family Toasted Oats Whole Grain Oat Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Nash Finch Company, Minneapolis, MN Pathmark Toasted Oats Whole Grain Toasted Oat Cereal, Net Wts. 15 Oz. and 35 Oz. in paper boxes, packed for Pathmark Stores, Inc., Woodbridge, NJ

Safeway Toasted Oats Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Safeway, Inc., Pleasantan, CA Schnucks Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Schnuck Markets, Inc., St. Louis, MO Shaw's Toasted Oats Whole Grain Oat Cereal, Net Wts. 15 Oz. and 20 Oz. in paper boxes, distributed by Shaw's Supermarkets, Inc., E. Bridgewater, MA

Shop 'n Save Toasted Oats Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Preferred Products, Inc., Eden Prairie, MN

Smith's Whole Grain Toasted Oats, Net Wt. 15 Oz. in paper boxes, distributed by Smith's Food & Drug Centers, Inc., Salt Lake City, UT

Stater Bros. Markets Toasted Oats Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Stater Bros. Markets, Colton, CA

Sweet Life Toasted Oats Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Sweet Life Products Corp., Suffield, CT

Toasted Oats (generic) Whole Grain Cereal, Net Wts. 15 Oz. and 35 Oz. in paper boxes, distributed by MOMCO, Minneapolis, MN Toasted Oats Cereal (generic), Net Wt. 15 Oz. in plastic bags, distributed by Stater Bros. Markets, Colton, CA Tops Toasted Oats Toasted Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, distributed by Tops Markets, Inc., Buffalo, NY Value Wise Toasted Oats Toasted Whole Grain Oat Cereal, Net Wt. 10 Oz. in plastic bags, distributed by American Procurement & Logistics Co., Salt Lake City, UT

Weis Quality Toasted Oats Toasted Whole Grain Cereal, Net Wt. 15 Oz. in paper boxes, packed for Weis Markets, Inc., Sunbury, PA Western Family Toasted Oats Whole Grain Cereal, Net Wts. 15 Oz. and 35 Oz. in paper boxes, distributed by Western Family Foods, Inc., Portland, OR. Recall #F-577-8.

CODE
All lots remaining on retail shelves, stockrooms and warehouses as of June 5, 1998.

MANUFACTURER
Malt-O-Meal Company, Northfield, Minnesota.

RECALLED BY
Malt-O-Meal Company, Minneapolis, Minnesota, by letter and press release on June 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Firm has estimated that 2-3 million pounds of cereal in 15, 20, and 35 ounce boxes and 10, 15, 32, and 40 ounce plastic bags were in commerce at the time of the recall.

REASON
Product may be contaminated with Salmonella agona.

CODE
8B54, 8A18, 7L78, 7G76, 7E99, 7C50, 7B26, 6L74, 6G79, 6E59.

MANUFACTURER
H & P Industries, Inc., Mukwonago, Wisconsin.

RECALLED BY
Manufacturer, by letter on March 5, 1998. Firm-initiated recall complete

DISTRIBUTION
Canada.

QUANTITY
1,574 cases (10 boxes per case, 25 foil pouches per box, 3 swabs per foil pouch) were distributed. REASON
Microbial contamination.

CODE
Lot Numbers: 7049878, 7049633, 7072823, 8064755, 7117566, 7118008, 7095452.

MANUFACTURER
Granutec, Inc., Largo, Florida.

RECALLED BY
Granutec, Inc., Wilson, North Carolina, by telephone on August 4, 1998, followed by letter on August 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
28,386 units were distributed.

REASON
Mislabeling - Product bears the tamper resistant instructions for blister packaged product not bottled product.

CODE
Unit #6552383.

MANUFACTURER
New York Blood Services (Center West), New York, New York.

RECALLED BY
New York Blood Center, Inc., New York, New York, by letter dated March 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
Platelets, Pooled. Recall #B-1429-8.

CODE
Unit #P62655.

MANUFACTURER
Carter Blood Center, Fort Worth, Texas.

RECALLED BY
Manufacturer, by telephone on February 7, 1998, and by letter dated February 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit.

REASON
Platelets, pooled from both O negative and A negative donors, were distributed labeled as O negative.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1430/1431-8.

CODE
Unit #4557421.

MANUFACTURER
Carter Blood Care, Dallas, Texas.

RECALLED BY
Manufacturer, by letter dated March 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products which tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc on two separate donations.

CODE
All of the products shipped prior to July 6, 1998 are affected. The six-digit lot number of the affected products have the first four digits of 8001--to 8187--. The "8" indicates the year (1998), and the next three digits ("001" to "187") indicate the Julian date.

MANUFACTURER
Guy & O'Neill, Inc., Fredonia, Wisconsin.

RECALLED BY
Preefil Corporation, Milwaukee, Wisconsin, by letter on July 28, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Arizona, California, Colorado, Connecticut, Georgia, Illinois, Maryland, Ohio, Oregon, Pennsylvania, Texas.

QUANTITY
________ 22,144 cartons, each containing 30 flush syringes, or 10 kits of 3 syringes were distributed.

REASON
Incorrect content of package insert.

UPDATE
Recall #Z-704-8 (Hospital for Special Surgery, New York), which appeared in the July 29, 1998 Enforcement Report should read: PRODUCT: Ceramic Femoral Heads.

2) Nasal Accessory Pack, Non-Sterile, Reorder # ET0272, Lot # 31409, containing component Eudermic Gloves, Expiration Date of 12/2002.

3) Lap Chole Pack, Reorder # GS0056D, Lot number # 30803, Component is Syringe with Expriation Date of 7/2002; Reorder #GS0056E, Lot # 31057, Component is Syringe with expiration date of 7/2002; Reorder # GS0087B, Lot # 30641, Component is Syringe with an expiration date of 3/2002; Reorder # GS0087C, Lot # 30940, Component is Syringe with an expiration date of 6/2002; Reorder # GS1098, Lots #'s 30742, 30892, 30905 & 31238, containing the component Anti-Fog Sponge, Exp. Date 11/1998. 4) Eye Pack, Reorder # EY0203, Lot #'s 30738, 30880 & 30891 containing the component Instrument Wipe, Expiration Number 7/2000.

5)Arthroscopy Pack, Reorder # OR0066B, Lot #'s 30681, 30799, and 30882 containing the component Syringe/Needle with an expiration date of 2/2002; Reorder Number OR0079, Lot number 30643, with the componenet Needle with an expiration date of 10/1999; Reorder # OR0079A, Lot # 31124, with the component Spinal Needle with an Expiration date of 3/2000 ; Reorder # OR0093B, Lot #'s 30829 & 31112 with component Spinal Needle with expiration dates of 4/2002 and 2/2002 respectively; Reorder number ORO123A, lot number 31110 with component needle with an expiration date of 10/1999.

8) Laparoscopy Pack, Reorder # GY0059C, Lot Number 30969 with component syringe with an expiration date of 12/2001; Reorder # GY0089C, Lot Numbers 30831, 30925 & 30968 with component syringe with expirations dates of 4/2002, 6/2002 and 1/2002 respectively; Reorder # GS0149A, Lot Numbers 30617 & 30983 with component Sterile Strip 1/4X4 and with expiration dates of 9/2002 and 8/2002 respectively.

9) C-section Accessory Pack, Reorder # LDO002B, Lot Number 31013, with component syringe with expiration date of 6/2002; Reorder # LD0017B and Lot Numbers 30813, 30921, and 31067 with the component syringe with expiration dates of 3/2002, 8/2002 and 6/2002 respectively.

10) Cysto Pack Reorder # CY0057A, Lot Number 3072B with component syringe with an expiration date of 5/2001; and Reorder # OPO083, Lot Numbers 30822 & 31080 with an expiration date of 2/2001. 11) Shoulder Pack, Reorder # OROO48C, Lot Numbers 31459 & 30777 with component Spinal Needle with expiration date of 1/2000. 12) Minor Pack, Reorder Number GS0153A, Lot Numbers 30855 & 31111 with component syringe with expiration dates of 7/2002 & 8/2002 respectively.

13) Custom Basic Pack, Reorder Number GS0125B (Lot No. 30890) and Reorder Number GS0125B (Lot No. 30898) with component needle with an expiration date of 1/2002.

14) Hand Pack, Reorder # GS0074B( lot # 30980) with component needle with an expiration date of 1/2002 and Reorder # OR0092B (lot # 30783) with component Dressing with an expiration date of 4/2002.

15) Special Procedures Pack Reorder # CL0097B, lot number 31257 with component syringe with an expiration date of 3/2000 and Reorder # CL0169A, lot number 31105 with component Custom Manifold Kit with an expiration date of 12/1999. 16) Laceration Tray, Reorder # SP02CMHB, Lot Numbers 30719, 30961 and 31222 with the component needle with the expiration dates of 12/2001, 2/2002 and 2/2002 respectively.

17) Riley Sterile Custom Tray, Reorder # OR0257 (lot Number 31243) with component Duraprep with an expiration date of 8/1999 and Reorder # ORO244 (lot number 31255) with component Adaptic with an expiration date of 3/2002.,

18) Basic Accessory Pack, Reorder Number GS0003B lot numbers 30737, 30825, 31069 and 31167 with the component syringe with expiration dates of 2/2002, 3/2002, 8/2002 and 8/2002. 19) Cath Lab Pack, Reorder Number CL0139C, lot number 31418 with the component Manifold Kit with an expiration date of 1/1999 and lot number 31368 with the component Manifold Kit with the expiration date of 1/1999.

20) Kay Heart Accessory Pack, Reorder Number HT0095E, and lot numbers 31120, 31070 and 30686 with component Suture Staples expiration date of 8/2000; Suture Staples expiration date of 5/2002 and Suture Staples with expiration date of 5/2002 respectively.

21) Newborn Admission Pack, Reorder Number LD0029C, lot numbers 31198 and 30949 with component Brush, E-Z Scrub with an expiration date of 10/2002 and 7/2002 respectively.

22) Swanz Pacer Pack, Reorder # CV0146A, lot # 30779 with component needle with an expiration date of 2/2002.

23) Cesarean Pack, Reorder # LD0104B, lot Number 31121 with component Scrub Tray with an expiration date of 5/1999.

24) Hip Pack, Reorder # OR0020, lot number 30655, with component Ioban Drape with an expiration date of 4/1999.

25) Basic Laparoscopic Pack, Reorder # GS0223, lot number 31128, with component Lube Jelly with an expiration date of 3/2000.

26) EPS Accessory Pack, Reorder # CL0060A, lot number 31060, with component PVP Sponge Sick with an expiration date of 3/2000.

27) Minor Start Kit, Reorder # GS0162A, lot number 31152, with component syringe with an expiration of 8/2002.

28) Anesthesia Kit, Reorder Number GS0270, lot number 31362 with the component IV Cath with an expiration date of 8/2002.

29) Vad Pack, Reorder # GS0112A, lot number 30706, with the component Spinal Needle, Expiration Date of 8/1999.

30) Duke Arthro Pre-Op Pack, Reorder # ORO252, lot number 31300, with the component IV Catheter with an expiration Date of 11/2002.

31) Lap/Hyst Pack, Reorder # GY0175, lot number 30564, with the component Blade with the expiration date of 3/2002.

32) Mammoplasty Pack, Reorder # GS0052E, lot number 31143, with the component Syringe, with an expiration date of 8/2002.

33) Vaginal Hysterectomy Pack, Reorder # GY0053C, lot number 31473, with the component Syringe with the expiration date of 4/2001. Recall #Z-743/775-8.

CODE
See above.

MANUFACTURER
Sterile Recoveries, Inc., Apopka, Florida.

RECALLED BY
Sterile Recoveries, Inc., Clearwater, Florida, by visit beginning January 21, 1998, and completed on April 15, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Florida, Tennessee, Michigan, Georgia, Indiana, Idaho, Texas, California.

QUANTITY
7,426 kits were distributed.

REASON
Sterile sealed kits contain a component with an expiration date but kit has no expiration dating on outside.

END OF ENFORCEMENT REPORT FOR AUGUST 19, 1998. BLANK PAGES MAY FOLLOW. ####