FDA

Enforcement Report

January 27, 1999                                       
99-04

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

CODE
Lot #363, 367, 373, 375, 381, 391.

MANUFACTURER
Winter Garden Quality Food, Inc., New Oxford, Pennsylvania.

RECALLED BY
Manufacturer, by adding a corrected label to the already distributed product, and by letter. Firm-initiated field correction ongoing.

DISTRIBUTION
Mid-Atlantic states.

QUANTITY
34 2-4 pound cartons were distributed.

REASON
Product contains undeclared FD&C Yellow No. 6 and FD&C Red No. 40.

________
PRODUCT
Fresh Oysters distributed for raw consumption in 100 pound sacks, 100 count boxes, quart and pint jars. Recall #F-135-9.

CODE
All shipments harvested for raw consumption on May 27 through June 25, 1998.

MANUFACTURER
Jeri's Seafood, Inc., Anahuac, Texas.

RECALLED BY
Manufacturer, by telephone on June 24, 1998, and by press release issued by Texas Department of Health. Firm-initiated recall complete.

DISTRIBUTION
Colorado, Louisiana, New Mexico, Texas.

QUANTITY
Undetermined.

REASON
Product may have been contaminated with Vibrio parahaemolyticus.

________
PRODUCT
Fresh Oysters distributed for raw consumption in 30, 60, 70, and 100 count boxes and in 100 pound sacks. Recall #F-136-9.

CODE
All shipments harvested for raw consumption on May 27 through June 25, 1998.

MANUFACTURER
Johnny's Oyster & Shrimp, San Leon, Texas.

RECALLED BY
Manufacturer, by telephone on June 24, 1998, and by press release issued by the Texas Department of Health. Firm-initiated recall complete.

DISTRIBUTION
Alabama, California, Florida, Texas.

QUANTITY
Undetermined.

REASON
Product may have been contaminated with Vibrio parahaemolyticus.

________
PRODUCT
Fresh Oysters distributed for raw consumption in 100 pound sacks. Recall #F-137-9.

CODE
All shipments harvested for raw consumption on May 27 through June 25, 1998.

MANUFACTURER
Fisherman's Harvest, Inc., Smith Point, Texas.

RECALLED BY
Manufacturer, by telephone on July 1, 1998, followed by press release issued by the Texas Department of Health. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
Undetermined.

REASON
Product may have been contaminated with Vibrio parahaemolyticus.

________
PRODUCT
Fresh Escolar Fish Filets and Pieces, sold in bulk to restaurants and grocers, imported from Ecuador. Recall #F-138-9.

CODE
None. Fish distributed on October 7-10, 1998.

MANUFACTURER
Happy World America, Inc., (also known as True World Foods, Inc.), Miami, Florida (importer).

RECALLED BY
The Plitt Company, Chicago, Illinois (processor), by telephone on October 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Wisconsin.

QUANTITY
156 pounds were distributed.

REASON
Product contained high levels of histamine and was associated with an outbreak of scombroid poisoning.

________
PRODUCT
Saithe (Pollack) in Slices, Smoked in Oil, 65 grams for each plastic package. Recall #F-139-9.

CODE
None.

MANUFACTURER
Norda Lysell Fischspezialitaten, Cuxhaven, Germany.

RECALLED BY
Haram-Christenson Corporation, Carlstadt, New Jersey, by letter, telephone, or visit on or about February 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
408 cartons (10 packages per case) were distributed.

REASON
Product contained an unapproved color additive.

________
PRODUCT

Thomas' Pre-Sliced Bagels packaged in clear flexible plastic
bags:
a) PLAIN, package of 6 with net  13 oz. (368 g) and
package of 6 "New York Style" with net weight 22 oz. (623 g)
b) BLUEBERRY, package of 6 with net wt. 13 oz. (368 g) and
package of 6 "New York Style" with net weight 22 oz. (623 g)
c) CINNAMON RAISIN, package of 6 with net weight 13 oz. (368 g)
and package of 6 "New York Style" with net weight 22 oz. (623 g)
d) EVERYTHING: Sesame, Poppy, & Sunflower Seeds, Onion,
Garlic, package of 6 "New York Style" with net weight 22 oz.
(623 g)
e) MULTI-GRAIN, package of 6 with net weight 13 oz. (368 g) and
package of 6 "New York Style" with net weight 22 oz. (623 g)
f) ONION, package of 6 with net weight 13 oz. (368 g) and
package of 6 "New York Style" with net weight 22 oz. (623 g).
Recall #F-140/145-9.

CODE
Sell By (Pull dates) Oct. 12 to Nov. 3, and also bearing a four digit manufacturing code preceded by the letter "A" (example A1141). The Sell By date and code number are printed on the plastic lock tab that closes the bag.

MANUFACTURER
The Bagel Works, Charlotte, North Carolina (packer).

RECALLED BY
BestFoods Baking Company, Bay Shore, New York, by press release on October 23, 1998, and by telephone and fax, followed by visit on October 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina, Tennessee and Virginia.

QUANTITY

a)  6 PLAIN, 13 oz.:  72,336 units; 22 oz.:  143,874 units were
distributed;
b)  6 BLUEBERRY, 13 oz.:  19,632 units; 22 oz.:  32,211 units
were distributed;
c)  6 CINNAMON RAISIN, 13 oz.:  59,688 units; 22 oz.:  93,852
units were distributed;
d) 6 EVERYTHING, 22 oz.:  77,139 units were distributed;
e) 6 MULTI-GRAIN, 13 oz.:  33,396 units; 22 oz.:  51,912 units
were distributed;
f) 6 ONION, 13 oz.:   4,632 units; 22 oz.:  32,445 units were
distributed.

REASON
The products may have contained pieces of sifter screen wire.

________
PRODUCT
Tiny Tins Imported Danish Butter Cookies, 2 ounces each, packaged in a 2.5 cubic inch tin box. Recall #F-146-9.

CODE
All product on the market at the time of recall initiation.

MANUFACTURER
Kelson The International Bakery, Suede Denmark.

RECALLED BY
Renpaul Sales, Ramsey, New Jersey (distributor/repacker), by telephone on November 11, 1997 and December 17, 1997. Firm-initiated recall ongoing.

DISTRIBUTION
Connecticut, Massachusetts, Rhode Island, Maine, New Hampshire, Vermont, New York, New Jersey, Pennsylvania, and areas throughout the Northeast.

QUANTITY
54,000 units were distributed.

REASON
Product does not bear an ingredient statement and contains eggs.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

CODE
N2958C2.

MANUFACTURER
Country Pure Foods, Inc., Akron, Ohio.

RECALLED BY
Ohio Pure Foods, Inc., doing business as Country Pure Foods, Inc., Akron, Ohio, by telephone on November 5&6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio and Pennsylvania.

QUANTITY
75,264 cups were distributed.

REASON
Some containers of the apple juice were labeled as tomato juice.

________
PRODUCT
Galbani Mini Bel Paese Semi Soft Cheese, 6 ounces. Recall #F-134-9.

CODE
Sell by 3/15 1998.

MANUFACTURER
Park Cheese Company, Fond du Lac, Wisconsin.

RECALLED BY
Cucina Classica Italiana, Inc., Lakewood, New Jersey (distributor), by letter dated December 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
Firm estimates none remains on the market.

REASON
Product was contaminated with visible yeast and mold.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

CODE
Lot #0637 EXP 4/01.

MANUFACTURER
Hoffman-La Roche, Inc., Totowa Antibiotic Focused Facility, Totowa, New Jersey.

RECALLED BY
Hoffman-La Roche, Inc., Nutley, New Jersey, by telephone on July 23 & 24, 1998, followed by letter sent on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
55,700 vials were distributed.

REASON
Label mix-up - Some 250 mg units were labeled as 500 mg units.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CODE
Unit Numbers: FG37303, GJ21587, GJ21605, GR04192, KC05961, KJ13568.

MANUFACTURER
Central Blood Bank, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on November 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania.

QUANTITY
6 units were distributed.

REASON
Unit of Platelets, implicated in a transfusion reaction, was found to be contaminated with anaerobic Propionibacterium acnes.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

CODE
Serial numbers ranged from 4348-4372. All were part of batch #12790, manufactured on April 28, 1998.

MANUFACTURER
Medrad, Inc., Indianola, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on July 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania, Indiana, Ohio, Rhode Island, Georgia, The Netherlands.

QUANTITY
25 units were distributed and all have been retrieved.

REASON
The coils were manufactured with the incorrect connector.

________
PRODUCT
Synthetic Absorbable Surgical Suture, Nonabsorbable Suture and Absorbable Gut. Recall #Z-426/462-9.

CODE

 
Reorder Code Material Lot Number:
UL203H Coated, Braided LACTOMER A8J662NW
CL825 Coated, Braided LACTOMER ASJ70ON
CL893 Coated, Braided LACTOMER A8J704N
CL839 Coated, Braided LACTOMER A8J781N
SL1637 Coated, Braided LACTOMER A8KO1NW
GL332 Coated, Braided LACTOMER A8KI59N
CL885 Coated, Braided LACTOMER A8KI65N
L113 Coated, Braided LACTOMER A8K228N, A8K78lN
L74 Coated, Braided LACTOMER A8K235N, A8K639N
CL925J Coated, Braided LACTOMER A8K559N
SLI615 Coated, Braided LACTOMER A8K574N 
L73H Coated, Braided LACTOMER A8K628N 
CL906 Coated, Braided LACTOMER A8K674N 
CL864 Coated, Braided LACTOMER A8K713N
L1742 Coated, Braided LACTOMER A8K743, A8L77
CL511 Coated, Braided LACTOMER A8K746N, A8K752N
L75 Coated, Braided LACTOMER A8K804N
CL880 Coated, Braided LACTOMER A8K937N
SL613 Coated, Braided LACTOMER A8K96N
SL712 Coated, Braided LACTOMER A8L232N
SM644G Monofilament, GLYCOMER A8L139
CM975 Monofilament, GLYCOMER A8K280
CM925 Monofilament, GLYCOMER A8K29I
CM844 Monofilament, GLYCOMER A8K360
CM547 Monofilament, GLYCOMER A8K364
SM693 Monofilament, GLYCOMER A8K248
SM3688 Monofilament, GLYCOMER A8K583T
SM1678G Monofilament, GLYCOMER A8L393T
UL203 Monofilament, GLYCOMER A8K103NW
VP900 Monofilament Propropylene A8K302T, A8K270T
VP745 Monofilament Propropylene A8K87T
VP744 Monofilament Propropylene A8K167T
VDP817 Coated, Braided Nylon A8K252T
G1758 Chromic Gut Suture A8K482
G1790 Chromic Gut Suture A8K507, A8L360
US0435 USSC Procedure Pak A8L246
CG829 Plain Gut Suture A8L407.

MANUFACTURER
United States Surgical Corporation, North Haven, Connecticut.

RECALLED BY
Manufacturer, by visit beginning December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
71,514 units were distributed.

REASON
Defective packaging may compromise sterility of suture.

________
PRODUCT
Adjustable Base Unit, with base unit Handle Assembly (part #41A1310), a mounting device for the Mayfield Headrests and Mayfield Skull Clamps, used to provide rigid skeletal fixation in the prone, supine, tic, and sitting positions: a) Catalog # A-1000; b) A-1001; c) 1002; d) 2001. (A-1000 is the older model of A-1002. A-1002 is an older model of A-2001.) Recall #Z-463/466-9.

CODE
Lot #989.

MANUFACTURER
Ohio Medical Instrument Company, Inc., Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter dated December 30, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
194 units were distributed.

REASON
The handle assembly casting may fracture at the lever handle connection pins.

________
PRODUCT
Maxxim Procedural Tray, Catalog No. RDM889D, Lot No. 68100461, containing Merit CCS Control Syringe Kit, Product No. K-10-00507FP, Lot No. 1152729. Recall #Z-489-9.

CODE
Tray lot #68100461.

MANUFACTURER
Merit Medical Systems, South Jordan, Utah (Syringe kit); Maxxim Medical, Temecula, California (Tray).

RECALLED BY
Maxxim Medical, Temecula, California, by telephone on November 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
2 trays were distributed.

REASON
The control syringe barrel may be cracked where it attaches to the rotating adapter, which may allow air to be aspirated into the syringe.

________
PRODUCT
Small Duracon(r) Stabilizer Tibial Insert (standard version) with locking screw, a component of the Duracon Total Knee System: a) Small Duracon Stabilizer Tibial Inserts; b) Duracon Duration Stabilizer Tibial Inserts. Recall #Z-491/492-9.

CODE
Catalog numbers: a) 6632-4-109, 6632-4-111, 6632-4-113, 6632-4-116, 6632-4-119, 6632-4-122, 6632-4-125; b) 6642-4-109, 6642-4-111, 6642-4-113, 6642-4-116, 6642-4-119, 6642-4-122, 6642-4-125.

MANUFACTURER
Howmedica, Inc., Pfizer Hospital Products Group, Rutherford, New Jersey.

RECALLED BY
Manufacturer, by letter on December 15 and 16, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
5,060 units were distributed; firm estimated that 2,124 units remained on market at time of recall initiation.

REASON
The locking screw was found to be too short and has the potential to fail.

________
PRODUCT

System 98 Intra-Aortic Balloon Pumps, cardiac assist medical
device which provides temporary circulatory support:
a) Model No. 0998-00-0446-53 (English/North American);
b) Model No. 0998-00-0446-55 (English/International);
c) Model No. 0998-00-0446-61 (German);
d) Model No. 0998-00-0446-64 (French/International);
e) Model No. 0998-UC-0446-53 (English/North American).
Recall #Z-493/497-9.

CODE
All serial numbers.

MANUFACTURER
Datascope Corporation, Paramus, New Jersey.

RECALLED BY
Manufacturer, by letter on September 25, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Florida, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, Ohio, Oklahoma, Texas, Virginia, Wisconsin, international.

QUANTITY
69 units were distributed.

REASON
The K6A valve assembly was manufactured incorrectly and may not function as intended.

________
PRODUCT
2 Fr. E.C.C. Neonatal Catheter and 2 Fr. E.C.C. Catheter Tray, Rx sterile, single-use device used to administer medication intravenously to infants: a) 2 Fr. E.C.C. Neonatal Catheter, Product No. 2184.01; b) 2 Fr. E.C.C. Neonatal Catheter and Tray, Product No. 2184.00K. Recall #Z-500/501-9.

CODE
a) All Lot Numbers - Expiration Date 08/02 - 12/02, Lot Nos. G01A33, G02A38, G03A45, G04A48, G04A50, G05A51, G06A51, G07A51; b) Lot No. 9789; Expiration Date 12/00.

MANUFACTURER
Vygon GMBH & Company, KG, Aachen, Germany.

RECALLED BY
Vygon Corporation, East Rutherford, New Jersey (importer/distributor), by letter dated July 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, New York, Pennsylvania, Maryland, Georgia, Florida, Ohio, Minnesota, Illinois, Missouri, Louisiana, Oklahoma, Texas, Colorado, Arizona, California, Hawaii, Washington state, Puerto Rico, Canada.

QUANTITY
a) 4,752 units; b) 1,133 units were distributed.

REASON
Devices exhibited cracking at the catheter hub during use due to a change in the product hub dimensions and a change in material.

________
PRODUCT
Haemotronic Arterial - Venous Blood Tubing Sets, sterile device used in conjunction with dialyzers during hemodialysis: a) Product Code 53505/H2; b) Product Code 53505/2; c) Product Code 505/H2. Recall #Z-502/504-9.

CODE
Lot numbers: a) No. B97-1294; b) B97-2945; c) No. B96-303.

MANUFACTURER
Haemotronic LTD, S.p.A., Mirandola (Modena), Italy.

RECALLED BY
Haemotronic, Inc., Fairfield, New Jersey, by telephone on April 26, 1996, and by letters dated May 3, 1996, and August 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
11,688 sets were distributed; firm estimates none remains on the market.

REASON
The devices sometimes leak blood during use.

________
PRODUCT
Haemotronic Arterial - Venous Blood Tubing Sets, used in conjunction with dialyzers during hemodialysis: a) Product No. TS 505/H2,; b) Product No. TS 508/H2. Recall #Z-505/506-9.

CODE
Lot numbers: a) B98-67; b) B97-6263.

MANUFACTURER
Haemotronic LTD, S.p.A., Mirandola (Modena), Italy.

RECALLED BY
Haemotronic, Inc., Fairfield, New Jersey, by fax on June 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
5,510 sets were distributed.

REASON
Devices have the potential to leak blood during use.

________
PRODUCT
Ventilator and Keyboards Field Replacement Units a) Model No. 840 Ventilator, designed to be used for infants greater than 7.7 pounds, pediatric patients, and adults to 330.7 pounds; b) Keyboard Field Replacement Units with Part Nos. 4-023383-sp through 4-023388-sp. Recall #Z-507/508-9.

CODE

The devices are individually serial numbered.  All 90 serial
numbers are under recall.  There were also 21 Field Replacement
Units for the keyboards under recall. The part numbers for the
replacement keyboards are as follows:
4-023383-sp - International English
4-023384-sp - France
4-023385-sp - Germany
4-023386-sp - Spain
4-023387-sp - Italy
4-023388-sp - Portugal.

MANUFACTURER
Board manufacturer: Praegitzer, Dallas, Oregon; Board Assembler: SCI, Rapid City, South Dakota.

RECALLED BY
Nellcor Puritan Bennett, Carlsbad, California, by telephone and letter on June 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
90 ventilators and 21 keyboards were distributed.

REASON
Devices do not consistently meet performance specifications.

________
PRODUCT

Syringes:
a) 1 ml Insulin Syringe w/Permanently Attached
Needle, Size 29G x ´" U-100 Ultra Fine  (Reorder No. 329464), 
for diabetic injection use;
b) 1 ml Tuberculin Syringe w/Permanently Attached Needle, Size
27G x ´" (Reorder No. 305553), for TB injection use;
c) 1 ml Tuberculin Syringe w/Permanently Attached Needle, size
25G x 5/8" (Reorder No. 305554), for TB injection use.
Recall #Z-509/511-9.

CODE

Lot numbers:  a) 3E604, 3E605, 3E606, 3E607, 3E608, 3E609, 3E610,
3E611, 3E612, 3F600, 3F606, 3F607, 3H609, 3J600, 3J601, 3J602,
3J603, 3J604, 3J605, 3J606, 3K601, 3K602, 3K603, 3K604, 3K605,
3K606, 3K607, 3L600, 3L601, 3L602, 3M605, 3M606, 4A600, 4A601,
4B604, 4C600, 4C602, 4C603, 4C604, 4C605, 4C606, 4C607, 4C608,
4D603, 4D604, 4D607, 4E600, 4E601, 5D600, 5D601, 5D602, 5D603,
5E600, 5E601, 5F600, 5F601, 5F602, 5F603, 5F604, 5G600, 5K600,
5L600, 5L601, 5L602, 5L603, 5L604, 5L605, 5M600, 5M601, 6D602,
6D603, 6E600, 6E601, 6E602, 6G601, 6G602, 6H600, 6J600, 6J601,
6J602, 6K600, 6K601, 6K602, 6K603, 6K604, 6L600, 6L601, 6L602,
6L603, 6M600, 6M601, 6M602, 7E600, 7E601, 7E602, 7E603, 7G601,
7H600, 7H601, 7H602, 7J600, 7J601, 7J602, 7J603, 7K602, 7K603,
7L602, 7M600, 7M601, 7M602, 8A600, 8B601, 8B602, 8C600, 8C601,
8C602, 8D600;
b) 3C600, 3C601, 3C602, 3C603, 3D604, 3E600, 3E601, 3E602, 3E603,
3F604, 3F605, 3H604, 3H605, 3H606, 3H607, 3H608, 3J607, 3J608,
3J609, 3K600, 3L607, 3M600, 4A602, 4A603, 4B603, 4D602, 4D605,
4D606, 5E602, 5E603, 5E604, 6C602, 6C603, 6D600, 6D601, 6E603,
6F600, 6F601, 6F602, 6G600, 6H601, 6H602, 7G600, 7K600, 7K604,
7L600, 8B600, 8D600, 8D601;
c) 3D600, 3D601, 3D602, 3D603, 3F601, 3F602, 3F603, 3F608, 3F609,
3F610, 3H600, 3H601, 3H602, 3H603, 3L603, 3L604, 3L605, 3L606,
3M601, 3M602, 3M603, 3M604, 4A604, 4A605, 4B600, 4B601, 4B602,
4C609, 4C610, 4D600, 4D601, 4E602, 4E603, 4E604, 5E605, 6C600,
6C601, 6C604, 6C605, 6H603, 6H604, 7F600, 7F601, 7F602, 7J604,
7J605, 7L601, 8A601, 8A602, 8A603.

MANUFACTURER
Becton Dickinson Consumer Products, Holdrege, Nebraska.

RECALLED BY
Becton Dickinson and Company, Franklin Lakes, New Jersey, by letter on June 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 28,909,150 units; b) 10,299,470 units; c) 9,991,800 units were distributed.

REASON
The devices may have a cracked hub which could result in the safety shield separating from the syringe during activation.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

CODE
Product No. 01-316, Lot No. 5680 EXP 11/98.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone on October 14-15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, New Jersey, Iowa, New York.

QUANTITY
240 units were distributed.

REASON
Ent. faecalis ATCC No. 29212 (vancomycin sensitive) may show some growth.

________
PRODUCT
Potassium Hydroxide (20%) with Glycerol, 25 ml bottle, for use in qualitative procedures to detect fungal elements in clinical specimens by microscopic examination. Recall #Z-394-9.

CODE
Product No. 21-233, Lot No. 5505 EXP 11/99.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone on August 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon and Texas.

QUANTITY
3 units were distributed.

REASON
Product was discolored with a precipitate floating in it.

________
PRODUCT
Lysostaphin Reagent Set Test Kit, containing 4 ml vial of phosphate buffer and .5 ml lysostaphin stock solution, for use in qualitative procedures to differentiate between Staphylococcus species and Micrococcus species. Recall #395-9.

CODE
Product No. 21-130, Lot No. 5516 EXP 10/98.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone during the period of February 23, 1998 through March 3, 1998, and by letter dated February 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Italy, Spain, Australia, Canada

. QUANTITY
Approximately 118 units were distributed.

REASON
Positive reactions were not observed with Staphylococcus quality control stains.

________
PRODUCT
Lysostaphin Reagent Set Test Kit, containing 4 ml vial of phosphate buffer and .5 ml lysostaphin stock solution, for use in qualitative procedures to differentiate between Staphylococcus species and Micrococcus species. Recall #Z-396-9.

CODE
Product No. 21-130, Lot No. 5527 EXP 4/99.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone on May 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Connecticut.

QUANTITY
3 units were distributed.

REASON
The phosphate buffer component failed the Microbial Load Analysis.

________
PRODUCT
Middlebrook 7H11 Agar Slant, a medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacterium sp. particularly fastidious drug-resistant strains of Mycobacterium tuberculosis. Recall #Z-397-9.

CODE
Product No. 08-570, Lot No. 5571.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone on October 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri, New Mexico, Arkansas, Nebraska, Ohio, Texas, Illinois.

QUANTITY
1,400 units were distributed.

REASON
The product failed the Microbial Load Analysis.

________

PRODUCT
r/b 1 In-Vitro Diagnostic Tubes for Presumptive Identification of Enterobacteriaceae. Recall #Z-399-9.

CODE
Product No. 73-10010, Lot No. 5540 EXP 1/00.

MANUFACTURER
Remel Limited Partnership, Lenexa, Kansas.

RECALLED BY
Manufacturer, by telephone on August 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland, New York, California, Michigan, Florida, Hawaii, Illinois, North Carolina.

QUANTITY
67 units were distributed.

REASON
Quality control lactose-fermenting microorganisms may not give the appropriate lactose reaction.

________

PRODUCT
Tryptic Soy Broth, 4 ml media tube, a general purpose enrichment broth for cultivation and isolation of microorganisms. Recall #Z-400-9.

CODE
Product No. 06-4900, Lot No. 5537 EXP 4/99.

MANUFACTURER
Remel (formerly DiMed Corp.), St. Paul, Minnesota.

RECALLED BY
Remel Limited Partnership, Lenexa, Kansas, by telephone on May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Dakota, Missouri, Pennsylvania, Illinois, Nebraska, Rhode Island, Georgia.

QUANTITY
2,200 units were distributed.

REASON
Product does not support expected growth of microorganisms.

________
PRODUCT
HMP Triumph 1 Low Profile Port, Catalog #PSD-10-1. Recall #Z-468-9.

CODE
Lot numbers: 3-134975, 3-135747, 3-136323, 3-136439, 3-136442, 3-136802.

MANUFACTURER
Horizon Medical Products, Inc., Manchester, Georgia.

RECALLED BY
Manufacturer, on June 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Georgia, Kentucky, Mississippi, New York, Tennessee.

QUANTITY
49 units were distributed.

REASON
The devices have the product contained a 12 Fr. Introducer instead of a 7 Fr. Introducer.

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PRODUCT
ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostic tests. Recall #Z-490-9.

CODE
All lot numbers with software version 1.0-1.2.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by Bulletin #35, dated August 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
International.

QUANTITY
29 analyzers were distributed.

REASON
The test results will be inaccurate if the user changes the reporting units and/or slope and intercept for a test.

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PRODUCT
ACS:Centaur Automated Chemiluminescence System, used to conduct various laborataory diagnostic tests. Recall #Z-498-9.

CODE
All Serial Numbers from 1230 through 1278.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio; Colder Products Company, St. Paul, Minnesota (component (O-Rings)).

RECALLED BY
Chiron Diagnostics Corporation, Oberlin, Ohio, by E-mail on November 3, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
49 Centaurs with incorrect O-rings.

REASON
The O-rings are made of the wrong material.

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PRODUCT
ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostic tests. Recall #Z-499-9.

CODE
All lots with Software Version 1.2.

MANUFACTURER
Chiron Diagnostics Corporation, Oberlin, Ohio.

RECALLED BY
Manufacturer, by Technical Bulletin #42 dated November 2, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
244 units were distributed.

REASON
The device may go into a premature ready state with bleach still remaining in the analyzer lines due to a software error in version 1.2.

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UPDATE
Recall #Z-330-9, 90 Degree Child Osteotomy Plate 9.5 x 30mm Blade, 8mm Offset, Product #235.262, recalled by Synthes USA, Paoli, Pennsylvania, which appeared in the January 13, 1999 Enforcement Report should read:

QUANTITY
: 13 units.

END OF ENFORCEMENT REPORT FOR JANUARY 27, 1999.