FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
12/20/1995
ENFORCEMENT REPORT FOR 12/20/95
December 20, 1995 95-51
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Savory Select San'wich brand Ready-to-eat deli sandwiches,
an extension of Recall #F-001/006-6 which appeared in the
October 11, 1995 Enforcement Report:
1. Hot Dog
2. Sausage Croissant
3. Double Double Cheeseburger
4. Hamburger
5. Doublemeat Cheeseburger
6. Twin Chili Dogs
7. Mushroom Mozzarella Burger
8. Pizza Burger Sandwich
9. Savory Single Sandwich
10. Bacon Cheeseburger
11. Grand Stacker Sandwich
12. Super Sub Sandwich
13. Hoagie Polish Sausage
14. All American Stacker Sandwich
15. Ham and Cheese Hoagie
16. Hoagie Ham & Turkey
17. Chicken Filet Sandwich
18. Hero Submarine
19. Roast Beef Sub
20. Turkey and Cheddar Kaiser
21. Ham & Swiss Rye Sandwich
22. Ham & Cheddar Kaiser
23. Pizza Sub
24. Jumbo Submarine
25. Jumbo Ham & Cheese Sandwich
26. Philly Beef Submarine
27. Supreme Italian Sandwich
28. Italian Chicken Provolone Sandwich
29. Bacon Croissant
30. Chicken & Swiss Sandwich
31. Ham Croissant and Egg
32. American Cheese Croissant. Recall #F-105/136-6.
CODE All sandwiches produced by the firm with an expiration date
"Enjoy by", up to and including 29 September 1995 and Julian
day code of "254" or earlier.
MANUFACTURER Savory Foods, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by telephone on September 16-18, 1995.
Distributor's delivery drivers were also instructed to
remove any recalled product from the account sites during
the next scheduled delivery. Firm-initiated recall
complete.
DISTRIBUTION Michigan, Indiana, Ohio, Illinois, Wisconsin.
QUANTITY Firm estimated that between 20,000 to 25,000 sandwiches were
on the market at the initiation of recall.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Aligen brand Trimethobenzamide HCl 250 mg Capsules, in
bottles of 100, Rx antiemetic. Recall #D-040-6.
CODE Lot #TC4-C.
MANUFACTURER Crandall Associates, Inc., Warren, Michigan.
RECALLED BY Manufacturer, on or about May 12, 1995. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 24 bottles were affected.
REASON A number of bottles of Chlorpheniramine Maleate
Pseudoephedrine HCl sustained release capsules were
mislabeled as Trimethobenzamide HCl Capsules.
_______________
PRODUCT Prednisone Tablets, 5 mg, Rx corticosteroid.
Recall #D-042-6.
CODE Lot #31936 EXP 9/97.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by letter on November 21, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,663 tablets were distributed.
REASON A bottle of Sulfa/Trim D.S. Tablets, 100 count, was
mislabeled as Prednisone Tablets, 5 mg, 1000 count.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT (a) 50 mg Nitroglycerin in 5% Dextrose Injection, 250 ml;
(b) 100 mg Nitroglycerin in 5% Dextrose Injection, 250 ml,
used for angina. Recall #D-038/039-6.
CODE Lot numbers and EXP dates: (a) G894261, G894279, G894345
EXP 12/95; G895276 EXP 1/96; G896290, G896308 EXP 2/96; (b)
G894352 EXP 3/96, G896217 EXP 5/96.
MANUFACTURER Baxter Healthcare Corporation, Cleveland, Mississippi.
RECALLED BY Manufacturer, by letter November 8, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 1,500 units remained on market at time
of recall initiation.
REASON Marginally subpotent.
_______________
PRODUCT Acthar Lyophilized Corticotropin for Injection, 40 USP units
per vial, Rx injectable after reconstitution, for diagnostic
testing of adrenocortical function. Recall #D-041-6.
CODE Lot #N20501 EXP 1/97.
MANUFACTURER Armour Pharmaceutical Company, Bradley, Illinois.
RECALLED BY Rhone-Poulenc Rorer Pharmaceuticals, Inc., Collegeville,
Pennsylvania, by letter dated November 30, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 10,969 vials were distributed; firm estimated that 1,000
vials remained on market at time of recall initiation.
REASON Variability of biological potency assay.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
UPDATE Recall #B-122-6, Red Blood Cells Deglycerolized, which
appeared in the December 13, 1995 Enforcement Report is a
Class II Recall.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Bioscrew Absorbable Interference Screw, used in certain bone
implantations/surgeries. Recall #Z-205-6.
CODE Catalog #C8013, Lot #44234.
MANUFACTURER Linvatec Corporation, doing business as Linvatec/Hall
Surgical, Largo, Florida.
RECALLED BY Manufacturer, by letter on April 3, 1995. Firm-initiated
field correction complete.
DISTRIBUTION Minnesota, Texas, Tennessee, Pennsylvania, North Carolina,
Illinois, Washington state, Mississippi, Utah, Missouri,
Canada.
QUANTITY 87 devices were distributed.
REASON The bone screw was not the labeled size.
-3- _______________
PRODUCT Cannulated Interface Screw, sterile single use, titanium,
used to provide bone fixation in various orthopedic
procedures. Recall #Z-206-6.
CODE Catalog #8970S, Lot #2322.
MANUFACTURER Linvatec Corporation, doing business as Linvatec/Hall
Surgical, Largo, Florida.
RECALLED BY Manufacturer, by letter on April 10, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Australia, The Netherlands.
QUANTITY 100 devices.
REASON The bone screw was not the labeled size.
_______________
PRODUCT Stryker Femoral Canal Sponge with Suction Adaptor, Part
#206-714, intended for use in total joint or joint revision
arthroplasty to aid in the cleaning and preparation of bone
prior to the introduction of bone cement and/or a
prosthesis. Recall #Z-211-6.
CODE Lot numbers: 95030442S and 95040572S.
MANUFACTURER BioMedical Devices, Irvine, California.
RECALLED BY Stryker Instruments, Division of Stryker Corporation,
Kalamazoo, Michigan, by letters dated August 10, 1995, and
September 11, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide, France, Canada, Netherlands, United Kingdom,
Hong Kong.
QUANTITY 185 boxes (6 units per box) were distributed.
REASON Lack of assurance of the sterility of the device.
_______________
PRODUCT Puritan Bennett Medical Gas Automatic Manifold Control with
Electronic Changeover, designed for use in hospitals and
health care facility applications to meet the flow demands
of multiple gas outlet distribution:
(a) Oxygen, Part Numbers: 106240-106245;
(b) Nitrous Oxide, Part Numbers: 106250-106255;
(c) Nitrogen, Part Numbers: 106270-106275;
(d) Carbon Dioxide, Part Numbers: 106290-106295;
(e) Medical Air, Part Numbers: 106280-106285.
Recall #Z-212/216-6.
CODE Numerous serial numbers are involved.
MANUFACTURER Western Enterprises, Westlake, Ohio.
RECALLED BY Puritan-Bennett, Lenexa Medical Division, Lenexa, Kansas, by
telephone on July 20, 1995, followed by letters dated August
9 and 21, 1995. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 339 units were distributed.
REASON Failure of the manifold system to deliver gas from the
secondary supply source.
-4- _______________
PRODUCT Davol, Bile Bag, Regular, sterile, Reorder #0015850, a
patient worn appliance designed to collect bile from a T-
tube by gravity drainage. Recall #Z-217-6.
CODE Lot #76EF2984.
MANUFACTURER Bard Urological Division, Nogales, Mexico.
RECALLED BY Davol, Inc., subsidiary of C.R. Bard, Inc., Cranston, Rhode
Island, by letter dated November 17, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 10,023 units were distributed.
REASON The bag has been incorrectly assembled resulting in the T-
Tube connector end and the drain cap connector end being
reversed.
_______________
PRODUCT Stryker Sterile, Disposable Burs and Blades which are used
with Stryker Heavy Duty and MicroElectric powered
instruments:
1. Sternum Blade (32.0mm Cut Edge), Part No. 277-87-100,
2. Sagittal Blade, SafEdge Sternum Revision, Part No.
277-88-125
3. Sagittal Blade Sternum Revision, Part No. 277-88-137,
4. 8mm Casper Blade, Part No. 296-31-308,
5. Sternum Blade (32.0mm Cut Edge), Part No. 298-97-100,
6. Large Section Blade (94.0 mm Cut Edge), Part No.1100,
7. Spinal Column Blade (96.0 mm Cut Edge), Part No. 1105,
8. Deep Cut Blade (20.0 mm Cut Edge), Part No. 1106
9. Oscillating Blade (8.0mm Cut Edge), Part No. 1107,
10. Twist Drill (2.8mm), Part No. 1351-14,
11. Lindemann Drill (2.2mm), Part No. 1608-2-43
12. Round Fast Cutting Bur (6.3mm), Part No. 1608-9-143
13. Acorn Bur (8.0mm), Part No. 1608-9-158
14. Barrel Bur (6.0mm), Part No. 1608-9-166
15. Sagittal Blade Safedge Sternum Revision, Part No.
2108-125
16. Sternum Revision, Part No. 2108-137
17. Sagittal Blade Wide, Thick, No Offset, Part No. 2108-183
18. Sagittal Blade Wide, Flared, Medium, Part No. 2108-195
19. Sagittal Blade Thin with Wide Flare, Part No. 2108-197
20. Aggressive Tooth Blade Wide, Medium, Long, Part No.
2108-302. Recall #Z-220/239-6.
CODE: Lot numbers:
1. 95041155, 95051225, 95052185, 95052205, 95061255
2. 95041155, 95051205
3. 95051205
4. 94042175
5. 95051195, 95052205, 95052215, 95061235
6. 9531135
7. 95032105
8. 95051185, 95051225
9. 94101425
-5- 10. 95021065
11. 95031115, 95052205
12. 94022085
13. 93101415
14. 93111455
15. 95042145, 95051215, 95062255
16. 95042175, 95051225
17. 95042175, 95051205, 95061265
18. 95042145
19. 95012035
20. 95062255.
MANUFACTURER Stryker Instruments, Division of Stryker Corporation,
Kalamazoo, Michigan.
RECALLED BY Manufacturer, by medical device alerts dated July 21, 1995,
followed by notices sent August 22, 1995, and September 21,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide, France, Japan.
QUANTITY 1,396 devices were distributed.
REASON The sterility of the device has been compromised due to loss
of package integrity.
_______________
PRODUCT Puritan-Bennett Model 0112 Oxygen Regulator, indicated for
the regulation of pressure from high pressure medical oxygen
bottles. Recall #Z-241-6.
CODE Lot code 621, serial numbers 9410021 through 9410061; Lot
code 631, serial numbers 9410062 through 9410091.
MANUFACTURER Puritan-Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by letter, fax and or telephone on September
27, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Illinois, New Jersey, Thailand, England.
QUANTITY 71 units were distributed.
REASON A retainer ring was omitted during manufacture.
_______________
PRODUCT O.M.S. Titan Phaco Needle, Part #34-23-02B (30 degree
round), and Part #34-23-02C (45 degree round), used for
cataract surgery. Recall #Z-242-6.
CODE Lot numbers: 22151, 22220, 22383, 22326, 22556, 22627,
22628.
MANUFACTURER Fuller Precision Vinemont, Alabama (needle).
RECALLED BY Allergan, Inc., Irvine, California, by letter on May 3,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 967 needles were distributed.
REASON Metal particles may flake off the device into the eye.
_______________
PRODUCT Baxter K-Mod II Heat Therapy System, a microprocessor based,
heat therapy instrument, that circulates warm, distilled
water through a pad to provide heat for patient therapy.
Recall #Z-244-6.
-6- CODE Catalog numbers 64N05500 and 64N00500. All serial numbers.
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida;
Gaymar Industries, Orchard Park, New York.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letter dated December 6, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,251 units were distributed; firm estimated that 80 percent
of product remained on market at time of recall initiation.
REASON The plastic housing of the hot water pump may crack, which
may result in excessive current leakage.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Vacutainer brand Blood Collection Needles, used for venus
blood sample collection. Recall #Z-218-6.
CODE Reorder #7212, Lot #5A002.
MANUFACTURER Becton Dickinson Vacutainer Systems, Inc., Sumter, South
Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New
Jersey, by telephone on April 28, 1995, and by letter June
5, 1995. Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, Georgia, Illinois, Indiana, Michigan,
Minnesota, Nebraska, Texas.
QUANTITY 1,893,000 units were distributed; firm estimates none
remains on the market.
REASON The unit shelf cartons were mislabeled with the incorrect
reorder number.
_______________
PRODUCT Leptospira Enrichment EMJH Culture Media, in 100 ml bottles,
used as an additive to Leptospira Medium Base for the
cultivation and maintenance of Leptospira. Recall #Z-219-6.
CODE Product code for carton: 0795-73-1, for bottle 0795-72,
Lot #58941JA.
MANUFACTURER Difco Laboratories, Detroit, Michigan.
RECALLED BY Difco Laboratories, Livonia, Michigan, by letter dated March
22, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 55 cartons (6 units per carton) were distributed.
REASON The bottles contained a gram positive spore forming
bacillus.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Medicated water additives: (a) Aqua Pro, a water additive
for use in poultry; (b) Aqua Pro S (also known as port
power), a water additive for use in swine, packaged in 2-1/2
and 5 gallon jugs and in 50 gallon drums.
Recall #V-002/003-6.
-7- CODE None. All product manufactured and shipped from 8/94.
MANUFACTURER Bioxy, Inc., Raleigh, North Carolina.
RECALLED BY Manufacturer, by letters faxed on May 3, 1995, followed by
memorandum dated June 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Alabama, Arkansas, California, Iowa, Indiana, Minnesota,
North Carolina, Texas, Canada, Denmark, England, Finland,
Greece, Malaysia, South Africa, Thailand.
QUANTITY (a) 9,187 gallons; (b) 5,452 gallons were distributed.
REASON Products are investigational new animal drugs that were
being sold commercially and not labeled as investigational
drugs for use in clinical trials.
-8-
END OF ENFORCEMENT REPORT FOR DECEMBER 20, 1995. BLANK PAGES MAY
FOLLOW.
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