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.
January 22, 1997 97-04
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Pepperidge Farm Old Fashioned Lemon Nut Crunch
Cookies, net weight 5-1/2 ounces.
Recall #F-177-7.
CODE Product with codes PRUP2636, PRUP3506, and all
known codes beginning with the letters PWO.
MANUFACTURER Pepperidge Farm, Inc., Willard, Ohio and
Pepperidge Farm, Inc., Richmond, Utah.
RECALLED BY Pepperidge Farm, Inc., Norwalk, Connecticut,
by letter and by and press release on December
19, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Bermuda, the Caribbean Islands.
QUANTITY 15,816 retail units of product code PRUP2636,
17,328 retail units of product code PRUP3506,
and 201,720 retail units of product code PWO
were distributed.
REASON Product contains undeclared peanut butter.
_______________
PRODUCT Kitchen Fresh Sandwiches:
(a) Footlong (Hot Dog with Chili & Cheese)
(b) Toasted Ham & Cheese
(c) HC Hoagie (Ham & Cheese)
(d) Torpedo (Combination of Meats and Cheeses)
(e) Twin Burger
(f) Cheeseburger
(g) DBL Cheese Burger
(h) Beef Barbecue
(i) Sausage Biscuit
(j) Cold Ham
(k) Roast Beef
(l) Smoke Sausage
(m) Ham & Cheese
(n) Salami & Cheese
(o) Chili Cheese Dog
(p) Pimento Cheese
(q) Chicken Salad
(r) Ham Salad
(s) Tuna Salad
(t) Turkey Breast
(u) Bologna & Cheese. Recall #F-184/204-7.
CODE None.
MANUFACTURER Kitchen Fresh Sandwiches, Jackson,
Mississippi.
RECALLED BY Manufacturer, by telephone on October 3, 1996.
Completed recall resulted from sample analysis
and followup by the Mississippi State
Department of Health and Human Services.
DISTRIBUTION Mississippi.
QUANTITY Undetermined.
REASON The products may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Golden Bowl Citrus Flavor Fortune Cookies, net
weight 3-1/2 ounce cellophane packages
(individually wrapped). Recall #F-165-7.
CODE None.
MANUFACTURER Wonton Food Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone on August 14, 1996.
Completed field correction resulted from
inspection and follow-up by New York State
Department of Agriculture and Markets.
DISTRIBUTION New York, New Jersey, Minnesota, Canada.
QUANTITY 55 cases were distribute, each case contains 1
12 3-1/2 ounce net weight boxes.
REASON The product contains undeclared certified
colors FD&C Yellow No. 5 & 6.
_______________
PRODUCT Carnation Follow-up Infant Formula, ready to
feed, in 32 fluid ounce cans.
Recall #F-176-7.
CODE Lot numbers: 6192EWFR617 and 6192EWFR618.
-2-MANUFACTURER Nestle Food Company, Nutritional Products
Division, Eau Claire, Wisconsin.
RECALLED BY Nestle USA, Inc., Glendale, California, by
letter September 19, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 11,317 cases (6 cans per case) were
distributed.
REASON The product is adulterated because it may have
been produced under insanitary conditions
whereby it may have been rendered injurious to
health. Furthermore, the product appears
separated and has been linked with mild
gastrointestinal illness.
_______________
PRODUCT Papaya Spears, 1 pound packages.
Recall #F-179-7.
CODE None.
MANUFACTURER Unknown in Thailand.
RECALLED BY Betta Foods, Parrottsville, Tennessee
(repacker), by telephone. Completed recall
resulted from sample analysis and followup by
the State of New York Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY 10 to 15 1-pound bags were distributed.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Gatorade Thirst Quenchers:
(a) Lemon-Lime; 11.6 oz. - UPC #52000-00901,
16 oz. - UPC #52000-00310, 64 oz. - UPC
#52000-33832 warehouse club pack of 16 oz. -
UPC #52000-33942
(b) Citrus Cooler; 16 oz. - UPC #52000-33500,
64 oz. - UPC #52000-33836
(c) Fruit Punch; 11.6 oz. - UPC #52000-30903,
16 oz. - UPC #52000-00330, 32 oz. - UPC
#5200-03805, 64 oz. - UPC #52000-33830
(d) Lemon Ice; 11.6 oz. - UPC #52000-30905, 16
oz. - UPC #52000-00340, 64 oz. - UPC
#52000-33833
(e) Orange; 16 oz. UPC #52000-00320, 64 oz. -
UPC #52000-33831
(f) Grape; 16 oz. UPC #52000-32671, 32 oz. -
UPC #52000-32673, 64 oz. - UPC #52000-32669
(g) Watermelon; 16 oz. - UPC #52000-32878, 64
oz. - UPC #52000-32874
-3- (h) Tropical Burst; 32 oz. - UPC #52000-32617,
64 oz. - UPC #52000-32616
(i) Cool Blue Raspberry; 32 oz. - UPC
#52000-33820, 64 oz. - UPC #52000-33581
(j) Rainbow Pack; 24 - 16 oz. glass bottle
case, UPC #52000-32942, containing 8 bottles
of Lemon-Lime, 8 bottles of Fruit Punch, 8
bottles of Orange. Recall #F-166/175-7.
CODE NOV-07-96 T through NOV-22-96 T case codes;
T08K6** through T22K6** bottle codes; rainbow
pack sticker codes: TS7574, TS7575, TS7576,
TS7586; lemon-lime warehouse club pack sticker
code: TS7603, TS7577.
MANUFACTURER Quaker Oats Company, Dallas, Texas.
RECALLED BY Quaker Oats Company, Chicago, Illinois, by
letter dated December 4, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and South America.
QUANTITY 571 cases of 11.6 oz. cans, 12,427 cases of 16
oz. bottles, 20,661 cases of 32 oz. bottles,
28,597 cases of 64 oz. bottles, 5,799 cases of
rainbow pack, and 108 cases of warehouse club
packed lemon lime 16 oz. bottles were
distributed, with the firm estimating that 50%
of the product remains on the market.
REASON Products are contaminated with mold.
_______________
PRODUCT Imitation Bacon Bits, in 1 pound packages.
Recall #F-178-7.
CODE None.
MANUFACTURER Unknown in Thailand.
RECALLED BY Betta Foods, Parrottsville, Tennessee
(repacker), by telephone. Completed recall
resulted from sample analysis and followup by
the State of New York State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY 10 to 15 1-pound packages were distributed.
REASON Product contains undeclared FD&C Red No. 3.
_______________
PRODUCT Various Rocky Road Chocolate Candies:
(a) F-180-7 Rocky Road MILK CHOCOLATE COATED
MARSHMALLOW WITH CASHEWS
- 1.82 oz. each, 12 boxes per case/24 bars
per carton; UPC 70602-43900
- .33 oz. each, packed in 12 oz. bags; UPC
70602-49900
- .33 oz. each, packed in boxes of 40 bars;
UPC 70602-49700
- .33 oz. each, sold in bulk; UPC 70602-41900
-4- (b) F-181-7 Rocky Road DARK CHOCOLATE COATED
MARSHMALLOW WITH CASHEWS, 1.82 oz. each, 12
boxes per case/24 bars per carton; UPC
70602-33900.
(c) F-182-7 Rocky Road DARK CHOCOLATE COATED
MARSHMALLOW MINT WITH CASHEWS, 1.82 oz. each,
12 boxes per case/24 bars per carton; UPC
70602-23900.
(d) F-183-7 Rocky Road MILK CHOCOLATE COATED
MARSHMALLOW BITS WITH CASHEWS [AKA "THEATER
PACKS"], 4 oz. boxes; UPC 70602-49800.
Recall #F-180/183-7.
CODE All codes.
MANUFACTURER Annabelle Candy Company, Hayward, California.
RECALLED BY Manufacturer, by letter on October 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3 million pieces were
distributed.
REASON Product is contaminated with insects,
specifically Indian meal moth.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin Kapseals (Extended Phenytoin Sodium),
USP, 100 mg, antiepileptic drug, in bottles of
1000 and 100. Recall #D-074-7.
CODE Lot numbers: 05785F EXP 7/97 (1000'S); 04885F
EXP 7/97 (100'S); 03075F EXP 7/97 (100'S);
02395F EXP 9/97 (100'S); 01595F EXP 8/97
(100'S); 00666F EXP 5/98 (100'S); 084N5F EXP
11/97 (100'S); 04185F EXP 7/97 (1,000'S);
10055F, 016N5F AND 04356F (100'S); 03385F,
07416F (1000'S).
MANUFACTURER Warner-Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner-Lambert
Company, Morris Plain, New Jersey, by letter
on October 26, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Lot No. Quantity Shipped
05785F 4,016
04185F 3,973
04885F 39,694
03075F 39,115
02395F 40,176
01595F 38,586
00666F 72
084N5F 41,184
016N5F 40,080
04356F 40,607
-5- 03385F 3,936
07416F 3,840
10055F 40,680.
REASON Stability dissolution failure.
_______________
PRODUCT Loestrin, Fe 1/20 (1 mg Norethindrone Acetate
and 20 mcg Ethinyl Estradiol Tablets, USP, and
Ferrous Fumarate Tablets, 75 mg), 5 dispensers
of 28 tablets per dispenser. Recall #D-077-7.
CODE Lot #001N5F EXP 10/97.
MANUFACTURER Warner-Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner-Lambert
Company, Morris Plain, New Jersey, by letter
on August 26, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 47,225 dispensers were distributed.
REASON Product failed potency assay for Ethinyl
Estradiol at the three month stability
timepoint.
_______________
PRODUCT Liquid Oxygen, USP, in low pressure , 165
cryogenic vessels. Recall #D-082-7.
CODE Lot numbers: 001L611, 002L612, 002L613,
002L615, 002L618, 003L618, 003L620, 003L621,
004L622, 004L625, 004L627.
MANUFACTURER Haun Welding Supply, Inc., Watertown, New
York.
RECALLED BY Haun Welding Supply, Syracuse, New York,
verbally and by letter on December 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY None remains in distribution.
REASON Good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Klor-Con 10 meq (Potassium Chloride, 750 mg,
USP) Extended Release Tablets, Rx.
Recall #D-075-7.
CODE All lots.
MANUFACTURER Uspher-Smith Laboratories, Inc., Minneapolis,
Minnesota.
RECALLED BY Physicians Total Care, Tulsa, Oklahoma, by
letter on September 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois and Missouri.
QUANTITY 6 bottles were distributed; firm estimates
none remains on the market.
-6-REASON Some units may contain Klor-Con 8 Tablets.
_______________
PRODUCT Nystatin-Triamcinolone Acetonide Cream, USP,
packaged in 15 g tubes, 30 tubes, 60 g tubes,
and 120 (4 ounce) jars, Rx topical
corticosteroid with anti-inflammatory, anti-
pruritic and vasoconstrictive actions
(triamcinolone) and an anti-fungal (Nystatin).
The product was distributed under the
manufacturer's label and the following three
private labels:
- Tri-Statin II Cream (Nystatin and
Triamcinolone Acetonide Cream, USP)
Rugby Laboratories, Inc. Norcross, GA
- Mycobiotic II (Nystatin-Triamcinolone
Acetonide Cream) h. l. Moore Drug Exchange New
Britain, CT
- MYOCIDIN (nystatin-triamcinolone acetonide
cream) Major Pharmaceutical Corp. Chicago, IL
Recall #D-076-7.
CODE LOT # EXP DATE LABEL(S) SIZE(S)
5A523 1/97 NMC 15g
60g
5B540 2/97 NMC 15g
Rugby 15g
Major 15g
h.l. Moore 15g
NMC 30g
h.l. Moore 30g
Rugby 30g
NMC 120g
5B624 2/97 Rugby 15g
NMC 15g
Rugby 30g
NMC 30g
h. l. Moore 60g
NMC 60g
Major 60g
Rugby 60g
5F800 6/97 NMC 15g
Major 15g
NMC 30g
h. l. Moore 30g
Major 60g
NMC 120g.
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
RECALLED BY Manufacturer, by letter mailed on December 19,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 266,627 units were distributed; firm estimates
none remains on the market.
-7-REASON Potency of Triamcinolone is not assured
through expiration (stability lot 5B540 failed
potency assay at the 18-month timepoint --
88.3%; SPEC is 90-110%).
_______________
PRODUCT Armour Thyroid (2 gr Tablets, 76mcg
Levothyroxine and 18 mcg Liothyronine), Rx, in
bottles of 100, indicated for use as a
replacement or supplemental therapy in
patients with thyroid disorders.
Recall #D-078-7.
CODE FP0622 EXP 12/98.
MANUFACTURER Rhone-Poulenc Rorer, Puerto Rico, Inc.,
Manati, Puerto Rico.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri, by letter dated October 2, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Belgium.
QUANTITY 17,616 bottles were distributed.
REASON Product failed content assay for one active
ingredient, Levothyroxine.
_______________
PRODUCT FML Forte (Fluorometholone), 0.25%, Liquifilm
Sterile Ophthalmic, in 5, 10, and 15 ml
bottles, for use as a topical anti-
inflammatory sterile ophthalmic suspension.
Recall #D-079-7.
CODE PRODUCT# LOT # EXP Date
136 5288A 9/96
136 5289A 3/97
227 5282X 3/96
227 5280X 9/96
227 5281A 10/96
227CP 5281A 10/96
227 5282A 2/97
228 5296X 4/96
228 5294A 8/96
228 5295A 5/97
228 5296A 5/97
4550 5303X 4/96
4550 5302A 8/96
4550 5303A 1/97
4550 5304A 5/97.
MANUFACTURER Allergan America, Hormingueros, Puerto Rico.
RECALLED BY Allergan, Inc., Irvine, California, by letter
dated February 2, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Great Britain.
-8-QUANTITY Lot # Quantity Shipped
5288A 9,738
5289A 3,672
5282X 38,979
5280X 10,692
5281A 39,462
5282A 24,932
5296X 18,162
5294A 18,905
5295A 17,089
5296A 2,116
5303X 3,560
5302A 4,686
5303A 4,833
5304A 381.
REASON Product fails preservative effectiveness test
near the end of its 18-month expiration date.
_______________
PRODUCT Leucovorin Calcium Tablets, USP: (a) 5 mg,
packaged in bottles of 30, 100, and 1000; (b)
25 mg, packaged in bottles of 25 and 500, Rx
indicated to diminish the toxicity of
Methotrexate, under the following labels:
Barr, Rugby, Geneva Pharmaceuticals, Zenith
Goldline.
Recall #D-080/081-7.
CODE (a) 5K484AY EXP 12/97, 6A484AJ EXP 3/98,
6B484DI EXP 3/98; (b) 6A485AK EXP 1/98.
MANUFACTURER Barr Laboratories, Inc., Northvale, New
Jersey.
RECALLED BY Barr laboratories, Inc., Pomona, New York, by
letter sent on December 20, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,776/30's, 802/100s and 60/1000s (lot
5K484AY); 2,892/30s, 72/1000 (lot 6A484AJ);
1,117/30s, 2,109/100s (lot 6B484DI);
1,418/25s, 48/500s (lot 6A485AK) bottles were
distributed.
REASON One lot failed content assay at the 6-month
stability timepoint due to higher than normal
particle size range. The other lots contain
the same active ingredient lot as the failing
lot.
_______________
PRODUCT Prenatal multivitamin/mineral products,
packaged in bottles of 100:
(a) Natalcare; (b) Advanced Formula Prenatal
Z; (c) Prenatal MTR. Recall #D-084/086-7.
-9-CODE (a) Lot # Exp Date Lot # Exp Date
L8332 1/98 L8362 2/98
L8335 1/98 L8363 2/98
L8336 1/98 L8364 2/98
L8337 1/98 L8429 4/98
L8338 1/98 L8430 4/98
L8359 1/98 L8431 4/98
L8360 1/98 L8432 4/98
L8361 1/98
(b) L8263 1/98 L8265 2/98
L8264 1/98 L8354 2/98
(c) L7580 2/98 L7864 3/98.
MANUFACTURER KV Pharmaceutical Company, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on December 17-18,
1996, and by letter dated December 13, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 96,600 bottles were distributed.
REASON Potency of Vitamin D is not assured through
the expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) AS-1 Red Blood Cells; (b) Platelets.
Recall #B-235/236-7.
CODE Unit #50F26063.
MANUFACTURER American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY Manufacturer, by letter dated March 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-239/240-7.
CODE Unit #40GR45616.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 23, 1996,
and on June 3, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) were subjected to
additional retesting.
-10-_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-241/242-7.
CODE Unit #40GR45578.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 23, 1996,
followed by letter dated June 3, 1996. Firm-
initiated recall complete.
DISTRIBUTION New York and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) were subjected to
additional retesting.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-243/244-7.
CODE Unit #47K46270.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 18, 1996,
followed by letters dated June 24, 1996, and
July 3, 1996. Firm-initiated recall complete.
DISTRIBUTION Iowa and Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
the antibody to the hepatitis B core antigen
(anti-HBc); were not retested as required.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-248/250-7.
CODE Unit #40GN11584.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 23, 1996,
followed by letters dated June 3, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the hepatitis B surface antigen (HBsAg) were
subjected to additional retesting.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-253/254-7.
CODE Unit #40GT44325.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois and California.
-11-RECALLED BY Manufacturer, by telephone on May 23, 1996,
followed by letter dated June 3, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) were subjected to
additional retesting.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Gambro Centrysystem 3 Ultrafiltration (UF)
Pump Thermal Fuse. Recall #Z-201-7.
CODE All catalog and all serial numbers.
MANUFACTURER Gambro Healthcare (formerly COBE Renal Care),
Lakewood, Colorado.
RECALLED BY Manufacturer, by letter on October 7-9, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 13,064 systems were distributed.
REASON The Ultra Filtration Pump Thermal Fuse can
fatigue and shut down the UF pump without
alarming.
_______________
PRODUCT Charging units for Sonicare Dental Hygiene
Products, battery operated toothbrushes that
use sonic frequency brushing to clean teeth:
(a) Sonicare Personal, PS-1; (b) Sonicare
Plus, PL-1; (c) Sonicare with Quadpacer, QP-1.
Recall #Z-205/207-7.
CODE Charging units with lot numbers 19636 through
19644.
MANUFACTURER Optiva Corporation, Bellevue, Washington.
RECALLED BY Manufacturer, by press release on November 6,
1996, and by letters on November 7 and 8,
1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 86,627 units; (b) 41,573 units; (c) 14,805
units were distributed.
REASON The charging units may have been manufactured
without electrical insulation (potting
compound) potentially exposing the user to
electrical shock.
-12-_______________
PRODUCT 3M Electrosurgical Patient Plates, Split with
Cord, Catalog No. 1179, a disposable
dispersive electrode and is the return
electrode for electrical current introduced
into the body during surgery by
electrosurgical cutting and coagulation
procedures. Recall #Z-210-7.
CODE Lot Nos. 1999-10CG, 1999-10CH, 1999-10CP,
1999-10CJ, 1999-10CC.
MANUFACTURER 3M Company Valley Plant, Valley, Nebraska.
RECALLED BY 3M Health Care, 3M Company, St. Paul,
Minnesota, by letter sent on December 26,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 146,280 units were distributed.
REASON An intermittent electrical continuity within
the plug terminal on the cord plate may
prevent activation of the electrosurgical
generator.
_______________
PRODUCT Supra-Annular Aortic Carbomedics Prosthetic
Heart Valve, Size 21, Model No. S500.
Recall #Z-211-7.
CODE Lot #255857.
MANUFACTURER CarboMedics, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone on November 22,
1996, followed by letter on December 2, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Georgia, Illinois,
Maryland, Massachusetts, Michigan, New York,
North Carolina.
QUANTITY 23 valves were distributed.
REASON The valve may have been placed on the holder
upside down.
_______________
PRODUCT Cardiac Pacemaker Maestro II, single chamber
implantable, multi-modal, multiprogrammable
pulse generator with bi-directional telemetry:
(a) Model 235; (b) Model 325; (c) Model 333;
(d) 533. Recall #Z-212/215-7.
CODE The following serial numbers (prefixed with
the model number) are involved in this recall:
235-01001 through 235-01009; 325-01177 through
325-01186; 333-02297 through 333-02308;
333-02371 through 333-02379 and 533-01062
through 533-01071.
MANUFACTURER Cardiac Control Systems, Inc. (CCS), Palm
Coast, Florida.
-13-RECALLED BY Manufacturer, by telephone and by letter on
November 20, 1996. Firm-initiated recall
complete.
DISTRIBUTION Connecticut, Massachusetts, Florida,
Pennsylvania, New York, New Jersey, Louisiana,
Tennessee, Arkansas.
QUANTITY 30 pacers were distributed.
REASON Loss of connection between the battery and the
internal circuitry can result in an inoperable
pacemaker.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Q.E.D. Saliva Alcohol Test: (a) Product #A150
(31150); (b) Product A350 (31350).
Recall #Z-216/217-6.
CODE A150 EXP DATE A350 EXP DATE
025531 JUN 97 045504 JUL 96
025537 JUN 97 075521 SEP 96
025614 JUN 97 046551 SEP 97
035500 JUL 97 046554 SEP 97
035503 JUL 97 056509 OCT 97
035532 JUL 97 056511 OCT 97
035545 JUL 97
035546 JUL 97
035582 JUL 97
035589 JUL 97
035595 JUL 97
045548 AUG 97
045566 AUG 97
045588 AUG 97
055541 SEP 97
055551 SEP 97
055566 SEP 97
055588 SEP 97
065513 SEP 97
065558 SEP 97
065612 OCT 97
115511 FEB 98
115512 FEB 98
115551 MAR 98
046513 JUL 98
046518 JUL 98
046527 JUL 98.
MANUFACTURER STC Technologies, Inc., Bethlehem,
Pennsylvania.
RECALLED BY Manufacturer, by letters on December 6 and 12,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 69 units were distributed.
-14-REASON The test reaction does not develop within five
minutes for negative samples as specified in
the package insert.
-15-
END OF ENFORCEMENT REPORT FOR JANUARY 22, 1997. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
![[FDA HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20081006154229im_/http://www.fda.gov/icon/iconhome.gif)