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
05/08/1996

ENFORCEMENT REPORT FOR 05/08/1996

May 8, 1996 96-19

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Cooked, Peeled, IQF Shrimp, packed in 16 ounce
clear plastic bags. Recall #F-494-6.
CODE "WE 2835" handwritten on back of 1 pound
packages. Recall #F-494-6.
MANUFACTURER Washington Crab Producers, Inc., Westport,
Washington.
RECALLED BY Manufacturer, by letter faxed on March 28,
1996, and by E-mail on March 29, 1996. Firm-
initiated recall complete.
DISTRIBUTION Washington state, Oregon, California, Idaho,
Nevada, Arizona.
QUANTITY 4,379 pounds of frozen product was produced.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
PRODUCT Savory Foods, Inc. "Savory Select San'wich"
Ready-to-eat deli sandwiches including:
(a) Hoagie Ham & Turkey Sandwich with American
Cheese
(b) Jumbo Submarine Sandwich
(c) Ham & Cheese Sandwich
(d) Jumbo Ham & Cheese Sandwich.
Recall #F-497/500-6
CODE (a) 1996011080107 use by 1/25/96 and
1996017081948 use by 1/31/96;
(b) 1996017081237 use by 1/31/96;
(c) 1996014081648 use by 1/31/96;
(d) 1996017080133 use by 1/31/96.
MANUFACTURER Savory Foods, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by telephone on or about January
19, 1996; extended on or about January 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Michigan, Indiana, Ohio, Illinois.
QUANTITY 1,341 sandwiches were distributed.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
PRODUCT Pillsbury Banana Quick Bread Mix, in 14 ounce
boxes. Recall #F-502-6.
CODE Codes beginning with B6M07.
MANUFACTURER The Pillsbury Company, Murfreesboro,
Tennessee.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota,
by E-mail and by press release on April 2,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,283 cases (12 boxes per case) were
distributed.
REASON Product contains undeclared walnuts and
almonds.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Cocktail mixes:
(a) Liquid Whiskey Sour drink mix in 32 ounce
opaque plastic bottles labeled in part:
***PREMIUM WHISKEY SOUR MIX***
(b) Liquid Sweet & Sour drink mix in 32 ounce
opaque plastic bottles labeled in part:
***PREMIUM SWEET N' SOUR MIX***
(c) Liquid Sweet & Sour drink mix in 1 gallon
opaque plastic bottles labeled in part:
***SWEET AND SOUR COCKTAIL MIX***.
Recall #F-479/481-6.
CODE All lots containing undeclared FD&C Yellow
No. 5 and 6.
MANUFACTURER Lemate of New England, Inc., Foxboro,
Massachusetts.
RECALLED BY Manufacturer, by visit commencing April 2,
1996, and by letter dated April 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Rhode Island.
QUANTITY Estimated 3,600 bottles remained in commerce.

-2-REASON Product contains undeclared FD&C Yellow No. 5
and 6.

_______________
PRODUCT Smoked fish products packed in thermally
processed, hermetically sealed 1 pint mason
jars:
(a) Onolicious Hawaiian Smoked Salmon
(b) Onolicious Hawaiian Smoked Marlin
(c) Onolicious Hawaiian Smoked Swordfish
(d) Onolicious Hawaiian Smoked Ono
(e) Onolicious Hawaiian Smoked Ahi
Recall #F-485/489-6.
CODE All codes, all products.
MANUFACTURER Kiana Seafood, Inc., Waianae, Hawaii.
RECALLED BY Manufacturer, by telephone on or about January
12, 1996. State of Hawaii issued press
release on January 12, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nevada, Hawaii.
QUANTITY Firm estimates none remains on the market.
REASON Manufacturer of these low acid canned food
products has not registered with FDA and has
not filed processes for these products.

_______________
PRODUCT Aunt Anne Assortment Cookies, in 13 ounce
(370 g) packages. Recall #F-501-6.
CODE All lots.
MANUFACTURER Falcone's Cookieland, Ltd., Brooklyn, New
York.
RECALLED BY Manufacturer, by letter sent on April 22,
1996, followed by telephone. Ongoing recall
resulted from sample analysis by the New York
State Department of Agriculture & Markets and
followup by FDA.
DISTRIBUTION Pennsylvania.
QUANTITY 90 cases (12 packages per case) were
distributed; firm estimates none remains on
the market.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Green Beans in #300 metal can labeled in part:
"***The Allens Sunshine CUT ITALIAN GREEN
BEANS***NET WT. 14.5 OZ.***". Recall F-463-6.
CODE 5IGB2/52271.
MANUFACTURER Allen Canning Company, Moorehead, Mississippi.
RECALLED BY Manufacturer, by letter faxed on March 22,
1996. Firm-initiated recall complete.
-3-DISTRIBUTION Virginia, Florida, Georgia, Alabama,
Mississippi, Louisiana.
QUANTITY 7,393 cases (24 cans per case) were
distributed.
REASON The product is adulterated with filth.

_______________
PRODUCT S'UG a spicy Mediterranean condiment packaged
in 8 ounce glass jars. Recall #F-478-6.
CODE None.
MANUFACTURER Nina Ltd. of Trenton, Trenton, Missouri.
RECALLED BY Manufacturer, by telephone on January 10,
1996. Firm-initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY 308 jars were distributed.
REASON The product is unfit for food due to sour
smell and fermentation and has no scheduled
process in file with FDA.

_______________
PRODUCT Classic Selection Natural Spring Water in one
gallon clear plastic bottles.
Recall #F-482-6.
CODE Production Production
Date Lot No. Date Lot No.
3/22/95 PR0032295 5/10/95 PR0051095
3/27/95 PR0032795 6/01/95 PR0060195
4/03/95 PR0040395 6/14/95 PR0061495
4/10/95 PR0041095 7/18/95 PR0071895
4/17/95 PR0041795 8/24/95 PR0082495
4/24/95 PR0042495 9/05/95 PR0090595
5/01/95 PR0050195 9/16/95 PR0091695
5/04/95 PR0050495 10/03/95 PR0100395.
MANUFACTURER North Country Natural Spring Water Company,
Kent, New York.
RECALLED BY Cott Beverages USA, Columbus Georgia, by visit
beginning December 7, 1995, and by notice sent
on or about January 16, 1996. Firm-initiated
recall complete.
DISTRIBUTION Connecticut, Delaware, Massachusetts, Maine,
Maryland, North Carolina, New Hampshire, New
Jersey, New York, Pennsylvania, Virginia, West
Virginia, Washington, D.C.
QUANTITY 226,680 cases (4 1-gallon bottles per case)
were distributed.
REASON Product is contaminated with mold.

_______________
PRODUCT Shaw's apple juice products:
(a) Apple Juice from Concentrate;
(b) Frozen Apple Juice from Concentrate.
Recall #F-483/484-6.

-4-CODE (a) All bottles with "V-073" on UPC coding on
product label;
(b) All cans with "V-026" on label below firm
name & address.
MANUFACTURER Shaw's Supermarkets, Inc., E. Bridgewater,
Massachusetts (distributor).
RECALLED BY Distributor, by telephone and by E-mail on
February 29, 1996. Firm-initiated recall
complete. See also FDA talk paper T96-14,
February 26, 1996.
DISTRIBUTION Massachusetts, New Hampshire, Rhode Island,
Maine, Connecticut.
QUANTITY (a) Approximately 9,000 10-ounce bottles and
34,000 60-ounce bottles; (b) Approximately
75,000 12-ounce cans were distributed.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.

_______________
PRODUCT Sysco Classic Bagels, frozen, 6 bagels per
plastic bag: (a) Sysco Classic Bagels, Onion;
(b) Sysco Classic Bagels, Cinnamon Raisin; (c)
Sysco Classic Bagels, Plain.
Recall #F-491/493-6.
CODE Lot 0014 on the white case label. There is no
lot number on the plastic bags. Pallet
numbers 41845, 41750, 41846, and 41860.
MANUFACTURER La Francaise Bakery, Northlake, Illinois.
RECALLED BY Manufacturer, by telephone, followed by letter
faxed on April 3, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Michigan, Idaho, Texas, Colorado,
Missouri, Pennsylvania, Kansas.
QUANTITY 50 cases of Plain Bagels, 7 cases of Onion
Bagels and 204 cases of Cinnamon Raisin Bagels
were distributed, and all of the product was
destroyed at the direct accounts as of 4/8/96.
REASON Products may be contaminated with wood chips
on the bottom of the bagel.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin (extended Phenytoin Sodium Capsules,
USP) Kapseals, 30 mg, an anticonvulsant
packaged in bottles of 100. Recall #D-131-6.
CODE Lot #60885L EXP 7/97.
MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
dated February 22, 1996, followed by
telephone. Firm-initiated recall complete.

-5-DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product does not meet dissolution
specifications.

_______________
PRODUCT Milontin, Phensuximide Capsules, 0.5g, an
anticonvulsant, packaged in bottles of 100,
Recall #D-132-6.
CODE Lot #961N4L EXP 10/96.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
mailed on March 5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product does not meet dissolution
specifications.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-254-6.
CODE Unit #24LF09690.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter sent on August 2,
1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Red Blood Cells containing S antigen positive,
but labeled as S antigen negative, were
distributed.

_______________
PRODUCT AlphaNine SD Coagulation Factor IX (Human).
Recall #B-367-6.
CODE Lot numbers: CA5410A EXP 3/16/97, CA5412A EXP
4/6/97, CA5413A EXP 4/27/97, CA5421A EXP
6/7/97.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles,
California.
RECALLED BY Manufacturer, by letter on January 12, 1996,
followed by telephone on March 1 through 4,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Spain.
QUANTITY 5,680 units were distributed.
REASON Factor IX products may have been adulterated
in that it my contain Hepatitis A virus (HAV),
were distributed.

-6-_______________
PRODUCT Gammar-P I.V., Immune Globulin Intravenous
(Human), in 10 gram vials. Recall #B-392-6.
CODE Lot #N600509 EXP 9/21/97.
MANUFACTURER Centeon a Company of Armour and Behring,
Bradley, Illinois.
RECALLED BY Centeon, King of Prussia, Pennsylvania, by
letter dated February 29, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,802 vials were distributed; firm estimated
that 300 vials remained on market at time of
recall initiation.
REASON Blood product, for which the reconstitution
time exceeds specifications, was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-394-6.
CODE Unit #40FF34324.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on September 26,
1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who
traveled to an area considered endemic for
malaria, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Platelets, Pheresis; (d) Fresh Frozen Plasma;
(e) Cryoprecipitated AHF; (f) Recovered
Plasma. Recall #B-369/374-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone on May 22, 1995,
followed by letters dated May 22 and 26, 1995.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Ohio, Illinois, West Virginia,
New Jersey, California, Switzerland.
QUANTITY Firm estimates none remains on the market.
REASON Blood products, collected from donors whose
health history screening was inadequately
performed, were distributed.

-7-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Model 20508C Disposable Contact Fiber,
indicated for a wide variety of surgical uses,
including incision, excision, ablation, and
coagulation. Recall #Z-632-6.
CODE Lot #11367.
MANUFACTURER Trimedyne, Inc., Irvine, California.
RECALLED BY Manufacturer, by telephone on December 21,
1995, followed by letter on December 22, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois and Pennsylvania.
QUANTITY 8 units were distributed; firm estimates none
remains on the market.
REASON The device was shipped without being
sterilized.

_______________
PRODUCT QUIK-PACE external non-invasive packing
cassette which have been upgraded to allow use
of QUIK-COMBO pacing/defibrillation/ECG
electrodes: (a) Part Numbers: 802904-04;
(b) 804904-08, upgraded with kit part number
3005895-00. Recall #Z-696\697-6.
CODES The serial numbers listed are for the
QUIK-PACE external noninvasive pacing
cassette:
003904 007365 007655 007858 007859
005373 002415 004820 005898 002629
002061 002066 003411 005826 009022
006150 005238 006762 003904 003726
94490010.
There are additional kits involved, however,
these would be the kits the customers
installed themselves, and once installed, the
kits loose their identity/serial number.
MANUFACTURER Physio Control Corporation, Redmond,
Washington.
RECALLED BY Manufacturer, by visit and by letter beginning
on March 22, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Massachusetts, Florida, California,
Pennsylvania, Texas, Oregon, Kansas, Missouri,
Wisconsin.
QUANTITY 36 units were distributed.
REASON The upgrade kit contains a miswired cable
(reversed).

_______________
PRODUCT Advantx Console, (a) Model 2121197;
(b) 2106684. Recall #Z-698/699-6.
CODE None.

-8-MANUFACTURER General Electric Medical Systems (GEMS),
Milwaukee, Wisconsin.
RECALLED BY Manufacturer. FDA approved firm's corrective
action plan April 29, 1996. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 184 units were distributed.
REASON The devices were found to be in noncompliance
with Section 21 CFR 1010.2(b), in that the
identification labels on the devices did not
have the manufacturer's statement certifying
conformance with all applicable standards, and
Section 21 CFR 1010.3(a)(2), in that the
identification labels on the devices did not
have the date of manufacture.

_______________
PRODUCT Lingo Portable Two-Way Radios with Software
Version R02.02.00, used for two way
communications: (a) Lingo Radios with P6A
Chassis; (b) Lingo Radios with P5 Chassis.
Recall #Z-700/701-6.
CODE Units with software version R02.02.00.
MANUFACTURER Motorola, Inc., Land Mobile Products Sector,
iDEN Subscriber Division, Plantation, Florida.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on April 29, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,282 units were distributed.
REASON The electronic product had a defect as defined
in 21 CFR 1003.2, in that under certain
conditions they may emit a loud audio noise,
"pop."

_______________
PRODUCT UltraPulse Surgical C02 Lasers, for general
surgery and dermatology:
(a) Model No. 4000; (b) Model No. 5000;
(c) Model No. 5000L; (d) Model No. XL80;
(e) Model No. XL100. Recall #Z-702/706-6.
CODE UltraPulse and XL series.
MANUFACTURER Coherent, Palo Alto, California.
RECALLED BY Manufacturer, by telephone January 26, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 136 units.
REASON The devices failed to comply with 21 CFR
1003.2(b)(2) because it was found that, under
certain unusual circumstances, the shutter may
not close completely, potentially causing
emission of a laser beam during the system's
self-calibration phase.
-9-_______________
PRODUCT Medcomp Silverguard Catheters, used to access
a patient's circulatory system:
(a) Silver-Coated Polyurethane Hemodialysis
Catheters, brand names: Silverguard Duo-Flow
Double Lumen Internal Juglar Catheter and
Silverguard Duo-Flow II Double Lumen Catheter;
(b) Silver-Coated Silicone Hemodialysis
Catheters, brand names: Silverguard Hemo-Cath
Silicone (Double Lumen) Catheters; Silverguard
Tesio Catheters. Recall #Z-707/708-6.
CODE All lots.
MANUFACTURER Medical Components, Inc., Harleysville,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated January 30,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that there were 1,465 trays of
the polyurethane and 6,268 trays of the
silicone remained on market at time of recall
initiation.
REASON The devices were distributed without an
approved premarket notification submission
510(k).

_______________
PRODUCT Cryotech/Candela & Spembly/Candela
Cryosurgical System used in prostate and liver
cryosurgery:
(a) Model #LCS2000, Part #8085-20-2700
(b) Model #LCS2000, Part #8085-20-2701,
(c) Model #LCS2000, Part #8085-20-2704,
(d) Model #LCS3000, Part #8085-20-0010,
(e) Model #LCS3000, Part #8085-20-0011,
(f) Model #LCS3000, Part #8085-201-0010.
Recall #Z-710/715-6.
CODE (a) All lot numbers; (b) Lot #90079;
(c) All lot numbers; (d) All lot numbers;
(e) Lot #923034; (f) Lot #923010.
MANUFACTURER Cryogenic Technology Ltd., Belkper,
Derbyshire, England; Spembly Cryosurgery Ltd.,
Hampshire, England.
RECALLED BY Candela Laser Corporation, Wayland,
Massachusetts, by letter on January 17, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 46 units were distributed.
REASON Devices are subject to possible overheating
and melting of the units' exhaust heat
exchanger during use.

-10-_______________
PRODUCT Venture Demand Oxygen Delivery Device (a)
20PSI; (b) 50PSI, used to deliver oxygen upon
demand. Recall #Z-722/723-6.
CODE All units identified with serial numbers
beginning with 95L through 96A. Devices were
manufactured from December 1995 through
January 1996.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on March 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 426 affected devices remained in distribution
at time of recall initiation.
REASON Due to a software defect in the component, the
delivery valve might not open, or might not
remain open for the full time period at
operating extremes, such as a cylinder with
little oxygen content.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Gelfilm, a sterile absorbable gelatin film
designed for use in neurosurgery and thoracic
and ocular surgery:
(a) Gelfilm Sterile Film Absorbable Gelatin
Film; (b) Gelfilm Sterile Ophthalmic Film
Absorbable Gelatin Film. Recall #Z-610/611-6.
CODE (a) Lot No. 004JK; (b) Lot No. 379KP.
MANUFACTURER Pharmacia & Upjohn, Inc., Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter sent on March 14,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 751 units were distributed; firm estimated
that very little product remained on market at
time of recall initiation.
REASON Devices are failing to meet the USP
digestibility specification within the labeled
expiration period.

-11-

END OF ENFORCEMENT REPORT FOR MAY 8, 1996. BLANK PAGES MAY FOLLOW.

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