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
12/28/1994
Recalls and Field Corrections: Foods -- Class II -- 12/28/1994
December 28, 1994 94-52
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Nutritional supplements containing propolis:
(a) Bee Pollen, Royal Jelly & Propolis Capsules;
(b) Propolis Chewable Tablets, 200 mg;
(c) Propolis Chewable Tablets, 500 mg;
(d) Propolis Capsules, 500 mg, except lot #M4767;
(e) Propolis & Echinacea Capsules;
(f) Pro-Tech Capsules;
(g) Zinc Cold Care Cherry Lozenges;
(h) Stay Calm Capsules;
(i) Garlic & Propolis Capsules. Recall #F-137/145-5.
CODE All lots of all propolis containing products except lot
M4767 of the 500 mg Bee Propolis (See F-006-5, which
appeared in the October 19, 1994 Enforcement Report).
MANUFACTURER Montana Naturals International, Inc., Arlee, Montana.
RECALLED BY Manufacturer, by letter July 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Firm estimated that 40,000 bottles were on the market at
time of recall.
REASON Product is contaminated with lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Kraft Cheez Whiz Cheese and Salsa Dip, Medium and Mild
flavors, in 10.5 ounce glass jars, packaged in 12 packs.
Recall #F-146/147-5.
CODE All lots.
MANUFACTURER Kraft, Inc., Springfield, Missouri.
RECALLED BY Kraft General Foods, Inc., Northfield, Illinois, by fax
November 1, 1994, followed by visit. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 2,194,000 jars of Medium and 1,800,000 jars of Mild were
distributed; firm estimated that 40 percent of the cheese
remained on the market at time of recall initiation.
REASON Product is contained in jars that may crack after being
microwaved.
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PRODUCT Bottled Spring Water, in 2.5 gallon and 1.5 liter plastic
bottles, under Deer Park and Ice Mountain labels.
Recall #F-148-5.
CODE 061894/061896 through 063094/063096.
MANUFACTURER Poland Spring Bottling Company, Poland Spring, Maine.
RECALLED BY Manufacturer, by telephone July 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Connecticut, Maine, Massachusetts, New Hampshire, Vermont
(Ice Mountain brand); Connecticut, Massachusetts, New
Jersey, New York, Pennsylvania (Ice Mountain brand).
QUANTITY 12,790 cases of 1.5 liter bottles and 13,489 cases of 2.5
gallon bottles (Dear Park brand); 8,899 cases of 1.5 liter
bottles and 22,729 of 2.5 gallon bottles (Ice Mountain
brand) were distributed.
REASON Product has an off odor/off taste.
_______________
UPDATE Recall #F-133-5, Promise Extra Light Margarine, which
appeared in the December 21, 1994 Enforcement Report should
read:
MANUFACTURER: Van Den Bergh Foods, Industrial Airport,
Kansas.
RECALLED BY: Van Den Bergh Foods, New York, New York, by
letter August 9, 1994. Firm-initiated recall complete.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
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PRODUCT Platelets, Pheresis. Recall #B-108-5.
CODE Unit numbers: 12LW03315A, 12LW03495A, 12LW03513A,
12LW04151A.
MANUFACTURER The American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letters on or about March 28, 1994. Firm-
initiated recall complete.
-2- DISTRIBUTION Georgia, Tennessee.
QUANTITY 4 units.
REASON Unlicensed blood products were distributed in interstate
commerce.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
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PRODUCT Accufix Atrial "J" Active Fixation Endocardial Pacing Leads:
(a) Model #329-701; (b) Model #330-801; (c) Model #033-812.
Recall #Z-209/211-5.
CODE All lot numbers and serial numbers.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by phone
mail October 21, 1994, followed by letters of October 27 and
31, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international. (NOTE: Model 033-812 has
foreign distribution only.
QUANTITY (a) 1243 units; (b) 40,738 units; (c) 734 units were
distributed.
REASON "J" retention wires can break away from the leads, protrude
through the polyurethane insulation, through the right
atrial appendage, and perforate the aorta.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT Posterior Chamber Intraocular Lenses:
(a) Model 3267B, Soft J, Biconvex;
(b) Model 4241B, Formflex, Biconvex;
(c) Model 4241S, Formflex, Optic. Recall #Z-184/186-5.
CODE 33 devices with unique, non-sequential control numbers.
MANUFACTURER Iolab Corporation, a Johnson & Johnson Company, Claremont,
California.
RECALLED BY Manufacturer, by letter October 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Georgia, Idaho, Illinois, Indiana,
Maryland, Michigan, Missouri, Mississippi, New Hampshire,
Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Hong
Kong, Indonesia.
QUANTITY 33 lenses were distributed; no unimplanted lenses remain in
commerce.
REASON The carton label may indicate the incorrect dioptric power.
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PRODUCT CA Cellulose Acetate Hollow Fiber Dialzyers, a single use
sterile device for hemodialysis of patients with acute or
chronic renal failure:
(a) Model CA-50G, Product Code 5M1729 - 0.5 square meters
surface area hemodialyzer;
(b) Model CA-70G, Product Code 5M1730 - 0.7 square meters
surface area hemodialyzer;
-3- (c) Model CA-90G, Product Code 5M1731 - 0.9 square meters
surface area hemodialyzer;
(d) Model CA-110G, Product Code 5M1732 - 1.1 square meters
surface area hemodialyzer;
(e) Model CA-130G, Product Code 5M1733 - 1.3 square meters
surface area hemodialyzer;
(f) Model CA-150G, Product Code 5M1734 - 1.5 square meters
surface area hemodialyzer;
(g) Model CA-170G, Product Code 5M1735 - 1.7 square meters
surface area hemodialyzer;
(h) Model CA-210G, Product Code 5M1736 - 2.1 square meters
surface area hemodialyzer. Recall #Z-187/194-5.
CODE Lot numbers: 89J, 89K, 89L, 90A through 90L, 91A through
91H.
MANUFACTURER Nissho Corporation, Osaka, Japan.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letter October 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 6,282,932 units were distributed between October 1989 and
August 15, 1994; firm estimates little if any product
remains on the market.
REASON A change in the dialyzer fiber manufacture resulted in an
increase in the formation of Cellulose Acetate Oligomer
which resulted in an increase in allergic reactions.
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PRODUCT Clay Adams Sterile Disposable Cantor Tubes, intestinal
decompression tubes and replacement bags are distributed as
a primary care diagnostic product for use as an intestinal
device in humans:
(a) Catalog Number 7690 - Rubber Cantor Tube, Adult Size,
16FR;
(b) Catalog Number 7691 - Replacement Bag for Cantor Tub,
Adult Size;
(c) Catalog Number 7692 - Rubber Cantor Tube Pediatric Size,
12FR;
(d) Catalog Number 7693 - Replacement Bag for Cantor Tube,
Pediatric Size;
(e) Catalog Number 7695 - Sterile Disposable Cantor Tube,
Adult Size, 16FR;
(f) Catalog Number 7696 - Sterile Disposable Cantor Tube,
Pediatric Size, 12FR. Recall #Z-195/200-5.
CODE Catalog numbers: 7690, 7691, 7692, 7693, 7695, 7696.
MANUFACTURER Becton Dickinson, Primary Care Diagnostic, Sparks, Maryland.
RECALLED BY Manufacturer, by letter September 27, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 16,295 units were distributed.
REASON The bags dislodge from the tubes and remain in the patient
or leak mercury from the bag while still in the patient.
-4- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
________________
PRODUCT Ideas' Port Implantable Catheter, Model IP-1001, designed to
accept a .021 straight guidewire for the introduction of
various cardiac catheters. Recall #Z-143-5.
CODE D062294-11.
MANUFACTURER Ideas for Medicine, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by telephone followed by letter July 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Massachusetts, New Jersey, Pennsylvania, Arkansas,
Nevada, New Jersey.
QUANTITY 40 units were distributed.
REASON The shipping box was labeled as having a detached catheter,
instead the catheter is actually pre-attached to the port.
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PRODUCT Series 5 Outer Bow Angulated 15 Degrees Gingival Short
Facebows, used for the orthodontic treatment of malposed
teeth:
(a) Part Number 328-215, Size 1;
(b) Part Number 328-225, Size 2;
(c) Part Number 328-235, Size 3;
(d) Part Number 328-245, Size 4;
(e) Part Number 328-255, Size 5. Recall #Z-179/183-5.
CODE All lots.
MANUFACTURER 3M Unitek Corporation, 3M Dental Products Division,
Monrovia, California.
RECALLED BY Manufacturer, by letter September 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,162 units were distributed; firm estimates none remains on
the market.
REASON The outer bow is angulated more than 15 Degrees.
-5-
END OF ENFORCEMENT REPORT FOR DECEMBER 28, 1994. BLANK PAGES MAY
FOLLOW.
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