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
11/24/1993
Recalls and Field Corrections: Foods -- Class II -- 11/24/1993
November 24, 1993 93-47
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT All types and sizes of bags of corn meal:
(a) Sholar's River Bank Buttermilk Hush Puppy Mix, 16
ounces;
(b) Sholar's River Bank Hushpuppy Mix, 5 pounds;
(c) Sholar's Shur-Rise Stone Ground Air Sifted White Self
Rising Corn Meal Mix, 24-ounce and 5-pound size;
(d) Stone Ground Air Sifted White Sholar's Medium ground
Corn Meal Mix, in 2-pound and 5-pound bags;
(e) Stone Ground Air Sifted White Sholar's Fine Ground Corn
Meal Mix, in 2-pound and 5-pound bags;
(f) Sikes' Corn Meal, in 5-pound bags. Recall #F-096/101-4.
CODE All lots manufactured through JUL 13, 1993.
MANUFACTURER C & C Corn Products, Inc., Pelham, Georgia.
RECALLED BY Manufacturer, by visit beginning July 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY Firm estimates 5,125 pounds of all products remain on the
market.
REASON The products are contaminated with aflatoxin.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
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PRODUCT Ultravate (halobetasol proprionate) Ointment, 0.05%, 50 g
tubes, Rx topical corticosteroid. Recall #D-026-4.
CODE Lot #145F016 EXP 5/96.
MANUFACTURER Westwood Squibb, Buffalo, New York.
RECALLED BY Manufacturer, by telephone followed by letters dated October
27, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 394 cases (24 units per case) were distributed.
REASON A portion of the lot was adulterated with an equipment
cleaning solution.
_______________
PRODUCT Transfilled Compressed Medical Oxygen in C, D, E, M, and S
size cylinders. Recall #D-027-4.
CODE All fill dates.
MANUFACTURER Robinson's Industrial Gas and Equipment Corporation,
Amityville, New York.
RECALLED BY Manufacturer, by visit November 8, 1993, to be followed by
letters. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY Approximately 86 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Transfilled Compressed Medical Oxygen in D, C, E, M, and 244
cubic feet cylinders. Recall #D-028-4.
CODE All fill dates.
MANUFACTURER Anderson Fire Equipment Company, Inc., Batshore, New York.
RECALLED BY Manufacturer, by letter delivered beginning the week of
November 8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 304 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Percodan Tablets, in blister packs of 25, used for the
relief of moderate to moderately severe pain.
Recall #D-029-4.
CODE Lot EEA-00A1 EXP 12/94.
MANUFACTURER Dupont Merck Pharm, Manati, Puerto Rico.
RECALLED BY Manufacturer, by telephone September 24, 1993, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 5,691 boxes containing 10 blister packs were distributed;
firm estimates 75 boxes remain on the market.
REASON Aspirin component does not meet stability specifications for
dissolution.
-2- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT Pacemaker/Defibrillators: (a) Zoll PD 1200
Pacemaker/Defibrillator; (b) Zoll D 900 Defibrillator, for
the purposes of converting ventricular fibrillation (VF), to
sinus rhythm or other cardiac rhythms capable of producing
hemodynamically significant heart beats.
Recall #Z-037/038-4.
CODE Serial numbers: (a) 4663 to 6191 inclusive; (b) 2009 to
2637 inclusive.
MANUFACTURER Omron, Japan (manufacturers the K1-G6B component relay).
RECALLED BY Zoll Medical Corporation, Burlington, Massachusetts, by
letter June 15, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately (a) 1,467 units; (b) 622 units.
REASON A defective high voltage board component and a
malfunctioning relay switch makes the defibrillation
function inoperative.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT System 1000 Thyroid Uptake System using Software Version
2.30, used to determine the activity of the thyroid gland by
measuring the amount of radionucleide taken up by the gland.
Recall #Z-043-4.
CODE All units.
MANUFACTURER Canberra Industries, Meriden, Connecticut (software
developer).
RECALLED BY Capintec, Inc., Pittsburgh, Pennsylvania, by letter June 14,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Saudi Arabia, France.
QUANTITY 165 units.
REASON Software Version 2.30 contains a defect whereby incorrect
capsule counts occurred during a Thyroid Uptake Test when
the initial count was taken between 7:00 pm and 12:00
midnight.
_______________
PRODUCT Software upgrade revision 0.1 used in Ultrasound Imaging
Systems: (a) Sonos 500 Ultrasound Imaging System Model
77025A; (b) Sonos 1000 Ultrasound Imaging System Model
77030A; (c) Sonos 1500 Ultrasound Imaging System Model
77035A; (d) Sonos or Ultrasound Imaging System Model 77040A.
Recall #Z-079/082-4.
CODE HP Sonos Software Revision 0.1.
MANUFACTURER Hewlett-Packard Company, Imaging Systems, Andover,
Massachusetts.
RECALLED BY Manufacturer, by letters of March 11 and 19, 1993. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
-3- QUANTITY 665 systems or upgrade kits with Revision 0.1.
REASON The 0.1 software revision used in these devices was released
without being validated to the original design
specifications resulting in an error in the mean pressure
gradient.
_______________
PRODUCT Acryl-X System Ultrasound Bone Cement Removal System.
Recall #Z-083-4.
CODE A varied range of combination serial numbers.
MANUFACTURER Lydo Precision Product, Mountain Lakes, New York.
RECALLED BY Sonokinetics Group, Hoboken, New Jersey, by letter January
21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23 units; firm estimates none remains on the market.
REASON If the Acryl-X handpiece is improperly autoclaved or cleaned
with Cidex, the patient or operating room personnel could be
exposed to above normal levels of electrical current during
surgery.
_______________
PRODUCT Advertisements for "Dry Docs Disposable Protective Shoe
Covers" used to eliminate the risk of contamination and
provide security against contagious disease and "Economy dry
Docs", used to eliminate the risk of contamination. Recall
#Z-088-4.
CODE None.
MANUFACTURER Hydro-Med Products, Inc., subsidiary of The Spectrum
Companies, Dallas, Texas.
RECALLED BY Hydro-Med Products, Inc., subsidiary of The Spectrum
Companies, Houston, Texas, by letters dated September 30,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Georgia, Illinois, Kansas,
Michigan, Missouri, New Jersey, New York, Oregon, Texas,
Wisconsin, Canada.
QUANTITY Undetermined.
REASON The advertised devices were labeled for medical use without
an approved 510(k).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Hearing Aids: (a) Starkey CE 7 and CE 8 in-the-ear Hearing
Aids; (b) SA 57 and SA S8 Custom Canal - Starkey SecretEar
Mini in-the-ear Hearing Aids; (c) Trilogy - Programmable
Hearing Aids. Recall #Z-114/116-4.
CODE All lots.
MANUFACTURER Starkey Labs, Inc., Eden Prairie, Minnesota.
RECALLED BY Manufacturer, by memorandum May 7, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 20,000 to 30,000 units per year are distributed.
-4- REASON Unwarranted claims. The use of the devices does not cause
injury in itself; however, lack of appropriate medical
evaluation may lead to potential delay or error in
treatment.
_______________
PRODUCT Miracle Ear Hearing Aids. Recall #Z-117-4.
CODE All lots.
MANUFACTURER Dahlberg, Inc., Golden Valley, Minnesota.
RECALLED BY Manufacturer, by letters of April 22 and 29, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 20,000 to 30,000 units per year are distributed.
REASON Unwarranted claims. The use of the device does not cause
injury in itself; however, lack of appropriate medical
evaluation may lead to potential delay or error in
treatment.
-5-
END OF ENFORCEMENT REPORT FOR NOVEMBER 24, 1993. BLANK PAGES MAY
FOLLOW.
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