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
12/18/1990
FDA Enforcement for the week of December 19, 1990
FDA ENFORCEMENT REPORT
FOR DECEMBER 19, 1990
December 19, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Pride of the Shore Crabmeat in 16 ounce containers:
(a) Claw Crabmeat; (b) Special Crabmeat; (c) Lump
Crabmeat; (d) Backfin Crabmeat. Recall #F-673/676-0.
Code: Not coded.
Manufacturer: Eastern Shore Seafood Company, Inc., Onancock, Virginia.
Recalled by: Manufacturer, by telephone July 18, 1990. Firm-initiated
recall complete.
Distribution: Maryland, Virginia.
Quantity: Firm estimates none remains on the market.
Reason: Products were contaminated with Listeria monocytogenes.
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-1-
Product: Pride of the Shore Crabmeat in 16 ounce containers:
(a) Claw Crabmeat; (b) Special Crabmeat; (c) Lump
Crabmeat. Recall #F-011/013-1.
Code: Not coded. Product processed 8/22/90.
Manufacturer: Eastern Shore Seafood Company, Inc., Onancock, Virginia.
Recalled by: Manufacturer, by telephone September 17, 1990.
Firm-initiated recall complete.
Distribution: Virginia, Pennsylvania.
Quantity: Firm estimates none remains on the market.
Reason: Products were contaminated with Listeria monocytogenes.
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Product: Keyser Brothers brand (a) Fresh Claw Crabmeat, in
5 pound plastic bags; (b) Frozen Claw Crabmeat, in
5 pound plastic bags. Recall #F-014/015-1.
Code: Some bags are uncoded and some are coded 9/25/90.
Manufacturer: Keyser Brothers, Inc., Lottsburg, Virginia.
Recalled by: Manufacturer, by telephone September 26, 1990 followed
by letter. Firm-initiated recall ongoing.
Distribution: Maryland, Virginia, Ohio, Pennsylvania, South Carolina.
Quantity: Approximately 1,000 pounds were distributed.
Reason: Products are contaminated with Listeria monocytogenes.
----
Product: (a) Ham 'N' Cheese Sandwich, 3.75 ounces, packaged in a
polypropylene overwrap with yellow stick-on label;
(b) Ham and Swiss Cheese Croissant, 3 3/4 ounces.
Recall #F-034/035-1.
Code: (a) 2762; (b) 081.
Manufacturer: Stewart Sandwiches, Inc., Norfolk, Virginia.
Recalled by: Manufacturer, (a) by telephone October 26, 1990;
(b) by telephone June 27, 1990. Firm-initiated recall
ongoing.
Distribution: (a) Southeastern United States; (b) Maryland.
Quantity: (a) 11,232 sandwiches (b) 1,980 croissants
were distributed; firm estimates none remains on
the market.
Reason: Products are contaminated with Listeria monocytogenes.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Flowing Wells Pure Drinking Water, in 16 ounce and
in 1 gallon plastic containers. Recall #F-016-1.
Code: Lot numbers: 051891, 062591, 062691, 091990, 062690.
Manufacturer: Southern Beverage Packers, Agusta, Georgia.
Recalled by: Manufacturer, by visit October 10, 1990.
Firm-initiated recall ongoing.
Distribution: Georgia, South Carolina, North Carolina.
Quantity: 20,000 gallon bottles and 817 cases of 16 ounce containers
were distributed.
Reason: Product is contaminated with mold.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
NONE
Class III -
EXTENSION NOTE: Conjugated Estrogen Tablets, 0.625 mg, manufactured
by Duramed Pharmaceuticals, Inc., Recall #D-089-1
which appeared in the November 7, 1990 Enforcement
Report has been extended to include the following lot
numbers: 91696, 91707, 91705, 91703, 91695, 92024,
91698, 92304, 92332, 92333, 92337, 92339, 92335, 92349,
92346, 91714, 91716, 91694, 91697, 92338.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Parallel Hole Collimator for Gamma Camera, Siemens
Model ZLC 0.070. 10 mil., 1.0". Recall #Z-083-1.
Code: No lot or serial numbers.
Manufacturer: Nuclear Technologies, Inc., New Haven, Connecticut.
-3-
Recalled by: Manufacturer, by telephone August 27, 1990. Firm-initiated
recall ongoing.
Distribution: Georgia, Ohio.
Quantity: 4 units were distributed.
Reason: Threaded inserts failed in collimator housing causing
collimator to fall off the camera.
----
Product: (a) Pediatric Urine Meter without Catheter;
(b) Pediatric Urine Meter with 5 FR Catheter;
(c) Pediatric Urine Meter with 8 FR Catheter.
Recall #Z-093/095-1.
Code: Catalog No. Lot No.
(a) 153206 76J9X275, 76DA2330
(b) 895605 76D9X246A, 76H9X573
(c) 895608 76J9X277, 76J9X278, 76AA2275, 76DA2329.
Manufacturer: Bard Urological Division, Sonora, Mexico.
Recalled by: C.R. Bard Urological Division, Covington, Georgia, by
telephone September 6, 1990 followed by letter.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 1,255 cases were distributed.
Reason: The product may have blocked drainage tubes which prevents
proper drainage of the bladder.
----
Product: Cobe Precision Pump Rear Panel Breaker/Harness Assembly,
a component of the Cobe Precision Blood Pump, which is a
microprocessor controlled device used to control and
monitor blood flow rates during surgery. Recall #Z-100-1.
Code: Catalog #043600-000, serial numbers:
3105AP 3120AP 3141AR 3151AR
3106AP 3129AR 3143AP 3152AR
3107AP 3130AR 3144AR 3153AR
3108AP 3131AP 3145AR 3154AR
3110AP 3132AR 3146AR 3155AR
3113AP 3133AR 3147AR 3156AR
3114AP 3138AR 3148AR
3116AP 3139AR 3149AR
3117AP 3140AR 3150AR
Manufacturer: COBE Laboratories, Inc. Cardiovascular Division,
Arvada, Colorado.
Recalled by: Manufacturer, by letter October 1, 1990. Firm-initiated
recall ongoing.
Distribution: Utah, California, Illinois, Texas, Georgia, Pennsylvania.
Quantity: 33 pumps were distributed.
Reason: Circuit breaker on the back panel pump is improperly wired
resulting in only one winding of the primary transformer
being connected to main voltage.
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-4-
Product: Hirider Powered Wheelchairs. Recall #Z-112-1.
Code: All serial numbers.
Manufacturer: Retec P.R. Inc., Guayama, Puerto Rico.
Recalled by: Retec USA Inc., Orchard Park, New York, by letter
October 4, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide, Canada, England.
Quantity: 174 units were distributed.
Reason: The wheelchairs are subject to uncommanded movements
due to possible malfunction in the joystick module.
----
Product: IRIS Oculight SL Laser Diode Endophotocoagulator.
Recall #Z-113-1.
Code: Serial numbers: Undetermined.
Manufacturer: Iris Medical Instruments, Inc., Mountain View,
California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan November 6, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 22 units were distributed.
Reason: Device is noncompliant with the Radiation Control for
Health and Safety Act due to the lack of an interlock
at the fiberoptic connector, the lack of a calibration
procedure in the user manual and inappropriate placement of
the noninterlocked protective housing label on the product
housing.
----
Product: R-1000 Automated Reticulocyte Analyzer, a medical laser
product. Recall #Z-114-1.
Code: Serial numbers: Undetermined.
Manufacturer: TOA Medical Electronics, Kobe, Japan.
Recalled by: TOA Medical Electronics (USA), Inc., Los Alamitos,
California. FDA approved the firm's corrective action
plan November 25, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 31 units were distributed.
Reason: The device is noncompliant with the Radiation for
Health and Safety Act in that the units allowed human
access to Class IIIb level of laser light. Also, the
products did not have the correct text on the
noninterlocked protective housing labels, and the user
information did not have the appropriate safety information
and label reproduction.
----
-5-
Product: AMK Total Knee System with Metal Backed Patella
Component, 9.5 mm thick by 38 mm diameter, a sterile
device intended for implant. Recall #Z-118-1.
Code: Product #1488-18-000, lot #668072***, where *** is a
sequential number between 001 through 012.
Manufacturer: DePuy, Inc., Division of Boehringer-Mannheim Corporation,
Warsaw, Indiana.
Recalled by: Manufacturer, by telephone September 10, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 12 units were distributed.
Reason: The device was labeled as product 1488-18 on one end
and product 1488-17 on the other end. The two products
differ in size.
----
Product: Fehling Disposable Bioptome, an endomyocardial
instrument. The recall covers all product licensed to DLP,
Inc. for packaging, sterilizing and distribution. This
includes 10 different model numbers differentiated by shaft
length and cup outside diameter:
Model Number Shaft Cup O.D.
(a) 41116 Disposable Bioptome 510 mm 1.6 MM
(b) 41118 Disposable Bioptome 510 mm 1.8 MM
(c) 41122 Disposable Bioptome 510 mm 2.2 MM
(d) 41216 Disposable Bioptome 800 mm 1.6 MM
(e) 41218 Disposable Bioptome 800 mm 1.8 MM
(f) 41316 Disposable Bioptome 1000 mm 1.6 MM
(g) 41318 Disposable Bioptome 1000 mm 1.8 MM
(h) 41416 Disposable Bioptome 1200 mm 1.6 MM
(i) 41418 Disposable Bioptome 12000 mm 1.8 MM
(j) 41422 Disposable Bioptome 12000 mm 2.2 MM
Recall #Z-121/130-1.
Code: All model numbers and all lot numbers:
Lot numbers: (a) 6890-5002, 6890-7005, 6900-3002, 6900-6001
(b) 6900-1009, 6900-3002
(c) 6890-7008, 6900-3002, 6900-6002, 6900-8001
(d) 6900-3002
(e) 6900-3005, 6900-8001
(f) 6900-3002
(g) 6900-7001
(h) 6890-7008, 6900-3002, 6900-5009
(i) 6900-3002, 6900-8001
Manufacturer: Fehling Medizintechnik GMBh, Karlstein, West Germany.
Recalled by: DLP, Inc., Grand Rapids, Michigan, by telephone
October 3, 1990 followed by letter October 5, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 319 units were distributed; firm estimates 50 units
remain on the market.
-6-
Reason: The jaws of the device will not close after multiple uses
in the same patient because the core wire becomes
disengaged.
----
Product: Insall/Burstein II Modular Knee System, product #5220-31-03,
posterior stabilized series, tibial articular surface, a
component of a knee prosthesis. Recall #Z-151-1.
Code: Lot #69761700.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by letter October 30, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, France, Japan, England, Spain.
Quantity: 59 pieces subject to recall.
Reason: The word "BACK" was incorrectly stamped onto the front
surface of the device.
----
CORRECTION: Respironics BIPAP Ventilatory Support Systems, Airway
Management Systems, and Remote Control Systems,
Recall #Z-054/061-1 which appeared in the November 14,
1990 Enforcement Report should read:
Code: Various serial numbers ranging from 3801 through
and including 5850.
----
Class III -
Product: Sterile Disposable Microhone Needles, Bunnels Straight,
Model 220002. Recall #Z-104-1.
Code: 90D06.
Manufacturer: Richard-Allen Medical Industries, Inc., Richland, Michigan.
Recalled by: Manufacturer, by telephone on or about July 11, 1990.
Firm-initiated recall complete.
Distribution: Michigan, Wisconsin, California, Colorado.
Quantity: 864 needles were distributed.
Reason: The package labeled as Bunnels Straight, Model 220002
but actually contained Model 2222 curved needles.
----
Product: PRO SOL CHX (Chlorhexadine) Antimicrobial Irrigating
Medicament, in 16 ounce bottles, formulated for use with
Cavi-Med System, an Rx product used during dental procedures.
Recall #Z-115-1.
Code: 051490.
Manufacturer: L.D. Caulk Company, Milford, Delaware.
Recalled by: Dentsply International Inc., York, Pennsylvania, by
letter October 3-4, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
-7-
Quantity: 2,532 bottles were distributed; firm estimates 442 bottles
remain on the market.
Reason: Product contains cinnamon oil in the ingredient alcohol
instead of peppermint oil as stated on the label.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: McNess Bulk Custom Dairy Supplement, in 2,000 pound
bags. Recall #V-051-1.
Code: Control #0J890.
Manufacturer: Furst-McNess Company, Freeport, Illinois.
Recalled by: Manufacturer, by telephone October 15, 1990.
Firm-initiated recall ongoing.
Distribution: Illinois.
Quantity: firm estimates 2 bags remain on the market.
Reason: Selenium content is superpotent.
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Class III -
Clarification Note:
Anti-Globulin Control (AGS) Serum, manufactured by
Immuno-Mycologics, Recall #Z-064-1 which appeared in the
November 14, 1990 Enforcement Report should read:
Reason: As a result of a failure in the Anti-Globulin
Control Lot 10IR2, it does not become negative
after the detacher enzyme treatment, thus
making the detacher enzyme appear defective
erroneously.
----
Medical Device Safety Alerts:
Product: Omni-Flow I.V. Pump, Model No. 4000, designed to deliver
up to four different medications either continuously or
intermittently. Safety Alert #M-005-1.
Code: All serial numbers.
Manufacturer: Omni-Flow, Inc., Wilmington, Massachusetts.
Alerted by: Abbott Laboratories, Hospital Products Division, Abbott
Park, Illinois, by letter November 6, 1990.
Distribution: Nationwide, Canada.
Quantity: Approximately 5,000 units were distributed.
-8-
Reason: The infusion pump generates electronic noise, i.e. static
electricity, during operation which may create artifacts
on patient monitoring devices, such as ECG, EMG and EEG
machines. These artifacts, if not recognized as such, may
lead to an erroneous interpretation of the readings from
the patient monitoring.
----
Seizure Actions Filed:
Product: Enriched Rice (90-638-721).
Charge: Adulterated - Product is contaminated with rodent urine.
In addition product was held in a rodent infested warehouse
in bags bearing rodent excreta pellets and rodent urine
stains.
Firm: Havanera Tropical Market Corp., Bronx, New York.
Filed: June 29, 1990 - U.S. District Court for the Southern
District of New York; Civil #90 CIV 4342 (PRL), FDC #65873.
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Product: Curry Powder and Other Foods (90-626-628/90-626-661).
Charge: Products were held under insanitary conditions whereby
they may have become contaminated with filth.
Firm: Glendale Warehouse, Brooklyn, New York/
Manhattan Milling & Drying Co., Brooklyn, New York.
Filed: October 1, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV-90-3391/CV-90-3392,
FDC #65929/65935
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Product: Canned Fish (89-353-331).
Charge: Product was prepared, packed or held under insanitary
conditions whereby it may have been rendered
injurious to health.
Firm: Gold Star Smoked Fish, Brooklyn, New York.
Filed: April 25, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV-90-1404, FDC #65841.
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Product: Sesame Seeds (90-638-673).
Charge: Adulterated - Product was stored in a warehouse with
extensive bird activity.
Firm: Aceste Trucking Company, Brooklyn, New York.
Filed: September 7, 1990 - U.S. District Court for the
Eastern District of New York;
Civil #CV-90-3104, FDC #65907.
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Product: Anaform Femoral Endoprothesis and Tempromandibular Joints
(90-451-984/5).
Charge: Anaform (hip) implant -- Adulterated under 501(f)(1)(B)
in that it is a Class III device distributed without an
approved PMA aand is not exempt from such approval.
Temporomadibular Joints (jaw) implants are misbranded
under 502(j), 502(f)(1) and 502(o) in that they are
dangerous to health when used in the manner or duration
prescribed, recommended, or suggested in the labeling; its
labeling fails to bear adequate directions for use and
failure to file notice under 510(k);
Firm: Novamed, Inc. and Oral Surgery Marketing Inc.,
Houston, Texas.
Filed: September 20, 1990 - U.S. District Court for the Southern
District of Texas, Houston Division; Civil #CA H-90-3000,
FDC #65918.
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Product: Anaform Femoral Endoprothesis (90-451-986).
Charge: Adulterated within 501(f)(1) because they are Class III
devices distributed without premarket approval and they
are not exempt from such approval.
Firm: Novamed, Inc., Houston, Texas.
Filed: September 20, 1990 - U.S. District Court for the
Southern District of Texas, Houston Division;
Civil #CA H-90-3001, FDC #65919.
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Product: Temporomandibular Joints (90-604-175).
Charge: TMJs are misbranded under 502(j), 502(f)(1) and 502(o)
in that they are dangerous to health when used in the manner
or duration prescribed, recommended, or suggested in the
labeling; its labeling fails to bear adequate directions
for use and failure to file notice under 510(k);
Firm: Vitek, Inc., Houston, Texas.
Filed: September 20, 1990 - U.S. District For the Northern
District of Texas, Dallas Division; Civil #CA 3-90-2142-G,
FDC #65920.