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
08/13/1991
Enforcement Report for August 14, 1991
August 14, 1991
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: Fresh Refrigerated Regular Crabmeat, in 1 pound plastic
containers. Recall #F-508-1.
Code: Not coded.
anufacturer: Wicker's Crab and Seafood Company, Portsmouth, Virginia.
Recalled by: Manufacturer, by telephone July 11, 1991. Firm-initiated
recall complete.
Distribution: Virginia.
Quantity: 144 pounds were distributed.
Reason: Product is 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
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Chloroplex Tablets, in 60 tablet bottles, oil soluble
chlorophyll with other factors. Recall #F-509-1.
Code: Lot #18498 EXP 11/92.
anufacturer: V M Nutri, Inc., Batesville, Arkansas.
Recalled by: Multiway Associates, Batesville, Arkansas, by telephone
April 29, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 164 bottles were distributed.
Reason: Product is subpotent in Vitamin A.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Operand Iodine Prep Solution - Povidone Iodine Solution -
Povidone Iodine USP - 1% Available Iodine - Antiseptic/
Microbicide - For Hospital and Professional Use.
Recall #D-514-1.
Code: All product bearing the statement "Dilute to half strength
for ophthalmic use".
anufacturer: Redi Product, Prichard, West Virginia.
Recalled by: General Medical Manufacturing Company, Richmond, Virginia,
by letter May 9, 1991 and July 13, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Firm estimates little to no recalled product remains
on the market.
Reason: Label bears unapproved indication for ophthalmic use.
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Product: Clenbuterol Tablets, 20 mcg, in 50 tablet bottles.
Recall #D-517-1.
Code: None
anufacturer: Nutritional Marketing Inc., Richards Products, Inc.,
Pompano Beach, Florida (distributor).
Recalled by: Distributor, by letter May 2, 1991. Firm-initiated recall
ongoing.
Distribution: North Carolina.
Quantity: 1,527 bottles were distributed.
Reason: Product is an unapproved new drug.
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Product: Human Alpha Interferon. Recall #B-308-1.
Code: Lot numbers 1.2.3.5 and 8.9.13.
anufacturer: National Geno Sciences, Inc., Southfield, Michigan.
Recalled by: Manufacturer, by letter June 2, 1990 followed by letter
June 5, 1990. Firm-initiated recall complete.
Distribution: India.
Quantity: 3,000 vials.
Reason: Interferon that was not approved for human use was
distributed.
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Product: Platelets. Recall #B-358-1.
Code: Unit #3232358.
anufacturer: Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
Recalled by: Manufacturer, by telephone March 11, 1991 and by letter
dated April 12, 1991. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Blood product, which tested repeatably reactive for
the antibody to the hepatitis C virus (anti-HCV), was
distributed.
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Product: Red Blood Cells. Recall #B-359-1.
Code: Unit #S25368.
anufacturer: Mississippi Valley Regional Blood Center, Davenport,
Iowa.
Recalled by: Manufacturer, by telephone May 29, 1991.
Firm-initiated recall complete.
Distribution: Illinois.
Quantity: 1 unit.
Reason: Blood product, which tested non-reactive for the
antibody to the hepatitis C virus (anti-HCV),
but was collected from a donor who previously tested
repeatably reactive for anti-HCV, was distributed.
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Class III -
Product: Rugby brand Calcium Carbonate 10 Grain Tablets, in
1,000 tablet bottles, for the relief of acid
indigestion, heartburn, sour stomach, and upset stomach
associated with these symptoms. Recall #D-515-1.
Code: 3976-0930 EXP 3/93.
anufacturer: Tishcon Corporation, Westbury, New York (bulk)
Recalled by: Manufacturer, by letter July 2, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 3,200 bottles were distributed.
Reason: Product contains foreign niacin tablets.
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Product: Fluocinolone Acetonide USP 0.01% Topical Solution, in
60 ml bottles, an Rx topical product sold under the
Bausch and Lomb brand label. Recall #D-516-1.
Code: Lot #9970 EXP 4/93.
anufacturer: Bausch & Lomb Pharmaceuticals Division, also known as
Pharmafair Inc., Hauppauge, New York.
Recalled by: Bausch & Lomb Pharmaceuticals Division, Tampa, Florida,
by letter June 24, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,379 units were distributed.
Reason: The product was inadvertently labeled as a sterile
topical solution.
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Product: (a) Heparin Lock Flush Solution, USP, 100 USP unit
packages of 50 tubex, 1 ml size;
(b) Heparin Lock flush Solution, USP, 10 USP unit
packages of 50 tubex, 1 ml size. Recall #D-518/519-1.
Code: All codes except lots with the first four digits 2910
and 4915.
anufacturer: Wyeth-Ayerst Laboratories Inc., Radnor, Pennsylvania.
Recalled by: Manufacturer, by visit July 26, 1991 and by letter
July 29, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 606,411 packages were produced; firm estimates
7,500 packages of 50 tubex remain on the market;
(b) 510,410 packages were produced; firm estimates 7,500
packages of 50 tubex remain on the market.
Reason: Products manufactured using procedures pending New
Drug Application supplement approval.
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Product: Red Blood Cells. Recall B-360-1.
Code: Unit #3301267.
anufacturer: Blood Bank of Alaska, Inc., Anchorage, Alaska.
-4-
Recalled by: Consignee notified firm of labeling error February, 22,
1991. Recall complete.
Distribution: Alaska.
Quantity: 1 unit.
Reason: Blood component was distributed labeled with an
incorrect expiration date.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Reflex Model 8220 Multiprogrammable SSIC Pulse
Generator with Telemetry, an implantable pacemaker,
class III critical Rx device. Recall #Z-646-1.
Code: Catalog #031-139. Various specific individual serial
numbers beginning with the letter "A", produced from
January 1989 until May 1990.
anufacturer: Telectronics Proprietary, Ltd., Sydney, Australia.
Recalled by: Telectronics Pacing Systems, Inc., Englewood, Colorado,
by letter April 5, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 1,604 units were distributed.
Reason: The ceramic terminal feedthrough may crack causing
a loss of hermeticity and subsequent loss of output.
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Class II -
Product: Vertical Cassette Stand Model KS80, with automatic
cassette centering and collimator sensing.
Recall #Z-742-1.
Code: Models within serial numbers 100 - 1998.
anufacturer: Hans-Pausch Rontgengeratebau, GMbH.
Recalled by: Pausch Corporation, Little Silver, New Jersey, by
letter October 27, 1987. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Firm estimated 1,146 units remained on market at time
of recall.
Reason: The cassette positioning bar may release inadvertently
and cause injury to the staff or patient.
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Product: SLT Connectors (fiber optic cable adaptors).
Recall #Z-769-1.
Code: Undetermined.
anufacturer: Surgimedics/SLP, Inc., The Woodlands, Texas.
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Recalled by: Manufacturer. FDA approved the firm's corrective
action plan February 21, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 5 units were distributed.
Reason: Noncompliance with performance standard for laser products
in that modifications made to fiber optic connectors owned
by the users to accommodate disposable fiber optic
cables, rendered the required safety interlocks of the host
laser defeated upon removal of the disposable cables.
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Product: Heart/Respiration Monitors:
(a) Model 2000W Heart/Respiration Monitor (Home use) -
Revision G Operator Manual;
(b) Model 2000W Option H Heart/Respiration Monitor
(Hospital use) - Revision E Operator's Manual.
Recall #Z-752/753-1.
Code: Serial numbers: (a) 24136 to 24883 with some sequential
omissions, 3980, 4132, 4135, 20118, 21108, 21398, 22428,
23349, 23625, 23991; (b) 7180 to 7330 with some sequential
omissions, 4579, 4598, 5123, 5517, 6189, 8266.
anufacturer: EdenTec Corporation, Eden Prairie, Minnesota.
Recalled by: Manufacturer, by letter May 13, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada, Germany.
Quantity: 750 manuals were distributed with monitors. An
additional 317 home monitor manuals and 83 hospital
monitor manuals were distributed to customers to
fulfill orders for the manuals only.
Reason: The Operator's Manual covers were switched, which
resulted in manuals with correct cover pages, but
inappropriate text. The cover identifying the manual as
being Revision G for the Model l2000W (home) actually
contains the text of the Revision E manual for the Model
2000W Option H (hospital), and vice versa.
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Product: Toshiba CT Scanner Systems:
(a) Model TCT-80; (b) Model TCT-60AX;
(c) Model TCT-300S; (d) Model TCT-400;
(e) Model TCT-500S; (f) Model TCT-600HQ;
(g) Model TCT-600XT; (h) Model TCT-600S;
(i) Model TCT-900S; (j) Model TSX-001.
Recall #Z-784/793-1.
Code: Serial numbers: Undetermined.
anufacturer: Toshiba America Medical Systems, Inc., Tustin, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan June 14, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
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Quantity: 381 units were distributed.
Reason: Product failed to meet manufacturer's specifications for
computed tomography dose index, failed to provide all dose
measurements required by regulations, and failed to
provide change of accuracy specifications for kVp and mA.
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Product: Tru-Sound Model TS9200 Portable Ultrasound Theraphy Unit
with Applicator Model K003. Recall #Z-800-1.
Code: Serial numbers: Undetermined.
anufacturer: Tru-Trac Theraphy Products, Inc., Temecula, California.
Recalled by: Manufacturer. FDA approved the frim's corrective action
plan June 14, 1991. Firm-initiated field correction
ongoing.
Distribution: California, Colorado, Georgia, Hawaii, Massachusetts,
New York, Pennsylvania, South Carolina, Texas, Virginia,
Canada.
Quantity: 100 units were distributed.
Reason: Noncompliance with performance standards for ultrasonic
radiation-emitting products in that the specifications
of the ultrasonic beams exceed the required limits.
Equipment labeling was also inadequate.
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Product: Abbott IMx CEA (Carcinoemybryonic antigen) Reagent Pack,
used for in-vitro diagnostic testing. Recall #Z-806-1.
Code: List #2272-20, Lot numbers: 50195M100, 50195M101, 50965M200.
anufacturer: Abbott Laboratories, Abbott Park, Illinois.
Recalled by: Manufacturer, by telephone March 20, 1991 and April 3,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,455 kits were distributed; firm estimates none
remains on the market.
Reason: The reagents expiration dating period has been found to
be unstable. This could lead to potential error in
diagnosis and treatment.
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Product: Nephrostomy Drainage Catheters:
(a) Reorder No. PU8.5-38-25-P-40-NCL Cook-Cope Type
Loop Nephrostomy Catheter 8.5 French, 25cm Catheter;
(b) Reorder No. PU10.2-38-25-P-4S-NCL, Cook-Cope Type
Loop Nephrostomy Catheter 10.2 French, 25cm Catheter;
(c) Reorder No. NCL-8.5, 8.5 French Cook-Cope Type
Loop Nephrostomy Set;
(d) Reorder No. NCL-10.2 French Cook-Cope Type
Nephrostomy Set. Recall #Z-883/886-1.
Code: Lot numbers: (a) 284693 through 284698, 285855 through
285860, 288301 through 288306, 289644 through 289648,
291779, 291780, 292872, 293925, 293927, 297382, 297384,
297386, 297389, 297391, 297394;
-7-
(b) 284685 through 284688, 285845, 285846, 285847, 296190,
287124 through 287127, 288296 through 288299, 289630,
289631, 289632, 289633, 290717 through 290720, 291765,
291766, 291768, 292860, 292861, 292862, 292863, 296189;
(c) 283515, 284680, 284681, 287119, 287120, 288294, 288294A,
288295, 292855, 292856, 297373, 297373A,;
(d) 283511, 285839, 285840, 288291, 288292, 288292A,
289624, 289625, 289625A, 291761, 291762, 292853, 292853A,
292853B, 292853C.
anufacturer: William Cook Europe A/S, Denmark.
Recalled by: Cook, Inc., Bloomington, Indiana, by letter May 17, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 3,735 units were distributed.
Reason: Leakage may occur around the exit site of the drawstring.
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Product: Occucoat Ophthalmic Surgical Aid, 20 mg/ml, sterile
solution, contained in a 1 ml single-use syringe, an Rx
ophthalmic surgical aid for use in anterior segment surgery
introduced via syringe/cannula/needle. Recall #Z-887-1.
Code: Lot #M325HB 8.92.
anufacturer: Sterling Drug, Inc., McPherson, Kansas.
Recalled by: Storz Ophthalmics, Inc., Clearwater, Florida, by letter
dated July 3. 1991. Firm-initiated recall ongoing.
Distribution: Florida, Texas, Arizona, California, Vinezuela, Chile,
Colombia, Germany, Australia, Guatemala, Puerto Rico,
Brazil, Argentina.
Quantity: 6,478 units were distributed.
Reason: Filters used in processing the device failed post processing
membrane integrity testing. The product may not be sterile.
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Product: Contraceptive Latex Diaphragms, all sizes:
(a) Koromex Coil Spring Diaphragm;
(b) Koro-Flex Arcing Diaphragm. Recall #Z-889/890-1.
Code: Lot numbers: (a) 330, 340, 350, 360, 370, 390, 400, 410,
420, 430M, 440, 0450, 490M;
(b) 280, 300, 430, 470, 490, 500.
anufacturer: Schmid Laboratories, Anderson, South Carolina.
Recalled by: London International US Holdings, Inc., Sarasota,
Florida, by telephone beginning April 20, 1991 followed
by letter April 29, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, England, Canada.
Quantity: Approximately (a) 24,258 units; (b) 5,543 units were
distributed; firm estimates 4,585 units remain on the
market.
Reason: Latex tearing at seam near spring mechanism of the
device.
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Product: GS-1002 Grasping Forcep with Ratchet Handle.
Recall #Z-888-1.
Code: None.
anufacturer: Trimed, Warsaw, Indiana.
Recalled by: Solos Endoscopy, Duluth, Georgia, by telephone and by
letter April 24, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 142 units were distributed.
Reason: The black coating used on the barrel of the instrument
may flake off during use into the patient or during the
sterilization process.
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VETERINARY PRODUCTS
NONE
edical Device Safety:
Product: Hope III Resuscitator, a manually operated resuscitator
used for emergency treatment of victims suffering from
respiratory failure:
(a) Pediatric Version;
(b) Adult Version. Safety Alert #M-027/028-1.
Code: All units.
anufacturer: Matrx Medical, Inc., Orchard Park, New York.
Alerted by: Manufacturer, by letter May 24, 1991.
Distribution: Nationwide and international.
Quantity: 25,601 units were distributed.
Reason: The patient valve of the Hope III Resuscitator is
subject to sticking and blocking exhalation as the
result of improper cleaning.