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
04/22/1992
Recalls and Field Corrections: April 22, 1992
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.
NONE
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.
Product: Hungry Jack Buttermilk Complete Pancake & Waffle Mix, in
32 ounce boxes. Recall #F-225-2.
Code: C2M13 and C2M16.
Manufacturer: The Pillsbury Company, Murfreesboro, Tennessee.
Recalled by: The Pillsbury Company, Minneapolis, Minnesota, by facsimile
March 24, 1992. Firm-initiated recall ongoing.
Distribution: Indiana, Kentucky, Michigan, New York, Ohio.
-1-
Quantity: 896 cases (12 boxes per case) were distributed.
Reason: Product contains undeclared corn flour.
----
Product: Fruit syrups, in 750 ml and 187 ml glass bottles:
(a) Lime Flavored Fruit Syrup; (b) Lemon Flavored Fruit Syrup;
(c) Kiwi Flavored Fruit Syrup; (d) Mandarino Flavored Fruit
Syrup; (e) Mango Flavored Fruit Syrup; (f) Orange Flavored
Fruit Syrup; (g) Peach Flavored Fruit Syrup; (h) Apricot
Flavored Fruit Syrup; (i) Pineapple Flavored Fruit Syrup;
(j) Passion Fruit Flavored Fruit Syrup. Recall #F-247/256-2.
Code: None.
Manufacturer: R. Torre & Company, Inc., San Francisco, California.
Recalled by: Manufacturer, by letter January 21, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 1,720; (b) 770; (c) 825; (d) 580; (e) 275; (f) 1499;
(g) 1,485; (h) 430; (i) 385; (j) 1,040 cases were distributed.
FDA estimates none remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Vacuum packed Smoked Whitefish, gutted, unskinned fish
individually packed in a vacuum type wrap. Recall #F-257-2.
Code: None.
Manufacturer: Goode Foods, Otto, New York.
Recalled by: Southtowns Seafoods, Inc., Orchard Park, New York.
Firm-initiated recall complete.
Distribution: New York, Pennsylvania.
Quantity: Firm estimates none remains on the market.
Reason: Product was in swollen packages and contained sodium
nitrites.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS
Class I -
NONE
-2-
Class II -
Product: Prescribing Information booklet accompanying the
Copper T Model TCU 380U Intrauterine Copper Contraceptive.
Recall #D-295-2.
Code: Lot numbers: 89569 through 91630. Only portion shipped or
potential of being shipped to Arabic speaking countries.
Manufacturer: Finishing Enterprises, Inc. (FEI), North Tonawanda,
New York.
Recalled by: Manufacturer, by letter March 30-31, 1992. Firm-initiated
field correction ongoing.
Distribution: Egypt, Morocco, Jordan, Israel.
Quantity: Approximately 3,473,100 units were distributed.
Reason: There is an inaccurate translation in the Arabic language
portion of the prescribing information booklet.
----
Product: Artificial Tears with Phenylepherene Ophthalmic Solution,
in 5 ml opaque white plastic squeezable bottles.
Recall #D-298-2.
Code: Lot #18660.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Abita Springs, Louisiana, by
letter December 31, 1991. Firm-initiated recall ongoing.
Distribution: Colorado.
Quantity: 5,392 bottles were distributed.
Reason: Use of unapproved grade of polyvinyl alcohol.
----
Product: Artificial Tears Sterile Ophthalmic Solution, in 15 ml
bottles, a clear solution in white opaque plastic vials with
dropper fitting, under Phoenix Pharmaceutical, Safety Supply
America, Continental Imports, and Maurry Biological labels.
Recall #D-299-2.
Code: Lot #18823 EXP 11/92.
Manufacturer: Walnut Pharmaceuticals, Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter January 10, 1992. Firm-initiated recall ongoing.
Distribution: Missouri, California, Arizona.
Quantity: 18,390 bottles were distributed.
Reason: Current good manufacturing practice deficiencies.
----
Product: Rose Bengal Ophthalmic Solution 1%, in 10 ml opaque white
squeezable plastic bottles with a 5 ml fill, indicated for use
as a diagnostic reagent under Akorn, Eagle Vision, and Wilson
Ophthalmic labels. Recall #D-300-2.
Code: Lot numbers: 18845 EXP 11/91, 18978 EXP 6/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
-3-
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 13, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Tennessee, Louisiana.
Quantity: 15,736 bottles were distributed.
Reason: Product is hypertonic.
----
Product: Sulfa-Prednisolone Acetate Ophthalmic Suspension (predamide),
a white aqueous suspension in an opaque white plastic bottles,
under Akorn, Occusoft, Medical Ophthalmic and Wilson
Ophthalmics labels. Recall #D-301-2.
Code: Lot numbers: 18948 EXP 5/92, 18859 EXP not provided,
19019 EXP 6/92, 19024 EXP 6/92, 19035 EXP 7/92,
19142 EXP 11/92, 19150 EXP 11/92, 19297 EXP 4/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 13, 1991. Firm-initiated recall ongoing.
Distribution: Louisiana, Oklahoma, Florida, Texas.
Quantity: 96,408 bottles were distributed.
Reason: Use of unapproved manufacturing process.
----
Product: Sodium Sulfacetamide Ophthalmic Solution 10%, 2 ml, a
clear colorless solution in a opaque white plastic bottle,
under Akorn label. Recall #D-302-2.
Code: Lot numbers: 18980 EXP 5/93, 19011 EXP not provided.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana,
by letter January 10, 1992. Firm-initiated recall ongoing.
Distribution: Louisiana.
Quantity: 24,486 bottles were distributed.
Reason: Lack of assurance of sterility.
----
Product: Fluorescein/Proparacaine Ophthalmic Solution, a clear
orange to pale yellow solution in a 5 ml amber glass
screw cap bottle, under the Akorn label. Recall #D-303-2.
Code: lot numbers: 18986 EXP 5/92, 19010 EXP 5/92, 19014 EXP 6/92,
19105 EXP 9/92, 19009 EXP 5/92, 19013 EXP 9/92, 19104 EXP 9/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 31, 1991. Firm-initiated recall ongoing.
Distribution: California, Louisiana.
Quantity: 65,697 bottles were distributed.
Reason: Product does not meet pH specifications.
----
Product: AK-Nefrin with Phenylephrine HCl Sterile Ophthalmic
Solution, in 15 ml white squeezable plastic bottles, under
Akorn, Ocusa Eye Drops, De La Cruz PDTS; Ojo De Aguila,
Grandall Distribution labels. Recall #D-304-2.
-4-
Code: Lot #18908 EXP 2/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 13, 1991. Firm-initiated recall ongoing.
Distribution: Louisiana, California.
Quantity: 15,224 bottles were distributed.
Reason: Lack of assurance of sterility.
----
Product: Sodium Chloride Ophthalmic Solution 5%, a clear colorless
solution in 15 ml opaque white plastic bottles, under Akorn,
Medical Ophthalmics labels. Recall #D-305-2.
Code: Lot #19124 EXP 10/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter January 10, 1992. Firm-initiated recall ongoing.
Distribution: Louisiana, Florida.
Quantity: 19,743 bottles were distributed.
Reason: Lack of assurance of sterility.
----
Product: Methylprednisolone Acetate Suspension 40 mg/ml and 80 mg/ml
injection in a clear glass 5 ml vial, under Americal
Pharmaceuticals, URL, In Source, WE Hauck, Stat
Pharmaceuticals, Rugby, Maurry Biological, and Merit
Pharmaceuticals labels. Recall #D-306/307-2.
Code: Lot numbers: 19191 EXP 06/92, 19316 EXP 12/92,
19354 EXP 11/92, 19385 EXP 12/92, 19388 EXP 01/93,
19436 EXP 01/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 13, 1991. Firm-initiated recall ongoing.
Distribution: Virginia, Georgia, Pennsylvania, California.
Quantity: 45,190 bottles were distributed.
Reason: Product does not meet pH specifications.
----
Product: Magnesium Sulfate Injection, 10% ampules, a clear
colorless solution in 20 ml clear glass ampules.
Recall #D-308-2.
Code: Lot #19129 EXP 10/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 31, 1991. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 6,100 ampules were distributed.
Reason: Lack of assurance of sterility.
----
-5-
Product: Fluorescein Injection USP 25%, a deep reddish brown
solution in a 2 ml clear glass ampule. Recall #D-309-2.
Code: Lot numbers: 19146 EXP 10/92, 19156 EXP 10/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana,
by letter December 30, 1991. Firm-initiated recall
ongoing.
Distribution: Louisiana, Canada.
Quantity: 17,724 ampules were distributed.
Reason: Lack of assurance of sterility.
----
Product: Sodium Heparin Injection, USP, 40,000 units per ml, a
clear colorless solution, in 5 ml clear glass vials.
Recall #D-310-2.
Code: Lot #19110 EXP 8/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 13, 1991. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 1,888 vials were distributed.
Reason: Product packaged in unapproved vials.
----
Product: Heparin Sodium Injection 1000 USP units/ml, a clear
colorless solution in clear 30 ml glass vials.
Recall #D-311-2.
Code: Lot numbers: 19092 EXP 9/93, 19128 EXP 10/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by
letter December 31, 1991. Firm-initiated recall ongoing.
Distribution: Louisiana.
Quantity: 14,214 vials of lot 19091 and 13,738 vials of lot 19128.
Reason: Use of unapproved manufacturing process.
----
Product: Effervescent Potassium Tablets, 25 mEq, lime flavored,
individually wrapped in foil packets, in boxes of 30,
100 and 250, an Rx preparation of an oral solution of
potassium for prevention of potassium depletion.
Recall #D-316-2.
Code: Lot LPS10710-1.
Manufacturer: Tower Laboratories Ltd., Centerbrook, Connecticut.
Recalled by: Bajamar Chemical Company, Inc., St. Louis, Missouri
(responsible firm), by telephone April 9, 1992, followed by
letter. Firm-initiated recall ongoing.
Distribution: California, New Jersey, Florida, Rhode Island, Michigan,
Texas, Virginia, South Dakota.
Quantity: 456 30-tablet boxes, 12 100-tablet boxes, and 1 250-tablet
box was distributed.
-6-
Reason: Labeling does not comply with respect to declaration of
Yellow No. 5.
----
Class III -
Product: E-Z-Paque, oral barium sulfate for suspension, in 176 g
cups, used as a testing indicator of gastro-intestinal
problems. Recall #D-296-2.
Code: Lot #TPO-006.
Manufacturer: E-Z-EM, Inc., Westbury, New York.
Recalled by: Manufacturer, by telephone March 23-24, 1992, followed by
letter March 25, 1992. Firm-initiated recall ongoing.
Distribution: Great Britain.
Quantity: 234 cases (36 cups per case) were distributed.
Reason: Some units of the E-Z-Paque were mislabeled as E-Z-HD
(another E-Z-EM barium product).
----
Product: Dexamethasone Tablets, 0.75 mg, in 100 and 1000 tablet
bottles, under the following labels: Richlyn, Parmed
Pharmaceutical, IDE-Interstate, Genetco, URL.
Recall #D-312-2.
Code: Lot numbers: 41920 EXP 7/92, 42812 EXP 10/93.
Manufacturer: Richlyn Laboratories, Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by letter March 25, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 93,400 tablets remain on market.
Reason: Use of unapproved supplier of active ingredient.
----
Product: (a) Methyltestosterone Tablets, 10 mg, oral;
(b) Methyltestosterone Tablets, 10 mg, sublingual;
(c) Methyltestosterone Tablets, 25 mg, oral, under the
following labels: Rugby - 10 mg - oral and sublingual
(100's only); 25 mg - oral
Goldline - 10 mg - oral and sublingual; 25 mg - oral
(all 100's only)
Schein Pharmaceutical- 10 mg - oral and sublingual; 25 mg -
oral (all 100's only)
United Research Laboratories - 10 mg - oral and sublingual;
25 mg - oral (all 100's only)
IDE-Interstate, Inc. - 10 mg - oral and sublingual; 25 mg -
oral (all 100's only)
Major Pharmaceutical - 10 mg - oral and sublingual; 25 mg -
oral (all 100's only)
C.O.Truxton, Inc. - 10 mg - sublingual (1000's only)
Richlyn - 10 mg - oral and sublingual; 25 mg - oral
(all in 100's & 1000's). Recall #D-313/315-2.
-7-
Code: (a) 43084 43005 42865 42643 42546 42307, 42205 42084
41906, 41793, 41770
(b) 43085, 43003, 42551, 42463, 42228, 42147, 41907, 41792
(c) 44084, 44048, 43083, 43004, 42956, 42864, 42716
42642, 42587, 42545, 42498, 42308, 42269, 42204, 42148, 42082
42033, 41939, 41909, 41794, 41690.
Manufacturer: Richlyn Laboratories, Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by letter March 25, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Undetermined.
Reason: Use of unapproved supplier of active ingredient.
----
Product: Various Rx drugs. Recall #D-317-2.
Code: All lots.
Manufacturer: Various.
Recalled by: Morris and Dickson Company, Ltd., Shreveport, Louisiana
(distributor), by letter March 5, 1992. Firm-initiated recall
ongoing.
Distribution: Louisiana, Texas, Arkansas, Oklahoma, Mississippi, Missouri,
Kansas.
Quantity: Unknown.
Reason: Repackaging of products without accompanying prescribing
information inserts.
----
BIOLOGICS
Class I -
NONE
Class II -
Product: Elisa Computer Software, Version 4.6C. Recall #B-250-2.
Code: Product #937988.
Manufacturer: Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
Recalled by: Manufacturer, by letter February 13, 1991. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 73 pieces were distributed.
Reason: Design defect in computer software that could cause the
inadvertent distribution of untested blood and blood
products.
----
Product: Elisa Computer Software, Versions 4.6C, 4.6D, 5.0, and
5.1. Recall #B-251-2.
Code: 937988.
Manufacturer: Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
Recalled by: Manufacturer, by telephone February 28, 1992, followed
by letters of March 3, 1991 and by telefax March 9, 1992.
Firm-initiated recall ongoing.
-8-
Distribution: Nationwide and international.
Quantity: 379.
Reason: Design defect in computer software that could cause the
inadvertent distribution of blood and blood products
inadequately tested for the antibody to human immunodeficiency
virus type 1 (anti-HIV-1).
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-255/258-2.
Code: Unit numbers: (a) 6200452, 6253797, 6312769, 6359583,
6374953, 6393719, 6414431;
(b) 6200452, 6253797, 6312769, 6359583, 6374953, 6393719;
(c) 6374953, 6393719;
(d) 6200452, 6253797, 6312769, 6359583.
Manufacturer: Broward Community Blood Center, Inc., Lauderhill, Florida.
Recalled by: Manufacturer, by letter October 5, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, New York.
Quantity: (a) 7 units; (b) 6 units; (c) 2 units; (d) 4 units.
Reason: Blood products, which tested nonreactive for the
antibody to human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
Class III -
Product: Red Blood Cells. Recall #B-209-2.
Code: Unit numbers 4412564 and 4412721.
Manufacturer: Florida Georgia Blood Alliance, Jacksonville, Florida.
Recalled by: Consignees notified firm by telephone June 13, 1991 and
July 3, 1991. Recall complete.
Distribution: Florida.
Quantity: 2 units.
Reason: Blood products, labeled with incorrect expiration dates,
were distributed.
----
Product: (a) Red Blood Cells; (b) Red Blood Cells, Leukocytes
Removed. Recall #B-211/212-2.
Code: Unit numbers: (a) 1611479, 1620674; (b) 167959, 1676660.
Manufacturer: Palm Beach Blood Bank, West Palm Beach, Florida.
Recalled by: Manufacturer, by telephone March 27, 1991, April 16, 1991,
and by telephone and follow-up letter on December 27, 1991.
Firm-initiated recall ongoing.
Distribution: California, Washington, D.C.
Quantity: 2 units of each component.
-9-
Reason: Blood products, labeled with incorrect expiration dates,
were distributed.
----
Product: Red Blood Cells. Recall #B-231-2.
Code: Unit #68479.
Manufacturer: Metropolitan Washington Blood Banks, Inc., Silver Spring,
Maryland.
Recalled by: Manufacturer, by retrieving the recalled product from the
consignee on August 15, 1991. Recall complete.
Distribution: Washington, D.C.
Quantity: 1 unit.
Reason: Blood product which was labeled with an incorrect expiration
date was distributed.
----
Product: Red Blood Cells. Recall #B-252-2.
Code: Unit #45G77095.
Manufacturer: American Red Cross Blood Services, Waterloo, Iowa.
Recalled by: Manufacturer, by telephone January 16, 1992. Firm-initiated
recall complete.
Distribution: Iowa.
Quantity: 1 unit.
Reason: A unit of Red Blood Cells, labeled with the incorrect
expiration date, was distributed.
----
Product: Anti Human Globulin (anti-IgG), an in-vitro diagnostic
used in the Coombs test. Recall #B-253-2.
Code: Lot #MSGG42-1B.
Manufacturer: Baxter Diagnostics, Inc., Miami, Florida.
Recalled by: Manufacturer, by letter February 6, 1992. Firm-initiated
recall complete.
Distribution: Nationwide, Canada, Australia, Brazil, Spain.
Quantity: 196 packages were distributed.
Reason: Anti-Human Globulin labeled with the incorrect expiration
date was distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Cordis Shuttle Catheters, sterile single lumen catheters
designed to reach cardiovascular system arterial stenoses.
Recall #Z-455-2.
-10-
Code: Catalog numbers: 525-402 and 525-402S - All lots.
Manufacturer: Cordis Corporation, Miami Lakes, Florida.
Recalled by: Manufacturer, by letter June 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Firm estimates none remains on the market.
Reason: The tips may separate from the catheters.
----
Product: Palmaz-Schatz Balloon-Expandable STENT, for the biliary
system, 20 cm length, 2.5 mm diameter, used to maintain patency
of a major bile duct which is obstructed by scar tissue or
impinging tumor. Recall #Z-516-2.
Code: Product #PS20M, Lot #CG068 EXP Use before July '93.
Manufacturer: Johnson & Johnson Interventional Systems Company, Warren,
New Jersey.
Recalled by: Manufacturer, by letter January 23, 1992. Firm-initiated
recall ongoing.
Distribution: New Jersey, Pennsylvania, Maryland, Ohio, Michigan, Illinois,
Wisconsin, Florida, Oklahoma, Minnesota, Kansas, Nebraska,
Nevada, Texas, Colorado, Arizona, California, Washington state,
Oregon, Ireland, Chile.
Quantity: 80 boxes (4 units per box) were distributed.
Reason: Product was distributed without premarket approval authority
for use in the renal arteries.
----
Product: Bateman UPF II Outer Head BiPolar Shell, a component in a
modular hip replacement system, and is produced in a
number of sizes. Recall #Z-554-2.
Code: Catalog #10644, lot #004084.
Manufacturer: Kirschner Medical Corporation, Timonium, Maryland.
Recalled by: Manufacturer, by letter February 13-14, 1992. Firm-initiated
recall ongoing.
Distribution: Illinois, Massachusetts, Tennessee, Florida.
Quantity: 12 units were distributed.
Reason: The labeling on the outside box is incorrect. The label on
the box stated that the product was 46 mm, but the device
was actually 43 mm.
----
Product: Performance Knee Tibial Component Modular Insert.
Recall #Z-555-2.
Code: Catalog #7404-08-072, lot #006475.
Manufacturer: Kirschner Medical Corporation, Timonium, Maryland.
Recalled by: Manufacturer, by letter February 13-14, 1992. Firm-initiated
recall ongoing.
Distribution: California, Pennsylvania, Oregon, Texas, Alabama, France,
Belgium, Holland.
Quantity: 47 units were distributed.
-11-
Reason: The color coding labeling on the outside box is incorrect.
The label on the box stated that the product was 46 mm,
but the device was actually 43 mm.
----
Product: Cordis Hakim Hydrocephalus Valve; Pediatric Shunt System,
an implantable device which serves as a parallel flow pathway
to divert cerebrospinal fluid (CSF) from the cerebral
ventricles to an appropriate drainage site in patients with
hydrocephalus or other conditions in which CSF flow and/or
absorption is impaired. Recall #Z-558-2.
Code: Catalog #908-162, serial numbers: 52894, 52889, 52888.
Manufacturer: Cordis-Biot, Valbonne, France.
Recalled by: Cordis Corporation, Miami Lakes, Florida, by telephone
January 25, 1991. Firm-initiated recall complete.
Distribution: Texas, Florida.
Quantity: 3 units were distributed; firm estimates none remains
on the market.
Reason: Certain body parts are incorrectly fabricated from 316
stainless steel (instead of 304 stainless steel).
----
Product: Karlin Crank Frame Retractor Blades, components of the spinal
retractor set, designed for posterior lumbar and thoracic
surgery. Recall #Z-559-2.
Code: Lot numbers: 60L, 049L, 060L, 90L, 30L, 129L, 109L, 020L,
089L, 69L, and all product that does not bear a lot number.
Manufacturer: T. Koros Surgical Instruments, Moorpark, California.
Recalled by: Karlin Technology, Inc., Torrance, California, by
letter August 23, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 6,619 sets were distributed.
Reason: Some of the welds which hold the blades together may not be
adequate, with the possibility for failure and patient
injury.
----
Product: PCA Two Piece Cup - Low Profile Acetabular Shell, used
for total hip replacement orthopedic implant surgery.
Recall #Z-560-2.
Code: Catalog #6289-5-064, Lot #ACCUAA 9129017.
Manufacturer: Howmedica Division Pfizer Hospital Products Group, Inc.,
Rutherford, New Jersey.
Recalled by: Manufacturer, by telephone January 10, 1992. Firm-initiated
recall complete.
Distribution: New York, Michigan, Nebraska, New Mexico, Georgia, Texas,
Ohio, Canada.
Quantity: 9 units were distributed. Firm estimates none remains
on the market.
-12-
Reason: The package was incorrectly labeled Catalog #6289-5-046,
46 mm size shell, instead of Catalog #6289-5-064, 64 mm size
shell.
----
Product: XT Fixed Height Single Monitor Support, Model 46-240838G1,
used with x-ray systems as a monitoring tool. Recall #Z-563-2.
Code: Supports used on B2056FF (oyster gray) and on B2057FF
(mist gray) systems were affected.
Manufacturer: General Electric Company, Inc., Waukesha, Wisconsin.
Recalled by: Manufacturer, by letter March 16, 1992. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 135 units were distributed.
Reason: The "pivot stud" of the suspension system could shear off
allowing the system to fall onto a patient or operator.
----
Product: Percutaneous Cardiovascular Catheter, Pigtail Curve,
80 cm, 4F, disposable, used for injecting a dye to
diagnose blockage. Recall #Z-565-2.
Code: Catalog #0001-10-1545, lot #134117.
Manufacturer: Universal Medical Instruments Corporation, Ballston Spa,
New York.
Recalled by: Manufacturer, by telephone March 3, 1992, followed by
letter March 4, 1992. Firm-initiated recall ongoing.
Distribution: Michigan, New York, California, Massachusetts.
Quantity: 161 units were distributed; firm estimates 103 units
remain on the market.
Reason: Product may leak at the proximal end of the assembly under
the shrink tube when fluids are injected through the
catheter.
----
Product: Fixed Wing Huber Infusion Sets, a non-coring needle
administration set with a "Y" injection site, under
Medical Specialties and Churchill labels:
(a) Product Nos. MS-425-192, MSNS-425-192 and CHNS-425-192,
19GA x 3/4" long needle;
(b) Product Nos. MS-425-193, MSNS-425-193 and CHNS-425-193,
19GA x 1" long needle;
(c) Product Nos. MS-425-202, MSNS-425-202 and CHNS-425-202,
20GA x 3/4" long needle;
(d) Product Nos. MS-425-203, MSNS-425-203 and CHNS-425-203,
20GA x 1" long needle;
(e) Product Nos MS-425-206, MSNS-425-206 and CHNS-425-206,
20GA x 1 1/4" long needle. Recall #Z-566/570-2.
Code: All lots.
Manufacturer: Nipro Medical Industries, Ltd., Tatebayashi, Gumma, Japan.
Recalled by: Medical Specialties Co., Inc., South Easton, Massachusetts,
by letter March 16, 1992. Firm-initiated recall ongoing.
-13-
Distribution: Nationwide.
Quantity: 21,387 pieces were distributed.
Reason: Cannula separation can occur.
----
Product: Hewlett-Packard Sonos 100, 500 and 1000 Ultrasound Imaging
Systems, used with software revisions B.0 through B.0.2 and
M.0 through M.3.1. Recall #Z-571/573-2.
Code: Model numbers: HP series (a) 77000A; (b) 77025A; (c) 77030A.
Manufacturer: Hewlett-Packard Company, Andover, Massachusetts.
Recalled by: Manufacturer, by letter September 6, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada, Europe, Asia, Latin America.
Quantity: (a) 219 units; (b) 1,721 units; (c) 1,720 units were
distributed. As of 3/5/92 the firm had corrected 1,850
units.
Reason: Software design error may lead to misdiagnosis
resulting in unnecessary invasive procedures when
analyzing mitral valve flow rates.
----
Product: LaserCat L2503 CNC Laser Cutting Center, used for cutting
sheet metal. Recall #Z-575-2.
Code: Serial numbers: Not applicable.
Manufacturer: Trumpf, Inc., Farmington, Connecticut.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
April 3, 1992. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 19 units.
Reason: Noncompliance with the performance standard for laser
products in that the operational and adjustment controls
were not adequately located to prevent the operator from
being exposed to laser beams.
----
Product: MISTI Mammary Prostheses:
(a) MISTI (silicone) Gel-Filled Textured Mammary Prostheses,
all sizes (80-980 cc);
(b) MISTI (silicone) Double-Lumen Textured Mammary Prostheses,
all sizes;
(c) MISTI GOLD Bio-Oncotic Gel Single-Lumen Mammary Prostheses,
all sizes (80-620 cc). Recall #Z-610-612-2.
Code: All lots.
Manufacturer: Biomanufacturing, Inc., Minneapolis, Minnesota.
Recalled by: Bioplasty, Inc., St. Paul, Minnesota, by letter dated
March 10, 1992. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: (a & b) Approximately 50,000 units were distributed;
(c) Unknown.
-14-
Reason: The devices are not approved for marketing.
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Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Banminth 48 Type A Medicated Article, in 50 pound bags,
an anthelmintic for use in swine, under the Pfizer label.
Recall #V-030-2.
Code: Lot numbers: K10735539 and K10735540.
Manufacturer: Pfizer, Inc., Lee's Summit, Missouri.
Recalled by: Manufacturer, by letter February 14, 1992. Firm-
initiated recall complete.
Distribution: North Carolina, Iowa, South Dakota, Nebraska, Tennessee,
Minnesota, Utah.
Quantity: 236 bags were distributed; firm estimates none
remain on the market.
Reason: Product is subpotent.
----
Seizure Actions Filed:
Product: Herbal Shampoo and Herbal Cosmetic Scalp Cleanser
(92-649-597).
Charge: Products are unapproved new drugs.
Firm: Catherine Michael's Hair Salon.
Filed: March 20, 1992 - U.S. District Court for the District of
Massachusetts; Civil #92-10684MA, FDC #66370.
Seized: April 10, 1992 - products and pamphlets valued at
approximately $1,600.
----
-15-
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