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
10/02/1990
FDA Enforcement for the week of October 3, 1990
FDA ENFORCEMENT REPORT
FOR OCTOBER 3, 1990
October 3, 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: Salt-Cured, Smoked and Air dried Uneviscerated Smoked
Herring, packed in either cardboard boxes containing
eight 2-pound packages per carton or wood boxes containing
18 smoked unenviscerated herring per box. Recall #F-608-0.
Code: Not coded.
Manufacturer: McCurdy Fish Company, Lubec, Maine.
Recalled by: Manufacturer, by telephone May 28, 1990. Firm-initiated
recall ongoing.
Distribution: South Carolina.
Quantity: Firm estimates 60 boxes/cartons remain on the market.
Reason: Potential Clostridium Botulinum Toxin contamination.
----
-1-
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: Fresh Apricots in 12 or 24 pound shipping cartons.
Recall #F-600-0.
Code: All cartons bearing the grower number 70 located on one
end panel.
Manufacturer: Stadelman Fruit, Inc., Yakima, Washington.
Recalled by: Manufacturer, by telephone July 30, 1990. Firm-initiated
recall ongoing.
Distribution: Iowa, North Dakota, Wisconsin, Canada.
Quantity: 1,600/12 pound cases and 1,104/24 pound cases were
distributed.
Reason: Product contains chlorothalonil in excess of tolerance.
----
Product: Top Seed Mauby Cordial, in 500 ml. bottles. Recall #F-601-0.
Code: Not coded.
Manufacturer: National Fruit Processors, Ltd., Trinidad and Tobago.
Recalled by: New Maras West Indian Market, Brooklyn, New York, by
posting signs in its' retail establishments July 17, 1990.
Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 120 bottles were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Turban Madras Curry Powder in 85 gram cellophane bags.
Recall #F-602-0.
Code: Not coded.
Manufacturer: Turban Brand Products Ltd., Trinidad, West Indies.
Recalled by: New Maras West Indian Market, Brooklyn, New York, by
posting signs in its' retail establishments July 17, 1990.
Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 1,600 bags were distributed; firm estimates 5 percent
remain on market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Superior Coffee & Foods brand (a) Egg Pancake Mix,
in 5 pound multi-layer paper sacks;
(b) Buttermilk Pancake Mix, in 5 pound multi-layer sacks.
Recall #F-613/614-0.
Code: All lots distributed before 7/24/90 or code 205--
The first 3 digits of the code represent the Julian
date followed by a 2 digit batch number.
-2-
Manufacturer: Foxtail Farms, Cincinnati, Ohio.
Recalled by: Manufacturer, by telephone July 24, 1990. Firm-initiated
recall ongoing.
Distribution: Illinois, Michigan, Indiana, Wisconsin, Ohio, Pittsburgh,
Minnesota, California.
Quantity: (a) 344 cases; (b) 904 cases were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
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 AND BIOLOGICS
Class I -
NONE
Class II -
Product: Various Rx products:
(a) Carisoprodol Compound 200 mg Tablets, used as a muscle
relaxant, in bottles of 100, 500 or 1,000 tablets; under the
following labels: Vita-Rx, Geneva Generics, American
Preferred Pharm, H.L. Moore Drug Exchange, Glenlawn, Bioline
Laboratories, Parmed Pharmaceuticals, Schein
Pharmaceuticals, Goldline Laboratories, Rugby Laboratories,
IDE-Interstate, Best Generics, Bolar Pharmaceutical,
Dixon-Shane, Harber Pharmaceutical, The Arkansas Cooperative
Association, Genetco, Major Pharmaceutical;
Procainamide HC1 Tablets, a sustained release drug used in
the treatment of ventricular arrhythmias, in bottles of
100, 250, 500 or 1,000 tablets:
(b) Procainamide HC1 SR 250 mg Tablets, under the
following labels: Bolar Pharmaceutical, Rugby Laboratories,
Parmed Pharmaceuticals, Best Generics, Harber
Pharmaceutical, Goldline Laboratories, Reid-Rowell,
IDE-Interstate, Squibb-Mark;
(c) Procainamide HC1 SR 500 mg Tablets, under the following
labels: Parmed Pharmaceutical, Glenlawn, Genetco, Geneva
Generics, Bioline Laboratories, Qualitest Products,
Dixon-Shane, H.L. Moore Drug Exchange, Major Pharmaceutical,
Rugby Laboratories, Best Generics, Harber Pharmaceutical,
Bolar Pharmaceutical, Goldline Laboratories, Reid-Rowell,
IDE-Interstate, Squibb Mark;
-3-
(d) Procainamide HC1 SR 750 mg Tablets, under the following
labels: Major Pharmaceutical, H.L. Moore Drug Exchange,
Best Generics, Rugby Laboratories, Parmed, Qualitest
Products, Bolar Pharmaceutical, Glenlawn, Genetco, Baxter
Healthcare, Squibb-Mark, Reid-Rowell, Geneva Generics;
Methocarbamol, used to relieve painful musculo-skeletal
conditions, in bottles of 100, 500 or 1,000 tablets, under
the following labels: Bolar Pharmaceutical, Harber
Pharmaceutical, Major Pharmaceutical, Parmed
Pharmaceuticals, Best Generics, Bioline Laboratories,
American Preferred Pharmaceutical, Vita Rx, Genetco, IDE
Interstate, J.J. Balan, Goldline Laboratories, UDL
Laboratories:
(e) Methocarbamol 750 mg Tablets;
(f) Methocarbamol 500 mg Tablets;
Propranolol HCl, an antihypertensive in bottles of 100,
500 and 1,000 tablets:
(g) Propranolol HC1 10 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical,
American Preferred Pharmaceutical;
(h) Propranolol HC1 20 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical,
American Preferred Pharmaceutical, Squibb-Mark;
(i) Propranolol HC1 40 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical,
American Preferred Pharmaceutical, Squibb-Mark;
(j) Propranolol HC1 60 mg Tablets, under the following
labels: Squibb-Mark;
(k) Propranolol HC1 80 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical,
American Preferred Pharmaceutical, Squibb-Mark;
Tolazamide, a hypoglycemic agent for diabetes, in bottles
of 100, 200, 500, or 1,000 tablets:
(l) Tolazamide 100 mg Tablets, under the following labels:
Bolar Pharmaceutical, Best Generics, Genetco;
(m) Tolazamide 250 mg Tablets, under the following labels:
Bolar Pharmaceutical, Best Generics, Genetco, American
Preferred Pharmaceutical, Squibb-Mark;
(n) Tolazamide 500 mg Tablets, under the following labels:
Bolar Pharmaceutical, Best Generics, Genetco, UDL
Laboratories;
(o) Metoclopramide HCL, 10 mg, used to relieve symptoms of
gastro-esophageal reflux, in bottles of 100, 500, or 1,000
tablets, under the following labels: Bolar Pharmaceutical,
American Preferred Pharmaceutical;
-4-
Timolol Maleate, an antihypertensive, in bottles of
100, 250, 500 or 1,000 tablets:
(p) Timolol 5 mg Tablets, under the following labels:
Bolar Pharmaceutical, Parmed Pharmaceuticals, Rugby
Laboratories, Bioline Laboratories, Schein Pharmaceutical,
Qualitest Products, Goldline Laboratories, Warner Chilcott
Labs, Major Pharmaceutical, Best Generics;
(q) Timolol 10 mg Tablets, under the following labels:
Bolar Pharmaceutical, Parmed Pharmaceuticals, Rugby
Laboratories, Schein Pharmaceutical, Qualitest Products,
Goldline Laboratories, Warner Chilcott, Major
Pharmaceutical, Best Generics;
(r) Timolol 20 mg Tablets. Recall #D-372/389-0.
Code: All lots within expiration date.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: Manufacturer, by letter August 23, 1990 and addendum
August 27, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: Firm estimates the following amounts remain on market:
(a) 6,053,775 tablets;
(b) 2,069,775 tablets;
(c) 11,463,875 tablets;
(d) 5,784,762 tablets;
(e) 4,215,225 tablets;
(f) 1,252,500 tablets;
(g) 3,327,125 tablets;
(h) 5,065,500 tablets;
(i) 4,438,950 tablets;
(j) 125,000 tablets;
(k) 847,875 tablets;
(l) 155,825 tablets;
(m) 2,364,875 tablets;
(n) 144,025 tablets;
(o) 1,161,825 tablets;
(p) 327,950 tablets;
(q) 1,030,375 tablets;
(r) 230,675 tablets.
Reason: Carisoprodol Compound, Procainamide HC1 SR and
Methocarbamol Tablets are being recalled due to
lack of assurance that the products were
manufactured in conformity with the conditions
approved in their ANDAs, and Propranolol HC1,
Tolazamide, Metoclopramide HC1 and Timolol
Maleate are being recalled because
bioequivalence cannot be assured.
----
Product: (a) Cal-Ban 3000 Tablets; (b) Cal-Ban 3000 Caplets, in
474 caplet and 440 tablet bottles, an OTC product promoted
for weight control and contains 500 mg of guar gum,
distributed by Anderson Pharmacals. Recall #D-402/403-0.
-5-
Code: All Lots.
Manufacturer: Not determined.
Recalled by: General Nutrition Corporation, Pittsburgh, Pennsylvania,
by memorandum August 31, 1990. Firm-initiated recall
ongoing. See also FDA press release P90-39, July 27, 1990.
Distribution: Nationwide.
Quantity: 121,451 units were distributed.
Reason: Products were marketed without new drug approval. Reports
of esophaegeal obstruction.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Cryoprecipitate;
(f) Recovered Plasma. Recall #B-212/217-0.
Code: Unit numbers: (a) 23F85613, 23F89133, 23F90202, 23F99202;
(b) 23F00322, 23F00656, 23F00952, 23F01366,
23F01422, 23F79369, 23F80795, 23F82308, 23F82353, 23F83552,
23F84247, 23F84258, 23F84578, 23F85127, 23F85183, 23F85459,
23F86284, 23F86466, 23F86592, 23F86693, 23F87135, 23F87916,
23F88043, 23F88989, 23F89233, 23F89776, 23F90107, 23F90168,
23F90707, 23F91629, 23F91848, 23F91972, 23F91980, 23F92033,
23F92238, 23F93119, 23F93183, 23F93621, 23F93672, 23F93967,
23F95288, 23F95589, 23F96395, 23F96491, 23F96787, 23F96843,
23F98259, 23F98594, 23F99195, 23G37980, 23G39142, 23G40303,
23G40311, 23G42455, 23G42920, 23G42922, 23G44224, 23G44723,
23G45665, 23G45923, 23G48495, 23G49443, 23G53291, 23G54460,
23G54745, 23G56618, 23G58604, 23G59117, 23G62669, 23G63911,
23G64593, 23G64901, 23G65323, 23G66183, 23G66845, 23G67312,
23G67325, 23G68381, 23G68651, 23G68742, 23H00342, 23H02316,
23H02626, 23H03998, 23H04009, 23H05008, 23H06662, 23H07851,
23H08141, 23H08345, 23H94467, 23H95070, 23H95086, 23H95450,
23H95922, 23H98108, 23H98570, 23H98796, 23H99976, 23K18432,
23K22930, 23K23513, 23K25206, 23K25610, 23K29558, 23T01777,
23T02155, 23T03244, 23T04859, 23T05624, 23T10403, 23T11097,
23T17237, 23T19145.
(c) 23F00322, 23F00656, 23F01422, 23F79369, 23F80795,
23F82308, 23F82353, 23F83552, 23F84247, 23F84258, 23F84578,
23F85127, 23F85183, 23F87135, 23F86284, 23F86466, 23F86693,
23F87916, 23F88043, 23F89233, 23F90107, 23F91848, 23F91972,
23F91980, 23F92238, 23F93119, 23F93183, 23F93621, 23F93672,
23F93967, 23F95288, 23F95589, 23F96395, 23F96491, 23F96787,
23F96843, 23F98259, 23F98594, 23F99195, 23G37980, 23G40303,
23G40311, 23G45665, 23G48495, 23G54745, 23G56618, 23G58604,
23G64901, 23G65323, 23G67312, 23G68381, 23G68651, 23G68742,
23H00342, 23H02316, 23H06336, 23H07851, 23K25610, 23K29558,
23T01777, 23T02155, 23T04859, 23T05624, 23T11097.
-6-
(d) 23F00322, 23F01422, 23F84578, 23F89233,
23F90107, 23F91972, 23F93672, 23G42920, 23G42922, 23G44723,
23G48495, 23G56618, 23G63911, 23G66845, 23G68172, 23G68742,
23H95922, 23T04859.
(e) 23G49443, 23G59117, 23G62669, 23H08345,
23K23513.
(f) 23F00656, 23F00952, 23F01366, 23F79369,
23F80795, 23F82308, 23F82353, 23F83552, 23F84247, 23F84258,
23F85127, 23F85183, 23F85459, 23F86284, 23F86466, 23F86592,
23F86693, 23F87135, 23F87916, 23F88043, 23F88989, 23F89776,
23F90168, 23F90707, 23F91629, 23F91848, 23F91980, 23F92033,
23F92238, 23F93119, 23F93183, 23F93621, 23F93967, 23F95288,
23F95589, 23F96395, 23F96491, 23F96787, 23F96843, 23F98259,
23F98594, 23F99195, 23G37980, 23G39142, 23G40303, 23G40311,
23G42455, 23G44224, 23G45665, 23G45923, 23G49443, 23G50522,
23G53291, 23G54460, 23G54745, 23G58604, 23G59117, 23G62669,
23G64593, 23G64901, 23G65323, 23G66183, 23G67312, 23G67325,
23G68381, 23G68651, 23H00342, 23H02316, 23H02626, 23H03998,
23H04009, 23H05008, 23H06662, 23H06336, 23H07851, 23H08141,
23H08345, 23H94467, 23H95070, 23H95086, 23H95450, 23H98108,
23H98570, 23H98796, 23H99976, 23K18432, 23K22930, 23K23513,
23K25206, 23K25610, 23K29558, 23T01777, 23T02155, 23T03244,
23T05624, 23T10403, 23T11097, 23T14086, 23T17237, 23T19145.
Manufacturer: American Red Cross Blood Services, Asheville Region,
Asheville, North Carolina.
Recalled by: Manufacturer, by letters of November 2, 4, 21, 28, 1989,
December 1, 20, 29, 1989 and January 29, 1990.
Firm-initiated recall complete.
Distribution: North Carolina, California, Florida, Michigan.
Quantity: (a) 4; (b) 114; (c) 64; (d) 18; (e) 5; (f) 100
units were distributed.
Reason: Blood products which tested non-reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1)
were distributed, but were collected from donors
who previously tested repeatably reactive for
anti-HIV-1.
----
Class III -
Product: Levophed brand of Norepinephrine Bitartrate Injection,
in 4 ml ampuls, an Rx inotropic stimulator of the heart
and dilator of coronary arteries. Recall #D-370-0.
Code: Lot #M255FD.
Manufacturer: Winthrop Pharmaceuticals, New York, New York.
Recalled by: Manufacturer, by telephone June 20, 1990. Firm-initiated
recall ongoing.
Distribution: Maryland.
Quantity: 100 units of 10 ampuls each were distributed.
Reason: Some units reveal cracks in ampuls.
----
-7-
Product: Nystatin Vaginal Tablets, 10,000 units, in boxes of 15 and
30 individually foiled wrapped tablets, an Rx drug for
treatment of vulvovaginal candidiasis, under the Lemmon
Bioline and Goldline labels. Recall #D-371-0.
Code: Lot #6354 EXP 2/92.
Manufacturer: Lemmon company, Sellersville, Pennsylvania.
Recalled by: Manufacturer, by letter September 11, 1990. Firm-initiated
recall ongoing.
Distribution: Nstionwide.
Quantity: 16,254 boxes of 15 and 4,248 boxes of 30 were distributed.
Reason: Subpotency.
----
Product: Margon brand herbal teas packed in plastic bags within
paper boxes labeled to contain 2-1/2 ounces, OTC products
with the following names and medical conditions for which
they are promoted:
(a) Artritecil - arthritis;
(b) Colestrocil - high and uncontrollable cholesterol;
(c) Corazoncil - coronary conditions;
(d) Delgadita - weight loss;
(e) Diabecil - diabetes;
(f) Ovariocil - Ovary/uterus problems;
(g) Pancrecil - pancreas problems;
(h) Potentecil - sexual impotence;
(i) Rinocil - kidney problems;
(j) Riumacil - rheumatism. Recall #D-390/399-0.
Code: All lots.
Manufacturer: Margon Herbal Products Company, San Antonio, Texas.
Recalled by: Manufacturer, by visit between August 1 and 8, 1990.
Firm-initiated recall complete.
Distribution: Texas.
Quantity: 8,012 boxes were distributed; firm estimates none
remains on market.
Reason: False and misleading medical claims and lack of all
mandatory labeling.
----
Product: Medical Oxygen Gas USP, in sizes E, D, Q, DEY, S, LK and T
metal cylinders, an Rx product. Recall #D-400-0.
Code: All lots manufactured prior to July 6, 1990.
Manufacturer: Louisiana Welding Supply Company, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by letter July 9, 1990. Firm-initiated
recall ongoing.
Distribution: Louisiana.
Quantity: Firm estimates 75 cylinders (various sizes) remain
on market.
Reason: Current good manufacturing practice deficiencies.
----
-8-
Product: Acetaminophen (APAP) USP, bulk powder in 50 kg containers,
an OTC drug raw material under the Monsanto label.
Recall #D-401-0.
Code: Lot #LKAP-09-825.
Manufacturer: Monsanto Company, Luling, Louisiana.
Pharma Tech Industries, Inc., Union, Missouri (repacker).
Recalled by: Monsanto Company, St. Louis, Missouri, by telephone on or
about January 18, 1989. Firm-initiated recall complete.
Distribution: United Kingdom.
Quantity: 100 drums were distributed; firm estimates none remains
on market.
Reason: Adulteration with foreign material, (e.g., cardboard,
wood, plastic, fibers).
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-163/167-0.
Code: All units processed from February 14 through March 30, 1990.
Manufacturer: J.K. and Susie L. Wadley Research Institute and Blood Bank,
doing business as The Blood Center at Wadley, Dallas, Texas.
Recalled by: Manufacturer, by telephone April 6, 1990 followed by letter.
Firm-initiated recall ongoing.
Distribution: Transfusable components were distributed in Texas and
New York; recovered Plasma distributed in Texas.
Quantity: (a) 1,099; (b) 595; (c) 92; (d) 88; (e) 614 units were
distributed.
Reason: Blood products collected into blood bags possibly
adulterated with particulate matter were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Sentry III Collimators, Model 46-233686, used for
diagnostic fluoroscopic examinations. Recall #Z-889-0.
Code: Model 46-233686.
Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan on or about August 7, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 863 units were distributed.
Reason: Noncompliance with performance standard for x-ray
products due to leakage radiation from the diagnostic
source assembly.
----
-9-
Product: Whiteside Ortholoc Modular Femoral Holder/Driver,
an Rx orthopedic device used to implant the femoral
prosthesis into the femur during knee stabilization
procedures. Recall #Z-890-0.
Code: Catalog #1871-0180, lot numbers: 060M461860, 060M461861,
070M473930.
Manufacturer: Dow Corning Wright, Arlington, Tennessee.
Recalled by: Manufacturer, by electronic mail message August 24, 1990,
followed by telephone August 27, 1990. Firm-initiated
recall ongoing.
Distribution: California, Colorado, Iowa, Kansas, Louisiana, Missouri,
New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania,
Tennessee, Texas, Virginia, Washington state.
Quantity: 45 units were distributed; firm estimates 43 remain in
trade channels.
Reason: The tabs that hold the femoral implant at the end of
the condylar notch may break off during surgery.
----
Product: G.E. Signa brand Magnetic Resonance Imaging System,
a restricted device designed for diagnostic imaging
of the human body. Recall #Z-896/897-0.
Code: (a) Model 46-243180 G (1, 2 or 3);
(b) Model 46-271752 G (1 or 2).
Manufacturer: General Electric, Medical Systems, Waukesha, Wisconsin.
Recalled by: Manufacturer, by visit April 1989 (survey evaluation) and
April 1990 (modification of selected sites). Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 135 units are subject to modification.
Reason: The helium venting systems may rupture during a quench of
the cryogenically cooled superconducting magnet. The vent
rupture may lead to helium being vented into the scan room
and exposing individuals to frost bite or asphyxiation.
----
Product: G.E. Emergency Rundown Unit (ERU) incorporated into
G.E.'s Signa brand Magnetic Resonance Imaging System.
Recall #Z-898-0.
Code: Model numbers Phase 1 -- all serial numbers;
Phase 2 All Signa**Systems shipped before March 1, 1989
with the following GE Magnetic Model numbers:
Model No. Magnet Type Model No. Magnet Type
46-209910G1 S-I 46-260531G3 S-I
46-209910G2 S-I 46-260531G120 S-I
46-209910G3 S-I 46-260531G130 S-I
46-209910G4 S-I 46-260531G150 S-I
46-260266G3 S-I 46-260531G160 S-I
46-260266G4 S-I 46-260531G170 S-I
46-260266G300 S-I 46-260805G1 S-II
-10-
46-206531G1 S-I 46-206805G2 S-II
46-260531G2 S-I 46-281380G1 S-III,
Serial numbers: 670001-670201, C001-C043, C045-C060,
C062-C077, C079-C108, C112-C113, D001-D004, D006-D018,
D020-D028, D031-D038.
Manufacturer: General electric Company, Waukesha, Wisconsin.
Recalled by: Manufacturer, by visit on or about September 1989.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 258 sites of Phase 1 and 219 sites of Phase 2 were
distributed.
Reason: Device may cause the cryogenically cooled super-
conducting magnet to quench. If the vent system fails,
helium may be vented into the scan room providing a
potential for frost bite or asphyxiation.
----
Product: Sentry III Collimators:
(a) Models 46-194750G1 and G50;
(b) Model 46-19495G1;
(c) Model 46-194765G1 and G2;
(d) 46-194769G1;
(e) 46-194770G1;
(f) 46-233767G1. Recall #Z-899/904-0.
Code: Serial numbers none indicated.
Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan September 4, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,200 units were distributed.
Reason: Noncompliance with performance standard for x-ray
products in that the device's numerical field size
indication may be in error by more than 2% of the SID.
----
Product: GE Signa brand Magnetic Resonance Imaging System utilizing
an Oxford-brand Superconducting Magnet. Recall #Z-908-0.
Code: All Signa Systems with the following Oxford Magnet model/
serial numbers:
Model No. Serial No. Model No. Serial No.
46-235706P20 40373 46-235706P20 40381
46-235706P20 40386 46-235706P20 40926
46-235706P200 40355 46-235706P200 40362
46-235706P200 40638 46-235706P200 40377
46-235706P200 40379 46-235706P200 40393
46-235706P200 40398 46-235706P200 40404
46-235706P200 40410 46-235706P200 40412
46-235706P200 40416 46-235706P200 41378
46-235706P201 40396 46-235706P202 40369
46-235706P202 40401 46-235706P202 40925
46-235706P202 41382 46-235706P202 41480
-11-
46-235706P202 41500 46-235706P202 41501
46-235706P202 41503 46-235706P202 41505
46-235706P202 41743 46-235706P202 41763
46-235706P202 41767 46-255952G1 40376
46-255952G1 40922 TC630709 40952
TC630709 41880 TC630709 43319
TC630941 41215 TC630941 41295
TC630941 41631 TC630941 41981
TC630941 43321.
Manufacturer: Oxford Magnet Technology, Oxford, England.
Recalled by: General Electric - Medical Systems, Waukesha, Wisconsin.
Firm initiated field modification instruction (FMI)
60191, September 1988. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Saudi Arabia.
Quantity: 44 systems were distributed.
Reason: Corrosion in the aluminum o-rings due to moisture build-up
may increase the probability of quenching due to loss
of vacuum.
----
Product: Lloyd brand chiropractic tables:
(a) Galaxy 900 HS Electric Height Selector Adjusting Table;
(b) Galaxy HYLO Hydraulically Controlled Adjusting Table.
Recall #Z-905/906-0.
Code: Serial numbers 33803 to 34676. Tables produced from
March 3, 1989 to January 30, 1990.
Manufacturer: Lloyd Table Company, Lisbon, Iowa.
Recalled by: Manufacturer, by letter July 2, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and international.
Quantity: 222 beds were distributed.
Reason: A cylinder Pin that attaches the vertical lift/tilt
cylinder which raises/lowers the bed is not secured
adequately and can come out of position, allowing the
bed to fall.
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Product: (a) White Polyethylene Angiographic P5.OB, DP5.0B
Catheters; (b) 5.0 French and Part-5.OB Bulk Tubing.
Recall #Z-909/910-0.
Code: All lot numbers manufactured from November 1986 to July
18, 1990.
Manufacturer: Cook, Inc., Bloomington, Indiana.
Recalled by: Manufacturer, by letter July 24, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 134, 016 units were distributed.
Reason: The catheter and tubing may become brittle after
prolonged exposure to fluorescent lighting which could
cause the catheter to partially or fully break during
use within the patient's vascular system.
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-12-
Class III -
Product: (a) Bardex Red Latex Double Balloon (40cc - 20cc)
Hemostatic catheter (Coleman Model);
(b) Bardex Continuous Irrigation 30cc red Latex
Catheter (Hotter Model). Recall #Z-705/706-0.
Code: Catalog No. Lot No.
(a) 601622 39J9B045
(b) 600322 39J9B045.
Manufacturer: C.R. Bard Urological Division, Covington, Georgia.
Recalled by: Manufacturer, by telephone and by letter June 11, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Japan.
Quantity: (a) 720 (b) 432 units were distributed.
Reason: The two products were mixed up during manufacturing
and were subsequently mislabeled.
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Product: Handi-Vak II disposable collection units (DCU), used to
collect drainage fluids and materials from patients:
(a) Catalog No. 20-05-0001, 2, 400 ml DCU, DISS-Type
(top fitting type), packed 54/case;
(b) Catalog No 20-05-0002, 2, 400 ml DCU, stem type
fitting, packed 54/case;
(c) Catalog No 20-05-0003 1, 500 ml DCU, stem type
fitting, packed 64/case;
(d) Catalog No 20-05-0004 1, 500 ml DCU; DISS Type
fitting, packed 64/case. Recall #Z-884/887-0.
Code: All lot numbers.
Manufacturer: Mitchell Plastics, Inc., Indianola, Pennsylvania.
Recalled by: Allied Healthcare Products, Inc., St. Louis, Missouri, by
letter August 3, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 119; (b) 69; (c) 96; (d) 625 cases were distributed.
Reason: Units may implode or break out upon application of
vacuum.
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Product: Right Atrial Catheter Raaf Dual Lumen 4.5 mm Catheter,
intended for long term vascular access. Recall #Z-892-0.
Code: Part #14525-001, lot #401646-89042.
Manufacturer: Quinton Instrument Company, Seattle, Washington.
Recalled by: Manufacturer, by telephone and by FAX on or about
August 15, 1990. Firm-initiated recall ongoing.
Distribution: North Carolina, Florida, Iowa, Massachusetts, Minnesota,
Illinois, Kansas, Louisiana, Oregon, Washington state,
Canada, Spain, Ireland, Germany.
Quantity: 132 units were distributed.
-13-
Reason: Mislabeling -- Raaf Dual Lumen Catheter labeled as
Mahurkar 10 French.
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Product: Smart Card Version C:3.1 Software Package for the
Pie Medical Scanner 150 Ultra-sound Scanner.
Recall #Z-891-0.
Code: Version C:3.1 Released: 17-05-1989.
Manufacturer: Pie Medical Equipment BV, The Netherlands.
Recalled by: Pie Medical USA BV, Neptune, New Jersey, by update to
software sometime in November 1989 and January 1990 through
April 1990. Firm-initiated recall ongoing.
Distribution: Florida, Georgia, Louisiana, New York, Oregon,
Pennsylvania, Texas.
Quantity: 30 disks were distributed.
Reason: An error in the software program does not allow the
user to program his/her own parameters in the last two
of eight menu selections which could cause a delay in
the diagnosis/treatment of prenatal or perinatal conditions.
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VETERINARY PRODUCTS
NONE