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
05/15/1990
FDA Enforcement for the week of May 16, 1990
FDA ENFORCEMENT REPORT
FOR MAY 16, 1990
May 16, 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.
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.
NONE
-1-
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: 100% Orange Juice from Concentrate, in gallon, 1/2 gallon,
quart, pint, 8 ounce and 4 ounce containers, under the
Cloverfield Dairy and Spring Valley Farms labels.
Recall #F-517-0.
Code: The gallon, 1/2 gallon, quart and pint sizes are
packaged in plastic containers coded with sell by
dates and plant number, PLT #34-130 on the shoulder. The
8 ounce and 4 ounce sizes are packaged in paper board
containers and are coded with sell by date followed by the
letter C branded in the gable of the box. Sell by dates
are 3/21, 3/27, 4/3, 4/5, 4/7.
Manufacturer: Cumberland Farms Inc., Burlington, New Jersey.
Sun-up Foods Inc., Benton, Kentucky (concentrate supplier).
Recalled by: Cumberland Farms Inc., Canton, Massachusetts, by
telephone March 12, 1990. Firm-initiated recall ongoing.
Distribution: Delaware, Pennsylvania, New Jersey.
Quantity: Approximately 7,659 gallons were distributed.
Reason: Product is adulterated with beet juice medium invert
sugar.
----
Product: Rain Drop brand Guanabana Drink, 20% fruit pulp in
6 ounce and 12 ounce cans. Recall #F-518-0.
Code: All lots.
Manufacturer: Jugos del Valle S.A. de C.V., Tepotcotlan, Mexico.
Recalled by: Americana International, Houston, Texas, by letter
February 19, 1990 and March 6, 1990. Firm-initiated
recall ongoing.
Distribution: Arizona, Illinois, Colorado, Kansas, Kentucky, Missouri,
Oklahoma, Texas.
Quantity: 9,312 cases (48/6 ounce cans) and 7,125 (24/12 ounce cans)
were distributed.
Reason: Product contains toxic guanabana seeds.
----
Product: 100% Orange Juice from Concentrate, in gallon, 1/2
gallon, quart, pint, and 8 ounce containers,
under the Cloverfield Dairy, Rosev Dairy and Sun Foods
labels. Recall #F-519-0.
Code: The gallon, 1/2 gallon, quart and pint sizes are
packaged in plastic containers coded with sell by dates and
plant number PLT #025-042 on the shoulder. The 8 ounce size
(Cloverfiled label only) is packaged in paperboard containers
coded with sell by date followed by letter B branded
in the gable of the box. The sell by dates are:
3/23, 3/27, 3/30, 4/3, 4/6.
-2-
Manufacturer: Cumberland Farms Inc., Canton, Massachusetts.
Sun-Up Foods Inc., Benton, Kentucky (concentrate supplier).
Recalled by: Cumberland Farms Inc., Canton, Massachusetts, by
telephone March 12, 1990. Firm-initiated recall ongoing.
Distribution: Connecticut, Massachusetts, Rhose Island, New Hampshire,
Maine.
Quantity: Approximately 4,700 gallons were distributed.
Reason: Product is adulterated with beet juice medium invert
sugar.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
EXTESNION Recall #D-091-0, which appeared in the January 3, 1990
NOTICE: Enforcement Report has been extended to include an
additional label, Rugby Laboratories (Eye Irrigating
Solution) under lot number N4189 EXP 6/91.
----
Class II -
Product: (a) Platelets; (b) Pooled Recovered Plasma.
Recall #B-137/138-0.
Code: (a) Unit #8055717; (b) Pool number 89-12292
(which includes Recovered Plasma, unit 8073362.)
Manufacturer: The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
Recalled by: Manufacturer, (a) by telephone June 26, 1989; (b)
by telephone September 27, 1989. Firm-initiated
recall complete.
Distribution: (a) Louisiana; (b) California.
Quantity: 1 unit of each component was distributed and destroyed.
Reason: Blood products testing repeatably reactive for the
antibody to the human immunodeficiency virus by EIA
(anti-HIV-1) and the antibody to the human T-
lymphotropic virus by EIA (anti-HTLV-1) were distributed.
----
Class III -
Product: Rx small volume parenterals (solution) of various strengths
and fill sizes under the Quad label:
(a) Nitroglycerin Injection, USP, 10mg/ml in 5cc
and 10 cc vials;
(b) Metoclopramide HCl Injection (non-USP version),
5mg/ml, 2cc vials;
-3-
(c) Metoclopramide HCl Injection, USP, 5mg/ml, in 2cc
vials. Recall #D-274/275-0.
Code: Lot Nos EXP date
(a) (5 cc) 609H30 7/90
609J19 5/91
(10cc) 609J06 2/91
(b) (2 cc) 235H34 8/90
235H35 8/90
235H44 11/90
235H49A 12/90
235H49B 12/90
235H49C 12/90
235H49D 12/90
235J09 3/91
235J10A 3/91
235J10B 3/91
(c) 235J10C 3/91
235J16A 4/91
235J16B 4/91
235J16C 4/91
235J16D 4/91
235J18 5/91
235J25A 6/91
235J26 6/91
235J30 7/91
235J34 8/91
235J42 10/91
Manufacturer: Quad Pharmaceuticals, Inc., Indianapolis, Indiana.
Recalled by: Manufacturer, by letter April 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 45,170 vials; (b) 1,247,575 vials; (c) 1,397,225
vials were distributed.
Reason: Unapproved overages in active ingredients and/or
preservatives.
----
Product: Thyroid Tablets, USP (a) 1/4 grain strength;
(b) 4 grain. Recall #D-276/277-0.
Code: Lot numbers: (a) W409 (uncoated), W409-1 (coated);
(b) T842 (uncoated); T842-1 (coated).
Manufacturer: JMI-Canton Pharmaceuticals, Canton, Ohio.
Recalled by: Manufacturer, by FAX April 10, 1990 and by letter
April 12, 1990. Firm-initiated recall ongoing.
Distribution: Missouri, Texas.
Quantity: 419 bottles containing 1,008 tablets each and 251,188
bulk tablets were distributed.
Reason: The 1/4 grain product was found subpotent. The 4 grain
product was found superpotent.
----
-4-
Product: Emergency Oxygen Inhalator, in 17 cubic feet tanks, an Rx
product. Recall #D-278-0.
Code: Lot #221 through 226.
Manufacturer: SOS Technologies/Stewart Oxygen, Torrimar, Guaynabo,
Puerto Rico (repacker).
Recalled by: Manufacturer, by visit beginning April 2, 1990. Firm-
initiated field correction ongoing.
Distribution: Puerto Rico.
Quantity: 53 tanks were distributed.
Reason: Current good manufacturing practice deficiencies.
----
EXTENSION Inulin and Sodium Chloride Injection, USP, in 50 ml
NOTICE: vials, Recall #D-175-0, which appeared in the
March 28, 1990 Enforcement Report has been extended
to include lot #78807 EXP 7/90.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
CORRECTION: Life Design System Pulmanex Adult Manual resuscitator with
swivel elbow and popple tubing as oxygen reservoir,
Recall #Z-386-0 which appeared in the March 7, 1990
Enforcement Report should read:
Code: Model numbers 8700, 8701, 8702, 8703 and all model
numbers followed by suffixes containing numbers 47, 62, 63
or 87 manufactured prior to lot 8341 (December 7, 1988).
----
Class II -
Product: I.V. Administration set (Batch No. 06890029) packaged with
albumin or Human Plasma Protein Fraction (HPPF) products:
(a) Albumin (Human), USP 5% Solution;
(b) Albumin (Human), USP 25% Solution;
(c) Plasma Protein Fraction (P.P.F.) (Human), USP 5%
Solution. Recall #Z-557/559-0.
Code: Lot numbers: (a) 27459259AA, 27459260AA, 27459261AA;
(b) 29049560AA; (c) 28369432AA, 28369433AA.
Manufacturer: Hyland Division, Baxter Healthcare Corporation,
Glendale, California.
Recalled by: Manufacturer, by telephone December 13, 1989 followed by
letter December 29, 1989. Firm-initiated recall complete.
Distribution: Kentucky, Michigan, Virginia.
Quantity: 35,078 sets were distributed; firm estimates none remains
on market.
-5-
Reason: Lots were packaged with administration sets that
contained beetle-type insects.
----
Product: Bennett Mammographic X-Ray System Model No. CM205.
Recall #Z-560-0.
Code: Serial number B12047.
Manufacturer: Bennett X-Ray Company, Inc., Copiague, New York.
Recalled by: L&W X-Ray Company, Inc., Beaumont, Texas. FDA approved
the firm's corrective action plan March 15, 1990.
Firm-initiated field correction completed May 25, 1989.
Distribution: Texas.
Quantity: 1 unit was distributed and corrected.
Reason: Noncompliance with performance standard for x-ray products
in that the half value layer was measured to be 0.254mm of
AL at 36kVp.
----
Product: G.E. Stationary Radiographic X-Ray System, control
model #46-276004G1. Recall #Z-561-0.
Code: Serial #221072WK2.
Manufacturer: General Electric Medical System, Milwaukee, Wisconsin.
Recalled by: General Electric Medical System, Irving, Texas. FDA
approved the firm's corrective action plan April 2, 1990.
Firm-initiated field correction completed March 13, 1990.
Distribution: Texas.
Quantity: 1 unit was distributed and corrected.
Reason: Noncompliance with performance standard for x-ray products
in that the actual x-ray field size dimension deviated from
indicated size.
----
Product: LIFEPAK 10 Defibrillator/Monitor and External Transchest
Pacer, intended for field use by first response or
emergency medical services. Recall #Z-563-0.
Code: Part 2000881-01, high voltage diode -- units below
serial numbers 850; Part 804285-02, high voltage
capacitor, component lot 8851: serial number #586.
Manufacturer: Physio-Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by visit beginning March 21, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 1 unit of part 804285-02 are involved; the actual
number of units for part 200881-01 is unknown. The
firm's Technical Service Update (TSU) lists a total
of 188 nits.
Reason: Manufacturing defects in two components could potentially
cause critical field failures. The failures could result
in an inability to charge the defibrillator or an increased
charge time.
----
-6-
Product: Hall Acetabular Reamer System, used during surgery to
remove bone for artificial hip socket placement. The
system (kit) contains 21 reamer head assemblies and 2
reamer shafts which are also sold separately.
Recall #Z-565-0.
Code: Lot numbers: NOV89, DEC89.
Manufacturer: Hall Surgical Division, Zimmer, Inc., Carpenteria,
California.
Recalled by: Manufacturer, by visit beginning December 23, 1989 or
by telephone. Firm-initiated recall complete.
Distribution: Georgia, Illinois, Kansas, Kentucky, Minnesota,
New York, Pennsylvania.
Quantity: 38 kits, 37 head assemblies and 5 shafts were distributed.
Firm estimates none remains on market.
Reason: The reamer head assembly and shaft are incompatible, due
to a design error.
----
Product: Baxter Pharmaseal Adult Lumbar Puncture Tray, used for
drawing spinal fluid samples. Recall #Z-566-0.
Code: Catalog #4301C, lot #C9L241.
Manufacturer: Pharmaseal Division, Baxter Healthcare Corporation,
Irwinedale, California.
Recalled by: Pharmaseal Division, Baxter Healthcare Corporation,
Valencia, California, by letter January 2, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,298 trays were distributed.
Reason: The Adult Lumbar Puncture Tray (4301C) is mislabeled as a
Pediatric/Infant Lumbar Puncture Tray (4302C).
----
Product: Elbow Swivel Connector, used to connect a patient's
tracheostomy tube to respiratory or anesthesia equipment.
Recall #Z-567-0.
Code: Lot #8900846400 EXP 7/94.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado
(connector).
Recalled by: Shiley, Inc., Irvine, California, by letter February 13,
1990. Firm-initiated recall ongoing.
Distribution: Alabama, California, Georgia, Idaho, Indiana, Maryland,
Maine, Michigan, New Jersey, New York, Ohio, Oklahoma,
Pennsylvania, Rhode Island, Tennessee, Texas.
Quantity: 610 units were distributed; firm estimates less than
10 percent remains on market.
Reason: Device contains excessive flash (plastic particles)
which may restrict the air flow to/from the patient.
----
-7-
Product: Servo Humidifier 153 with Flex Tube, in boxes of 100
(product #91 51 119) and in boxes of 25 (product
#91 51 51), a heat and moisture exchanger used with
ventilators. Recall #Z-568-0.
Code: Batch numbers: 89 08 and 89 09.
Manufacturer: Samhill, Midland, Sweden.
Recalled by: Siemens Life Support Systems, Division of Elema-Schonander,
Inc., Schaumburg, Illinois, by letter December 8, 1989.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,173 cases of 100 and 9 boxes of 25 humidifiers were
distributed; firm estimates 200 cases remain on market.
Reason: The flex tube may contain small holes which could result
in a leakage of inspiratory tidal volumes up to 100 cc/min.
and leakage of expiratory volumes.
----
Product: Cobe Spectra Apheresis Blood Tubing Sets, intended
for use with the Cobe Spectra Blood Component
separator:
(a) Extended Life Platelet Set, a functional closed
set used either to collect donor platelets for storage
up to 5 days or for therapeutic platelet depletions;
(b) Platelet Set, not functional closed, used either
to collect donor platelets for storage up to 24 hours or
for therapeutic platelet depletions;
(c) Therapeutic Plasma Exchange Set, used to remove
plasma from patients requiring therapeutic plasma exchange.
Recall #Z-576/578-0.
Code: (a) Catalog No. 77003-000, All lot numbers beginning with
02S, 03S,... through 12S; 01T, O2T,... through 12T, 01U, and
Specific Lot Nos. 02U15399, 02U15362, 02U15366;
(b) Catalog No. 777004-000, All Lot Numbers beginning with
02S, 03S,... through 12S, 01T, 02T,... through 12T, and
01U15388;
(c) Catalog No. 777005-000, All Lot Numbers beginning with
02S, 03S,... through 12S, 01T, 02T,... through 12T, and
01Uxxxxx.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by telephone beginning April 5, 1990 and
by letter April 18, 1990. Firm-initiated recall ongoing
Distribution: Nationwide and international.
Quantity: (a) 48,618 units; (b) 8,928 units; (c) 24,546 units
were distributed;
Reason: The loops may leak because bearings in the tubing set
line are not seated properly against the sleeve ends.
----
-8-
Product: (a) Lifecare PLV-100 Portable Volume Ventilator,
a microprocessor controlled positive pressure, volume
cycled ventilator designed especially for the care of
patients (primarily home care) with respiratory
disabilities;
(b) Kit, Charger, Alarm Battery. Recall #Z-579/580-0.
Code: Serial Nos. (a) 841226, 851116, 851136, 850727, 850833,
850852, 850418, 851230, 851043, 851104, 851010,
850223, 851205, 851246, 850734, 851155, 850935,
860764, 860563, 860625, 860705, 860570, 861076,
860618, 860517, 860943, 860711, 8606105, 8607100,
8609163, 8610109, 861050, 860518, 8609114, 860524,
860714, 860339, 860635, 8609174, 860911, 8610108,
860907, 870490, 870750, 870475, 870432, 870225,
870629, 871120, 870345, 870418, 870566, 870589,
870339, 870658, 870508, 881147, 881236, 880112,
880748, 880703, 881115, 890535, 8905132, 890213,
890273, 890519, 890258, 890271, 890506, 890480,
890497, 890221, 890559, 890260, 890511, 890224;
(b) 35-250.
Manufacturer: (a) Lifecare Services, Inc., Lafayette, Colorado;
(b) Starr Corporation International, Broomfield, Colorado.
Recalled by: Lifecare Services, Inc., Lafayette, Colorado, by letter
April 5, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: (a) 77 units; (b) 12 kits were distributed.
Reason: The alarm battery charger board may have had an incorrect
diode installed in the circuit. This could cause the
alarm to be weak or not sound at all in the event of
ventilator failure.
----
Product: (a) NEOVOR Breathing Circuit, sold separately, 25 units
per box (part 20116) and or case of 4 boxes of 25 units
each (20115) and used with; (b) NEOVO2R (sic) Manual
Neonatal/Infant Resuscitator, intended for the ventilation
of infants weighing less than 10 kgs;. Recall #Z-581/582-0.
Code: (a) Lot Nos: SL-102, SL-103, SL-104, SL-105, SL-106 and
SL-107;
(b) Serial Nos. 0105 through 0107, 0109 through 0184, 0188,
0191, 0193 through 0204, 0210, 0221, 0223 through 0234,
0236 through 0237, 0251, 0254 through 0255, 0257 through
0270, 0273, 0291 through 0300.
Manufacturer: Neomed Company, Inc., London, Ontario, Canada.
Recalled by: Sechrist Industries, Inc., Anaheim, California, by
letters dated February 12 and 26, 1990. Firm-initiated
recall ongoing.
Distribution: Alabama, California, Connecticut, Florida, Illinois,
Indiana, Louisiana, Massachusetts, Michigan, Minnesota,
Missouri, North Carolina, New Jersey, New York, Ohio,
South Dakota, Tennessee, Texas, Vermont, Utah, Virginia.
and international.
Reason: Devices may contain a defective inspiratory valve.
----
-9-
Product: Pediatric and infant feeding tubes, nasal-gastric tubes
used to deposit liquid food into the stomachs of
pediatric and infant patients:
(a) Catalog No. R31, Pediatric Feeding Tube 8 Fr length
15" radiopaque stripe sterile;
(b) Catalog No. R32, Infant Feeding Tube 5 FR length 15"
Radiopaque stripe sterile. Recall #Z-583/584-0.
Code: All lot numbers beginning with H9A, H9B, H9C, H9D, H9H,
H9J, H9K, H9L, H9P, H9S.
Manufacturer: Pharmaseal Division, Baxter Healthcare Corporation,
Toa Alta, Puerto Rico.
Recalled by: Pharmaseal Division, Baxter Healthcare Corporation,
Valenica, California, by letter March 29, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Singapore, United Kingdom.
Quantity: (a) 347,450 units; (b) 148,900 units were distributed.
Reason: Product's sterility may be compromised.
----
Class III -
Product: Beckman Uric Acid Standards Kit, an in-vitro diagnostic
product intended for standardizing manual and automated assay
for uric acid in plasma and serum. Recall #Z-569-0.
Code: Kit part #683640, lot #M906023 EXP 5/31/90.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Brea, California, by telephone
January 29, 1990. Firm-initiated recall complete.
Distribution: Arizona, California, Florida, Georgia, Hawaii, Illinois,
Louisiana, Massachusetts, Michigan, Mississippi, Montana,
Nebraska, New Jersey, New York, Ohio, Washington state,
Wisconsin.
Quantity: 333 units were distributed; firm estimates none remains
on market.
Reason: The product had lost activity and recovery as the
standard had aged. The 10 mg/DL standard recovered only
6mg/DL.
----
VETERINARY PRODUCTS
Class I -
Product: 20% Range Meal Mix, in 50 pound bags, a non-medicated
feed for beef cattle. Recall #V-039-0.
Code: Not coded -- lot manufactured February 6, 1990.
Manufacturer: Farmers Association, Little Rock, Arkansas.
Recalled by: Manufacturer, by letter March 7, 1990. Firm-initiated
recall complete.
Distribution: Arkansas.
Quantity: Firm estimates none remains on market. Twenty-seven
bags were recovered from the market.
-10-
Reason: The product contained unsafe levels of urea.
----
Class II -
Product: Furosemide 12.5 mg Veterinary Tablets, in bottles of
100, 500 or 1,000 tablet, an Rx diuretic under the
following labels: Vedco, The Butler Company, Bolar
Pharmaceutical, IDE - Interstate, Burns Veterinary Supply
(100's); Vedco, IDE - Interstate, Burns Veterinary Supply,
The Butler Company, H.L. Moore Drug Exchange, Bolar
Pharmaceutical (500's); Bolar Pharmaceutical (1,000's).
Recall #V-038-0.
Code: Lot numbers: 014459, 023879, 023884, 036894, 037620,
039010, 043965, 048418, 074705, 076147, 077898, 084708,
085452, 103301, 103312, 108709, 116383, 124999, 127146.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: Manufacturer, by letter February 19-20, 1990. Firm-
initiated recall ongoing.
Distribution: Pennsylvania, Wisconsin, Massachusetts, Georgia, Ohio,
North Carolina, New York, Florida, New Jersey.
Quantity: 25,633 bottles of 100, 60,496 bottles of 500 and
33 bottles of 1,000 were distributed.
Reason: Product lacks assurance that they were manufactured in
conformity with conditions approved in the Abbreviated
New Drug Application.
----
Class III -
NONE
Medical Device Safety Alerts:
Product: Vitek Proplast II Temporomandibular (TMJ) Interpositional
Implants (IPI), concave trapezoidal shape with articular
eminence extension, used in replacing the meniscus disk in
the temporomandibular joint:
(a) Product No. 912.71, 26 x 26 x 1.3 mm, non-porous
teflon laminate;
(b) Product No. 912.72, 26 x 26 x 2.3 mm, non-porous
teflon laminate;
(c) Product No. 912.74, 26 x 26 x 4.3 mm, non-porous
teflon laminate;
(d) Product No. 912.76, 26 x 26 x 1.3 mm, non-porous
teflon laminate with reinforced polyaramid fabric;
(e) Product No. 912.77, 26 x 26 x 2.3 mm, non-porous
teflon laminate with reinforced polyaramid fabric;
(f) Product No. 912.78, 26 x 26 x 4.3, non-porous
teflon laminate with reinforced polyaramid fabric.
Safety Alert #M-040/045-0.
-11-
Code: All units.
Manufacturer: Vitek, Inc., Houston, Texas.
Alerted by: Manufacturer, by letter March 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 12,650 units were distributed.
Reason: IPI's may fragment, delaminate or otherwise be damaged or
punctured. Debris in the joint from the implants can
contribute to progressive bone degenerative changes and
to giant cell reaction.