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
07/16/1991
Enforcement Report for Week of July 17, 1991
July 17, 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.
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
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Best Health All Natural Gourmet Iced Tea, in 12 ounce
bottles. Recall #F-491-1.
Code: D011 printed on the bottom of the bottle.
Manufacturer: Unknown.
-1-
Recalled by: Miller Family of the Brooklyn Bottling Corporation,
Brooklyn, New York, by telephone April 12, 1991,
followed by visit. Firm-initiated recall complete.
Distribution: New York, New Jersey.
Quantity: 1,400 cases.
Reason: Product is contaminated with mold-like substance.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Bacitracin Differentiation Disk, an in-vitro diagnostic
used to provide presumptive identification of group A
Streptococci from other Lancefield groups of Hemolytic
Streptococci. Recall #Z-674-1.
Code: Lot #110603 EXP 4/91.
Manufacturer: Organon Teknika, Durham, North Carolina.
Recalled by: Manufacturer, by letter March 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 9,816 50 disk cartridges were distributed; firm estimates
981 cartridges remain on the market.
Reason: The product did not exhibit a zone of inhibition of
growth with Streptococcus pyrogenes.
----
Product: COBE 2991 Model 1 Cell Processor, equipped with LED
Program Board Collect Valve, a centrifuge device that
removes the preservative agent from a unit of red blood
cells that has been frozen and subsequently thawed.
Recall #Z-749-1.
Code: Catalog numbers 912991-000, 912991-001, 912991-002,
912991-005, 912991-010; Serial numbers 2000 through 2059.
Manufacturer: Cobe BCT, Inc., Blood Component Technology, Lakewood,
Colorado.
-2-
Recalled by: Manufacturer, by telephone May 9, 1991, followed by
letter June 6, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Canada, Australia, Belgium, Qatar, Portugal,
Switzerland, England, Japan, Spain.
Quantity: 43 units were distributed.
Reason: The centrifuge may stop spinning when the "CALL" or
"ZERO SPIN TIME" functions are programmed.
----
Product: Codman Holter Ventricular Catheter, Barium, Right Angle,
10 cm, indicated for use to gain access to the ventricles
for diagnostic purposes and in the treatment of
hydrocephalus. Recall #Z-767-1.
Code: Lot #GG-065, Model #82-1660.
Manufacturer: Codman & Shurtleff, Inc., Randolph, Massachusetts.
Recalled by: Manufacturer, by telephone March 5, 1991, followed by
letter March 7, 1991 and by Telefax. Firm-initiated
recall ongoing.
Distribution: Nationwide, Germany, England, France, Italy, Brazil,
Greece, Japan.
Quantity: 192 catheters were distributed.
Reason: 10 cm catheters were incorrectly packaged and labeled
as 7 cm catheters.
----
Product: Gutta Percha Condenser Model 5003 (Touch N' Heat),
used in root canal procedures. Recall #Z-768-1.
Code: All units with serial numbers prior to 5003-5006.
Manufacturer: Analytic Technology Corporation, Redmond, Washington.
Recalled by: Manufacturer, by letter August 29, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 980 units were distributed.
Reason: The heating unit may not turn off. The unit may behave
as if the touch switch was permanently engaged. The
problem appears to have been caused by a bad phenloic
insulator bushing located inside the probe.
----
Product: Kendall Curity Spinal Anesthesia Tray, Reorder
Code 4706. Recall #Z-770-1.
Code: Lot #DT8349KG EXP 9/30/91.
Manufacturer: Kenmex Especialidades Medicar, Tijuana, Mexico.
recalled by: Kendall Healthcare Products Company, Mansfield,
Massachusetts, by letter May 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 120 cases (10 trays per case) were distributed.
-3-
Reason: The trays may contain expired drug components, i.e.,
Marcaine, Adrenalin and Ephedrine.
----
Product: Intravenous transfer tubes used mainly by oral
surgeons and dentists to administer anesthesia during
oral surgery:
(a) Anesthesia Extension Tube,
Model No. A-12, Order No. 003-0012
(b) Anesthesia Extension Tube,
Model No. A-12M, Order No. 003-0121
(c) Anesthesia Extension Tube,
Model A-20, Order No. 003-0020
(d) Anesthesia Extension Tube,
Model No. A-20M, Order No. 003-0201
(e) Anesthesia Extension Tube,
Model No. A-30, Order No. 003-0030
(f) Anesthesia Extension Tube,
Model No. A-30M, Order No. 003-0301
(g) Administration Set,
Model AE-60, Order No. 003-0060
(h) Administration Set,
Model AE-60V, Order No. 003-0061
(i) Administration Set,
Model A-78, Order No. 003-0078
(j) Venoset, Order No. 03-1127
(k) Irrigation Set, Model IR-60, Order No. 003-1621
(l) Irrigation Set, Model IR-60V, Order No. 003-1620.
Recall #Z-771/782-1.
Code: Lot numbers 2827 through 2836.
Manufacturer: Ace Surgical Supply, Brockton, Massachusetts.
Recalled by: Manufacturer, by telephone June 7, 1991 followed by
letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 69 cases; (b) 79 cases; (c) 583 cases; (d) 281 cases;
(e) 236 cases; (f) 217 cases; (g) 23 cases; (h) 53 cases;
(i) 37 cases; (j) 185 cases; (k) 9 cases; (l) 4 cases were
distributed.
(The first 6 products are shipped in cases of 250 units
per case; the last six products are shipped in cases of
50, the firm stated that some of these last 6 products
are sold individually.)
Reason: Questionable sterility because of package design.
----
Product: Rasp Adaptor 10 mm from the HG Multilock Hip Prosthesis.
Recall #Z-797-1.
Code: Catalog #6631-010-02, Lot #7578100.
Manufacturer: Tuco, Inc., Instrument Division, Canton, Massachusetts.
-4-
Recalled by: Zimmer, Inc., Warsaw, Indiana, by telephone April 23, 1991
followed by letter April 24, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 36 pieces were distributed.
Reason: The rasp adaptor will not lock into the corresponding
rasp handle.
----
Product: DelMed Brand Y-Blood Solution Set with Large Filter,
a medical device restricted to sale by or on order of
a physician, used for mixing, infusing or reinfusing
patients. Recall #Z-798-1.
Code: Catalog #03-122-00, lot numbers: 8J-020-04, 8K-006-04;
9B-006-04X.
Manufacturer: DelMed, Inc. S.A., Soyapango San Salvador, El Salvador.
Recalled by: CharterMed, Inc., Lakewood, New Jersey, by letter
May 14, 1991. Firm-initiated recall ongoing.
Distribution: New York, California, Virginia, Massachusetts, Illinois,
Washington, D.C.
Quantity: 265 cases (48 units/case) were distributed.
Reason: Lots 8J-020-04 and 8K-006-04 may contain defective roller
clamps which may break during use, resulting in interrupted
or unrestricted flow of solution through the tubing; and
lot 9B-006-04X may have loosened needle adaptor protectors,
resulting in an inadequate sterility barrier.
----
Product: MIII Mammography System Bucky Adapters.
Recall #Z-799-1.
Code: All serial numbers.
Manufacturer: Lorad Medical Systems, Inc., Danbury, Connecticut.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan June 14, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 16 units were distributed.
Reason: Noncompliance with performance standards for x-ray
products in that the bucky adaptor changes the size of
the image receptor without changing the aperture.
This may result in the x-ray field not being aligned
properly with the image receptor.
----
Product: Schneider Teflon Fixed Core Guidewires, .038 inches.
Recall #Z-801-1.
Code: Lot #18802.
Manufacturer: Schneider (USA), Inc., Pittsburgh, Pennsylvania.
-5-
Recalled by: Schneider (USA) Inc., Plymouth, Minnesota, by
telephone April 18, 1991. Firm-initiated recall ongoing.
Distribution: Florida, New Jersey, Pennsylvania, Spain.
Quantity: 400 were distributed.
Reason: The seals on the sterile packages may not be secure.
----
Product: Chemspore Chemical and Biological Indicators, packaged
with 15 ampules per carton, Part #P-76427-015,
Catalog #NA016 or with 50 ampules per carton,
Part #P-764271-017, Catalog #NA018. Recall #Z-802-1.
Code: Lot numbers: CS031E EXP 3/93, CS041B EXP 4/93,
CS041C EXP 4/93.
Manufacturer: AMSCO Scientific, Apex, North Carolina.
Recalled by: Manufacturer, by letter May 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 269 cartons were distributed.
Reason: The manufacturer changed the media and the lot of media
used is killing the spores, thus changing resistance
of the indicator.
----
Product: Strato Micropump (a) Model 2400 Strato Micropump
Ambulatory Medication Infuser, Catalog #8810332;
(b) Model 2500 Strato Micropump Programmer,
Catalog #8810331 and 8810335 (international version).
Recall #Z-804/805-1.
Code: All serial numbers.
Manufacturer: Strato Medical Corporation, Beverly, Massachusetts.
Recalled by: Manufacturer, by telephone April 17, 1991 followed by
letters of April 17, 1991 and May 2, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Germany, Canada, Spain.
Quantity: (a) 55 units; (b) 59 units were distributed.
Reason: Two of the three operational modes do not operate
properly due to software errors. Overinfusion of
medication is possible under certain circumstances.
The effect of improper therapy would be dependant on the
type and dosage of drug infused through the infuser.
----
Product: Lemon Glycerine Pre-Moistened Swabs:
(a) Triad Lemon Glycerine Insta-Swab, Reorder #10-4002;
(b) ABCO Lemon Gylcerine Swabs, Reorder #5424500.
Recall #Z-813/814-1.
Code: Lot numbers: (a) 1D76, 1D84; (b) 1D92.
Manufacturer: H & P Industries, Inc., Franklin, Wisconsin.
-6-
Recalled by: Manufacturer, by telephone May 29, 1991 and by letter
June 5, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 649 cases (10 cartons/cases, 25 pouches/carton) were
distributed.
Reason: The above specified lots may have been contaminated
with Pseudomonas microorganisms.
----
CORRECTION: Fetal Bovine Serum (FBS), Recall #Z-763/764-1 which
appeared in the June 19, 1991, Enforcement Report should
read:
Reason: The Fetal Bovine Serum (FBS) has been implicated
in being imported illegally into the United States labeled
as human serum from Brazil.
----
Class III -
Product: Johnson & Johnson K-Y Lubricating Jelly, in 4 ounce tubes.
Recall #Z-803-1.
Code: All lots of 4 ounce tubes in blister packs with the
reorder number 8919 printed on the tube.
Manufacturer: Johnson & Johnson Consumer Products, Inc., Skillman,
New Jersey.
Recalled by: Merchandise, Inc., Miamitown, Ohio, by letter
December 24, 1990. Firm-initiated recall complete.
Distribution: Ohio, Kentucky, Indiana, Illinois, Michigan, New York,
Florida, Pennsylvania.
Quantity: 136 tubes were distributed; firm estimates none
remains on the market.
Reason: Product is not labeled appropriately for retail use.
----
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: Surgical Instruments (91-577-526).
Charge: Adulterated - Quality falls below that which they
are represented to possess in that they are represented
as stainless steel surgical instruments, but do not contain
sufficient amount of chromium.
Misbranded - Labeling is false and misleading in that
they are labeled as stainless steel suggesting that the
devices contain a certain amount of chromium, when in
fact they do not contain such amount of chromium.
-7-
Firm: Tamzon Instruments, Inc., Northbrook, Illinois.
Filed: July 3, 1991 - U.S. District Court for the Northern
District of Illinois; Civil #91C4128; FDC #66208.
----
Product: Surgical Instruments (91-577-413/414).
Charge: Adulterated - Quality falls below that which they
are represented to possess in that they are represented
as stainless steel surgical instruments, but do not contain
sufficient amount of chromium.
Misbranded - Labeling is false and misleading in that
they are labeled as stainless steel suggesting that the
devices contain a certain amount of chromium, when in
fact they do not contain such amount of chromium.
Firm: Magnum Instruments, Inc., Addison, Illinois.
Filed: July 3, 1991 - U.S. District Court for the Northern
District of Illinois; Civil #91C4129; FDC #66211.
----
Product: Surgical Instruments (91-577-610-416).
Charge: Adulterated - Quality falls below that which they
are represented to possess in that they are represented
as stainless steel surgical instruments, but do not contain
sufficient amount of chromium.
Misbranded - Labeling is false and misleading in that
they are labeled as stainless steel suggesting that the
devices contain a certain amount of chromium, when in
fact they do not contain such amount of chromium.
Firm: Surgical Instruments, Inc., Chicago, Illinois.
Filed: July 3, 1991 - U.S. District Court for the Northern
District of Illinois; Civil #91C4130; FDC #66212.
----
Product: Love Me Slender with Enhancer 6000 Guar Gum (91-378-283).
Charge: Product is an unapproved new drug and its labeling lacks
adequate directions for use.
Firm: Ad Fill Service, doing business as Love Me Slender,
Las Vegas, Nevada.
Filed: May 9, 1991 - U.S. District Court for the District of
Nevada; Civil #CV-S-91-354 LDG-LRL, FDC #66085.
----
-8-
Product: QLF-1 Frequency Generator (91-573-941).
Charge: Misbranded - Labeling is false and misleading and fails
to bear adequate directions for use.
Firm: Pat Hamm, M.D., Huntsville, Alabama.
Filed: May 17, 1991 - U.S. District Court for the Northern
District of Alabama, Northeastern Division;
Civil #CV-91-HM-1213-NE, FDC #66156.
----
Product: Frozen Shrimp (90-608-325).
Charge: Product is decomposed and contains rodent hair.
Firm: Cumberland Foods, Nashville, Tennessee.
Filed: October 19, 1990 - U.S. District Court for the
Middle District of Tennessee, Nashville Division;
Civil #3 90 0919, FDC #65946.