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
09/15/1993
Recalls and Field Corrections: Drugs -- Class II -- 09/15/1993
September 15, 1993 93-37
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
______________
PRODUCT Cefzil (Ceprozil HCl) 500 mg unit dose Tablets, a
broad
spectrum antibiotic. Recall #D-333-3.
CODE Lot numbers: B2V77A EXP 3/94, C2W64B EXP 4/94.
MANUFACTURER Bristol-Myers Carceloneta, Barceloneta, Puerto Rico.
RECALLED BY Bristol-Myers Squibb Company, New Brunswick, New
Jersey, by
letter dated August 18, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 922 units of lot B2V77A 449 units of lot C2W64B were
distributed.
REASON Strips of 500 mg unit dose tablets were packaged in
some
cartons labeled as 250 mg.
_______________
PRODUCT Nitrous Oxide, Compressed, USP, Medical Gas,
Anhydrous, Rx
medical gas used in anesthesia, in blue N (64
pound), G (56
pound), and E (6.9 pound) size cylinders. Recall
#D-334-3.
CODE Lot #CGH193P EXP AUG1998.
MANUFACTURER Liquid Carbonic Industries Corporation, Chicago,
Illinois.
RECALLED BY Liquid Carbonic Industries Corporation, Oak Brook,
Illinois,
by telephone September 1, 1993, followed by letter.
Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Indiana.
QUANTITY 1 E-cylinder, 10 G-cylinders, and 13 N-cylinders
were
distributed; firm estimates none remains on the
market.
REASON Some cylinders were contaminated with carbon
dioxide.
_______________
PRODUCT Compressed Medical Oxygen, USP, packaged in D and E
size
cylinders, Rx drug used for inhalation therapy.
Recall #D-336-3.
CODE All codes.
MANUFACTURER TriWeld Industries, Bayshore, New York (bulk
supplier).
RECALLED BY Newbridge Surgical Supply, Inc., Bellmore, New York,
by
visit September 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 17 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
______________
PRODUCT Sodium Polystyrene Sulfonate Suspension, USP, in 1
pint and
60 ml plastic bottles. Recall #D-335-3.
CODE All lots.
MANUFACTURER Carolina Medical Products Company, Farmville, North
Carolina.
RECALLED BY Manufacturer, by telephone August 30, 1993, and by
letter
August 31, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Canada.
QUANTITY Firm estimates 200 pint bottles and 75 10-bottle
cartons of
60 ml bottles remain on the market.
REASON Use of non-approved formulation.
______________
PRODUCT Kondremul Plain, in 16 ounce bottles, used for the
temporary
relief of constipation and sold under Fisons label.
Recall #D-337-3.
CODE Lot #RK2065 EXP 9/95 (Fisons lot 38487).
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter April 7, 1993.
Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 60,864 units were distributed; firm estimates none
remains
on the market.
REASON Product fails stability specifications for total
microbial
count.
-2- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
______________
PRODUCT Lifepak (LP) 10 Defibrillator/Cardiac Monitor
(including
paddles), a stand alone external medical device.
Recall #Z-678-3.
CODE All units manufactured and distributed prior to June
1992.
Also, units shipped between May 18, 1993 and
mid-August 1993
pertain to this recall only regarding the coil cord.
These
units received the other 3 upgrades prior to being
shipped.
MANUFACTURER Physio Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by letter dated July 9, 1993, followed
by
visit beginning July 21, 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 115,000 units were distributed prior to June 1992.
An
additional 1,000-1,500 units were distributed from
May 18,
1993 through mid-August 1993.
REASON Inherent reliability problems.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
______________
PRODUCT Osteogen (HA) Synthetic Non-Ceramic Hydroxylapatite
OsteoConductive Implant Material, indicated for the
contouring and improvement of alveolar ridge
deformities and
for the support and filling of tooth sockets and
cyst
defects following extraction or removal. Recall
#Z-280-3.
CODE Lot numbers: T002EJ, 040015, 040071.
MANUFACTURER Impladent Ltd. Holliswood, New York.
RECALLED BY Manufacturer, by letter December 4, 1992.
Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 4,668 vials were distributed; firm estimates none
remains on
the market.
REASON Product may contain foreign particles.
______________
PRODUCT Howmedica Precision Hip Long Stem Femoral Component
size #2
Left 225 mm, used for reconstructive hip
replacement.
Recall #Z-640-3.
CODE L0t #B4XIA, sterile lot #9127106.
MANUFACTURER Howmedica Division, Pfizer Hospital Products Gropup,
Inc.,
Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone August 24, 1992.
Firm-initiated
recall complete.
DISTRIBUTION Maryland, Tennessee, Arizona, Pennsylvania,
California,
Florida, New York, Canada.
QUANTITY 12 units were distributed. All distributed product
have
been accounted for.
REASON Devices are labeled with an incorrect size.
-3- ______________
PRODUCT Star Dental High Speed Handpiece, used with various
dental
tools: (a) 430 SWL High Speed Fiber Optic
Handpiece;
(b) 430/K/SW High Speed Handpiece. Recall
#Z-656/657-3.
CODE Lot numbers K0001 through K0046.
MANUFACTURER Nakanishi Dental Manufacturing Company, Ltd., Japan.
RECALLED BY Den-Tal-Ez, Inc., Star Dental Division, Lancaster,
Pennsylvania, by letter on or about September 10,
1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 20,032 units were distributed.
REASON Accidental contact of the end cap with the turbine
shaft can
cause sudden and severe heat rise in the distal end
of the
handpiece, which may result in burns to the oral
mucosa of
patients.
______________
PRODUCT Model BLR-15AA Beam-Limiting Device, used to limit
the beam
on an x-ray machine. Recall #Z-663-3.
CODE All serial numbers.
MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,
California.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action
plan August 5, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON The beam limiting device does not numerically
indicate the
field size in the plane of the image receptor to
which it is
adjusted when the positive-beam limitation (PBL)
override
key is turned to the override position.
______________
PROBLEM Battery assembly for the LifePak 8 ECG Monitor, used
as a
backup DC power source for the LifePak 8 ECG
Monitor.
Recall #Z-737-3.
CODE Battery assembly part #802850-01, date code 9238.
MANUFACTURER Gates Energy Products, Inc., Gainesville, Florida
(battery
assembly).
RECALLED BY Physio Control Corporation (PCC), Redmond,
Washington, by
telephone March 23, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Connecticut, Indiana, Nebraska, Idaho, Washington
state,
Alaska, Alabama, Virginia, California, Canada,
Japan.
QUANTITY 27 battery assemblies were distributed.
REASON Miswiring resulting in battery failure.
MEDICAL DEVICE SAFETY ALERTS:
=============================================
______________
PRODUCT Manan "Accura" Automatic Cutting Needle with
Ultrasound Tip
& Depth Markings (ACN), sterile single use biopsy
needles
for use in spring loaded biopsy guns; 5 needles per
box:
(a) Catalog #1810: 18 gauge x 4"
-4- (b) Catalog #1816: 18 gauge x 6"
(c) Catalog #1820: 18 gauge x 8"
(d) Catalog #1610: 16 gauge x 4"
(e) Catalog #1616: 16 gauge x 6"
(f) Catalog #1620: 16 gauge x 8"
(g) Catalog #1410: 14 gauge x 4"
(h) Catalog #1416: 14 gauge x 6"
(i) Catalog #1420: 14 gauge x 8"
(j) Catalog #2010: 20 gauge x 4"
(k) Catalog #2016: 20 gauge x 6"
(l) Catalog #2020: 20 gauge X 8"
Safety Alert #N-065/076-3.
CODE All lots.
MANUFACTURER Manan Medical Products, Northbrook, Illinois.
ALERTED BY Manufacturer, by letter June 11, 1993.
DISTRIBUTION Nationwide, Canada.
QUANTITY 24,000 units were distributed; firm estimates 2,000
units
remain on the market.
REASON Device may malfunction if used with BIP HS/1 & HS/2
core
cutter. This malfunction is evidenced by the
extended
travel of the inner stylet. This may cause
unanticipated
needle placement and possible structural damage to
the
tissue being biopsied.
CONSENT DECREE OF PERMANENT INJUNCTION:
===================================
_______________
PRODUCT Infant formulas, special nutritional dietary
formulas, and
dried dairy blend foods (93-658-050).
AGAINST Maple Island, Inc., a corporation, and Daniel W.
O'Brien and
Ronald D. Zirbel, individuals, Stillwater and
Wanamingo,
Minnesota.
CHARGES The defendants were charged with adulterating their
products
because they were manufactured, prepared, processed,
packaged, and held for sale under insanitary
conditions
whereby they may have become contaminated with filth
or
rendered injurious to health. Defendants were
further
charged with adulterating products manufactured at
their
facilities due to the presence in those products and
in the
equipment that produced those products, of
salmonella
bacteria, a poisonous or deleterious substance,
which may
have rendered them injurious to health.
FILED August 17, 1993, Complaint for Injunction; August
20, 1993,
Consent Decree of Permanent Injunction; U.S.
District Court
for the District of Minnesota; Civil #4-93-789; INJ
1332.
-5- SEIZURES:
=================================================================
_______________
PRODUCT Frequency generator instruments and various other
medical
devices (92-641-318).
CHARGES Adulterated - The articles are class III medical
devices for
which no approved premarket approval application is
in
effect. Misbranded - The articles' labeling
contains
statements which represent that the devices are
effective
for treating conditions including cancer, AIDS,
heart
disease, arthritis, diabetes, infections, burns, and
pain,
which representations and suggestions are false and
misleading and otherwise contrary to fact. The
articles'
labeling fails to bear adequate directions for use
for the
purposes for which they are intended, because
adequate
directions cannot be written for such purposes; the
articles
were not manufactured in an establishment duly
registered as
required; they were not included in a list as
required; and,
premarket notification covering these devices was
not filed
as required.
FIRM Crane Foundation, San Diego, California.
FILED February 12, 1993; U.S. District Court for the
Southern
District of California; Civil #93-0230S(CM); FDC
#66496.
SEIZED July 28, 1993 - goods valued at approximately
$16,000.
_______________
PRODUCT Thor of Genesis I vibrational sound system
(93-670-674/8).
CHARGES Adulterated - The article is a class III medical
device
for which no approved premarket approval application
is in
effect. Misbranded - The article's labeling is
false and
misleading and otherwise contrary to fact; and, a
notice or
other information respecting the device was not
provided as
required.
FIRM Windows of the Mind Bookstore (also known as Calf
Mother
Company), South Euclid, Ohio.
FILED August 17, 1993; U.S. District Court for the
Northern
District of Ohio, Eastern Division; Civil #1:93CV
1724;
FDC #66704.
SEIZED August 18, 1993 - goods valued at approximately
$4,000.
_______________
PRODUCT "Relaxman" Synchro Energizer and accompanying
literature
(93-670-602).
CHARGES Adulterated - The article is a class III medical
device for
which no approved premarket approval application is
in
effect.
Misbranded - The article's labeling is false,
misleading,
and contrary to fact. The article's labeling fails
to bear
adequate directions for use for the purposes for
which it is
intended and against use in those pathological
conditions
where its use may be dangerous to health, or against
unsafe
dosage or methods or duration of administration or
-6- application, in such manner and form, as are
necessary for
the protection of users. The use of the article is
a danger
to health when used in the dosage or manner, or with
the
frequency or duration prescribed, recommended, or
suggested
in the labeling; and, the device is not listed as
required.
FIRM Meta Brain/Mind Biomedical Research Foundation,
Cleveland,
Ohio.
FILED July 28, 1993; U.S. District Court for the Northern
District of Ohio, Eastern Division; Civil #1:93CV
1577;
FDC #66662.
SEIZED August 3, 1993 - goods valued at approximately
$30,000.
_______________
PRODUCT Lymphtech Neon-Argon Photon Particle Beam Generator,
an
electrotherapy device which is held against the
lymph
channels of the body (93-670-824, et al.).
CHARGES Adulterated - The article is a class III medical
device for
which no approved premarket approval application is
in
effect.
Misbranded - The article's labeling fails to bear
adequate
directions for use; and, in that the article was
manufactured in an establishment not duly registered
as
required, it was not included in a required list,
notices or
other information respecting the device were not
provided as
required, and orders finding the device
substantially
equivalent did not issue.
FIRM Lymphtech N.A., Toledo, Ohio.
FILED August 20, 1993; U.S. District Court for the
Northern
District of Ohio, Western Division; Civil
#3-93-CV-7466;
FDC #66707.
SEIZED August 24, 1993 - goods valued at approximately
$1,500.
_______________
PRODUCT Breaded haddock fillets (93-660-372/373).
CHARGES Adulterated - Pollock has been substituted wholly or
in part
for haddock in the articles. Misbranded - The
articles'
labeling is false and misleading because it
represents and
suggests that the only fish in the articles is
haddock,
which is contrary to fact; and, pollock is offered
for sale
under the name of another food, haddock.
FIRM Americold Cold Storage Warehouse, Watertown,
Massachusetts.
FILED August 26, 1993; U.S. District Court for the
District of
Massachusetts; Civil #93-11860-WF; FDC #66770.
SEIZED September 1, 1993 - goods valued at approximately
$7,000.
_______________
PRODUCT Electrosurgery Units, Lletz-Leep Electrosurgical
Electrodes, and accompanying promotional literature
(93-662-
287, et al).
CHARGES Adulterated - The articles are class III medical
devices for
which no approved premarket approval applications
are in
effect.
-7- FIRM Cameron-Miller, Inc., Chicago, Illinois.
FILED September 1, 1993; U.S. District Court for the
Northern
District of Illinois, Eastern Division; Civil #93C
5350;
FDC #66721.
SEIZED September 1, 1993 - goods valued at approximately
$35,000.
_______________
PRODUCT Various articles of device for use in the practice
of
obstetrics and gynecology, and device components
used to
make them (93-544-578).
CHARGES Adulterated - Some of the articles are class III
devices
that lack approved premarket approval applications.
The
methods used in, and the facilities and controls
used for,
all of the articles' manufacture, packing, and
storage are
not in conformity with current good manufacturing
practice
requirements. Misbranded - Labeling for all of the
articles
represents and suggests that the devices are
sterile, which
representations and suggestions are false and
misleading or
otherwise contrary to fact. The articles' labeling
lacks
adequate directions for use for the purposes for
which the
devices are intended because adequate directions
cannot be
written for devices labeled as sterile which have
not been
sterilized. The articles are misbranded in that
they are
dangerous to health when used in the manner
prescribed,
recommended, or suggested in their labeling. All of
the
articles were manufactured, prepared, propagated,
compounded
or processed in an establishment not duly
registered, and
were not included in a required list. A notice or
other
information for some of the articles was not
provided as
required.
FIRM International Medical Technologies Group, Inc.,
Glens Falls,
New York.
FILED July 30, 1993; U.S. District Court for the Northern
District of New York; Civil #93-VO-683; FDC #66736.
SEIZED August 6 & 9, 1993 - goods valued at approximately
$113,000.
-8-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 15, 1993. BLANK PAGES MAY
FOLLOW.
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