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
02/21/1996

ENFORCEMENT REPORT FOR 02/21/96

February 21, 1996 96-08

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin, extended Phenytoin Sodium Capsules,
USP), Kapseals, 100 mg, antiepileptic drug, in
bottles of 100. Recall #D-086-6.
CODE Lot #09054FA EXP 5/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert,
Morris Plain, New Jersey, by letter December
12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,846 bottles were distributed.
REASON Product may not meet dissolution
specifications through expiration date.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Panama Jack brand Dark Tanning Lotion,
waterproof, 4 SPF, in 3 fluid ounce plastic
bottles. Recall #D-085-6.
CODE 5M01A.
MANUFACTURER Creative Cosmetics, Rockledge, Florida.
RECALLED BY Manufacturer, by letter April 3, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,344 units were distributed.
REASON Product does not meet manufacturer's microbial
specifications.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Multinex, a breath-by breath gas analyzer that
uses microprocessor technology to calculate
and display: End-Tidal CO2, Inspired CO2,
Inspired and Expired N2O, Inspired 02,
Inspired and Expired Anesthetic Agents,
Respiration Rate, Sa)2, and Pulse Rate: (a)
Multinex Plus, Model Number 0998-00-0071-13,
14, 15, 16; (b) Multinex Plus w/ID, Model
0998-00-0071-17, 18, 19, 20; (c) Multinex,
Model Number 0998-00-0071-01, 02, 03, 04; (d)
Multinex ID, Model 0998-00-0071-09, 10, 11,
12. Recall #Z-326/329-6.
CODE All Products contain the 4610 Gas Analyzer
Board and the 4640 Gas Identification Board.
MANUFACTURER Datascope Corp., Paramus, New Jersey.
RECALLED BY Manufacturer, by letter sent beginning August
31, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,248 units were distributed.
REASON The 4610 Gas Analyzer Board and the 4640 Gas
Identification Board have been found to have
defects which may cause a random and
intermittent failure message along with either
a temporary loss of gas monitoring or a
disabling of the Anesthesia Identification
function. Units with anesthesia agent
identification also have the potential to
mis-identify an agent.

_______________
PRODUCT Monogram Instrument Tibial Baseplate
Impactor/Extractor, used to install and remove
the tibial baseplate. Recall #Z-341-6.
CODE Catalog #6633-7-575.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter dated March 14, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 408 units were distributed.
REASON The product's threaded shaft was breaking
during impaction.

-2-_______________
PRODUCT (a) Alta Tibial Rod Driver Locking Bolt (bolt
only), used for the insertion of the Alta
tibial rod; (b) Alta Tibial Rod Driver and
Bolt (driver/bolt assembly) meant to absorb
the impact of the blows from the mallet during
insertion of the tibial rod. Recall #Z-
344/345-6.
CODE Catalog numbers: (a) 5255-2-697;
(b) 5255-2-690.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter dated July 29, 1994.
Firm-initiated complete.
DISTRIBUTION Nationwide and international.
QUANTITY 709 units were distributed; firm estimates
none remains on the market.
REASON The locking bolt was breaking near the
threaded end - smooth shaft interface during
surgical procedures.

_______________
PRODUCT Barrier Vu-Thru Cardiovascular Pack:
(a) Sterile BARRIER Vu-Thru Cardiovascular
Pack containing in part a C-V Split Sheet,
Product (Reorder) Number 127;
(b) Sterile BARRIER Vu-Thru Cardiovascular
Pack II containing in part a C-V Split Sheet,
Product (Reorder) Number 0173, (
(c) Bulk non-sterile BARRIER Vu-Thru C-V/Split
Sheet, Product (Reorder) Number 9573.
Recall #Z-374/376-6.
CODE Lot numbers: (a) S01620 through S01713
(b) S00170 through S00193
(c) S00440 through S00471.
MANUFACTURER Johnson & Johnson Medical, Inc., El Paso,
Texas.
RECALLED BY Johnson & Johnson Medical (J&J), Inc.,
Arlington, Texas, by letters dated December 8,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 569 cases (2,770 units) were distributed.
REASON The fabric of the clipping tabs are subject to
tearing, presenting potential harm to patient.

_______________
PRODUCT (a) Gesco brand 3.5 Fr. Umbili-Cath, a
sterile, single-use, prescription PVC
umbilical vessel catheter; (b) Umbili-Cath
Tray, a procedural tray for the insertion of
umbilical vessel catheters.
Recall #Z-379/380-6.

-3-CODE (a) Catalog No. UC 9823, Lot No. 06-112396;
(b) Catalog No. UCT 9823, Lot No. 26-024296.
MANUFACTURER Gesco International, Inc., subsidiary of
MedChem Products, Inc., San Antonio, Texas.
RECALLED BY MedChem Products, Inc., Woburn, Massachusetts,
by letters dated May 19, 1995. FDA-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 900 units; (b) 700 units were distributed;
firm estimates none remains on market.
REASON The catheter was manufactured without a
radiopaque stripe, thus precluding
radiographic confirmation.

_______________
PRODUCT Rite-Angle Disposable Prophy Angle with Soft
Cup, used in performing dental prophylaxis.
Recall #Z-408-6.
CODE Lot numbers: 950108-1, 950110-2, 950118-1,
950119-1, 950119-2.
MANUFACTURER Team Technologies, Inc., Morristown,
Tennessee.
RECALLED BY Dentsply International, York, Pennsylvania, by
letter April 26, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 112,320 were distributed.
REASON In some cases the device has demonstrated a
propensity for stalling, stopping, falling
apart, vibrating, freezing-up, and over-
heating during usage.

_______________
PRODUCT Power Sonic brand Battery Packs used in Uro-
View or UroView Model 2000 X-ray Imaging
Systems. Recall #Z-409-6.
CODE All Power Sonic brand batteries received
during 1995 and shipped to the field as
replacements.
MANUFACTURER OEC Medical Systems, Inc., Salt Lake City,
Utah.
RECALLED BY Manufacturer, by letter on December 14, 1995.
All of the affected batteries were replaced
between 12/15/95 and 12/28/95. Firm-initiated
recall complete.
DISTRIBUTION Florida, Illinois, Kentucky, North Carolina,
New York, Ohio, Virginia, Washington, D.C.
QUANTITY 8 units.
REASON The replacement battery pack could have been
damaged during shipment which could possibly
lead to premature failure, and in the worst
case, a change of a battery fire.

-4-_______________
PRODUCT Dextrolyte Peritoneal Dialysis 5-prong Cycler
Set. Recall #Z-411-6.
CODE Catalog #48-1110-5, Lot R5A516.
MANUFACTURER National Medical Care - Reynosa, Reynosa,
Mexico.
RECALLED BY National Medical Care, Rockleigh, New Jersey,
by letter May 26, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 2,990 sets were distributed.
REASON The connector lines are misassembled.

_______________
PRODUCT Baxter Arterial Bloodline, used for dialysis.
Recall #Z-412-6.
CODE Catalog #5M4253N, Lot #R4H604.
MANUFACTURER National Medical Care - Reynosa, Reynosa,
Mexico.
RECALLED BY National Medical Care, Rockleigh, New Jersey,
by letter June 2, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 725 cases were distributed.
REASON The arterial bloodlines were packaged in
cartons labeled as venous bloodlines.

_______________
PRODUCT (a) Stryker Universal Cement Restrictor with
Inserter, Part #206-701, intended to be
implanted during total joint or joint revision
arthroplasty; (b) Stryker Sterile, disposable
Cement Sculps, Part #206-716, intended to be
used in joint or joint revision arthroplasty
to remove excess bone cement from around the
prosthesis. Recall #Z-429/430-6.
CODE Lot numbers: (a) 95071402S; (b) 95071382S.
MANUFACTURER BioMedical Devices, Irvine, California.
RECALLED BY Stryker Instruments, Division of Stryker
Corporation, Kalamazoo, Michigan, by letter
dated August 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 60 boxes (6 units per box); (b) 32 boxes
(6 units per box) were distributed.
REASON The sterility of the product cannot be
guaranteed because the packaging may be
compromised.

_______________
PRODUCT Belmont Acuray 071A Dental Periapical X-Ray
System. Recall #Z-433-6.
CODE Serial numbers: M007051R to 007150R.
-5-MANUFACTURER Takara Medical Company, Kobe, Japan.
RECALLED BY Belmont Equipment Corporation, Somerset, New
Jersey, by letters of September 20, 1995, and
October 27, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 3,851 units were distributed.
REASON The horizontal arm of the device may separate
from its wall mount bracket and fall. In
addition, the horizontal arm may rise
vertically in its wall mount bracket, but did
not disengage.

_______________
PRODUCT Radiographic Intensifying Screens, intended to
expose medical radiographic film:
(a) Model Trimax T2; (b) Model Trimax T6; (c)
Model Trimax T12; (d) Model Trimax T4; (e)
Model Trimax T8; (f) Model Trimax T6/12.
Recall #Z-435/440-6.
CODE All serial numbers.
MANUFACTURER 3M Italia SPA, Viale Della Liberta, Italy.
RECALLED BY 3M Medical Imaging Systems Division, St. Paul,
Minnesota, by letter sent on November 17,
1995, and by electronic mail message November
21, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 39,150 screens were distributed.
REASON The intensifying screens will chemically react
with radiographic film and become heavily
discolored. The discolored screens will
result in decreasing the film speed and
increasing patient exposure to ionizing
radiation during a radiographic patient
exposure to ionizing radiation during a
radiographic examination.

_______________
PRODUCT ProSpecT(tm) Entamoeba Histolytic Microplate
Assay Kit, used for detection of Entamoeba
Histolytica specific antigens.
Recall #Z-443-6.
CODE Catalog #560-96, Lot numbers 940491 and
950023.
MANUFACTURER Alekon Biomedical, Inc., Sunnyvale,
California.
RECALLED BY Manufacturer, by fax on or about March 23,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 281 kits were distributed.
REASON The test could provide a false positive result
for Entamoeba histolytic in pediatric samples.

-6-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT ATI EO Gas Disposable Test Pack with ATI-Test
Biological Indicator, a disposable test pack
with a self-contained biological indicator
used to monitor ethylene oxide sterilization
cycles: (a) Catalog #00234/00234BX;
(b) Catalog #23404/23404BX.
Recall #Z-385/386-6.
CODE Lot numbers: (a) 9501940702, 9501940703,
9504931002, 9504940101, 9505940301,
9505940102, 9510940501, 9510940601,
9510940701, 9510940788, 9512940702,
9512940703, 9601940901, 9601940902,
9602941001, 9602941002, 9602941003,
9606950101, 9606950102, 9606950103,
9606950201, 9606950202, 9607950203,
9607950204, 9607950205, 9607950301;
(b) 9505940301, 9510940601, 9601940901,
9602941001, 9607950301.
MANUFACTURER PyMaH Corporation, North Hollywood,
California.
RECALLED BY PyMaH Corporation, Flemington, New Jersey, by
letter sent March 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Germany, Spain, Ireland,
Poland, Turkey.
QUANTITY 677.25 cases; firm estimated that 200 cases
(64 packages per case) remained on market at
time of recall initiation.
REASON Devices were found not to meet labeling claims
of an 18-month shelf life.

_______________
PRODUCT Ektachem Clinical Chemistry Slides Digoxin
(DGXN), for in-vitro diagnostic use to
quantitatively measure the drug digoxin in
serum and plasma. Recall #Z-410-6.
CODE All codes with expiration date of 1/1/96 or
earlier.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York.
RECALLED BY Manufacturer, by telephone July 17 and 18,
1995, followed by letters of July 17, 1995 and
August 10, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 14,904 cartridges were distributed.
REASON The digoxin slides may exhibit a positive bias
overtime on the first slide from each
cartridge.

-7-_______________
PRODUCT Caulk Friction Grip Carbide Super Burs, used
for cutting teeth. Recall #Z-434-6.
CODE Lot numbers 941201 through 950228.
MANUFACTURER Dentsply International Caulk Division, York,
Pennsylvania.
RECALLED BY Manufacturer, by letter March 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 537,000 were distributed.
REASON The device is subject to dulling of the
cutting edges or the bur tip, and possible
breakage in use at the weld location.

_______________
PRODUCT Ektachem Clinical Chemistry Slides for
Cholesterol (CHOL), for in-vitro diagnostic
use to quantitatively measure cholesterol in
serum plasma. Recall #Z-444-6.
CODE Catalog #168-8290, lot numbers all with an
expiration date of 7/96 or before.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
formerly Eastman Kodak Co., Clinical
Diagnostics Division, Rochester, New York.
RECALLED BY Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York, by letter sent on
November 29, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,336,000 cartridges were distributed.
REASON There was a drift in cholesterol results
within the same day caused by slide
temperature and humidity.

_______________
PRODUCT Kodak Ektachem Clinical Chemistry Slides
(TRIG), for in-vitro diagnostic use, for the
quantitative measurement of triglycerides
concentration in serum or plasma.
Recall #Z-445-6.
CODE Catalog #1648088; all lot numbers with an
expiration date of 11/96 or earlier.
MANUFACTURER Johnson & Johnson Clinical Diagnostics,
formerly Eastman Kodak Company, Clinical
Diagnostics Division, Rochester, New York.
RECALLED BY Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York, by letter sent May 18,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 760,000 cartridges were
distributed.

-8-REASON Triglyceride slides on-analyzer stability did
not support a four week expiration claim.

_______________
PRODUCT OPUS Total B-hCG Test Modules for in-vitro
diagnostic use for the quantitative
measurement of intact and free beta subunits
of human chorionic gonadotropin (hCG) in
serum, plasma, and urine.
Recall #Z-446-6.
CODE Catalog #304-050, Lot #BGFO EXP 5/18/96.
MANUFACTURER Behring Diagnostics, Inc., Westwood,
Massachusetts.
RECALLED BY Manufacturer, by telephone on January 30,
1996, followed by letter. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 409 boxes (50 units per box) were distributed.
REASON Insufficient conjugate in the wells may cause
false negatives or lower than expected
results.

_______________
PRODUCT ILab IL Test (tm) Albumin Reagent, intended
for the quantitative in-vitro diagnostic
determination of serum albumin using the ILab
Chemistry Systems. Recall #Z-447-6.
CODE Catalog #182500, Lot #N1133691 (kit), Lot
#N0833100 (reagent).
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York (responsible firm).
RECALLED BY Instrumentation Laboratory Company, (ILC),
Lexington, Massachusetts, by letter dated
January 14, 1994. Firm-initiated recall
complete.
DISTRIBUTION Canada.
QUANTITY 2 kits were distributed.
REASON The Albumin reagent had mold growth and
reagent deterioration.

_______________
PRODUCT Monarch IL Test Albumin Reagent, for the
quantitative in-vitro diagnostic determination
of serum albumin using the IL monarch (r)
Chemistry Systems. Recall #Z-448-6.
CODE Catalog #35191, Lot #N0932200 EXP 11/94.
MANUFACTURER Instrumentation Laboratory Company, ILC),
Orangeburg, New York (responsible firm).
RECALLED BY Instrumentation Laboratory Company, Lexington,
Massachusetts, by letter sent during January
1994. Firm-initiated recall complete.

-9-DISTRIBUTION Florida, Oregon, Texas, Kansas, Louisiana,
Wisconsin, Missouri, Pennsylvania, Ohio,
Kentucky, Michigan, Arkansas.
QUANTITY 704 kits were distributed.
REASON The Albumin reagent had mold growth and
reagent deterioration.

-10-

END OF ENFORCEMENT REPORT FOR FEBRUARY 21, 1996. BLANK PAGES MAY
FOLLOW.

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