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
10/25/1995
ENFORCEMENT REPORT FOR 10/25/1995
October 25, 1995 95-43
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Nestle Quik Strawberry Milk, Ultra-Pasteurized, 16 and 32
fluid ounce cartons. Recall #F-023-6.
CODE SEP 22 S3 21-031.
MANUFACTURER Ryan Milk Company, Murray, Kentucky.
RECALLED BY Manufacturer, by visits on August 15 and 16, 1995. Firm-
initiated recall complete.
DISTRIBUTION States east of the Mississippi.
QUANTITY 3,900 cases.
REASON Product contains an off odor and off color.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT (a) Dexamethasone Sodium Phosphate Injection, USP, 5 ml
multiple dose vial, 4 mg/ml, a sterile injectable
glucocorticoid; (b) Hydroxyzine HCl Injection, USP, 10 ml
multiple dose vial, a sterile, aqueous solution intended for
intramuscular administration, indicated for use in the
relief of anxiety and tension. Recall #D-007/008-6.
CODE Lot numbers 035021 EXP 3/98 and 015005 EXP 1/98.
MANUFACTURER Elkins-Sinn, Cherry Hill, New Jersey.
RECALLED BY Manufacturer, by letter August 21, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, The Netherlands, The Bahamas.
QUANTITY 1,886 boxes of Dexamethasone were distributed.
REASON A vial of Dexamethasone Injection was packaged in a carton
labeled Hydroxyzine Injection.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Bumex 2 mg Tablets, in 5,000 tablet bottles, Rx diuretic.
Recall #D-006-6.
CODE Lot #0331 EXP 11/1/96.
MANUFACTURER Hoffman-La Roche, Inc., Nutley, New Jersey.
RECALLED BY Manufacturer, by letter August 15, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 357 bottles were distributed.
REASON Product does not meet content uniformity specifications.
_______________
PRODUCT COPE Analgesic Tablets, packed in 36 and 60-tablet bottles,
OTC promoted for pain relief for tension headaches.
Recall #D-009-6.
CODE Lot numbers: L014C EXP 12/96, C015C EXP 3/97, E015C EXP
5/97.
MANUFACTURER Custom Pharmaceuticals, Fort Erie, Ontario, Canada.
RECALLED BY The Mentholatum Company, Inc., Buffalo, New York, by letter
issued between October 4 and 13, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,552 36-tablet bottles and 83,808 60-tablet bottles were
distributed.
REASON The bilayer tablets are exhibiting separation.
_______________
PRODUCT Neomycin 15%, Polymyxin B Sulfates (15%), and Dexamethasone
Ophthalmic Ointment (3%) USP, all 3.5 gram tubes under the
following brand and labels: Dexasporin: Bausch & Lomb,
Butler and Major Medical; Neopolydex: Medical Opthalmics;
NPD Ophthalmic Ointment: Phoenix Pharmaceuticals, Rugby; Neo
Poly Dex Ointment: Vedco. Recall #D-010-6.
CODE Lot #583381.
MANUFACTURER Bausch and Lomb Pharmaceuticals Division, Tampa, Florida.
RECALLED BY Manufacturer, by letter September 18, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,900 units were distributed; firm estimated that 10,000
units remained on market at time of recall initiation.
REASON Subpotency of the Polymyxin B sulfate ingredient.
-2- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Medical breathing kits:
(a) Adult Circle Breathing Circuit, 4"/101 cm HOSE, non-
conductive single use;
(b) Piggyback Breathing Circuit, non-conductive single use;
(c) General Anesthesia System, non-conductive single use.
Recall #Z-860/862-5.
CODE Product numbers and Lot numbers:
(a) 5033ACIM, 0654; 5033ACIM 0594; 5020AEM7, 0584;
5074H067, 0624; 5320AM, 0664; 5320A, 0615; 5033ACM8, 0634;
5020MA, 0594; 5072MOW, 0615; 5113AE07, 0625; 5080AE, 0594;
5030AAE, 0604; 5022MN, 0584; 5022MS, 0595; 5070AIMW, 0665;
5320AHIZ, 0585; 5031IKX6, 0624; 5031ES18, 0664; 5030ANS,
0634; 5030AMO, 0615; 5030AJ9, 0604; 5030AEM8, 0674;
5021IJMX, 0594; 5322AIMV, 0594; 5321HIOZ, 0625; 5322IJMX
0594; 5020STFR, 0634; 5331IZ18, 0624; 5330ACHY, 0624;
5321MOWI, 0654; 5321MOWI 0585; 5020MA, 0594; 5023MOXI, 0664;
5055HAYS, 0654; 5022HAYS, 0655; 5020AXJI, 0584; 5022JV,
0595; 5030ACJX, 0624; 5330GEIS, 0605; 5030AJ9, 0604;
5320AHM, 0594; 5330GEIS, 0605; 5030AJ9, 0595; 5071HIZ8,
0624; 5072HM8, 0604; 5320AAM, 0664; 5822IKMX, 0605; 5030AJ9,
0595; 5030AACE, 0604; 5021IJX8, 0604; 5030AE, 0625; 5030AE,
0624; 5330AMZI, 0654; 5330AMXI, 0585; 5020AJIO, 0595;
5020AXJI, 0584; 5020AEMT, 0604; 5321HIOZ, 0624; 5030AEMO,
0624; 5322, 0585; 5320AM, 0664; 5021IJMX, 0665; 50800AAM8.
0665; 5322E, 0594; 5320AMTW, 0624; 5322AAT, 0625; 5083HI07,
0665; 5022HAYS, 0654; 5030ABIX, 0604; 5030AJ9, 0595;
5020DO,I, 0604; 5322Z1, 0615; 5022IJX, 0655; 5022EM8, 0624;
5070A, 0634; 5030SAE, 0664; 5022EM8, 0624; 5020AXJI, 0584;
5021IJMX, 0665; 5320AMOX, 0664; 5322AIMV, 0595; 5070, 0634;
5073HIOV, 0665; 5322AIMW, 0665; 5320AMX, 0604; 5030AE, 0625;
5322IMTZ, 0605; 5029MA, 0594; 5320AIW8, 0655; 5320AIWU,
0605; 5020MA, 0594; 5035AFEO, 0595; 5030ANS, 0664; 5320A,
0615; 5020AEOS, 0604; 5021IJMX, 0665; 5020MA, 0594; 5030AE,
0624; 5020A, 0624; 5022AN, 0664; 5070A, 0634; 5020a, 0624;
5021HIJS, 0655, 5080AE, 0594; 5022MS, 0595;
(b) 5116, 0604; 5116AWEU, 0604; 5117AWE, 0604; 5116, 0604;
(c) 6CYOOO7A, 0624, 6QX00QXX, 0604, STA40ABA, 0595;
6G400GFX, 0654; 6QA00JHX, 0604; 6DEY0Z4B, 0615; 6GXY0P2X,
0604; 6GQXYW8Z, 0595; 6Q80007X, 0624, 6QN00D2X, 0624.
MANUFACTURER Vital Signs, Inc., Totowa, New Jersey.
RECALLED BY Manufacturer, by telephone followed by letters dated March
14 and 16, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 745 Cases (20 bags per case); (b) 3 cases (20 bags per
case); (c) 90 cases (15 bags per case) were distributed.
REASON The corrugated hose component packaged in the medical
breathing kits may contain pinholes that could cause a
circuit to leak.
-3- _______________
PRODUCT SL-Series Liner Accelerators and Vericord S3 Computer
Verification and Record System:
(a) SL-Series (15, 18, 20, and 25) Linear Accelerators, with
Version 2.0.0 Operating Software (or higher), a dual x-ray
and multi-electron linear accelerator to treat superficial
shallow and deep seated tumors;
(b) Vericord S3 Computer Verification and Record System,
used in conjunction with SL 75 Linear Accelerators.
Recall #Z-931/932-5.
CODE Software Versions 2.0.0 and 2.1.0.
MANUFACTURER Philips Medical Systems, Crawley, West Sussex, England.
RECALLED BY Philips Medical Systems, North America, Shelton,
Connecticut, by letter issued March 3, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 87 units; (b) 12 units were distributed.
REASON Software 2.0.0 could permit incorrect patient data or
prescription information to be presented to the operator(s).
_______________
PRODUCT Unprotected lead wires and patient cables distributed as
components of the following products:
Tumistore monitors for nocturnal tumescence,
Myoman biofeedback on incontinence,
EMG diagnosis module,
Pressure/EMG diagnosis module,
Tumi/EMG tumescence diagnosis module
Janus III tumescence diagnosis module,
Microphor electronystagmography analysis system, Ear
Electrode connector cable for iontophoresis ear canal
deadening,
Tray clip to attach to dental tray,
Cable EmpiIop electrode cable for iontophoresis using EMPI
electrodes,
Cable Eartrode connector for iontophoresis ear canal
deadening,
Ground plate electrode used during EMG testing,
ENG electrode sets,
Dual Treatment Lead Wire for iontophoresis,
Tumisensors expansion sensors to measure tumescence,
EMG module and audio monitor,
Janus III EMG module and audio monitor for measuring EMG,
Spectrum:EMG module and audio center for measuring EMG,
Ground reference electrode needle,
Monopolor electrode needles,
Dentaphor, Dentaphor II, Iontophor and Iontophor II
containing leads for active and reference electrodes;
Surface Return Electrode for iontophoresis reference;
Electrodes for ear canal deadening;
Gold Cup Electrodes for monitoring Electrode and lead
-4- Banana Plug to Tip Jack Connector converter lead from banana
plug to .080 pin;
Drug Delivery Cable between iontophoresis unit and electrode
leads;
Demo Case PI Distributors containing leads for nerve
location;
Electrode Connector containing Electrodes plus three lead
set for EMG testing;
Electrode .080 lead from PNS unit to clip for nerve
location;
Electrode iontophoresis lead;
Electrode PNS lead;
Regional Block needles for nerve location;
Tracer Nerve Locator;
Dual-Stim and Dual-Stim Plus Peripheral Nerve Stimulators;
EMG input cable to connect EMG electrodes and diagnostic
unit;
Starter Kit with Electrode leads for ENG testing;
Tumisensor Starter Kit;
ENG Thermal Array strip chart recorders;
TIP Plug to Regional Needle Connector for regional block;
TIP Plug to Tip Jack Connector;
Vestibular Autorotation Test Packages for Spatial diagnostic
units. Recall #Z-1039/1040-5.
CODE Serial numbers 1009101 through 1521201.
MANUFACTURER Life-Tech, Inc., Houston, Texas.
RECALLED BY Manufacturer, by letter dated August 4, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 65,737 units were distributed; as of July 31, 1995, firm
estimated that 47,215 units remained on the market.
REASON Labels fail to provide adequate directions for use, and the
cables and lead wires pose an unwarranted risk of injury to
patients because they are not labeled to contraindicate use
with apnea monitors.
_______________
PRODUCT Clamp and slide screws components of the 35000 Pennig
Dynamic Wrist Fixator (non sterile) and the 35001 Pennig
Dynamic Wrist Fixator with Distractor Module (non sterile),
external fracture fixation devices that are used to align
distal radius fractures and maintain their fixation
throughout the healing process:
(a) Pennig Dynamic Wrist Fixator (non-sterile), 35000;
(b) Pennig Dynamic Wrist Fixator with Distractor Module
(non-sterile), 35001;
(c) Pennig Dynamic Wrist Fixator Clamp Screw (non-sterile),
35080;
(d) Pennig Dynamic Wrist Fixator Slide Screw (non-sterile),
35081. Recall #Z-1072/1075-5.
CODE Lot numbers 003 and 001.
MANUFACTURER Orthofix Srl, Verona, Italy.
-5- RECALLED BY EBI Medical Systems, Inc., Parsippany, New Jersey, by using
the August 18, 1992 EBI Field Communication sheet. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide, Canada, Puerto Rico.
QUANTITY Firm estimates none remains on the market.
REASON In some instances, conditions have led to stress corrosion
cracking.
_______________
PRODUCT Omni Switchtip System, Model HP series:
(a) Model No. 20474-HP;
(b) Model No. 20475-HP;
(c) Model No. 20476-HP;
(d) Model No. 20479-HP;
(e) Model No. 20481-HP;
(f) Model No. 20489-HP. Recall #Z-038/043-6.
CODE (a) Lot No. 10391; (b) 10166, 10182;
(c) 10167, 10183, 10278; (d) 10168, 10181;
(e) 10394; (f) 10430.
MANUFACTURER Trimedyne, Inc., Irvine, California.
RECALLED BY Manufacturer, by telephone from April 6 to 10, 1995,
followed by letter April 7, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Austria, United Kingdom.
QUANTITY 555 units were distributed.
REASON The disposable fiber tips and handpieces have the potential
to heat excessively, causing melting and possible skin
burns.
_______________
PRODUCT RFX and SFX X-ray Tables, Model #46-262751G5.
Recall #Z-045-6.
CODE Units with serial number lower than 435634WK1.
MANUFACTURER General Electric Medical Systems (GEMS), Waukesha,
Wisconsin.
RECALLED BY Manufacturer, by issuing a Field Modification Instruction
(FMI 10587) on May 18, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 332 tables were distributed.
REASON The table top becomes free floating when the chain fails,
which may allow it to drop suddenly when in the vertical
position.
_______________
PRODUCT The Check Your Airway, a non-continuous manual ventilator.
Recall #Z-053-6.
CODE All units.
MANUFACTURER Heining Cherr Rui Bi Lok, China.
RECALLED BY J & I International Trading Group, Inc., College Station,
Texas, by letter dated September 18, 1995. FDA-initiated
recall ongoing.
-6- DISTRIBUTION Arizona, Texas.
QUANTITY 400 units were distributed.
REASON Product was distributed without an approved 510(k), and is
marketed as "sterile" without adequate documentation to
verify sterility.
_______________
PRODUCT InteliJet Disposable Tubing Set, Inflow Only, Catalog
#7204727, used in conjunction with the InteliJet Fluid
Management System which is a microprocessor controlled
system designed for controlled delivery of irrigation fluid
to control intra-articular pressure during athroscopic
surgery. Recall #Z-055-6.
CODE Lot numbers: 179980, 179990, 207860.
MANUFACTURER Smith & Nephew Endoscopy Dyonics, Inc., Andover,
Massachusetts.
RECALLED BY Manufacturer, by letters distributed on or about September
13, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, France, Belgium, United Arab Emerites.
QUANTITY 2,613 units.
REASON The packaging of the product had visible evidence of cracks,
therefore compromising the sterility of the product.
_______________
PRODUCT ESI Laser Product, Model #4210 with cantilevered custom
shroud, used for laser trimming. Recall #Z-056-6.
CODE Model #4210.
MANUFACTURER Electro Scientific Industries, Portland, Oregon.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan September 15, 1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 24 units.
REASON The laser product failed to comply in that gaps may exist in
the cantilevered custom shroud (protective housing) that
allow human access to direct or scattered laser radiation
above Class I.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Cournand Quadpolar 6 FR Electrode Catheter.
Recall #Z-921-5.
CODE Lot #07JE0081.
MANUFACTURER Bard Glen Falls Manufacturing Operation, Glen Falls, New
York.
RECALLED BY USCI Division, C.R. Bard, Billerica, Massachusetts, by
letter March 9, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 113 units were distributed.
REASON The product label which states "Cournand" curve style
differs from the actual"Damato" curve style of the catheter
contained in the package.
-7- _______________
PRODUCT Verifuse Disposable Administration Sets, for intravenous,
intra-arterial and subcutaneous infusions of patients
receiving infusion therapy:
(a) Model V021007; (b) Model V021013; (c) Model V021014;
(d) V021015. Recall #Z-001/004-6.
CODE Lot numbers: (a) 50921, 51324, 51723, 51820, 52020;
(b) 51724; (c) 50922, 50924, 51323, 51325, 51326, 51725;
(d) 50923, 50925, 51327, 51726.
MANUFACTURER Block Medical, Inc., Carlsbad, California.
RECALLED BY Manufacturer, by letter sent June 9 and 22, 1995, and by
telephone June 12 and 13, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Australia, Japan, The Netherlands.
QUANTITY Approximately 36,000 units were distributed; firm estimated
that 10,000 units remained on market at time of recall
initiation.
REASON The sets leak infusion fluids, due to a faulty weld.
_______________
PRODUCT Stockert Aortic Arch Cannula, Product #A211-65, indicated
for cannulating the major arterial vessels during heart
bypass operations. Recall #Z-052-6.
CODE Lot #9490834800.
MANUFACTURER Stockert Instrumente Gmbh, Munich, Germany.
RECALLED BY Sorin Biomedical, Inc., Irvine, California, by letter sent
June 5, 1995. Firm-initiated recall complete.
DISTRIBUTION Kansas, Minnesota, Wisconsin.
QUANTITY 223 units; firm estimates none remains on the market.
REASON The product is labeled "Connector A 3/8" Straight LL UP".
The correct labeling should be "Connector B 3/8" Straight LL
Down.
-8-
END OF ENFORCEMENT REPORT FOR OCTOBER 25, 1995. BLANK PAGES MAY
FOLLOW.
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