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
06/05/1996
ENFORCEMENT REPORT FOR 06/05/1996
June 5, 1996 96-23
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT J.B. Williams Cepacol Maximum Strength Sore
Throat Spray (cool menthol), Non Rx, in 4
ounce liquid spray bottles. Recall #D-150-6.
CODE Lot #L5010J EXP 7/97.
MANUFACTURER Les Emballages Knowlton, Knowlton, Quebec,
Canada.
RECALLED BY J.B. Williams Company, Inc., Glen Rock, New
Jersey, by letter on September 5, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 58,212 units were distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ==========
_______________
PRODUCT Avian Transport Adult and Pediatric Ventilator
(a) Avian Ventilator, Part No. 15304;
(b) Avian Ventilator, Part No. 15345;
(c) Avian Ventilator, Part No. 15345A;
(d) Avian Ventilator, Part No. 15345C;
(e) Avian Ventilator, Part No. 15345J;
(f) Avian Ventilator, Part No. 15345L;
(g) Avian Ventilator, Part No. 15345S;
(h) Avian Ventilator, Part No. 15365;
(i) Avian Ventilator, Part No. 15365A;
(j) Avian Ventilator, Part No. 15365C;
(k) Avian Ventilator, Part No. 15365J;
(l) Avian Ventilator, Part No. 15365L;
(m) Avian Ventilator, Part No. 15365S.
Recall #Z-729/741-6.
CODE All lots and all serial numbers.
MANUFACTURER Bird Products Corporation, Palm Springs,
California.
RECALLED BY Manufacturer, by letter on April 1, 1996,
followed by an updated letter dated April 15,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 3,200 units were distributed.
REASON All device models have oxygen bleeding or
leaking internally, which is not being
adequately vented to the outside of the case.
This causes elevated oxygen concentrations
within the device when the unit is operated
with an enriched gas supply (e.g., 40% - 100%
oxygen). Furthermore, one particular brand of
capacitor with an inadequate voltage
specification, found in approximately 120 to
150 of the devices, at one circuit board
location, fails due to overheating, which in
the presence of the elevated oxygen
concentrations, causes combustion within the
case.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Receptal Suction Liner System, used with the
Receptal hard canister for vacuum suction
waste body fluid management in hospital
operating rooms:
(a) List 43024- 01: 2000 ml liner/lid, 1/4"
port V3024-01: VHA+PLUS label;
(b) List 43027-01: 2000 ml liner/lid with pour
spout (arthroscopy) V3027-01- VHA+PLUS label;
(c) List 43042-01: 2000 ml Liner/Lid with
VAC-GARD internal non-mechanical shut off
valve/filter V3042-01-VHA+PLUS label;
(d) List 43044-05: 2000 ml liner/lid with
VAC-GARD internal non-mechanical shut off
valve/filter, pour spout V3044-05- VHA+PLUS
label;
(e) List 43043-01: 1500 ml liner/lid with
VAC-GARD internal non-mechanical shut off
valve/filter V3043-01 VHA+PLUS label;
-2- (f) List 43044-01: 1500 ml liner/lid with
VAC-GARD internal non-mechanical shut off
valve/filter, pour spout.
Recall #Z-781/786-6.
CODE Lot numbers: (a) 43024-01: 86021K4, 87015K4,
87016K4, 87017K4, 87018K4, 88026K4, 88027K4,
88028K4, 88029K4, 88040K4, 89006K4, 89007K4,
89088K4, 89089K4, 89094K4, 90001K4, 90002K4,
90003K4, 90011K4, 91003K4, 91004K4, 91005K4,
91064K4, 91065K4, 92044K4, 92045K4, 92080K4,
92081K4, 92082K4, 92106K4, 92109K4, 92110K4,
92113K4, 92115K4, 93044K4, 93072K4, 93073K4,
93074K4, 95058K4, 95059K4, 95060K4, 95061K4,
96002K4, 96003K4, 96004K4, 96005K4, 96082K4,
96130K4, 96131K4, 96132K4, 96133K4, 96134K4,
02019K4, 02020K4, 02021K4, 03015K4, 03016K4,
03017K4, 03051K4, 03052K4, 03053K4, 05054K4,
04003K4, 04004K4, 04005K4, 04006K4, 04007K4,
04008K4, 04088K4, 04089K4, 05001K4, 05002K4,
05075K4, 06006K4, 06040K4, 06041K4, 07017K4,
07018K4, 07019K4, 07039K4, 08019K4, 08020K4,
08047K4, 08106K4, 09008K4, 09009K4, 09010K4,
09048K4, 09094K4, 10006K4, 10007K4;
V3024-01: 87001K4, 87002K4, 87003K4, 88017K4,
88018K4, 88019K4
(b) 43027-01: 02101K4, 03055K4, 03056K4,
03057K4, 04022K4, 04023K4, 04024K4, 04106K4,
04107K4, 05012K4, 05013K4, 05094K4, 06042K4,
06043K4, 07020K4, 07041K4, 07091K4, 08012K4,
08013K4, 08126K4, 09012K4, 09013K4, 09014K4,
09049K4, 09095K4, 10009K4, 10010K4, 10011K4;
V3027-01: 06039K4, 07092K4, 08044K4, 08095K4,
10001K4
(c) 43042-01: 86022K4, 87021K4, 87022K4,
87055K4, 88033K4, 88034K4, 88042K4, 88043K4,
88058K4, 88059K4, 89013K4, 89095K4, 89118K4,
89119K4, 90024K4, 91009K4, 91010K4, 91011K4,
91066K4, 92056K4, 92087K4, 92107K4, 92111K4,
92116K4, 93076K4, 93077K4, 93078K4, 95062K4,
95063K4, 95064K4, 95065K4, 96022K4, 96023K4,
96135K4, 96136K4, 96137K4, 96138K4, 02022K4,
02023K4, 02088K4, 02108K4, 03018K4, 03019K4,
03020K4, 03058K4, 03121K4, 04026K4, 04027K4,
04028K4, 04029K4, 04090K4, 05003K4, 05076K4,
06007K4, 06044K4, 07021K4, 07022K4, 07023K4,
08026K4, 08027K4, 08102K4, 08127K4, 09015K4,
09016K4, 09050K4, 10014K4, 10015K4, 10016K4
V3042-01: 87007K4, 87008K4, 88021K4, 89002K4,
03028K4, 05009K4, 08024K4, 08096K4, 10002K4
(d) 43044-05: 04037K4, 04038K4, 05078K4,
05079K4, 06013K4, 06046K4, 07037K4, 08016K4,
-3- 08050K4, 09024K4, 09080K4, 10025K4, 10103K4
V3044-05: 06002K4, 07038K4, 08098K4, 10004K4
(e) 43043-01: 87023K4, 87024K4, 88035K4,
88036K4, 88037K4, 88131K4, 89014K4, 89019K4,
89091K4, 89092K4, 89120K4, 90005K4, 90006K4,
90050K4, 90051K4, 91012K4, 91013K4, 91014K4,
92057K4, 92058K4, 92088K4, 92089K4, 92090K4,
92091K4, 92092K4, 92093K4, 92108K4, 92112K4,
92114K4, 92117K4, 92118K4, 93079K4, 93080K4,
93081K4, 93082K4, 95066K4, 95067K4, 95068K4,
95069K4, 95087K4, 96024K4, 96025K4, 96026K4,
96139K4, 96140K4, 96141K4, 96142K4, 96143K4,
02024K4, 02025K4, 02026K4, 02038K4, 02039K4,
03021K4, 03022K4, 03023K4, 03024K4, 03059K4,
03060K4, 03061K4, 04030K4, 04031K4, 03032K4,
04108K4, 04109K4, 04110K4, 05017K4, 05018K4,
05077K4, 06008K4, 06009K4, 06045K4, 07034K4,
07035K4, 07036K4, 07094K4, 08014K4, 08015K4,
08048K4, 08107K4, 09017K4, 09018K4, 09019K4,
09020K4, 10018K4, 10019K4, 10020K4, 10021K4,
10022K4
V3043-01: 87009K4, 87010K4, 87011K4, 88022K4,
89003K4, 04001K4, 06001K4, 07093K4, 08045K4,
08097K4, 10003K4
(f) 43044-01: 04033K4, 04034K4, 04035K4,
04036K4, 04111K4, 04112K4, 05019K4, 05020K4,
05021K4, 06010K4, 06011K4, 06012K4, 07011K4,
07012K4, 07013K4, 08028K4, 08049K4, 08128K4,
09021K4, 09022K4, 09023K4, 10023K4, 10024K4,
10053K4, 10092K4, 10112K4.
MANUFACTURER Abbott Laboratories, Salt Lake City, Utah.
RECALLED BY Abbott Laboratories, Hospital Products
Division, Abbott Park, Illinois, by
interoffice memorandum on November 8, 1995,
and by letter on December 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 8,000,000 units are distributed
annually; firm estimates none remains on the
market.
REASON The receptal liner lids may pop off the
suction canisters compromising the function of
the device.
_______________
PRODUCT Calibration Gas Cylinders (10% 02, Balance
N2), used to calibrate and check an
oxygen/carbon dioxide analyzer.
Recall #Z-841-6.
CODE Lot #022434 EXP 8/97.
MANUFACTURER Scott Specialty Gases, Inc., Scott Medical
Products Division, Plumsteadville,
Pennsylvania.
-4- RECALLED BY
Manufacturer, by telephone on April 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state, Indiana, New York, Iowa,
Kansas, Wisconsin, Korea, Canada.
QUANTITY 36 cylinders were distributed.
REASON The cylinders labeled as 10% oxygen/balance
nitrogen, actually contain 10% carbon
dioxide/balance nitrogen.
_______________
PRODUCT Bird Ventilators, indicated for delivery of
medical gases to patients dependent on
artificial respiration:
(a) Model No. 8400STi Adult Volume Ventilator
and Upgrade Kits;
(b) Model "VIP" Infant and Pediatric
Ventilator and Upgrade Kits;
(c) Model No. 6400ST Adult Volume Ventilator;
(d) Model "Avian" Adult and Pediatric
Transport Ventilator. Recall #Z-842/845-6.
CODE 799 ventilators/up-grade kits, each with their
own serial number.
MANUFACTURER Vernay/Sfernice, Div. Potentiometers, Hyeres
Cedex, France (component)
RECALLED BY Bird Products Corporation, Palm Springs,
California, by letters dated December 21,
1995, and March 22, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 799 ventilators and upgrade kits are subject
to recall.
REASON The devices contain a defective potentiometer,
which can cause the ventilators to cease
operating while alarms remain functional.
_______________
UPDATE Recall #Z-752/753-6, Uroview Diagnostic
Imaging Systems and Recall #Z-754-6, Model
9400 Mobile Fluoroscopy Imaging System, which
appeared in the May 15, 1996 Enforcement
Report are completed recalls as of November
1994.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
=========
_______________
PRODUCT Lincomix 300 Injectable Swine Antibiotic for
the treatment of arthritis or mycoplasma
pneumonia. Recall #V-016-6.
CODE Lot #422MK EXP 8/99.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
-5- RECALLED BY Manufacturer, by letter mailed on June 22,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,830 cases of 6 vials each were distributed.
REASON Product is mislabeled. Cases of Lincomix,
labeled with the incorrect NDC Number 0009-
0617-12 and the incorrect strength of 100
mg/ml, containing vials properly labeled as
NDC Number 0009-3256-01, Lincomix 300
Injectable Swine Antibiotic (Lincomycin
Hydrochloride Sterile Solution, 300 mg/ml, 100
ml vial).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
========
_______________
PRODUCT Growing Ration E with Amprolium, medicated
feed. Recall #V-017-6.
CODE 257.
MANUFACTURER Molinos De Puerto Rico, Inc., Guaynabo, Puerto
Rico.
RECALLED BY Manufacturer, by visit on February 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 10 6000-pound batches were distributed; firm
estimates none remains on the market.
REASON Product failed to meet potency specifications
for amprolium (subpotent).
-6-
END OF ENFORCEMENT REPORT FOR JUNE 5, 1996. BLANK PAGES MAY FOLLOW.
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