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
03/23/1994
Recalls and Field Corrections: Cosmetics -- Class II -- 03/23/1994
March 23, 1994 93-12
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
_______________
PRODUCT Formula 405 Soapless Cleansing Lotion in 16 fluid ounce
bottles. Recall #F-318-4.
CODE All lots except lot 3510A and 31109, or any other lot
starting with 4.
MANUFACTURER Doak Pharmacal Company, Inc., Westbury, New York.
RECALLED BY Manufacturer, by letter January 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 450 units were distributed.
REASON Product contained a color additive not authorized for use in
cosmetics (D&C Red #19).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT SoloPak Heparin Lock Flush Solution, USP, Preservative
Free, 10 USP units/ml packaged in 1, 3 and 5 ml syringes;
for maintenance of patency of intravenous injection devices
only, not to be used for anticoagulant therapy:
(a) Catalog #10671: 1 ml fill in 1.5 ml Hy-Pod Syringe and
25G x 5/8" needle, individually wrapped, 120 per carton;
(b) Catalog #10673: 3 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton;
(c) Catalog #10675: 5 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton;
(d) Catalog #10681: 1 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton;
(e) Catalog #10683: 3 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton;
(f) Catalog #10685: 5 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton;
(g) Catalog #11771: 1 ml fill in 1.5 ml Hy-Pod Syringe,
contained in the Lok-Pak-N Heparin Flush Kit, 200 per case;
(h) Catalog #11773: 3 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Flush Kit, 200 per case;
(i) Catalog #11775: 5 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Flush Kit, 200 per case. Recall #D-196-4.
CODE (a) Catalog #10671: lot #93E059C, 93E060C, 93G001C, 93G002C;
(b) Catalog #10673: lot #93E002C, 93F005C, 93F005D, 93F006C,
93H006C, 93L003C;
(c) Catalog #10675: lot #93F011C, 93H012B;
(d) Catalog #10681: lot #93J073B;
(e) Catalog #10683: lot #93H071B, 93K071B;
(f) Catalog #10685: lot #93H074B, 93L007C;
(g) Catalog #11771: lot #93E059B, 93E060B, 93F001B, 93G001B,
93G002B;
(h) Catalog #11773: lot #93E002B, 93F005B, 93F006B, 93H006B,
93L003B;
(i) Catalog #11775: lot #93E003B, 93F011B, 93L007B.
MANUFACTURER SoloPak Medical Products Inc., formerly known as Smith &
Nephew SoloPak, Franklin Park, Illinois.
RECALLED BY SoloPak Medical Products Inc., Elk Grove Village, Illinois,
by letter February 22, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 997,800 syringes were distributed; firm estimates 48,890
syringes remain on the market.
REASON Potency not assured through expiration date.
_______________
PRODUCT S2 Inhalant, Racepinephrine HCl USP 2.25% Inhalation
Solution, 15 ml glass bottles. Recall #D-200-4.
CODE Lot #R11911 EXP 11/94.
MANUFACTURER Nephron Pharmaceuticals Corporation, Orlando, Florida.
RECALLED BY Manufacturer, by letter January 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 402 bottles were distributed; firm estimates none remains on
the market.
REASON Subpotency.
_______________
PRODUCT Pancrelipase Capsules, in 100 and 250 count bottles,
indicated for patients with exocrine pancreatic enzyme
deficiency, under the Trinity and Qualitest labels.
Recall #D-203/204-4.
CODE Lot #K108A EXP 10/93.
MANUFACTURER Pharmaceutical Delivery Systems, Inc., Creve Coeur,
Missouri.
-2- RECALLED BY Trinity Technologies Corporation, Roseville, Michigan, by
telephone August 4, 1993, followed by letter September 13,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,470 100-tablet bottles and 1,198 250-tablet bottles were
distributed.
REASON Subpotency of amylase ingredient.
_______________
PRODUCT Oxygen, USP in size D & E compressed gas aluminum cylinders.
Recall #D-205-4.
CODE All lots. Lot numbers all begin with #14 followed by the
date in which an H size cylinder was added to the tank bank.
MANUFACTURER Medical Services of America, Inc., doing business as Medi-
Home Care, Roanoke, Virginia.
RECALLED BY Manufacturer, by telephone March 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 9 size E cylinders and 3 size D cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Motrin IB Caplets (Ibuprofen) in foil packets of two, in
dispenser of 100 packets and in bulk containers of 2,500
packets. Recall #D-197-4.
CODE Lot #115HT EXP 4/30/97 for both containers.
MANUFACTURER The Upjohn Company, Kalamozoo, Michigan.
RECALLED BY Manufacturer, by telephone and memorandum April 14, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9,968 units were distributed.
REASON Trace quantities of the lacquer used on exterior of foil
package transferred to interior surface.
_______________
PRODUCT Patient brochure for Depo-Provera Contraceptive Injection.
Recall #D-198-4.
CODE Brochures with print date of November 1992 or February 1993
distributed since 12/15/92.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter. Distribution of the incorrect
patient brochure was discontinued 3/31/93 and new brochures
began to be shipped 4/14/93. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 238,600 brochures were distributed.
REASON Incomplete printing of the brochure.
-3- _______________
PRODUCT Hydrocodone Bitartrate/Acetaminophen (HCB/APAP), 5/500 mg
tablets, under the following labels: H.N Nortcon
Co./Luchem, 100's and 500's; Goldline 100's and 500's; Major
500's. Recall #D-199-4.
CODE All lots.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product does not meet dissolution specifications through
expiration date.
_______________
PRODUCT S2 Inhalant, Racepinephrine HCl USP 2.25% Inhalation
Solution, 15 ml glass bottles, . Recall #D-201-4.
CODE Lot numbers: 99219, R109308 EXP 8/95, 10/95.
MANUFACTURER Nephron Pharmaceuticals Corporation, Orlando, Florida.
RECALLED BY Manufacturer, by letter February 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,741 bottles of lot 99219 and 8,604 bottles of lot R109308
were distributed.
REASON Product does not meet USP specifications for color.
_______________
PRODUCT Medrol brand of methylprednisolone, USP, 4 mg tablets, in
blister packs of 100, a corticosteroid. Recall #D-202-4.
CODE Lot #995JP EXP 12/31/97.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter June 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,582 tablets were distributed.
REASON Carton incorrectly declares "Methylprednisolone" as
"Methylprednisone". Blisters and insert are correct.
_______________
PRODUCT Urinary Antiseptic Tablets, Rx indicated for the relief of
discomfort of the lower urinary tract, in 100 and 1,000
count bottles, under Trinity, Qualitest, Rugby, Moore, and
Goldline labels. Recall #D-204-4.
CODE Lot No. EXP Date
A108D 7/94
A119D 7/94
B115D 7/94
C114D 9/94
D109C 4/94
D112D 10/94
D113D 10/94
E110C 5/94
-4- F109C 6/94
G115C 7/94
J101C 9/94
J118C 9/94
L123C 5/94
M122C 6/94
F109D 10/94
J102C 9/94
L122C 5/94.
MANUFACTURER Trinity Technologies Corporation, Roseville, Michigan.
RECALLED BY Manufacturer, by letter July 21, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 106,534 units wre distributed.
REASON Product does not meet potency specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
======================
_______________
PRODUCT Red Blood Cells. Recall #B-097-4.
CODE Unit numbers: 04K28065, 04K28066, 04K28097, 04K28099,
04R78705, 04R78707, 04R78709, 04R78711, 04R78715, 04S43640,
04FK13491.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone July 28, 1992, followed by letter
August 8, 1992. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 11 units.
REASON Blood products, held at uncontrolled storage conditions were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-170-4.
CODE Unit #4052631.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, that tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBC), was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-172-4.
CODE Unit #6283895.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone September 7, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
-5- REASON Red Blood Cells, collected from a donor currently taking the
drug Proscar, were distributed for transfusion.
_______________
PRODUCT Red Blood Cells. Recall #B-173-4.
CODE Unit 647102.
MANUFACTURER W.E. and Lela I. Stewart Regional Blood Center, Tyler,
Texas.
RECALLED BY Manufacturer, by telephone February 25, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who reported taking
the medication Tegison, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-174-4.
CODE Unit #J27557.
MANUFACTURER Texoma Regional Blood Center, Sherman, Texas.
RECALLED BY Manufacturer, by visit January 6, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date, was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Naturalyte Acid Concentrate for Bicarbonate Dialysis, for
use in dialysis equipment during dialysis treatment:
(a) Catalog No. 13-4004-1, Series 4000
(b) Catalog No. 13-4010-8, Series 4000
(c) Catalog No. 13-4002-5, Series 4000
(d) Catalog No. 13-4018-1, Series 4000
(e) Catalog No. 13-4022-3, Series 4000
(f) Catalog No. 13-6608-7, Series 6000
(g) Catalog No. 13-9027-7, Series 9000
(h) Catalog No. 13-9029-3, Series 9000.
Recall #Z-161/168-4.
CODE Lot numbers: (a) E2S027; (b) E2S028, (c) E2S029;
(d) E2S030; (e) E2S031; (f) E2S032; (g) E2S033;
(h) E2S034; (i) E2S026.
MANUFACTURER National Medical Care, Medical Product Division, Livingston,
California.
RECALLED BY National Medical Care (NMC), Medical Product Division,
Rockleigh, New Jersey, by letter dated June 17, 1993, and by
telephone beginning on or about May 28, 1993 or June 1,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
-6- QUANTITY 434 55-gallon drums were distributed;
REASON The products do not meet the NMC pyrogen specification for
hemodialysate of 5.0 eu/ml.
_______________
PRODUCT O.R. Saracap Respiratory Monitor and Capnograph, Model
200009, for use during surgery and general anesthesia to
monitor airway levels of carbon dioxide, oxygen, and nitrous
oxide. Recall #Z-345-4.
CODE Software version 2.04.
MANUFACTURER PPG Industries, Inc., Lenexa, Kansas.
RECALLED BY Manufacturer, by visit beginning January 10, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 2,433 units remain in distribution.
REASON The device contains invalidated software.
_______________
PRODUCT Promatek ElectroStim Ultra 3F Therapy Ultrasound Systems,
ultrasonic generators and applicators. Recall #Z-402-4.
CODE All serial numbers, 5108 through 5794.
MANUFACTURER Diter-Elektroniikka Oy, Turku, Finland.
RECALLED BY Promatek Medical Systems, Inc., Joliet, Illinois. FDA
approved the firm's corrective action plan May 10, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 106 units were distributed; firm estimates 68 units remain
on the market.
REASON The units were found in non-compliance with the performance
standard for ultrasonic therapy products, in that:
The error in the indication of power output exceeds
the +/- 20 percent error allowed by the performance
standard for the following tests:
- continuous wave power measurements
- pulsed power measurements
- +/- 10 percent line voltage power measurements
- short term life test power measurements;
Discrepancies are found in the operation control labeling;
Incorrect values are listed for Rtpa in the user
information;
The measured effective radiating area (ERA) exceeds the
listed ERA for the 2 MHz large applicator in the user
information;
The measured beam non-uniformity ratio (BNR) exceeds the
labeled maximum BNR for the 0.86 and 3.0 MHz applicators;
and
The unit indicates output when none exists, and vice versa
under certain conditions.
_______________
PRODUCT Eight French Single Lumen Groshong High Performance
Catheters:
-7- (a) Product Code 7710922; (b) Product Code 7710924;
(c) Product Code 7711922; (d) Product Code 7711924;
(e) Product Code 7711932; (f) Product Code 7711934.
Recall #Z-404/409-4.
CODE All lots.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone beginning January 13, 1994,
followed by letters sent during the week of January 17-21,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,550 units.
REASON The thrombosed polyurethane liner of the distal silicone
catheter segment was extruding through the Groshong valve
opening out of the lumen of the silicone catheter into the
lumen of the patient's central venous system.
_______________
PRODUCT DeRoyal Surgical Laparotomy Sponges, pre-washed x-ray
detectable: (a) 18" x 18", Product #9-1818;
(b) 12" x 12" Lap Sponges, Product #1-1212.
Recall #Z-439/440-4.
CODE Lot numbers: (a) 16325; (b) 16580.
MANUFACTURER Qualtex, Inc., Division of DeRoyal Industries, Rose Hill,
Virginia (packager/sterilizer).
RECALLED BY DeRoyal Industries, Inc., Powell, Tennessee, by letters of
February 1, 1994, and March 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION (a) Alabama, Maryland, Texas, North Carolina, Tennessee; (b)
California, Maryland, New Jersey, South Carolina, Texas,
Pennsylvania, Tennessee.
QUANTITY (a) 47 cases; (b) 43 cases.
REASON The products were found to be non-sterile.
_______________
PRODUCT Diagnostic Magnetic Resonance Imaging Equipment, intended
for general diagnostic use to produce images used in
diagnosing disease: (a) Model SMT-50X; (b) Model SMT-100X.
Recall #Z-441/442-4.
CODE Serial numbers: 682001, 628002, 628004, 628021, 628591,
628631, 628633; (b) 628841, 628844, 628846, 628885.
MANUFACTURER Shimadzu Corporation, Koyoto, Japan.
RECALLED BY Shimadzu Medical Systems, Torrance, California, by letter
June 16, 1993. Firm-initiated field correction complete.
DISTRIBUTION Alaska, Arkansas, Florida, Louisiana, New Jersey, New York,
Pennsylvania.
QUANTITY (a) 8 systems; (b) 4 systems.
REASON Software versions 2.0, 2.1, or 2.2 do not correctly store
inverted image annotations on the disk. The annotations
will be reversed upon retrieval, for example, head to foot,
posterior to anterior, left to right, which could result in
misdiagnosis.
-8- _______________
PRODUCT Sunlamp Tanning Product, Sunquest 5000, Sunward I, and Tan
AM 4000. Recall #Z-460-4.
CODE Model STI 1000.
MANUFACTURER The Daavlin Distributing Company, Bryan, Ohio.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan February 18, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 544 units.
REASON Digital timers could be reset to exceed maximum recommended
time (MRET).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Blood Chemistry Vacutainer Collection Tubes, Reorder #6440,
an evacuated blood collection tube. Recall #Z-205-4.
CODE Lot #2C708 EXP 4/94.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumpter, South
Carolina.
RECALLED BY Becton Dickinson and Company, Becton Dickinson Division,
Franklin Lakes, New Jersey, by letter August 26, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 203,400 units were distributed; firm estimates less than 10%
of the amount shipped remains on the market.
REASON The Vacutainer Branch Tubes were defective causing red cells
to adhere to the glass surface of the tubes.
_______________
PRODUCT (a) Coulter Bilirubin, Total (B), Catalog #2907076; (b)
Coulter Bilirubin, Direct (A+C) DACOS Reagent System,
Catalog #2907075, intended for the in-vitro quantitative
determination of Total and Direct Bilirubin with the DACOS
DACOS XL chemistry analyzers. Recall #Z-378/379-4.
CODE Lot numbers: (a) 15672, 15703; (b) 15671, 15739, 15740.
MANUFACTURER Trace America, Inc., Australia (reagents).
RECALLED BY Coulter Corporation, Miami, Florida, by telephone followed
by letter May 3, 1993. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Pennsylvania, Texas, California, Georgia,
Colorado, Oklahoma, Oregon, Florida, Illinois, Minnesota,
Washington state, North Carolina, Michigan, Ohio,
Massachusetts, Kansas.
QUANTITY Firm estimates none remains on the market.
REASON The firm released a new bilirubin methodology with a new
line of DACO chemistry reagents, that are not
interchangeable. The labeling failed to identify that they
could not be interchanged.
-9- _______________
PRODUCT Coulter Optichem Chemistry Control, Level II, for in-vitro
diagnostic use. Recall #Z-380-4.
CODE Vial lot #165001, kit lot numbers: 160006K3 and 160006K4
EXP 10/14/94.
MANUFACTURER Ciba Corning Diagnostics Corporation, Irvine, California.
RECALLED BY Coulter Corporation, Miami, Florida, by letter October 7,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Turkey, United Kingdom, Germany, Puerto
Rico, France.
QUANTITY 239 kits of lot 160006k3 and 10 kits of lot 160006K4 were
distributed.
REASON The tables of assigned values had typographical errors.
_______________
PRODUCT Coulter Chemistry Control Level II, 10 x 15 ml, Part
#7546995, used as a quality control material for the Coulter
DACOS Analyzer, DACOS XL and Optichem Chemistry Systems.
Recall #Z-388-4.
CODE Kit lot numbers: 160006K, 160006K1, 160006K2.
MANUFACTURER Trace America, Inc., Australia.
RECALLED BY Coulter Corporation, Miami, Florida, by letter June 25,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Bermuda, Europe, Canada, United Kingdom, Spain,
Germany.
QUANTITY 336 kits of lot 160006K, 165 kits of lot 160006K1, and 150
kits of lot 160006K2 were distributed.
REASON There was a change in the DACAL Calibrator assigned values.
This resulted in a shift in the mean and low recovery values
when using new Coulter Dacos Uric Acid reagent.
_______________
PRODUCT Coulter ISE Module, a component of Coulter Opti-Chem 120 and
180 Systems, used to perform clinical chemistry analyses:
(a) Coulter OptiChem 120 & 180 Systems Software Catalog No.
6604263;
(b) Coulter OptiChem 120 & 180 Systems Software Catalog No.
6604264;
(c) Coulter OptiChem 120 & 180 Systems Software Catalog No.
6604271;
(d) Coulter OptiChem 120 & 180 Systems Software Catalog No.
6604273. Recall #Z-389/392-4.
CODE All serial numbers.
MANUFACTURER Kone Instruments, Helsinki, Finland.
RECALLED BY Coulter Corporation, Miami, Florida, by "important product
information" letter dated May 1, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 185 units ramain on the market.
REASON There was an error in the ISE module software that allowed
test results to be reported outside the validated range
which may not be accurate.
-10- _______________
PRODUCT 4C Plus Normal Cell Control, for in-vitro diagnostic use:
(a) 4C Plus Normal Cell Control, Part No. 7546923;
(b) 4C Plus Triple Cell Control 9 x 3.3 mL, Part No.
7546771;
(c) 4C Plus Triple Cell Control 6 x 3,3 mL, Part No.
7546968. Recall #Z-393/395-4.
CODE Lot numbers: (a) 776F; (b) 103434K; (c) 108159K.
MANUFACTURER Coulter Corporation, Diagnostics Group, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning
November 8, 1991. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON Customers reported high Hgb recovery when using these lots
of control, on Coulter T series, S880, and JT instruments.
Assay values printed in the package insert were unable to be
retrieved.
_______________
PRODUCT Centermark Dual Lumen Peripherally Inserted Central Venous
Catheter. Recall #Z-403-4.
CODE Catalog #C2-202-58G, Lot #308241.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by telephone and by letter in October 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON There was a potential for crossover leakage between the two
lumens during blood withdrawal.
_______________
PRODUCT Irrijet Irrigation System, Product #55-0504, used for
external wound irrigation. Recall #Z-410-4.
CODE Lot numbers: 3514 and 3529.
MANUFACTURER Ackrad Laboratories, Cranford, New Jersey.
RECALLED BY Manufacturer, by telephone and by letter February 26, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 560 units were distributed.
REASON The disposable tips may be plugged resulting in lack of
fluid flow.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT (a) Horse and Pony Feed (740); (b) Phase Two (751) and Phase
Three Horse Feed (752); (c) Horse and Pony Feed (747);
(d) Rabbit Pellets (711). Recall #V-037/038-4.
CODE Dates of productions: 11/9/93, 11/11/93, 11/23/93, 12/10/93,
12/30/93, 1/14/93.
MANUFACTURER Molinos de Puerto Rico, Inc., Guaynabo, Puerto Rico.
-11- RECALLED BY Manufacturer, by February 7, 1994 inspection. Firm-
initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY (a) 48,000 pounds; (b) 155,000 pounds; (c) 12,280 pounds;
(d) 20,000 pounds.
REASON Possible cross contamination of horse feed with lincomycin.
Possible cross contamination of rabbit pellets with tylosin
and sulfamethazine.
_______________
PRODUCT Stepsaver WDC, medicated swine feed containing carbadox and
pyrantel tartrate. Recall #V-039-4.
CODE LK8974.
MANUFACTURER Moorman Manufacturing Company, LaMars, Iowa.
RECALLED BY Moorman Manufacturing Company, Quincy, Illinois, by
telephone December 31, 1993. Firm-initiated recall
complete. See also FDA talk paper T94-10, February 2, 1994.
DISTRIBUTION Wisconsin.
QUANTITY 2 tons were distributed; firm estimates none remains on the
market.
REASON Unlabeled bulk swine feed containing carbadox and pyrantel
tartrate erroneously shipped to a dairy farmer.
MEDICAL DEVICE SAFETY ALERTS:
=============================================
_______________
PRODUCT Bipolar Forceps: (a) 60-5120-001, Cushing Bayonet;
(b) 60-5121-001, Scoville-Greenwood Bayonet;
(c) 60-5122-001, Jewelers, Straight Tip;
(d) 60-5123-001, Semkin, Micro-Tip.
Safety Alert #N-040/043-4.
CODE None.
MANUFACTURER Aspen Laboratories, Inc., Englewood, Colorado.
ALERTED BY Manufacturer, by letter August 25, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 351 units.
REASON Inadequate cleaning of the bipolar forceps may cause an
unintended change in power setting and/or difficulty in
activation of the Aspen Bistat electrosurgical unit.
SEIZURE:
==================================================================
_______________
PRODUCT Frozen Yellow Fin Tuna Loins (94-630-112).
CHARGE Adulterated - The article bears or contains a poisonous and
deleterious substance, histamine, which ordinarily renders
it injurious to health; and, it consists in part of a
decomposed substance by reason of the presence of decomposed
fish.
LOCATIONS Cityice Cold Storage Company, Seattle, Washington.
-12- FILED March 3, 1994; U.S. District Court for the Western
District of Washington; Civil #C 94-316R; FDC #66936.
SEIZED March 9, 1994 - goods valued at approximately $33,150.
-13-
END OF ENFORCEMENT REPORT FOR MARCH 23, 1994. BLANK PAGES MAY
FOLLOW.
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