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
02/08/1995
Recalls and Field Corrections: Foods -- Class II -- 02/08/1995
February 8, 1995 95-6
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Iceberg Lettuce packed as 2 dozen heads into cardboard
boxes. Recall #F-321-5.
CODE H2B which represents the name of the field in which the
lettuce was grown.
MANUFACTURER Reynold Mettler Farms, Bakersfield, California.
RECALLED BY Manufacturer, by fax April 20, 1994. Firm-initiated recall
complete.
DISTRIBUTION Alabama, California, Colorado, Louisiana, Oregon, New
Mexico, North Carolina, Canada.
QUANTITY 11,717 shipping cartons of unwrapped/wrapped lettuce were
distributed.
REASON Product contained chlorothalonil and there is no tolerance
for chlorothalonil in iceberg lettuce.
_______________
PRODUCT Fresh Raw Tuna, packaged in clear plastic bags.
Recall #F-322-5.
CODE None.
MANUFACTURER Top Catch Seafood, Mt. Pleasant, South Carolina (supplier).
RECALLED BY Crosby's Seafood, Charleston, South Carolina, by telephone
on or about November 18, 1994. Firm-initiated recall
complete.
DISTRIBUTION South Carolina.
QUANTITY 154 pounds were distributed.
REASON Product contained excessive levels of histamines.
_______________
PRODUCT Libby's brand Crispy Sauerkraut, in 32 ounce glass jars.
Recall #F-323-5.
CODE J5EH3A, J5EH4A.
MANUFACTURER Seneca Foods Corporation, Jackson, Wisconsin.
RECALLED BY Seneca Foods Corporation, Marion, New York, by press release
and by letter January 5, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Missouri, Ohio, Vermont, Washington, DC.
QUANTITY 2,511 cases (12 jars per case) were distributed.
REASON Product is contaminated with glass.
_______________
PRODUCT Various flavored pound cakes, 17 ounce (half ring) and 34
ounce (whole ring) sizes are packaged in plastic trays, and
2.2 ounce slices packaged in plastic wrap. Orange ring cake
packaged in 17 ounce and 34 ounce sizes only:
(a) Pineapple Pound Cake; (b) Orange Ring Cake; (c) Fudge
Marble Ring Cake; (d) Lemon Pound Cake; (e) Plain Butter
Ring Cake. Recall #F-324/328-5.
CODE All product manufactured before 11/17/94. Package codes are
dated up to and including NOV. 30, 1994.
MANUFACTURER R&S Miller Baking Company, Loganton, Pennsylvania.
RECALLED BY Manufacturer, by telephone November 18, 1994, followed by
letter November 20, 1994. Firm-initiated recall complete.
DISTRIBUTION Virginia, Pennsylvania.
QUANTITY Firm estimated that 600 units remained on market at time of
recall initiation.
REASON These products contain undeclared FD&C Yellow No. 5.
_______________
PRODUCT Keebler Cinnamon Crisp Graham Selects Old Fashioned Graham
Crackers, in 14 ounce boxes, 12 boxes per case.
Recall #F-329-5.
CODE Lot #304W.
MANUFACTURER Keebler Company, Macon, Georgia.
RECALLED BY Keebler Company, Elmhurst, Illinois, by visit January 11,
1995 and by issuing a limited press release on January 13,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 34 cases were distributed.
REASON Product is contaminated with glass.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
_______________
PRODUCT Exotic Fruits brand Shampoo in 6.8 fluid ounce plastic
bottles: (a) Passion Fruit; (b) Guava; (c) Kiwi.
Recall #F-330/332-5.
-2- CODE All lots.
MANUFACTURER Nimbus Laboratories, Northampton, England.
RECALLED BY Pier 1 Imports, Fort Worth, Texas, by electronic mail August
20 and 23, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 13,416; (b) 13,026; (c) 13,290 bottles were distributed.
REASON Product is contaminated with bacterial growth.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Hydroxyzine HCl Syrup for oral administration, in 16 fluid
ounce and in 1 gallon bottles, indicated for the symptomatic
relief of anxiety and tension. Recall #D-057-5.
CODE Lot #VD3199 EXP 6/95.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated January 11, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 33,032 16-fluid ounce bottles and 598 64-fluid ounce bottles
were distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTION: DRUGS -- CLASS III
=========================
_______________
PRODUCT XeScan (Xenon in Oxygen USP) Contrast Enhancement Agent in
605.2 liter cylinder. Recall #D-056-5.
CODE Lot #922-3252 EXP 8/98.
MANUFACTURER Praxair, Inc., East Chicago, Indiana.
RECALLED BY Manufacturer, by telephone in November 1993. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 cylinder.
REASON Cylinder valve was not secure.
_______________
PRODUCT KOL-SPANS/SINA-SPANS, and all other private label brands of
the firm's Timed Release Medicines for relief of cold
discomforts, distributed in 15, 30, and 1000 caplet bottles.
Recall #D-058-5.
CODE Lot numbers: 940973, 940543, 930643, 930317.
MANUFACTURER Wildflower Vitamin Corporation, Mineola, New York.
RECALLED BY The Reese Chemical Company, Cleveland, Ohio, by letter on or
about January 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 500,000 tablets were distributed.
REASON Label declares "Timed Release." Product is immediate
release.
-3- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-155-5.
CODE Unit numbers: 29118-0576, 29118-1399.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone May 6, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood products were distributed for transfusion labeled with
incorrect expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-154-5.
CODE 40FE25075, 40FE25079.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone October 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood products which were labeled with incorrect expiration
dates were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-156-5.
CODE Unit numbers: 6732875, 6732878.
MANUFACTURER Blood Center of Southeast Texas, Inc., Beaumont, Texas.
RECALLED BY Manufacturer, by telephone July 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Pleasure Plus brand Condoms:
(a) Product #40349, 3 pack; (b) Product #40449, 6 pack;
(c) Product #40549, 12 pack and bulk pack of 144 pieces.
Recall #Z-302/304-5.
CODE Lot numbers: 0793233 EXP 7/96, 0494283 EXP 4/94.
MANUFACTURER Suretex Ltd., Bangkok, Thailand.
RECALLED BY Reddy Distributors, Inc., Windsor, New Jersey, by telephone
September 22, 1994, and by letter dated September 29, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY Firm estimated that 16,500 condoms remained on market at
time of recall initiation.
-4- REASON Water leak testing of both lots of condoms revealed that
they exceeded the 0.4 AQL adulteration level.
_______________
PRODUCT All Physio-Control Disposable Defibrillation Electrode
Cables used with Lifepak defibrillation units and adaptors,
and FAST-PATCH adaptors. (Previously the subject of Safety
Alert #M-033-2 which appeared in the February 12, 1992
Enforcement Report). Recall #Z-326-5.
CODE All DDE cables.
MANUFACTURER Physio Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by telephone and letters beginning in July
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 40,000 to 50,000 cables were distributed.
REASON The connector configuration was incorrectly designed and
improper materials were used.
_______________
PRODUCT (a) Sarns brand Model 9000 Perfusion System with Delphin II
Control Module (centrifugal pump), Part #98-0702-0548-3;
(b) Sarns Modified Delphin I units, Part #78-8067-5418-6;
(c) Sarns Trial units, Part #78-8067-5151-3. The device is
indicated for use in extracorporeal circulation of blood
arterial perfusion, regional perfusion, and cardiopulmonary
bypass procedures, when used by a qualified perfusionist who
is experienced in the operation of Sarns or similar
equipment. (Previously the subject of Safety Alert N-058-3
which appeared in the October 20, 1993 Enforcement Report).
Recall #Z-328/330-5.
CODE All serial numbers.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter December 13, 1993. Firm-initiated
recall complete.
DISTRIBUTION California, Delaware, Florida, Kentucky, Massachusetts,
Michigan, New Hampshire, New Jersey, New York, Oregon,
Wisconsin, Washington, DC, Germany
QUANTITY 32 units were distributed.
REASON Products are susceptible to electrical noise in the
operating room which can adversely effect the air detection
system and the Delphin II module.
_______________
PRODUCT 4 and 5 FR Groshong PICC Full Procedural Trays:
(a) Product Code 7715407; (b) Product Code 7725507.
Recall #Z-333/334-5.
CODE Lot numbers: (a) 36EE0351; (b) 36EE0350.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone July 15, 1994, followed by letter
mailed July 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, New York, Minnesota, California, Wisconsin,
Oklahoma, Pennsylvania, Illinois, Massachusetts, Florida.
-5- QUANTITY 158 units were distributed.
REASON The packaging has large seal voids which occurred during
sterilization. This defect may compromise the sterility of
the device.
_______________
PRODUCT Sterilco brand custom packed surgical trays containing
Coated Vicryl (Polyglactin 910) Absorbable, Sterile Sutures:
(a) Total Hip A & B Pack, Catalog #SCH00033; (b) Total Knee
Pack, Catalog #SCH00018. Recall #Z-343/344-5.
CODE Lot numbers: (a) 941687; (b) 941130.
MANUFACTURER Sterile Design Southwest (SDS), formerly Southwest Medical
Packaging, division of Maxxim Medical, Stafford, Texas.
RECALLED BY Manufacturer, by letter September 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 13 hip packs and 18 knee packs were distributed; firm
estimates none remains on the market.
REASON The sterility of the sutures cannot be assured because of
possible microorganism contamination during aseptic
processing, following sterilization.
_______________
PRODUCT Deltran ABC Monitoring Kits, arterial blood collection
system. Recall #Z-348/363-5.
CODE Catalog No. Lot Number
ABC-248 40333-1, 40353-1, 40361-1, 41588-1,
42029-1, 42960-1;
ABC-248A 40355-1, 41589-1, 42030-1;
ABC-260 40363-1, 41590-1, 42032-1, 42961-1,
42962-1;
ABC-260A 41591-1, 42033-1, 42963-1;
ABC-324 40341-1, 40364-1, 41592-1;
ABC-330 42035-1, 42964-1;
901-760 40331-1;
901-761 40330-1;
901-771 40332-1;
900-803 41586-1;
901-837 42404-1;
901-868 42932-1, 43716-1;
901-994 43160-1;
901-995 43166-1;
901-997 43421-1;
901-999 43420-1.
MANUFACTURER Utah Medical Products, Inc., Midvale, Utah.
RECALLED BY Manufacturer, by letter December 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, South Africa, Sweden, Turkey, Canada, Germany,
Italy.
QUANTITY Approximately 3,705 units were distributed.
REASON The sterility is compromised due to the position of the
stopcock handle during sterilization.
-6- _______________
PRODUCT Gamma Camera Universal Table used with the Cirrus and Argus
Imaging Systems. Recall #Z-365-5.
CODE All units.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by performing upgrades. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 90 Cirrus Imaging units and 76 Argus Imaging units were
distributed.
REASON The patient table would drift during patient imaging for
therapy planning due to faulty hydraulic cylinders, thus
causing artifacts in the study, which could result in
misdiagnosis and mistreatment.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Pulse generators: (a) Meta DDDR Model 1254, rate
responsive, dual chamber pulse generator; (b) Meta III Model
1206M, rate responsive, single chamber pulse generator.
Recall #Z-319/320-5.
CODE Specific, individually serial numbered units with sterile
batch #4L00590.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by
telephone during July 1994. Firm-initiated recall complete.
DISTRIBUTION Washington state, Nebraska, Wisconsin, Texas, Australia,
France, Canada.
QUANTITY 24 units were distributed.
REASON The product is incorrectly labeled with the year 1990 rather
than 1994 for the sterilization date.
_______________
PRODUCT Meta DDDR Model 1250H, rate responsive, dual chamber pulse
generator. Recall #Z-321-5.
CODE Specific, individually serial numbered units with sterile
batch #4L00473.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by letter
dated August 3, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Australia.
QUANTITY 39 units were distributed.
REASON The product inner pack labels were incorrectly labeled for
another product namely, lead wires.
_______________
PRODUCT Torque Limiting Hex Wrench, used for surgical procedures.
Recall #Z-322-5.
CODE Units with sterile lot numbers before 4L00569.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
-7- RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by letter
on or about October 10, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY U.S. distribution is 1,540 unimplanted units; international
distribution is 11,372 units.
REASON The wrench may be cracked and therefore may not operate
correctly.
_______________
PRODUCT Vygon XRO Infant Feeding Tubes, used to provide nutrition to
infants: (a) 16 Inch 6 French Feeding Tube, Order #310.06;
(b) 20 Inch 8 French Feeding Tube, Order #310.08;
(c) 30 Inch 6 French Feeding Tube, Order #311.06.
Recall #Z-345/347-5.
CODE Lot numbers: (a) 07.10.93FI, 26.08.93FI;
(b) 03.12.93FI; (c) 30.09.93FE, 01.10.03FE.
MANUFACTURER Vygon XRO S.A., Ecouen, France.
RECALLED BY Vygon Corporation, East Rutherford, New Jersey, by telephone
March 8, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 29,825 units; (b) 15,302 units; (b) 15,503 units were
distributed.
REASON The end cap may become loose.
_______________
PRODUCT Reaction Cuvettes, Model 751060, in-vitro diagnostic, in
packages of 100 magazines. Recall #Z-364-5.
CODE Lot numbers 129C through 152C and two digit code = 65.
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by letter September 28, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,498 boxes of 100 magazines (13 cuvette strips x 5 wells
each were distributed.
REASON Some of the cuvettes have small holes and may leak fluid.
_______________
PRODUCT Abbott Vision SGOT (AST) Test Pack, in-vitro diagnostic used
with the Abbott Vision System for the quantitative
determination of glutamic oxaloacetate transaminase activity
in anticoagulated whole blood, plasma, or serum for the
diagnosis and treatment of certain types of liver and heart
disease.
Recall #Z-383-5.
CODE Lot numbers: 86889A400, 87052A400, 87166A400, 87153A400,
87298A400, 88080A400, 88147A400.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone June 9-14, 1994, and June 21,
1994, followed by letter dated June 1994. Firm-initiated
recall complete.
-8- DISTRIBUTION Nationwide, Brazil, Italy, Japan, Singapore, Taiwan,
Australia, Germany.
QUANTITY 18,249 cartons of 10 testpacks were distributed; firm
estimates none remains on the market.
REASON Component degradation can result in instrument error
message.
_______________
PRODUCT Staphaurex In-Vitro Diagnostic Test, rapid latex test kit
for the identification of Staphylococcus aureus.
Recall #Z-384-5.
CODE Lot numbers: K248210 EXP 2/28/95, K307320 EXP 3/28/95,
K307310 EXP 3/28/95.
MANUFACTURER Murex Diagnostics, Ltd., Kent England.
RECALLED BY Murex Diagnostics, Inc., Norcross, Georgia, by letter
September 7, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,630 kits were distributed.
REASON Some of the tests will give a positive reaction when
coagulase negative staphylococci or buffer are mixed with
the test latex.
-9-
END OF ENFORCEMENT REPORT FOR FEBRUARY 8, 1995. BLANK PAGES MAY
FOLLOW.
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