FDA

Enforcement Report

September 29, 1999                                       99-39

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Bumble Bee brand Chunk Light Tuna in Water, in 6 ounce cans.
Recall #F-669-9.
CODE
CLP4T over F16CC.
MANUFACTURER
Bumble Bee Seafoods, Inc., Santa Fe Springs, California.
RECALLED BY
International Home Foods, Inc., Parsippany, New Jersey, by E-mail,
fax, and press release on August 30, 1999.  Ongoing recall 
resulted from sample analysis and follow-up by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION
Mississippi, Colorado, Washington state.
QUANTITY
1,196 cases (48 cans per case) were distributed.
REASONS
Product contained high levels of histamine and was associated 
with histamine poisoning.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
TUSSIONEX Pennkinetic (hydrocodone polistirex), extended- release 
suspension (Hydrocodone polistirex equivalent to 10 mg 
hydrocodone bitartrate and Chlorpheniramine polistirex equivalent 
to 8 mg chlorpheniramine maleate), in 473 mL bottle, Rx 
medication for relief of cough and upper respiratory symptoms 
associated with allergy or a cold.
NDC #53014-548-67.  Recall #D-423-9.
CODE
90299, EXP 04/01
90300, EXP 04/01
90301, EXP 04/01
90302, EXP 04/01
90303, EXP 04/01
90309, EXP 05/01
90310, EXP 05/01.
MANUFACTURER
Medeva Pharmaceuticals, Inc., Rochester, New York.
RECALLED BY
Manufacturer, by letter dated August 6, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Lot 90299: 7,491 units were distributed between 5/17/99 and 
           5/19/99.
Lot 90300: 7,622 units were distributed between 5/18/99 and 
           5/28/99.
Lot 90301: 7,702 units were distributed between 5/28/99 and 
           6/10/99.
Lot 90302: 7,714 units were distributed between 5/24/99 and 
           6/15/99.
Lot 90303:  3,166 units were distributed on 6/15/99
Lot 90309: 7,446 units were distributed between 5/25/99 and 
           6/10/99.
Lot 90310: 7,637 units were distributed between 6/10/99 and 
           6/30/99.
REASON
Microbial contamination (acetobacter SPP).

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
a) Platelets; b) Fresh Frozen Plasma. 
Recall #B-1190/1191-9.
CODE
Unit #16LE49081.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone on June 10, 1999, and by letter dated 
June 11, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component.
REASON
Blood products were prepared from a unit of whole blood with an 
extended collection time.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
V.A.D. Access Kit/Dressing Change Tray, a sterile single use tray 
containing the equipment needed, including heparin lock flush, to 
change the dressing on a vascular access device.
Recall #Z-1253-9.
CODE
Catalog #DC-680, Lot 906014, EXP 06/01.
MANUFACTURER
MEDIKMARK, Inc., Buffalo Grove, Illinois.
RECALLED BY
Manufacturer, by telephone on August 4, 1999, followed by letter 
on August 9, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Illinois, New York, Texas, Arizona.
QUANTITY
360 trays.
REASON
Tray may contain 1000 u/ml heparin instead of 100 u/ml heparin.
________
PRODUCT
Gammamed 12i and 12it High Dose Rate Afterloader Sources, used 
for HDR afterloader radiation therapy, radionuclide  
brachytherapy source.  Recall #Z-1255/1256-9.
CODE
6455-6464 (source).
MANUFACTURER
MDS Nordion/Theratronics International, Ltd., Kanata, Ontario, 
Canada.
RECALLED BY
Manufacturer, by letter August 12, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
36 units were distributed.
REASON
Use of substandard Ir-192 sealed sources may lead to overexposure 
of the patient to radiation with the potential for a significant 
overdose.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Omni-Jug Disposable Suction Canister, 15000 cc, for collection, 
transport, and disposal of large amounts of irrigation fluid 
generated during surgical procedures:
a) Omni-Jug Disposable Suction Canister, Model #5036-00;
b) Omni-Jug Disposable Suction Canister, Model #5036-01.
Recall #Z-1243/1244-9.
CODE
O-rings are not coded; Canister lids are stamped with run dates 
of 7/5/99 to 7/26/99.
MANUFACTURER
Maryland Plastics, Inc., Federalsburg, Maryland.
RECALLED BY
Waterstone Medical, Inc., Falls Church, Virginia, by letter on 
July 29, 1999, followed by visit.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,000 units.
REASON
The O-ring component of the suction canister may fail to properly 
seal, which may not allow proper vacuum seal.
________
PRODUCT
Latex and Non-Latex Operating Room and Area Shoe Covers; Non 
Latex Gripper Shoe Covers and Boot Covers, packaged in cases of 
50, 100, 150, 200 and 300 covers each, under the American Health 
& Safety Sure-Tread label:
a) NON23758 - Gripper Shoe Covers, Non-Conductive, Universal
              Size
NON24758 - Gripper Shoe Covers, Non-Conductive, Universal
           Size
NON24759 - Gripper Shoe Covers, Non-Conductive, X-Large
b) NON24752 - Gripper Sport Shoe Covers, Sport Shoe Size
NON24852 - Gripper Sport Shoe Covers, SMS Material, Sport
           Shoe Size
c) NON24758R - Gripper Reverse Shoe Covers, Universal Size,
               Reverse Seam, Blue
NON24759R - Gripper Reverse Shoe Covers, X-Large, Reverse
            Seam, Blue
d) NON24758L - Gripper II Spunbond Shoe Covers, White
e) NON27144 - Boot Cover Impervious Knee High No Latex
NON27144XL - Boot Cover Impervious Knee High No Latex
f) NON27752 - Shoe Cover w/Non Latex Grid Sport Size,
NON27758R - Shoe Cover W/Non Latex Grid Reverse Blue,
NON27759R - Shoe Cover W/Non Latex Grid X-Large Reverse,
NON27852 - Shoe Cover W/Non Latex Grid Sport Size SMS
g) NON27758 - Shoe Cover Gripper Non-Skid Blue No Latex,
NON27759 - Shoe Cover Gripper Blue X-Large No Latex,
h) AHS1151009 - American Heath & Safety Sure Tread
                Disposable Shoe Covers, Stretch Size 5-12.
Recall #Z-1245/1252-9.
CODE
All lots ending with JC followed by a numeral of the part 
numbers/reorder numbers listed above.
MANUFACTURER
Hangzhou Jinchen Knitting & Textiles Co., Ltd., Hangzhou, China.
RECALLED BY
Medline Industries, Inc., Mundelein, Illinois, by letter dated 
August 27, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
39,266 cases.
REASON
Some of the shoe covers have the gripper pattern made of a water-
soluble substance, and may smear or may be more prone to slippage 
if exposed to water.
_______
PRODUCT
Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay, a 
quantitative immunoassay for the determination of cardiac 
troponin-I levels in serum and Plasma:
a) Catalog No. B5700-64 (Domestic), Stratus Cardiac Troponin-I 
Fluorometric Enzyme Immunoassay - 120 Tests,;
b) Catalog No. B5700-64R (International), Stratus Cardiac 
Troponin-I Fluorometric Enzyme Immunoassay - 120 Tests.  Recall 
#Z-1257/1258-9.
CODE
Lot Numbers:  a) KXTN-1146 through KXTN-1204, KXTN-1206 through 
KXTN-1210, KXTN 1212, KXTN-1214, KXTN-1215 and
KXTN-1219, EXP Dates from Oct. 28, 1999 through Feb. 18, 2000; b) 
KXTN-1146 through KXTN-1204, KXTN-1206 through KXTN-1210, KXTN 
1212, KXTN-1214, KXTN-1215 and KXTN-1219, EXP Dates from Oct. 28, 
1999 through Feb. 18, 2000.
MANUFACTURER
Dade Behring, Inc., Miami, Florida.
RECALLED BY
Manufacturer, by letter on April 14, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
12,604 kits were distributed.
REASON
The device may produce false positive test results.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 29, 1999.  BLANK PAGES MAY 
FOLLOW.

####