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
04/17/1996

ENFORCEMENT REPORT FOR 04/17/96

April 17, 1996 96-16

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Various sandwich products :
1. Egg Salad Sandwich
2. Luncheon Meat & Cheese Sandwich
3. Luncheon Meat & Pickle Sandwich
4. Luncheon Meat & Potato Salad Sandwich
5. Tuna Salad Sandwich
6. Chicken Salad Sandwich
7. Ham Sandwich
8. Ham & American Cheese Sandwich
9. Ham & Swiss Cheese Sandwich
10. Ham & Sliced Egg
11. Ham with Lettuce & Pickle
12. Turkey with Lettuce & Pickle
13. Roast Beef Sandwich
14. Club Sandwich
15. Muffuletta Sandwich
16. Ham & American Cheese, Long Bun
17. Roast Beef Sandwich, Long Bun
18. Super Sub Long Bun
19. Super Triple Sandwich
20. Ham & American Cheese Sandwich, French
Bread
21. Roast Beef with Gravy on French Bread
22. Ham & American Cheese Dressed, French
Bread
23. Roast Beef Dressed, French Bread
24. Plain Hot Dog
25. Small Hamburger
26. Chili Dog
27. Chili & Cheese Dog
28. Small Cheeseburger
29. Lil BBQ
30. Twin Hot Dog
31. Small Hot Sausage Sandwich
32. Grilled Cheese Sandwich
33. Sausage & Egg on Toast
34. Large Cheeseburger
35. Large Steak Sandwich
36. Large BBQ Beef Sandwich
37. Large Ham & American Cheese Sandwich
38. Large Lot-A-Burger
39. All Beef Burger
40. All Beef with Cheese Sandwich
41. Hot Cajun Sausage (patty) Sandwich
42. Double Cheeseburger
43. Meatball with Cheese Sandwich (steak bun)
44. Ham & Cheese Sandwich (steak bun)
45. Long Dog
46. Hot Sausage, long bun
47. BBQ Sausage, long bun.
Recall #F-394/440-6.
CODE Expiration date on or before "2 10".
MANUFACTURER Finest Foods, Inc. doing business as Mrs.
Drake's Sandwiches, New Orleans, Louisiana
RECALLED BY Manufacturer, on February 16, 1996. Route
drivers were instructed to pull recalled
product from retail. Firm-initiated recall
complete.
DISTRIBUTION Louisiana.
QUANTITY 20,000 to 25,000 sandwiches distributed per
week. Firm estimates none remains on the
market.
REASON The products are contaminated with Listeria
monocytogenes.

_______________
PRODUCT Creamy Gorgonzola Cheese, in approximately 20
pound wheels and 5 pound pieces.
Recall #F-441-6.
CODE PROD. DATE 92695 and PROD. DATE 92795 on
product labels.
MANUFACTURER BelGioioso Cheese, Inc., (formerly Auricchio
Cheese Company, Denmark, Wisconsin.

-2-RECALLED BY Manufacturer, by letters on January 18, 1996,
and February 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION California, Colorado, Florida, Georgia,
Illinois, Minnesota, New Jersey, New York,
North Carolina, Pennsylvania, Tennessee,
Washington state, Wisconsin.
QUANTITY 4,500 pounds were distributed.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
UPDATE Recall #F-374/379-6, Various Ice Cream, which
appeared in the April 10, 1996 Enforcement
Report should read:
REASON: Products are or may be contaminated
with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Various juice products containing apple juice:
(a) Red Cheek Apple Juice, 64 ounces;
(b) Mott's Apple Juice, 64 ounces and 10
ounces;
(c) Mini Mott's Apple Juice, 4.23 ounces;
(d) Mott's Fruit Punch, 8.45 fluid ounces;
(e) Mott's Tropical Punch, 8.45 fluid ounces;
(f) Mott's Apple/Grape Juice, 10 ounces;
(g) Mott's Juice Pak, 8.45 fluid ounces.
Recall #F-384/390-6.
CODE Product produced between 8/15/95 - 9/13/96.
Lot numbers: (a) A50821-A50823; (b) A50815-
A50818, A50821-A50831, A50905-A50908, A50912-
A50913 (64 ounces); A50829-A50831 (10 ounces);
(c) A50822, A50828-A50830; (d) A50823, A50824,
A50826; (e) A50829; (f) A50901; (g) A50824-
A50826, A50906.
MANUFACTURER Binder Gmbt1, Germany; Barasch, Switzerland
(apple juice concentrate suppliers).
RECALLED BY Mott‘s North America, Stamford, Connecticut,
by letter dated March 4, 1996. Firm-initiated
recall complete. See also FDA talk paper T96-
14, February 26, 1996.
DISTRIBUTION Nationwide.
QUANTITY Approximately 536,000 total cases were
distributed.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.

-3-_______________
PRODUCT Various juice products containing apple juice:
(a) Apple Juice, packaged as follows:
Glass bottles: 1 quart 1 pint (48 fluid
ounce) 1.42 liters, 2 quart (64 fluid ounce)
1.89 liters, 1 quart (32 fluid ounce) 946 ml;
Plastic bottles: 1 gallon (3.79 L), 64 fluid
ounce (2QT) 1.89 Liters;
Aseptic cardboard containers: net 250 mL (8.45
fluid ounces), contains nine 250 mL (8.45
fluid ounce) boxes;
(b) Apple Juice, Frozen Concentrate, in
Paperboard cans: 16 fluid ounce 473 mL, "48
fluid ounce (1.42 L);
(c) Apple Cider, packaged in 1 gallon (3.89L)
64 fluid ounce (2 quart) 1.89 liter plastic
bottles. Recall #F-391/393-6.
CODE Various codes. Product was packed between
7/95 and 2/96.
MANUFACTURER Barschash, Poland (supplier of inulin
containing concentrate).
RECALLED BY Tree Top, Inc., Selah, Washington, by
telephone and by fax February 28, 1996. Firm-
initiated recall complete. See also FDA talk
paper T96-14, February 26, 1996.
DISTRIBUTION Nationwide.
QUANTITY 375,206 cases were distributed.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Children's Cherry Flavored Acetaminophen
Suspension Liquid, in 4 ounce bottles, under
the following brand names: American Fare,
Brooks, Chateau, CVS, Food Lion, Goldline,
Good Sense, Health Life, Homebest, Kroger,
Marquee, The Medicine Shoppe, Meijer, NEX,
Osco, Pathmark, The Pharxm, Phar-Mor, REVCO,
Smiths, Thrifty, Topcare, Walgreens.
Recall #D-117-6.
CODE Lot #5ZA141 EXP 12/98.
MANUFACTURER Perrigo Company, Allegan, Michigan.
RECALLED BY Manufacturer, by letter sent between February
21 and 23, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,979 dozen bottles were distributed.
REASON Precipitate of active ingredient which may
result in non-uniform dosage.

-4-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Gelusil Liquid Antacid Anti-Gas Peppermint
Flavor 355 ml, in 12 fluid ounce bottles.
Recall #D-116-6.
CODE Lot # EXP Date
05413B 1/96
05513B 1/96
01523B 2/96
03242B 4/96
02253B 5/96
00173B 8/96
02124B 2/97
02024B 2/97
01034B 3/97
01334B 3/97
00274B 7/97
02284B 8/97
02384B 8/97
01994B 9/97
02494B 9/97
04604B 10/97
011N4B 11/97
00815B 1/98
01725B 4/98
03645B 4/98
03745B 4/98
10165B 7/98
(Per the recalling firms "recall" letter, they
stated "all lot numbers" were included in
their actions).
MANUFACTURER Warner Lambert Company, Brockville, Ontario,
Canada.
RECALLED BY Warner Lambert Company, Morris Plains, New
Jersey, by letter dated December 11, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 293,046 bottles were distributed; firm
estimated that 290,000 bottles remained on
market at time of recall initiation.
REASON Some units exhibited off-odor, off-taste and
presence of a Bacillus species.

_______________
PRODUCT Sterile Triamcinolone Diacetate Suspension,
USP, 40 mg/ml, injectable Rx drug for
intramuscular, intra-articular or soft tissue
use, for endocrine and rheumatic disorders.
Under the following labels: Schein, Legere,
Besse, TTLOORE. Recall #D-118-6.
CODE Lot numbers: 95G460 and 95G800.

-5-MANUFACTURER The Upjohn Company, Kalamazoo, Michigan (raw
material); Steris Laboratories, Inc., Phoenix,
Arizona. (dosage form).
Recalled by Steris Laboratories, Inc., Phoenix, Arizona,
by letter on November 17, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 14,500 units were distributed;
firm estimated that little, if any, product
remained on market at time of recall
initiation.
REASON Product contains trace quantities of
decabromdiphenylether resulting from synthesis
reagent used to manufacture raw material.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma; (c)
Cryoprecipitated AHF. Recall #B-363/365-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER Flushing Hospital Medical Center, Flushing,
New York.
RECALLED BY Manufacturer, by letter dated January 26,
1996. FDA-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 66 units; (b) 459 units; (c) 10 units.
REASON Blood products which were misbranded, were
distributed for further manufacture.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ==========
_______________
PRODUCT Siemens 3-Gas Model 962 Anesthesia Mixer, Part
#906588, designed for use with the Siemens
Servo Ventilator and may be used for mixing 02
(oxygen) with either N20 (nitrous oxide) or
air. Recall #Z-562-6.
CODE Serial Nos. 200789, 200825, 200784, 200824,
200783, 200239, 200798, 200166, 200816,
200794, 200258, 200225, 200169, 200266, 200235
THESE NUMBERS WERE IN THE 3/19/96
RECOMMENDATION FROM S. LINER).
MANUFACTURER Servo Ventilator, Siemens-Elma, Germany
(mixer).
RECALLED BY Siemens Medical Systems, Danvers,
Massachusetts, by telephone on March 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION California, Washington, D.C., Indiana,
Maryland, Michigan, Nebraska, New York, South
Carolina, Tennessee, Texas.
-6-QUANTITY 15 units were distributed.
REASON A manufacturing process error in which the
oxygen hose was connected to the nitrous oxide
outlet and vice versa.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Hunter High Performance Air Purifiers, Model
#30300, for home and business use.
Recall #Z-560-6.
CODE All serial numbers.
MANUFACTURER Hunter Fan Company, Memphis, Tennessee.
RECALLED BY Manufacturer, by letter beginning on January
30, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 42,283 units were distributed; firm estimated
that 39,146 units remained on market at time
of recall initiation.
REASON There is a potential fire hazard due to high
voltage arcing.

_______________
PRODUCT IVAC I.V. Solution Administration Sets, Model
numbers 28075 and 28273, indicated for use
with the IVAC "Medsystem III" Multi-Channel
Infusion Pump. Recall #Z-561-6.
CODE Lot numbers: 411648, 503635, 505631.
MANUFACTURER Ensembles Medicos, S.A. de C.V., Tijuana,
B.C., Mexico.
RECALLED BY IVAC Corporation, San Diego, California, by
letter on October 17, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 475 cases were distributed; firm estimates
none remains on the market.
REASON The device is labeled as containing 60
drops/ml sets, whereas it contains 20 drops/ml
sets.

_______________
PRODUCT Nuclear Imaging Systems, used in organ and
whole body scans: (a) BIAD, two head detector
SPECT system; (b) MONAD, single head detector
SPECT system. Recall #Z-568/569-6.
CODE Serial numbers: (a) 102 - 186; (b) 119 - 182.
MANUFACTURER Trionix Research Laboratory, Twinsburg, Ohio.
RECALLED BY Manufacturer, by letter on April 3, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Korea, Australia, Egypt,
Switzerland.

-7-QUANTITY 80 BIAD units were distributed. Six (6) BIAD
units and five (5) MONAD units are still in
stock.
REASON The detector head may drop on a patient or
healthcare provider because of metal fatigue
at the device's ball screw assembly.

_______________
PRODUCT P300 Power Wheelchair with airless solid
casters and P300 Power Wheelchair with
pneumatic casters using LaBac Specialized
Seating System. Recall #Z-582-6.
CODE Any model P300 power wheelchair with serial
numbers P3-1000 through P3-9468.
MANUFACTURER Quickie Designs, Inc., Fresno, California.
RECALLED BY Manufacturer, by letter dated December 6,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,762 units.
REASON The forks holding the front caster assemblies
in place may be subject to cracking which
could cause the caster assembly to collapse
and the user to potentially fall out of the
wheelchair.

_______________
PRODUCT Medline Custom Procedural Trays which contain
Johnson & Johnson Barrier Vu-Thru
Cardiovascular Split Sheets:
(a) Cardiovascular Packs
1) Catalog No. DYNJC1016B, CV Pack A&B-PK A &
PKB;
2) Catalog #DYNJC1622B, CV Pack;
3) Catalog #DYNJC2202, CV Pack A & B;
4) Catalog #DYNJC2202A, CV Pack-PK A & PK B;
(b) Trauma/Abdominal Aneurysm Pack, Catalog
No. DYNJC1267A;
(c) Coronary Drape Pack, Catalog #DYNJC1657A;
(d) Heart Packs
1) Catalog No. DYNJC1910, Murbach Heart Pack;
2) Catalog No. DYNJC1959, Heart Pack Murbach;
3) Catalog No. DYNJC1960, Heart Pack J
Campbell;
4) Catalog No. DYNJC1961, Heart Pack Spoto;
5) Catalog No. DYNJ08823D, Heart Pack I.
Recall #Z-588/591-6.
CODE All lots shipped between 10/1/95 and 11/28/95.
MANUFACTURER Medline Industrues, Waukegan, Illinois (kit);
Johnson & Johnson Medical, Inc., El Paso,
Texas (split sheet).
RECALLED BY Medline Industries, Inc., Mundelein, Illinois,
by letter on January 4, 1996. Firm-initiated
recall complete.
-8-DISTRIBUTION Florida, Georgia, Kansas, Kentucky,
Pennsylvania, South Carolina, Texas, Utah,
Virginia.
QUANTITY Firm estimates none remains on the market.
REASON The fabric of the clipping tabs are subject to
tearing, presenting potential harm to patient.

_______________
PRODUCT Nezhat-Dorsey SmokEvac Trumpet Valve for Pump
II, a laparoscopic suction/irrigation system
with metered smoke evacuation mechanism: (a)
Nezhat-Dorsey SmokEvac Trumpet Valve and Pump
II Cartridge, Catalog No. 2027P2;
(b) Nezhat-Dorsey SmokEvac Trumpet Valve and
Pump II Cartridge and 33 cm Probe Tip, Catalog
No. 2027P2A. Recall #Z-592/593-6.
CODE All sterilization lots with catalog numbers
2027P2 and 2027P2A.
MANUFACTURER Prent Thermoforming Janesville, Wisconsin
(component).
RECALLED BY Davol, Inc., Division of C.R. Bard
Corporation, Cranston, Rhode Island, by letter
on June 13, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 7,112 units; (b) 1,134 units were
distributed.
REASON The sterility of the device may be compromised
due to loss of package integrity, caused by
cracks.

_______________
PRODUCT Television Projectors Incorporated in the
Moving Target Simulators (MTS), used to
project target images on a screen.
Recall #Z-594-6.
CODE None.
MANUFACTURER AAI Corporation, Cockeysville, Maryland.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan April 1, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and Germany.
QUANTITY 16 units.
REASON The television projectors incorporated in the
Moving Target Simulators failed to comply with
the x-radiation emission limit of the Federal
Performance Standard for Television Receivers,
21 CFR 1020.10.

_______________
PRODUCT Model WS 2200 Laser System, used in metal
cutting. Recall #Z-595-6.
CODE Model WS 2200.
-9-MANUFACTURER Convergent Energy, Sturbridge, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan April 1, 1996. Firm-
initiated filed correction ongoing.
DISTRIBUTION Mississippi.
QUANTITY 1 unit.
REASON The product was found to be noncompliance with
the Federal performance standard for laser
products 21 CFR 1040.10(f)(2)(v) in that the
safety interlock electrical circuit
incorporated a bypass circuit, rendering the
system ineffective and permitted the laser
system to be returned to a fully operational
configuration with the interlock circuit
remaining overridden.

_______________
PRODUCT Cordis Trakstar 18, Long Balloon Catheters,
Catalog #535-303. Recall #Z-596-6.
CODE Lot #40895311.
MANUFACTURER Cordis Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter dated January 15,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 50 units were distributed.
REASON Small axially oriented abrasions present on
some balloons could cause a burst pressure
below that of the rated one.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Stratus Cardiac Troponin-I Fluorometric Enzyme
Immunoassay Kit, Catalog #B5700-64, used in an
automated procedure for the quantitative
determination of Troponin-I levels in serum
and heparinized-plasma. Recall #Z-583-6.
CODE Lot #KXTN-231 EXP 3/21/96.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by telephone on January 10-11,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas, California, Florida, Georgia, Kentucky,
Louisiana, Michigan, Minnesota, Missouri, New
York, Ohio, Pennsylvania, South Carolina,
Wisconsin, and international.
QUANTITY 118 kits were distributed.
REASON Calibrator lot XTN-215 was incorrectly shipped
to be used with kit lot No. KXTN-231, the
correct calibrator lot should have been lot
No. XTN-216Z.

-10-_______________
PRODUCT S/P Boiling Water Bath used for all laboratory
procedures requiring 100 degree C incubation.
Recall #Z-584-6.
CODE Catalog #W3022, Serial numbers 4897 through
5021.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated February 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois.
QUANTITY 109 units.
REASON The water bath has water leakage in the rear
of the unit which could cause a fire or
electrical shock hazard.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Medtronic CardioRhythm Atakr Ablation System,
Model 0610, intended primarily for use in
intracardiac radiofrequency ablation
procedures. Safety Alert #N-010-6.
CODE All units.
MANUFACTURER Medtronic CardioRhythm, San Jose, California.
ALERTED BY Manufacturer, by letter on January 4, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 430 units were distributed.
REASON Device does not turn off when the foot is
released from the foot pedal.

-11-

END OF ENFORCEMENT REPORT FOR APRIL 17, 1996. BLANK PAGES MAY
FOLLOW.

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