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
07/15/1992
RECALLS AND FIELD CORRECTIONS: July 15, 1992
FOODS - CLASS III
92-29
PRODUCT Various frozen baked goods or frozen products used as
ingredients in the manufacture of baked goods:
Retail/Consumer Products:
1. Rich's Chocolate Eclairs with Bavarian Cream Filling;
2. Rich's Double Chocolate Eclairs;
3. Hadder Chocolate Filling & Frosting Mix;
4. Hadder Vanilla Filling & Frosting Mix;
5. Rich's Cream Puffs;
Bakery/Food Service Products:
6. Rich's Vanilla Rich'n Smooth Non-Dairy Dessert Topping;
7. Rich's Vanilla Bettercreme Non-Dairy Filling & Icing;
8. Rich's Chocolate Bettercreme Non-Dairy Filling & Icing;
9. Redstar Starcreme Vanilla Non-Dairy Filling & Icing;
10. Rich's Prewhipped Chocolate Bettercreme Non-Dairy Filling
and Icing;
11. Rich's Prewhipped Vanilla Bettercreme Non-Dairy Filling &
Icing;
12. Rich's Toplife Vanilla Non-Dairy Filling & Icing;
13. Rich's Chocolate Eclair;
14. Rich's New York Style Eclair;
15. Rich's Chocolate Eclair with Freezeflo Bavarian Cream
Filling;
16. Rich's Cream Puffs with Freezeflo Bavarian Cream Filling;
17. Redstar Chocolate Starcreme Non-Dairy Filling & Icing;
18. Rich's New York Style Chocolate Eclair;
19. Petite Custard Eclairs;
20. Petite Custard Creme Puffs;
21. White Creme Filled Long John Donuts;
22. Thrift Pack Eclairs. Recall #F-371/392-2.
CODE For the Rich's retail/consumer products: All products prior to
production code P2155. For bakery/food service products: All
products prior to the productions code of C2155, B2145, P2155.
MANUFACTURER Rich Products Corporation, Buffalo, New York;
Rich Ice Cream Company, West Palm Beach, Florida;
Rich Products Corporation, Claremont, California.
RECALLED BY Rich Products Corporation, Buffalo, New York, by telephone,
June 5, 1992, followed by letter June 8, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Mexico, Israel.
QUANTITY Firm estimates little if any product remains on the market.
REASON Sodium Caseinate substituted for soy protein concentrate.
PRODUCT Cod Liver Oil, Regular and Mint Flavor, in 4 ounce bottles,
used as a supplemental source of Vitamins A & D, under the
following labels: Reliable Drug Stores, CVS, Peoples Drug
Stores, Good Health, American Drug Stores. Recall #F-393/394-2.
CODE Lot numbers: Reliable label - G1488D;
Peoples label - Regular: C1106D, B1038E, M1479D;
Peoples label - Mint: A1350D, G1489D, K1519D, A1467E, C1044E;
CVS label - D1477D, E1552D, J2015D, M1301D, A1311E, B1038E,
C1043C, C1546E, D1208E, F1526E, H1470E, J1429E, B1305F, B1364F,
C1046F, A1149D, B1185D, C1106D, C1366D, C1195F;
Good Health label (sold by Pic N Save) - Mint flavor: D1318D.
MANUFACTURER Pennex Products Company, Inc., Verona, Pennsylvania; R.W.
Grief, Old Greenwich, Connecticut (suppliers).
RECALLED BY Pennex Products Company, Inc., Verona, Pennsylvania, by letter
April 6, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Eastern United States.
QUANTITY Firm estimates 250 dozen bottles remain on the market.
REASON Product is superpotent for Vitamins A and D.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT Oxygen USP Compressed Medical Gas transfilled into size E
cylinders. Recall #D-409-2.
CODE Lot numbers: 1-31-92, 2-13-92, 2-19-92, 3-12-92, 3-19-92.
MANUFACTURER Eastern Home Health Supply & Equipment Company, Inc., Ayden,
North Carolina.
RECALLED BY Manufacturer, by letter March 26, 1992. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
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QUANTITY 79 units were distributed.
REASON Current good manufacturing practice deficiencies.
PRODUCT Hydroxyzine Hydrochloride Tablets, USP 50 mg, 100 tablets per
blister pack, a Rx drug used for symptomatic relief of
anxiety. Recall #D-410-2.
CODE Lot #430-031 EXP 9/93.
MANUFACTURER Sidmak Laboratories, Inc., East Hanover, New Jersey.
RECALLED BY Medirex, Inc., Pine Brook, New Jersey (responsible firm), by
letter April 29, 1992. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Virginia, South Carolina, Illinois, California,
Massachusetts, New York, Minnesota.
QUANTITY 434 boxes each containing 100 tablets were distributed; firm
estimates 289 boxes remain on the market.
REASON The product name was misspelled omitting the letter "Z".
PRODUCT VIP Bird Infant/Pediatric Ventilator, Part #15003, an
electrically powered, microprocessor controlled, pneumatically
activated, volume or time cycled critical care ventilator
designed for neonatal, infant and pediatric applications.
Recall #Z-772-2.
CODE All V.I.P. Bird devices produced before serial number KB002099.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
RECALLED BY Manufacturer, by letter dated April 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 216 units were distributed.
REASON Potential for premature failure of any one of three component
voltage regulators on the device printed circuit board. The
regulator may short out and fail due to improper encapsulation
of the regulator within it's encasement at the time of
component manufacture.
RECALLS AND FIELD CORRECTIONS: DEVICES - II
PRODUCT Baxter Arterial Bloodlines. Recall #Z-253-2.
CODE Catalog #5M4238, lot #R1N606.
MANUFACTURER National Medical Care, Medical Product Division, Mexico.
RECALLED BY National Medical Care, Medical Product Division, Rockleigh, New
Jersey, by letter dated March 31, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Tennessee.
QUANTITY 412 cases (12 units/case) were distributed. Firm estimates
2,000 units remain on the market.
REASON An incomplete bond of the bushing to the pressure pillow could
result in a blood leak if not detected during priming.
-3-
PRODUCT Cypress Medical Products, Ltd., Clinical Thermometers, Oral
(mercury in glass), tri-top color coded yellow back, in pencil
cases. Recall #Z-836-2.
CODE All lots of catalog #94-05.
MANUFACTURER China Jiangsu Machinery Import & Export Corporation, Nanjing,
China.
RECALLED BY Cypress Medical Products, Ltd., McHenry, Illinois, by telephone
May 26-27, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 80,928 units were distributed; firm estimates 1,200 units
remain on the market.
REASON The device was found to be inaccurate and when tested failed to
meet the ASTM E-667 performance standard as stated on the
product label.
PRODUCT Gish Biomedical D401S Sterile Disposable Pressure Monitoring
Dome, intended to be used with a Statham Cardiovascular
Pressure Transducer to measure arterial pressure during
perfusion procedures. Recall #Z-837-2.
CODE Lot #016281.
MANUFACTURER Gish Biomedical, Santa Ana, California.
RECALLED BY Manufacturer, by letter April 8, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Oklahoma, South Africa, Italy.
QUANTITY 500 units were distributed.
REASON Device is not compatible with a Statham Transducer as labeled.
PRODUCT 5 mm Laparoscopic ABC Electrosurgical Probe. Recall #Z-839-2.
CODE Catalog #160655, lot numbers: J70240, J70240A, J70240B,
J82682, J82682A, J82682B.
MANUFACTURER Birtcher Medical Systems, Inc., Irvine, California.
RECALLED BY Manufacturer, by telephone completed March 31, 1992 and by
letter dated March 31, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 960 units were distributed; firm estimates 150 units remain on
the market.
REASON There is a current leak near the probe tip which could allow an
argon plasma jet to occur at a right angle to the electrode
approximately 2" from the tip.
PRODUCT (a) Theraplan and (b) TP-11 Treatment Planning Systems,
computerized workstations used to calculate and determine
appropriate radiation treatment programs for doctors to
administer to cancer patients. Recall #Z-840/841-2.
CODE (a) Serial number range 01 through 3101 beginning with a "TH"
or "THL" prefix; (b) Serial number range 07 through 543
beginning with a "TP" or "TPL" prefix.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas.
-4-
RECALLED BY Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), by user bulletin TH UB 00-001 sent
January 31, 1992, Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 193 units; (b) 56 units were distributed.
REASON The 2 MByte National Memory Board responds incorrectly to a
floating point divide by zero error which may result in
creating a hazardous condition.
PRODUCT Theraplan Treatment Planning System, a radiation treatment
planning computer system. Recall #Z-842-2.
CODE Serial numbers: THL-500, THL-501, THL-504, THL-505, THL-513,
THL-528, THL-529, THL-531.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas.
RECALLED BY Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), by user bulletin TH HB 03-001.
Firm-initiated field correction complete.
DISTRIBUTION Hawaii, Michigan, New York, Ohio, Pennsylvania, Wisconsin.
QUANTITY 8 units were distributed.
REASON A change in the type of chip used in the manufacture of the MAP
4000 Array Processor circuit board can cause erroneous dose
calculations.
PRODUCT Model PE 3000 Laser Graphic System. Recall #Z-852-2.
CODE Serial numbers: Undetermined.
MANUFACTURER Purup Electronics, Saint Paul, Minnesota.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
June 23, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9 units were distributed.
REASON Noncompliance with applicable performance and labeling
requirements for laser products. Further, product reports were
not submitted for the device prior to its introduction into
commerce.
PRODUCT Holmium: Yttrium Aluminum Garnet (YAG) Laser System Model
Omni-Pulse 1210. Recall #Z-853-2.
CODE Serial #160.
MANUFACTURER Trimedyne, Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
June 23, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 28 units were distributed.
-5-
REASON Noncompliance with performance standard for laser products. If
the foot switch is immersed in conductive liquid (such as
saline) the laser may continue lasing even if the footswitch is
deactivated (released).
PRODUCT Entera-Flo Stationary Enteral Feeding Pump, for dietary
products systems stationary tube feeding. Recall #Z-856-2.
CODE Each unit has unique number, the sequence is:
0G10061 through 0G10207 except 0G10187
0G10771 through 0G10780
9G10001 through 9G10060 except 9G10002 and 9E10021.
MANUFACTURER Fresenius AG, Bad Homburg, Germany.
RECALLED BY Fresenius Pharma, USA, Inc., New Brunswick, New Jersey. Pumps
were removed from the field between 10/1/90 through 12/30/90.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Pennsylvania, New Jersey, Ohio.
QUANTITY 136 units were distributed; firm estimates none remains on the
market.
REASON The pump may fail due to frozen or blank screens, unresponsive
pumps or keyboards. The pump will not respond to commands and
will therefore fail to deliver feeding formula.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
PRODUCT Multi Level Protein Control Sera for Turbitime System (Human),
a diagnostic tool used to measure serum proteins.
Recall #Z-838-2.
CODE Catalog #OWIG 11, lot numbers: 23006 and 22857 EXP 6/30/92 on
kits; lot numbers: 018702 on Level L vial, 081802 on Level M
vial, 081902 on Level H vial.
MANUFACTURER Behringwerke AG, Marburg, Germany.
RECALLED BY Behring Diagnostics, Inc., Somerville, New Jersey, by telephone
March 12, 1992 and by letters March 23, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 885 kits were distributed.
REASON The reported albumin values were greater than the allowable 15%
deviation from the assigned value for each level (low, medium
and high) of the control.
PRODUCT In-vitro diagnostic test kits for utilization of the
cyanmethemoglobin technique as a method for the quantitative
assay of whole blood hemoglobin:
(a) CMH Cyanmethemoglobin Liquid Reagent;
(b) Unitized Hemoglobin Test Kit Catalog #12-321-100A;
(c) Unitized Hemoglobin Test Kit Catakig #12-321-100B;
(d) Unitized Hemoglobin Test Kit Catakig #2321-100;
(e) Hemoglobin Test Kit Catalog #G507-00 and #G507-25.
Recall #Z-843/847-2.
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CODE (a) CMH Cyanmethemoglobin Liquid Reagent
Catalog No. Control No. EXP Date
0321-380 91231 8/93
0321-380 91263 9/93
Each kit contains one 3800 ml flask of CMH Reagent
(b) Unitized Hemoglobin Test Kit -- 100 Tests
Catalog No. Control No. EXP Date
12-321-100A 91218 7/93
12-321-100A 91239 8/93
12-321-100A 91245 8/93
Each kit contains 100-2.5 ml vials of CMH Reagent
(c) Unitized Hemoglobin Test Set -- 100 Tests
Catalog No Control No. EXP Date
12-321-100B 91224 8/93
12-321-100B 91253 8/93
Each kit contains 100-5.0 ml vials of CMH Reagent
(d) Unitized Hemoglobin Test Kit -- 100 Tests
(Unitized for the Unimeter)
Catalog No. Control No. EXP Date
2321-100 91221 7/93
(e) Hemoglobin Test Kit (for use on Premiere, Eskalab-CCS or
Serometer Filter Photometer)
Catalog No. Control N. EXP Date
G507-00 (100 tests) 91225 2/93
G507-25 (25 tests) 91225 2/93
Each of these test kits contain the component cyanmethemoglobin
reagent (CMH) manufactured under one of the batch lot numbers
19711, 20611, 22511, 23111 and 25511
MANUFACTURER Stanbio Laboratory, Inc., San Antonio, Texas.
RECALLED BY Manufacturer, by telephone and by letter dated November 8,
1991. Firm-initiated recall complete.
DISTRIBUTION Mississippi, Florida, California, Virginia, South Carolina,
Maryland, Oregon, Tennessee, Pennsylvania, North Carolina, New
Jersey, Iowa, Illinois, Indiana, Kentucky, Ohio, Oklahoma, West
Virginia, Texas.
QUANTITY 597 kits were distributed; firm estimates none remains on the
market.
REASON Reports of contamination and low hemoglobin results involving
their test kits. Results of bacteriological studies revealed
that all water samples and reagent vials contained Pseudomonas
sp., now called Xanthomonas.
SEIZURES:
PRODUCT Chunk Light Tuna Fish (92-543-696).
CHARGE Adulterated - The product consists in part of decomposed
tuna fish; and the product is pet food which has been
relabeled as human food, thus concealing its inferiority.
Misbranded - The product is offered for sale under the name
of another food.
FIRM Food Bank of Central New York, North Syracuse, New York.
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FILED April 6, 1992 - U.S. District Court for the Northern
District of New York; Civil #92-CV-441; FDC #66400.
SEIZED April 14, 1992 - goods valued at approximately $2,400.
PRODUCT Chunk Light Tuna Fish (92-543-695).
CHARGE Adulterated - The product consists in part of decomposed
tuna fish; and the product is pet food which has been
relabeled as human food, thus concealing its inferiority.
Misbranded - The product is offered for sale under the name
of another food.
FIRM The Reclamation Center, Division of Victory Markets, Inc.,
Norwich, New York.
FILED April 6, 1992 - U.S. District Court for the Northern
District of New York; Civil #92-CV-441; FDC #66396.
SEIZED April 14, 1992 - goods valued at approximately $11,500.
PRODUCT Surgical Stockinettes (92-647-548).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, their manufacture and packing are not
in conformity with current good manufacturing practice
requirements.
FIRM Etex Company, Division of Eagle Beef Cloth Co., Inc.,
Hauppauge, New York.
FILED June 15, 1992 - U.S. District Court for the Eastern District
of New York; Civil #CV 92-2805; FDC #66047.
SEIZED June 22, 1992 - goods valued at approximately $58,000.
PRODUCT Dried Fungus and Hoisin Sauce (92-664-806/7).
CHARGE Adulterated - The products consist in part of a filthy
substance. Misbranded - The product label is false and
misleading because it incorrectly represents the distributor
as the packer, and misidentifies the location of the firm.
FIRM Intertrade Import-Export, Inc., San Lorenzo, California.
FILED June 11, 1992 - U.S. District Court for the Northern
District of California; Civil #C92 2206; FDC #66454.
SEIZED June 12, 1992 - goods valued at approximately $5,550.
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END OF ENFORCEMENT REPORT FOR JULY 15, 1992. BLANK PAGES MAY FOLLOW.
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