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
10/27/1993
Recalls and Field Corrections: Foods -- Class I -- 10/27/1993
October 27, 1993 93-43
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT King Salmon brand Smoked Salmon Pate, in 8 ounce plastic
cups. Recall #F-002-4.
CODE Sell by Sep 02 93, or 460512.
MANUFACTURER King Salmon, Inc., Chicago, Illinois, by telephone September
17, 1993 and by press release September 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 112 cups were distributed; firm estimates none remains on
the market.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Vitamin A 25,000 I.U. Tablets in bottles of 100.
Recall #F-528-3.
CODE Lot #110296.
MANUFACTURER Mission Pharmacal Company, Inc., Scientific Nutrition
Division, San Antonio, Texas.
RECALLED BY Manufacturer, by telephone August 23, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Florida, Georgia, Indiana, Louisiana,
Michigan, Nebraska, Oklahoma, Pennsylvania, Tennessee,
Texas.
QUANTITY Approximately 1,036 bottles.
REASON Product is mislabeled. Vitamin A tablets are labeled as
capsules.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT Trental (pentoxiffylline) 400 mg Tablets, in bottles of 100,
Rx indicated for the treatment of patients with intermittent
claudication. Recall #D-009-4.
CODE Lot Number Expiration Date
078-566-1 April 1994
078-568-1 April 1994
078-569-1 April 1994
078-572-1 April 1994
078-204-2 November 1994
078-201-2 November 1994
078-250-2 November 1994
078-244-2 November 1994
078-416-2 January 1995
078-423-2 February 1995
078-424-2 February 1995
078-428-2 February 1995
078-438-2 February 1995
078-445-2 February 1995
078-449-2 February 1995
078-464-2 February 1995
078-465-2 February 1995
078-466-2 February 1995
078-468-2 February 1995
078-469-2 February 1995
078-470-2 February 1995
078-476-2 February 1995
078-477-2 February 1995
078-480-2 March 1995
078-481-2 March 1995
078-482-2 March 1995
078-484-2 March 1995
078-485-2 March 1995
078-486-2 March 1995
078-487-2 March 1995
078-489-2 March 1995
078-735-2 April 1995
078-740-2 April 1995.
Note: The 2 lot numbers 078-201-2 and 078-244-2, are the 2
lot numbers included in the 8/30/93 recall extension.
MANUFACTURER Hoechst Roussel Pharmaceuticals, Inc., Somerville, New
Jersey.
RECALLED BY Manufacturer, by letters of June 22, 1993 and August 30,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
-2- QUANTITY Firm estimates 15,000 bottles remain on the market.
REASON Product does not meet sustained release specifications.
_______________
PRODUCT Declomycin HCl Capsules, 150 mg, in bottles of 100, Rx
antibiotic. Recall #D-010-4.
CODE Control numbers: 280-446 EXP 3/95, 297-437 EXP 6/95.
MANUFACTURER Lederle Labs, Pearl River, New York.
RECALLED BY Manufacturer, by letter September 30, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California, Illinois, Pennsylvania, Texas, Puerto Rico.
QUANTITY 10,396 bottles were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
_______________
PRODUCT Transfilled Compressed Medical Oxygen, in D, E, and M size
cylinders. Recall #D-011-4.
CODE All codes. All fill dates.
MANUFACTURER Accurate Fire and Safety Equipment, East Rockway, New York.
RECALLED BY Manufacturer, by visit on or about October 4, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 46 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Rugby Nasal Decongestant, Pseudoephedrine HCl 30 mg tablets,
in bottles of 100, OTC product used to provide temporary
relief of nasal congestion due to the common cold,
sinusitis, hay fever, or other respiratory allergies.
Recall #D-012-4.
CODE Lot numbers: P9334 EXP 12/94, P9666 EXP 2/95,
P10134 EXP 4/95.
MANUFACTURER LNK International, Inc., Hauppauge, New York.
RECALLED BY Manufacturer, by telephone September 27, 1993, followed by
letter October 8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 25,480 units were distributed.
REASON Label error - Directions should read not to exceed 4 tablets
in 24 hours for children instead of 8 tablets in 24 hours.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets. Recall #B-001-4.
CODE Unit numbers KK16483 and KG28713.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone January 20,1993, followed by
letter February 2, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
-3- QUANTITY 2 units.
REASON Blood product was collected from a donor who reported a
history of cancer; or contained anti-K antibodies but
labeled as negative for unexpected antibodies.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-004/006-4.
CODE Unit numbers: 60J54856, 60J56625.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by telephone December 8, 1992, and followed by
letter December 9, 1992. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 2 units of each component.
REASON Blood products which tested non-reactive for the antibody to
human immunodeficiency virus type 1/2 (anti-HIV-1/2,), but
were collected from a donor who previously tested repeatedly
reactive to anti-HIV 1/2; tested non-reactive for the
antibody to hepatitis B core antigen (antiHBc) but was
collected from a donor who previously tested repeatedly
reactive for anti-HBc on two separate donations.
_______________
PRODUCT PCS Plasma Collection System, Model 6001-CP.
Recall #B-015-4.
CODE All serial numbers.
MANUFACTURER Haemonetics Corporation, Holbrook, Massachusetts;
Kollsman Manufacturing Company, Amherst, New Hampshire.
RECALLED BY Haemonetics Corporation, Braintree, Massachusetts, by
initiating a field correction on July 22, 1992. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,980 units.
REASON Plasma collection device contains defect which may cause a
computer lock-up of the instrument.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT (a) Whole Blood; (b) Recovered Plasma. Recall #B-002/003-4.
CODE Unit numbers: (a) KP16874 and KP16877; (b) KK16134.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, (a) by telephone February 7, 1993; (b) by
telephone January 11, 1993, followed by letter January 12,
1993. Firm-initiated recall complete.
DISTRIBUTION Virginia, California.
QUANTITY (a) 2 units; (b) 1 unit.
-4- REASON Blood products: incorrectly labeled as Frozen Plasma (FP-15)
instead of Recovered Plasma; or labeled with the incorrect
expiration date.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-007-4.
CODE Unit numbers: 60J30322, 60J30323, 60J30326, 60J30327,
60J30328, 60J31807, 60J31810, 60J31815, 60K27543, 60K27544,
60K27545, 60K27547, 60K27548, 60K27549, 60K27550, 60K27553,
60R61459, 60R61460, 60R61464, 60R61467, 60R61523, 60R61524,
60R61526, 60R61527, 60R61528, 60R61532, 60R61554, 60S04394,
60S04396, 60S04397, 60S04599, 60S04600, 60T13682, 60T13684,
60T13686, 60T13687, 60T13688, 60T13709, 60T13711, 60T13712,
60T18072, 60T18074, 60T18075, 60T18076, 60W70278, 60W70280,
60W70281, 60W70282, 60W70283, 60W70284, 60W70285, 61J30325.
MANUFACTURER American Red Cross Blood Service, Miami, Florida.
RECALLED BY Manufacturer, by telephone August 12, 1992, followed by
letter August 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 52 units.
REASON Bags of Cryoprecipitated AHF were exposed to Toluidine.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT Trocar and surgical drain accessory for the AutoVac
autotransfusion device, serves as a draining system during
orthopedic surgery:
(a) Product #2062, 1/8" PVC Drain and Trocar;
(b) Product #2064, 1/4" PVC Drain and Trocar;
(c) Product #2073, 1/8" Silicone Drain and Trocar;
(d) Product #2074, 3/16" Silicone Drain and Trocar;
(e) Product #2075, 1/4" Silicone Drain and Trocar.
Recall Z-805/809-3.
CODE None.
MANUFACTURER Degania Silicone, Ltd., Buckhayarden, Israel.
RECALLED BY Boehringer Laborataories, Inc., Norristown, Pennsylvania, by
letters on May 26, 1993, and June 11, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Canada, Japan.
QUANTITY (a) 3,785 units; (b) 267 units; (c) 54 units; (d) 32 units;
(e) 129 units.
REASON Devices labeled as sterile, are not sterile.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Port-A-Cath Fluoro-Free Portal with Polyurethane Catheter
and 6 French Introducer Set, Product #21-4621.
Recall #Z-625-3.
CODE Lot #20652.
-5- MANUFACTURER Pharmacia Deltec, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone April 20, 1993, followed by
letter April 21, 1993. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Kansas, Maryland, Missouri, North
Carolina, Pennsylvania, Washington state.
QUANTITY 50 units.
REASON The sensor wire component may be difficult to withdraw or
become damaged during removal from the catheter.
_______________
PRODUCT Installation and service manual for CP 60, CP 80, and CP100
X-ray Controls High Voltage Generators.
Recall #Z-015/017-4.
CODE Not applicable.
MANUFACTURER Liebel-Flarsheim Company, Cincinnati, Ohio
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan June 18, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 258 units.
REASON Proper assembly and user information was not provided with
the system to ensure compliance with entrance exposure rate
requirement.
---------------
PRODUCT Robicsek Vascular Probe, bulb size 1.0 mm-1.5mm, product
#7151015, used to test for blockage in blood vessels.
Recall #Z-020-4.
CODE Lot #93E24.
MANUFACTURER Navarre Laboratories, Ltd., Hamel, Minnesota.
RECALLED BY Bio-Vascular, Inc., St. Paul, Minnesota, by telephone August
16, 1993. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Alabama.
QUANTITY 75 units. All units have been accounted for.
REASON Units were mislabeled. The bulb size of the recalled probes
was actually 1.5mm-2mm and not 1.0 mm-1.5mm as labeled.
_______________
PRODUCT Servo Ventilator #300, Model/Catalog #60 74 391 E380E, used
for advanced ventilatory treatment. Recall #Z-041-4.
CODE Serial numbers range from 414 through 1079.
MANUFACTURER Siemens Elema AB, Life Support Division, Solna, Sweden.
RECALLED BY Siemens Medical Systems, Iselin, New Jersey, by letter
November 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Natinwide.
QUANTITY 130 units.
REASON There is a potential for the tidal volume to be 20% greater
than the indicated volume when used at high altitudes.
-6- _______________
PRODUCT Micro-Temp, a heat therapy system which consistently
delivers a therapeutic level of moist heat for localized
applications. Recall #Z-044-4.
CODE Catalog #SMS-1000E, Serial numbers: 93120041, 92318094,
92318095, 92318096, 92318097, 92318298, 92318299.
MANUFACTURER Seabrook Medical Systems, Inc, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated April 27, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Indonesia, Belgium, Spain, Switzerland.
QUANTITY 7 units.
REASON Devices were assembled with an incorrect resistor.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Diala-Kit Sterile Kits, single use, dialysis on/off packs
containing venous bloodlines and finished OTC components:
(a) 46-5050; (b) 46-5040; (c) 46-5230; (d) 46-5010; (e) 46-
5110; (f) 46-5072; (g) 46-5100; (h) 46-5231; (i) 46-5250;
(j) 46-5080; (k) 46-5071; (l) 46-5200; (m) 46-5090; (n) 46-
5210; (o) 46-5220. Recall #Z-827/841-3.
CODE Catalog Nos. Lot Nos.
46-5050 M3A106
46-5040 M3A108
46-5230 M3A110, M3A113
46-5010 M3A120
46-5050 M3A140
46-5110 M3A705
46-5072 M3A741
46-5110 M3B105
46-5100 M3B144
46-5110 M3B152
46-5231 M3B155
46-5110 M3B158
46-5050 M3B161
46-5110 M3B181
46-5072 M3B183
46-5110 M3B195
46-5250 M3B702
46-5231 M3C131
46-5110 M3C147
46-5080 M3C736
46-5250 M3C738
46-5231 M3C777
46-5080 M3D116
46-5110 M3D117
46-5250 M3C768
46-5071 M2A101
46-5090 M2A137
46-5071 M2B124
-7- 46-5080 M2C127
46-5050 M2C179, M2D118
46-5010 M2D137
46-5200 M2D179
46-5072 M2D196
46-5050 M2E108
46-5080 M2E109
46-5050 M2E703
46-5080 M2E704
46-5072 M2E722, M2H730
46-5100 M3J148
46-5090 M2J170
46-5050 M2J709
46-5090 M2K149
46-5080 M2K705
46-5210 M3K732
46-5050 M2K733
46-5100 M2K766
46-5110 M2L141
46-5090 M2L143
46-5080 M2L146
46-5010 M2L147
46-5200 M2L191, M2L707
46-5210 M2L761
46-5090 M2N103
46-5080 M2N115
46-5100 M2N125, M2N168
46-5080 M2N175
46-5220 M2N189
46-5010 M2N726
46-5090 M2N791
46-5072 M2P123
46-5050 M2P757
46-5230 M2P760
46-5110 M2P773, M2S147, M2S729
46-5230 M2S730
46-5072 M2S740
MANUFACTURER National Medical Care, Medical Products Division, McAllen,
Texas; National Medical Care, Medical Products Division,
Reynosa, Mexico.
RECALLED BY National Medical Care, Medical Products Division, Rockleigh,
New Jersey, by letter April 22, 1993, and by telephone April
28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 66,635 units.
REASON The firm's shipping cartons incorrectly identified the
products as peritoneal dialysis on/off kits.
-8- _______________
PRODUCT Model 246 Pneumoplethysmograph, used to measure blood
pressure on the penis or digits using a proximal occluding
cuff connected to an aneroid manometer, and a distal sensing
cuff. Recall #Z-042-4.
CODE 038020 042550 046771 051433
038023 044767 046773 051434
041844 044768 046774 054583
041845 044769 046776 054585
041851 044770 050495 054586
042542 044771 051427 056505
042545 044774 051428 056508
042546 044775 051429 058302
042547 046767 051430 059037
042548 046770 051432.
MANUFACTURER Parks Medical Electronics, Inc., Aloha, Oregon.
RECALLED BY Manufacturer, by letter in April 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Saudi Arabia, Greece.
QUANTITY 50-60 units.
REASON There is a design flaw which prevents operation at cuff
pressures above 80 mm Hg.
_______________
PRODUCT Argyle Medicut 16 gauge Intravenous Cannula.
Recall #Z-045-4.
CODE Reorder #8888-100222, lot #90C1248.
MANUFACTURER Sherwood Medical Industries of Ireland, Ltd., Tullamore,
Ireland.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letter
June 16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 17,300 units.
REASON A portion of the lot were found to be incorrectly labeled as
20 gauge.
_______________
PRODUCT Hall Surgical Medium Bur Guard, used in oral surgery to
prevent wobble of dental burr. Recall #Z-048-4.
CODE Product #1375-12, lot #46203300.
MANUFACTURER Hall Surgical Division, of Zimmer, Carpinteria, California.
RECALLED BY Manufacturer, by letter August 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Finland, Mexico, Japan.
QUANTITY 125 units.
REASON Device is etched with a incorrect product number, 1375-11
instead of 1375-12.
-9- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
===========
_______________
PRODUCT D-Panthenol Injection, 100 ml vials, RX for use as a
nutritional source of d-panthenol, under the Phoenix
Pharmaceutical, Vedco, and The Butler labels.
Recall #V-001-4.
CODE Lot numbers: 2090234 EXP 3/94, 211308 EXP 5/94, 3040110 EXP
10/94.
MANUFACTURER Phoenix Scientific, Inc., St. Joseph, Missouri.
RECALLED BY Manufacturer, by telephone August 13, 1993, followed by
letter August 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Missouri, Ohio.
QUANTITY 7,356 units.
REASON Product is subpotent.
-10-
END OF ENFORCEMENT REPORT FOR OCTOBER 27, 1993. BLANK PAGES MAY
FOLLOW.
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