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
02/09/1994
Recalls and Field Corrections: Foods -- Class II -- 02/09/1994
February 9, 1994 94-6
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Stop and Shop Orange Juice from Concentrate, in 1 gallon
plastic containers. Recall #F-250-4.
CODE Sell by Jan 16.
MANUFACTURER The Stop & Shop Supermarket Company, Inc., Readville,
Massachusetts.
RECALLED BY Manufacturer, by voice mail December 26, 1993, and by Recall
Bulletin sent December 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION Connecticut, Rhode Island, Massachusetts.
QUANTITY Approximately 1,596 cases were distributed; firm estimates
none remains on the market.
REASON Product is contaminated with milk products.
_______________
PRODUCT Hana brand Salted Smelt Roe, 5.2 ounces. Recall #F-251-4.
CODE Lot #MN-S100.
MANUFACTURER Minaga Bussan K.K., Hyogo-Pref., Japan.
RECALLED BY Rhee Brothers, Inc., also known as New Japan Foods
Corporation, Columbia, Maryland, by letter August 17, 1993,
followed by telephone September 7, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, Pennsylvania, North Carolina, Ohio,
Massachusetts, Michigan, Tennessee, New York, Missouri,
Maryland, Virginia, Washington, D.C.
QUANTITY 59 boxes were distributed.
REASON Product contains undeclared FD&C Yellow No. 5, 6, and
Cochineal Red (Ponceau 4R).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-112/115-4.
CODE Unit numbers: (a) 30930, 31363, 34185, 35973, 38704, 40985,
47247, 62461, 62468, 65977, 66032, 66057, 68067, 74802,
75833, 78530, 80593, 81128, 82197, 82876;
(b) 30507, 34149, 34153, 34155, 34157, 34158, 34159, 34182,
34219, 34258, 34360, 34361, 34362, 35975, 35979, 36638,
36665, 36666, 37174, 37390, 39688, 39696, 39785, 39806,
39808, 39814, 39821, 39823, 39843, 39845, 39849, 40217,
40460, 41167, 41171, 41178, 41525, 42991, 43158, 45325,
45366, 45372, 45658, 47150, 47622, 49071, 49092, 50482,
50662, 52314, 58961, 61279, 62461, 62468, 62638, 65977,
66057, 68067, 68171, 70474, 71311, 74802, 75833, 78530,
80593, 81128, 82197;
(c) 30668, 34057, 35079, 37093, 37114, 38486, 38877, 39823,
39826, 39828, 39843, 40217, 41167, 41171, 41178, 41191,
42991, 47247, 49071, 54203, 54247, 54255, 57254, 57671,
62468, 65977, 66057, 68067, 70474, 71117, 71311, 74802,
75833, 78530, 81128, 82197, 82876;
(d) 30161, 30177, 34159, 34312, 34315, 34316, 34323, 34360,
34361, 34362, 34797, 34849, 35320, 35321, 35325, 35329,
36638, 36665, 36666, 37002, 37388, 37390, 38126, 39688,
39696, 39785, 39849 40364, 41799, 43761, 45372, 50662,
52662, 52978, 53747, 57844, 80593.
MANUFACTURER Metropolitan Washington Blood Bank, Silver Spring, Maryland.
RECALLED BY Manufacturer, by letter October 25 and 27, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Maryland, Virginia, Washington, D.C., Ohio, New York,
Alabama, Florida, Massachusetts, New Jersey.
QUANTITY (a) 20 units; (b) 67 units; (c) 37 units; (d) 37 units.
REASON Blood products were tested improperly for the Hepatitis B
surface Antigen (HBsAg), the antibody to the Human
Immunodeficiency Virus Type 1 (anti-HIV-1), or the antibody
to the Human T-Lymphotropic Virus Type I (anti-HTLV-I), or
tested repeatedly reactive for HBsAg or anti-HIV-1, or
tested nonreactive for HBsAg or anti-HIV-1 but were
collected from donors who previously tested repeatedly
reactive for HBsAg or anti-HIV.
_______________
PRODUCT Sterile Vials, (a) 10 ml with 20 mm openings and (b) 5 ml
with 13 mm openings, distributed for use with diluents and
allergenic extracts. Recall #B-140/141-4.
CODE Lot numbers (a) SB3986; (b) SB4045.
MANUFACTURER Wheaton Tubing Products, Syracuse, Nebraska.
-2- RECALLED BY Allergy Laboratories, Inc., (ALI), Syracuse, Nebraska, by
telephone October 5 and 7, 1993, followed by letters dated
October 6, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, Colorado, Connecticut, Georgia, Maryland, Nebraska,
New Mexico, Nevada, Ohio, Oklahoma, Texas, Washington state.
QUANTITY 16,070 vials were distributed; firm estimates less than 20
percent remain on the market.
REASON Sterile glass vials labeled for use with allergenic extracts
contained particulate matter determined to be glass
fragments.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Permobil Super-90 Powered Wheelchair. Recall Z-112-4.
CODE All units with serial numbers less than but not including
11414.
MANUFACTURER Samhall JHP AB, Svenstavik, Sweden (contract manufacturer).
RECALLED BY Permobil, Inc., Woburn, Massachusetts, by letter October 7,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 90 chairs were distributed.
REASON The motor and gearbox assemblies on the powered wheelchairs
are defective. The main drive shaft extending from the
electric motor into the gearbox may break rendering the
chair inoperable because the motor can no longer provide
power to the wheels.
_______________
PRODUCT Adult, Child and Infant Disposable Bageasy Manual
Resuscitators. Recall #Z-129/131-4.
(a) Adult BagEasy Manual Resuscitators:
Part No. 412038 Part No. 412009 Part No. 412151
Part No. 412039 Part No. 412012 Part No. 412013
Part No. 412040 Part No. 412021 Part No. 412014
Part No. 412041 Part No. 412022 Part No. 412015
Part No. 412042 Part No. 412025 Part No. 412026
Part No. 412043 Part No. 412036 Part No. 412034
Part No. 412142 Part No. 412037 Part No. 412035
Part No. 412143 Part No. 412045 Part No. 412046
Part No. 412144 Part No. 412050 Part No. 412048
Part No. 412145 Part No. 412051 Part No. 412049
Part No. 412146 Part No. 412052 Part No. 412053
Part No. 412147 Part No. 412119 Part No. 412054
Part No. 412152 Part No. 412120 Part No. 412155
Part No. 412153 Part No. 412122 Part No. 412139
Part No. 412004 Part No. 412149 Part No. 412140
Part No. 412150 Part No. 412148
(b) Child BagEasy Manual Resuscitators:
Part No. 412080 Part No. 412106 Part No. 412088
Part No. 412081 Part No. 412132 Part No. 412089
-3- Part No. 412082 Part No. 412133 Part No. 412090
Part No. 412083 Part No. 412134 Part No. 412091
Part No. 412105 Part No. 412135 Part No. 412130
Part No. 412131
(c) Infant BagEasy Manual Resuscitators:
Part No. 412084 Part No. 412108 Part No. 412092
Part No. 412085 Part No. 412109 Part No. 412093
Part No. 412086 Part No. 412110 Part No. 412094
Part No. 412087 Part No. 412111 Part No. 412095
Part No. 412107 Part No. 412112 Part No. 412114
Part No. 412113 Part No. 412115
CODE All models and all lots.
MANUFACTURER Respironics, Inc., Pittsburgh, Pennsylvania.
RECALLED BY Respironics, Inc., Murrysville, Pennsylvania, by Fax
November 1, 1993, and by letter November 3, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe, Asia.
QUANTITY 35,000 to 50,000 units were distributed.
REASON flash (remnants of plastic resulting from the plastic
molding process) may have broken off and may be present in
some resuscitators. This broken off flash could interfere
with the functioning of the resuscitator by blocking off the
valves or could travel through the pathway and be introduced
into the patients airway.
_______________
PRODUCT Amicon Diafilter 20S Hemofilter Kit, for continuous
arteriovenous ultrafiltration and hemodiafiltration of
critical care patients. Recall #Z-147-4.
CODE Product #18212, Lot #D20-0297.
MANUFACTURER Amicon Ireland, Ltd., Limerick, Ireland.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by memorandum,
followed by telephone July 29, 1993. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 12 kits were distributed. Firm estimates none remains on
the market.
REASON The sterilization process used was not a validated process.
Sterility cannot be assured.
_______________
PRODUCT Medicam 900 Insufflator, a microprocessor-base controlled
device used to insufflate C02 gas to distend the peritoneal
cavity. Recall #Z-188-4.
CODE Serial numbers: 033HA051 through 033HA078,
093HA079 through 093HA103, 372HA001 through 372HA025,
472HA026 through 472HA049.
MANUFACTURER Andronic Devices Limited, Richmond, BC, Canada.
RECALLED BY M.P. Video, Inc., Hopkinton, Massachusetts, by telephone
August 23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Chile, Taiwan, Argentina, The Netherlands,
England, Belgium, Italy, South Africa, Germany.
-4- QUANTITY 99 units were distributed.
REASON The devices pressure regulation component can go out of
tolerance and prevent insufflation.
_______________
PRODUCT Minicap III Carbon Dioxide Analyzer for ventilating systems,
a portable medical device used to identify the presence or
absence of carbon dioxide in a patient's ventilating system
during the respiratory cycle. Recall #Z-200-4.
CODE All production February 1991 through present.
MANUFACTURER Mine Safety Applications, Inc., Mars, Pennsylvania.
RECALLED BY Manufacturer, by letters mailed starting November 19, 1993,
and by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 563 units were distributed.
REASON The device may not be resistant to electromagnetic radiation
interference. Problems can occur when two-way radios or
similar devices that generate or emit electromagnetic
radiation are used near the Minicap III detector.
_______________
PRODUCT Respironics 12VDC Battery Adapter Cable:
(a) Part No. 332234, 12VDC Battery Adapter Cable;
(b) Part No. 332233, 12VDC Interface Module with Battery
Adapter Cable;
(c) Part No. 332236, 12VDC Cord with Battery Adapter Cable;
(d) Part No. 332277, 12VDC Interface Module with Battery
Adapter Cable (international Version). Recall #Z-201/204-4.
CODE All serial numbers.
MANUFACTURER Safeco Corporation, Chicago, Illinois.
RECALLED BY Respironics, Inc., Murrysville, Pennsylvania, by telephone
September 21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,738 cables were distributed.
REASON The cable may overheat which may cause the insulation to
melt and cause a fire.
________________
PRODUCT (a) DextroLyte II Peritoneal Dialysis 8 inch Catheter
Extension, Catalog #48-3028-7;
(b) DextroLyte II Peritoneal Dialysis 8 Inch Catheter
Extension with Roller Clamp, Catalog #48-3029-5.
Recall #Z-206/207-4.
CODE Lot numbers: (a) M2N504, M3C504, M3C519; (b) M2K511,
M2N503, M3A505, M3D523.
MANUFACTURER National Medical Care, Medical Products Division, McAllen,
Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by letter
dated November 4, 1993. Firm-initiated recall ongoing.,
DISTRIBUTION Nationwide.
QUANTITY 2,207 units were distributed.
-5- REASON Broken or cracked 8 inch catheter extensions may contribute
to the development of peritonitis.
_______________
PRODUCT Laser Illuminator Model-ALP-1, Used to illuminate object in
low light level for viewing through a night vision scope.
Recall #Z-216-4.
CODE None.
MANUFACTURER Night Optics International, Susanville, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan January 27, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14 units.
REASON Product lacked a certification label; lacked an
identification label; failed to incorporate a remote
interlock connector, failed to incorporate a key control;
failed to incorporate an emission indicator; failed to
incorporate a beam attenuator, failed to have Class IIIb
warning logotype affixed to the product; failed to have an
aperture label affixed to the product; user information
failed to include the required caution statement and a
reproduction for all required warning labels.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Performance Knee Tibial Tray Implant, Porous Coated with
Hole Plugs. Recall #Z-101-4.
CODE Lot #010722, Catalog #7804-03-088.
MANUFACTURER Kirschner Medical Corporation, Fair Lawn, New Jersey.
RECALLED BY Manufacturer, by telephone and letter on February 16, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 25 units.
REASON The oxygen content of the titanium material used to make the
device was too high. The oxygen content was incorrectly
reported as 0.119% instead of 0.199%, which is above the
maximum acceptable range of 0.150%.
MASS SEIZURE:
=============================================================
_______________
PRODUCT Intraocular lenses, lens blanks, raw materials and
accompanying labeling (93-682-750, et al).
CHARGE Adulterated - The articles are class III devices for which
no approved premarket approval applications are in effect.
The methods used in, and the facilities and controls used
for, the articles' manufacture, packing, and storage, are
not in conformity with current good manufacturing practice
requirements.
FIRM IOL International, Inc., Largo, Florida.
-6- FILED December 17, 1993; U.S. District Court for the Middle
District of Florida, Tampa Division; Civil #93-2009-Civ-T-
99A; FDC #66768.
SEIZED January 10, 1994 - goods valued in excess of $150,000.
SEIZURES:
=================================================================
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PRODUCT Soft Red Winter Wheat (94-611-032).
CHARGE Adulterated - The article consists in whole or in part of a
filthy substance by reason of the presence therein of
insects.
FIRM Consolidated Grain and Barge Co., Naples, Illinois.
FILED January 14, 1994; U.S. District Court for the Central
District of Illinois, Springfield Division; Civil #94 3007;
FDC #66913.
SEIZED January 24, 1994 - goods valued at approximately $195,000.
_______________
PRODUCT GEN-A-HORSE and ITCH-EX (veterinary biotin supplements)
(93-687-243/4).
CHARGE New animal drugs - The articles are unsafe because no
approved applications are in effect with respect to their
intended uses.
FIRM Burleson Veterinary Supply, Burleson, Texas.
FILED January 3, 1993; U.S. District Court for the Northern
District of Texas, Fort Worth Division; Civil #4-94-CV-2-A;
FDC #66767.
SEIZED January 4, 1994 - goods valued at approximately $1,989.
-7-
END OF ENFORCEMENT REPORT FOR FEBRUARY 9, 1994. BLANK PAGES MAY
FOLLOW.
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