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
04/29/1992 92-18
RECALLS AND FIELD CORRECTIONS: April 29, 1992
FOODS -- CLASS I
PRODUCT All flavors and sizes of Merkt's cold pack cheese foods, in 8
ounce, 9.5 ounce and 16 ounce plastic tubs. The cold pack
cheese foods were also produced for the holidays in 16 ounce,
18 ounce and 20 ounce crocks:
(a) Sharp Cheddar Cold Pack Cheese Food;
(b) Garlic Herb Cold Pack Cheese Food;
(c) Jalapeno Cold Pack Cheese Food
(d) Horseradish Cold Pack Cheese Food;
(e) Chunky Bacon Cold Pack Cheese Food;
(f) Cajun Cheddar Cold Pack Cheese Food;
(g) Almond Swiss Cold Pack Cheese Food;
(h) French Onion Cold Pack Cheese Food;
(i) Port Wine Cold Pack Cheese Food. Recall #F-259/267-2.
CODE All lots.
MANUFACTURER Merkt Cheese Company, Inc., Bristol, Wisconsin.
RECALLED BY Manufacturer, by letter March 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Arizona, California, Colorado, Florida, Georgia, Illinois,
Indiana, Iowa, Maryland, Michigan, Minnesota, New York, Ohio,
Pennsylvania, Tennessee, Texas, Vermont, Virginia, Wisconsin.
QUANTITY Unknown.
REASON Products are contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Diet Buddies Hard Candies, 2.25 ounces, each bag contains
candies of assorted fruit flavors. Recall #F-268-2.
CODE None.
MANUFACTURER Estee Corporation, Parsippany, New Jersey.
RECALLED BY General Nutrition, Inc., Pittsburgh, Pennsylvania, by letter
January 27, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON Product contains undeclared FD&C Yellow No. 5 and lacks an
ingredient statement.
PRODUCT Swedish Fish brand of (assorted Swedish fish), various colored
pieces of candy, in 8 ounce plastic bags. Recall #F-269-2.
CODE None.
MANUFACTURER Jeppi Nut and Candy Distributors, Baltimore, Maryland
(repacker/distributor).
RECALLED BY Repacker/distributor, by letter October 1, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION Maryland.
QUANTITY 4,536 bags were distributed; firm estimates none remains on
the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Various liquid shortenings salad oils, pan & grill oils and
salad
dressings in 1 gallon plastic containers and, where indicated,
38
fl oz plastic bottles:
(a) Seven Seas Free Italian Nonfat Dressing;
(b) Seven Seas Italian Reduced Calorie Dressing;
(c) Seven Seas Creamy Italian Dressing;
(d) Seven Seas Viva Italian Dressing;
(e) Seven Seas Free Red Wine Vinegar Nonfat Dressing;
(f) Seven Seas French Creamy Dressing;
(g) Seven Seas French Light Reduced Calorie Dressing;
(h) Seven Seas Family Style French Creamy Dressing;
(i) Seven Seas Chunky Blue Cheese Dressing;
(j) Seven Seas Buttermilk Recipe;
(k) Seven Seas Buttermilk Recipe Ranch Creamy Dressing;
(l) Seven Seas Deluxe Thousand Island Creamy Dressing;
(m) Seven Seas Green Goddess Creamy Dressing;
(n) Seven Seas Caesar Creamy Dressing;
(o) Seven Seas Creamy Bacon Artificially Flavored Dressing;
(p) Corn Oil in 1 gallon plastic jugs, under the following
labels: Capri Corn Oil, Code Pure Corn Oil, Weis Quality 100%
Natural Corn Oil, ShurFine All Natural Corn Oil, Meijer 100%
Pure Corn Oil, PMW Corn Oil, Parade Corn Oil, Mrs Tucker's All
Natural Pure Corn Oil;
(q) Pan and Grill Oil, under the following labels: Chiffon Pan
and Grill Oil, Capri Pan and Grill Frying Oil, Golden Flair
for Pan and
-2-
Grill Frying, Red & White Pan and Grill Oil, White Swan Pan
and Grill Frying Oil, Nugget Liquid Pan & Grill Shortening,
Code Pan and Grill Frying Oil, Sunday Dinner Pan and Grill
Frying Oil, Pocahontas Pan and Grill Frying Oil, Nifda Pan and
Grill Frying Oil, Unifax Pan and Grill Frying Oil, Mrs.
Winner's Chicken and Biscuits Pure Vegetable Bun Toaster Oil;
(r) Liquid Shortening, in 5 quart plastic jugs, under the
following labels: Capri Liquid Shortening for Deep Frying,
Liqui-Fry Non Foam Liquid Shortening for Deep Frying, Frosty
Acres Liquid Shortening for Deep Frying, Nifda Liquid
Shortening for Deep Frying, Nugget Liquid Frying Shortening,
Pocahontas Deep Frying Liquid Shortening, Red & White Pure
Vegetable Liquid Frying Shortening, Sunday Dinner Liquid
Shortening for Deep Frying, Unifax Liquid Shortening for Deep
Frying, White Swan All Vegetable Liquid Frying Shortening;
(s) Salad Oil, in 1 gallon containers, under the following
labels: Capri Special Salad Oil for Frying, Baking, Salads,
Nifda Winterized Salad Oil for Frying, Baking, Salads,
Pocahontas Winterized Vegetable Oil, Southern Queen Oil for
Frying, Baking and Salads;
(t) Soybean Oil, in 1 gallon containers under the following
labels: Capri Pure Vegetable Oil, Flako Pure Vegetable Oil,
Jaxmor Pure Vegetable Salad Oil, Kraft Vegetable Oil, Mrs.
Tucker's Pure Vegetable Oil, Vegetable Oil, Better Valu
Vegetable Oil, Food Club 100% Pure Vegetable Oil, Food Lion
Vegetable Oil, Giant Pure Vegetable Oil, also in 38 fl oz
plastic bottles, Kohl's Pure Vegetable Oil, Kroger Pure
Vegetable Oil, Meijer 100% Pure Vegetable Oil, National All
Natural Vegetable Oil, Nugget Vegetable Oil, PMW Light &
Natural Vegetable Oil, Piggly Wiggly Vegetable Oil, also in 38
fl oz plastic bottles, Price Saver Vegetable Oil, also in 38
fl oz plastic bottles, Purity Supreme Vegetable Oil, Red &
White Vegetable Oil, also in 38 fl oz plastic bottles, Saver's
Choice Vegetable Oil, Shop 'n Save Pure Vegetable Oil,
ShurFine All Natural Vegetable Oil, also in 38 fl oz plastic
bottles, Spartan Vegetable Oil, Staff 100% Pure Vegetable Oil,
Thorofare Vegetable Oil, also in 38 fl oz bottles, Tops Pure
Vegetable Oil, Unifax Soybean Oil, Weis Quality 100% Natural
Vegetable Oil, also in 38 fl oz plastic bottles, Western
Family 100% Natural Vegetable Oil, also in 38 fl oz plastic
bottles, Buyer's Choice Vegetable Oil, also in 38 fl oz
plastic bottles, Montco All Natural Vegetable Oil, 38 fl oz
plastic
bottle, Valu Time Vegetable Oil, 38 fl oz plastic bottle,
Pocahontas Vegetable Oil, 35 lbs. plastic drum. Recall
#F-227/246-2.
CODE Code dates containing the letter "J" in the fourth position of
the code.
MANUFACTURER Kraft Food Ingredients Corporation, Jacksonville, Illinois.
RECALLED BY Kraft General Foods, Inc., Kraft Food Ingredients Corp.
Division, Skokie, Illinois, by letter February 27, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 35,374 cases of dressings and 7,605,692 cases of oil products
were distributed; firm estimates that 3,000 cases of dressings
and 35,000 cases of oil products remain on the market.
REASON Products are in short weight containers.
PRODUCT Various fruit juices:
(a) Minute Maid Grape Juice From Concentrate, in 8.45 fluid
ounce tetra brik packages;
(b) Hi-C Fruit Punch in 8.45 fluid ounce tetra brik packages;
(c) Hi-C Hula Punch in 8.45 fluid ounce tetra brik packages.
Recall #F-270/272-2.
CODE Lot numbers: (a) NOV 02 92 and NOV 03 92;
(b) DEC 03 92, DEC 08 92, DEC 09 92;
(c) FEB 13 93 and FEB 14 93.
MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan.
RECALLED BY Coca-Cola Foods, a Division of The Coca-Cola Company, Houston,
Texas. Firm-initiated recall complete.
DISTRIBUTION Iowa, Illinois, Michigan, Minnesota, Missouri, North Carolina,
North Dakota, Ohio, Tennessee.
QUANTITY Firm estimates none remains on the market.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Nature's Way Guar Gum Capsules, in 100 and 180 count bottles;
and NuPro Guar Gum Capsules, in 100 count bottles. Recall
#D-318-2.
CODE All lots.
MANUFACTURER Nature's Way Products, Inc., Springville, Utah;
Nutritional Professionals, Inc., Springville, Utah.
RECALLED BY Manufacturer, by telephone March 17-19, 1992, and by undated
letter sent April 8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Antigua.
QUANTITY 6,883 units of 180 capsules size and 52,323 units of 100
capsule size bottles were distributed.
REASON Marketed without new drug approval.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Various repackaged drugs from different manufacturers. Recall
#D-297-2.
CODE Codes are broken down by Month, Day, Year and Packaging order.
MANUFACTURER Sentara Pharmacy Services, Virginia Beach, Virginia (repacker).
RECALLED BY Repacker, by visit March 2, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia.
QUANTITY 302 units.
REASON Retention of the manufacturer's expiration date without
stability data.
PRODUCT Oxycodone with Acetaminophen Tablets, 5 mg/325 mg, a Rx
analgesic, in 100 tablet bottles. Recall #D-319-2.
CODE Lot #0A278CT EXP 6/92.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter March 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,834 bottles were distributed.
REASON Subpotency of oxycodone ingredient.
PRODUCT Hydrox Isopropyl Rubbing Alcohol, USP (Isopropyl alcohol 70%
by volume), in 1 pint plastic bottles, an OTC external rubbing
and massaging compound. Recall #D-320-2
CODE Lot numbers: 5267 EXP 11/93 and 5511 EXP 4/94.
MANUFACTURER Hydrox Laboratories, Inc., Elk Grove Village, Illinois, now
located at Elgin, Illinois.
RECALLED BY Manufacturer, by telephone July 17, 1991. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Texas, Nebraska, Michigan, Minnesota.
QUANTITY 58,752 bottles were distributed; firm estimates none remains
on the market.
REASON Product contains amorphous particulate matter.
PRODUCT Amphotericin B for Injection, USP, Preservative Free, 500
mg/vial, an antibiotic for IV infusion in 15 ml vials. Recall
#D-321-2.
CODE Lot numbers: 101242 and 101245, EXP 6/92.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
RECALLED BY Manufacturer, by telephone April 1-3, 1992, and by letter
dated April 15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Nicaragua.
QUANTITY 60,445 vials were distributed; firm estimates less than 1,000
vials remain on the market.
REASON Superpotency.
PRODUCT (a) Carbon Dioxide, USP, ANE (size E) cylinders, filled under
the Medipure label; (b) Industrial Grade Carbon Dioxide, ANE
(size E) cylinders, filled under the Sooner Airgas and Sooner
Supplies labels. Recall #D-322-2.
CODE Lot numbers with last 4 digits of 1310, 1311, 1312, and all
cylinders without a lot number.
MANUFACTURER Sooner Airgas, Inc., Oklahoma City, Oklahoma (repacker).
RECALLED BY Repacker, by telephone February 5, 1992 followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY Unknown. All lots produced November 11-13, 1991.
REASON Current good manufacturing practice deficiencies.
PRODUCT Compressed Medical Oxygen in steel or aluminum cylinders,
various sizes. Recall #D-323-2.
CODE Lot numbers: 01011492, filled 1/14/92 and 10032692, filled
3/26/92.
MANUFACTURER Brammer Welding Supply Company, Inc., Lynchburg, Virginia.
RECALLED BY Manufacturer, by letter April 3, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia.
QUANTITY 136 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
PRODUCT Geneva Pharmaceuticals Prazosin, Hydrochloride Capsules, USP,
(a) 1 mg and (b) 2 mg, in bottles of 100, 250, 1000, and in
unit dose packages of 100, a Rx antihypertension drug. Recall
#D-324/325-2.
CODE Lot numbers: (a) 72328 EXP 10/91 (unit dose expired) and
73033 EXP 11/92 (unit dose EXP 5/92); (b) 73007 EXP 03/93 (no
unit dose), 74545 EXP 03/93 (unit dose EXP 9/92).
MANUFACTURER Geneva Pharmaceuticals, Inc., (formerly Geneva Generics),
Broomfield, Colorado.
RECALLED BY Manufacturer, by letter week of April 13, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,952 bottles of 100, 651 bottles of 250, 155 bottles of 1000,
and 4,416 unit dose packs of lot 72328; 2,311 bottles of 100,
1,992 bottles of 250, 143 bottles of 1000, and 911 unit dose
packs of lot 73007; 4,956 bottles of 100, 1,176 bottles of
250, and 177 bottles of 1000, of lot 73033; 6,878 bottles of
100, 1,120 bottles of 250, and 351 unit dose packs of lot
74545 were distributed.
REASON Products do not meet dissolution specifications.
PRODUCT Nitrous Oxide, USP, UN 1070, a Rx compressed medical gas in
size D, E, F, G, and H blue steel cylinders. Recall #D-326-2.
CODE 110B275, 110B276, 110B277, 110B281, 110B282, 110B287, 110B289,
110B290, 110B294, 110B302, 110B305, 110B312, 110B319, 110B324,
110B325, 110B330, 1901B331, 1901B340, 1901B345, 1901B346,
1900B357, 1900B360, 1900B361, 1901C003, 1900C008, 1900C010,
1900C017, 1900C028, 1900C031.
MANUFACTURER Sooner Airgas, Inc., Oklahoma City, Oklahoma (repacker).
RECALLED BY Repacker, by letter March 30, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Oklahoma.
QUANTITY 1,190 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Platelets Pheresis. Recall #B-249-2.
CODE Unit numbers: 191496, 191503, 191518, 191526.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas.
RECALLED BY Manufacturer, by telephone October 8, 1991. Recall complete.
DISTRIBUTION California.
QUANTITY 4 units.
REASON Unlicensed blood products were distributed in interstate
commerce.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS I
PRODUCT Infusaid Implantable Infusion Pumps. The device operates by
means of a bellows system for pumping drug at a controlled
rate through a catheter to a specific location in the body:
(a) Model M400, Catalog No. 36263;
(b) Model M400 Dual Catheter, Catalog #36287 and 36328;
(c) Model M100, Catalog #36638;
(d) Model M500, Catalog #36686. Recall #Z-422/425-2.
CODE Pumps manufactured from 4/89 to 12/91. Serial numbers:
22,094-22,101 and 22,850-28,544.
MANUFACTURER Infusaid, Inc., Norwood, Massachusetts.
RECALLED BY Manufacturer, by letters of December 13, 1991 and January 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Turkey, Argentina, Australia, Belgium, England,
Finland, France, Germany, Mexico, Canada, Brazil, Spain,
Sweden, Greece, Israel.
QUANTITY 3,923 pumps were distributed.
REASON There is a potential for drug leakage from the pump's refill
septum or sideport septum which could result in serious
complications to the patient.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS II
PRODUCT E-Z-EM Flow Angiographic Catheter, Headhunter (1) 4 French
size, 100 cm long with no sideholes, sterile, single use as
vehicles for administration of contrast agents in arterial
branches to facilitate films taken under Digital Subtraction
Angiography (DSA) or cut film. Recall #Z-065-2.
CODE Catalog #EZ4001X, lot #031913.
MANUFACTURER E-Z-EM, Inc., Glens Falls Division, Glens Falls, New York.
RECALLED BY E-Z-EM, Inc., Westbury, New York, by letter May 30, 1991.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Wisconsin, Florida, Ohio, California, United Kingdom.
QUANTITY 75 units were distributed.
REASON Product exhibited poor elongation properties and low break
points.
PRODUCT 9 Fr. RediFurl and 9 Fr. TaperSeal 30 cc Double Lumen
Intra-aortic balloon catheters (IAB), Components of 11 Fr.
RediFurl and 11 Fr. TaperSeal 30 cc Double Lumen Intra-Aortic
Balloon (IAB) IAB/Introducer Kits:
Double Lumen Intra-Aortic Balloon (IAB) IAB/Introducer Kits:
(a) 9 Fr. RediFurl DL IAB, 30 cc/8" IAB/Introducer Kit,
Catalog No. 060-0230;
(b) 9 Fr. RediFurl DL IAB, 30cc/11" IAB/Introducer Kit,
Catalog No. 060-0231;
(c) 9 Fr. TaperSeal DL IAB, 30cc/8" IAB/Introducer Kit,
Catalog No. 030-0130
(d) 9 Fr. TaperSeal DL IAB, 30cc/11" IAB/Introducer Kit,
Catalog No. 030-0131
(e) 11 Fr. RediFurl DL IAB, 30cc IAB Kit, Catalog No. 050-0073
(f) 11 Fr. TaperSeal DL IAB, 30cc IAB/Introducer Kit, Catalog
No. 030-0087
(g) 11 Fr. RediFurl DL IAB, 30cc IAB Kit, Catalog No. 050-0037.
Recall #Z-536/542-2.
CODE Lot numbers: 021093 DN, 031149 FN, 011253 JN, 081134 EJ,
031184 GJ, 041087 DJ, 071232 JP, 161120 EL, 081205 HN, 121298
LL, 131120 EC, 051277 KC, 111120 EN, 041184 GN, 061268 KN,
221149 FJ, 041232 JJ, 031178 GP, 061087 DL, 051184 GL, 021253
JL, 021088 DC, 041178 GC.
MANUFACTURER St. Jude Medical, Inc., Cardiac Assist Division, Chelmsford,
Massachusetts.
RECALLED BY Manufacturer, by letter January 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts, Illinois, Michigan, Maryland, New York,
Mississippi, Texas, Tennessee, Puerto Rico, Canada, New
Zealand.
QUANTITY 771 kits were distributed.
REASON The adapter supplied with the Redi-Furl and TaperSeal
catheters does not provide the correct inflation volume
when the catheters are supported with a Kontrol console.
PRODUCT 9 Fr. RediFurl and 9 Fr. TaperSeal 30 cc and 40 cc Double
Lumen Intra-Aortic Balloon Catheters (IAB), Components of 9
Fr. RediFurl and 9 Fr. TaperSeal 30cc and 40 cc Double Lumen
Intra-Aortic Balloon (IAB) IAB/Introducer Kits:
(a) 9 Fr. RediFurl DL IAB, 30cc/8" IAB/Introducer Kit, Catalog
No. 060-0230
(b) 9 Fr. RediFurl DL IAB, 30cc/11" IAB/Introducer Kit,
Catalog No. 060-0231
(c) 9 Fr. RediFurl DL IAB, 40cc/8" IAB/Introducer Kit, Catalog
No. 060-0232
(d) 9 Fr. RediFurl DL IAB, 40cc/11" IAB/Introducer Kit,
Catalog No. 060-0233
(e) 9 Fr. TaperSeal DL IAB, 30cc/8" IAB/Introducer Kit,
Catalog No. 030-0130
(f) 9 Fr. TaperSeal DL IAB, 30cc/11" IAB/Introducer Kit,
Catalog No. 030-0131
(g) 9 Fr. TaperSeal DL IAB, 40cc/8" IAB/Introducer Kit,
Catalog No. 030-0132
(h) 9 Fr. TaperSeal DL IAB, 40cc/11" IAB/Introducer Kit,
Catalog No. 030-0133. Recall #Z-543/550-2.
CODE Serial numbers (not inclusive):
(a) DL 1043-1092, EL 1001-1036, GL 1001-1015, HN 1002-1089, JL
1001-1168, LL 1001-1159;
(b) DL 1042-1100, EL 1009-1043, GL 1017-1018, HN 1004-1095, JL
1031-1181, LL 1006-1160;
(c) AD 1001-1160, BD 1002-1599, CD 1003-1491, DD 1001-1039, EE
1331, GD 1003-1179, HD 1006-1463;
(d) AD 1101-1199, BD 1008-1599, CD 1059-1500, DD 1044-1052, GD
1001-1198, HD 1001-1521;
(e) DN 1002-1038, EN 1003-1047, FN 1003-1117, GN 1013-1050, JN
1001-1038, KN 1005-1186;
(f) DN 1007-1030, EN 1005-1083, FN 1001-1114, JN 1041-1076, KN
1009-1187;
(g) CG 1007-1063, DE 1004-1298, EE 1002-1378, FE 1010-1692, GE
1083-1337, HE1005-1558;
(h) CG 1041-1161, DE 1001-21336, EE 1003-1377, EN 1038, FE
1001-1686, GE 1001-1379, HE 1003-1556.
MANUFACTURER St. Jude Medical, Inc., Cardiac Assist Division, Chelmsford,
Massachusetts.
RECALLED BY Manufacturer, by letter January 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Australia, Korea, New Zealand, Argentina.
QUANTITY 2,802 kits were distributed.
REASON The catheters may have internal diameters that will not allow
the catheter to be advanced over the supplied insertion
guidewire and through the balloon catheter.
PRODUCT Medtronic (a) 18K and (b) Buchbinder Omniflex Coronary Balloon
Dilatation Catheters, used during angioplasty. Recall
#Z-556/557-2.
CODE Model Lot Numbers
(a) 182020E 10821F1, 10826C1, 10903A1, 10906B1, 10909D1,
10927C1,
11018A1, 11024E1, 11104A1
18K2020 11114A1, 11119D1, 11122A1
18K2025E 10820F1, 10822B1, 10828B1, 10830C1, 10903D1,
10910C1,
10911F1, 11008E1, 11014B1, 11017C1, 11023E1,
11024A1,
11029F1, 11031A1, 11106A1, 11108A1, 11112F1,
18K2025 11115D1, 11118D1
18K2030E 10823C1, 10829E1, 10912B1, 10914A1, 11015B1,
11019A1,
11021D1, 11025A1, 11028C1, 11030D1, 11101C1,
11105C1,
11107B1, 11111C1, 11112G1, 11114D1
18K2035E 11010B1, 10904E1, 11022C1, 11026C1
CT18K2025E 11007C1
CT18K2030E 11007D1
CT18K2035E 10931D1
(b) 0002020 10807B1
0002025 11031C1
0002030 10830B1
0002035 10806A1.
MANUFACTURER Medtronic Interventional Vascular (MIV), San Diego, California.
RECALLED BY Manufacturer, by letter January 6, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,800 units were distributed.
REASON The sterility of the catheters may be compromised due to
defective pouch seals.
PRODUCT Brochure which accompanies the Jonicare Bipolar Balanced
Ionizer, an air cleaner which is used to remove positive ion
pollutants from the air. Recall #Z-574-2.
CODE All brochures.
MANUFACTURER Nion, Inc., Lexington, Kentucky (importer).
RECALLED BY Importer, by letter February 26, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION California, Florida, Illinois, Iowa, Kentucky, Maryland, New
York, Washington state, Wisconsin, Canada.
QUANTITY 25 units with accompanying brochures were distributed.
REASON The device has been marketed without a premarket approval
(PMA).
PRODUCT Cordis Hakim Valve Systems that may contain a specific
manufacturing lot of stainless steel right angle connectors,
sterile implantable devices which serve as a parallel flow
pathway to direct cerebrospinal fluid (CSF) from the cerebral
ventricles to an appropriate drainage site. Recall #Z-576-2.
CODE All lots packaged prior to October 1989 (lot numbers 21089001
and earlier for the following catalog numbers:
901-411, 951-101, 951-102, 881-056, 901-112, 901-122, 901-125,
901-142, 901-145, 901-162, 901-165, 901-182, 902-012, 902-045,
902-080, 902-125, 902-165, 902-525, 902-545, 902-580.
MANUFACTURER Cordis-Biot, Valbonne, France.
RECALLED BY Cordis Corporation, Miami Lakes, Florida, by letter January
31, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Brazil, Colombia, Argentina, Canada, The
Netherlands, Hong Kong.
QUANTITY 2,888 units were distributed; firm estimates 100 units remain
on the market.
REASON One of the implanted valves had to be explanted due to
increased intracranial pressure, and the right angle connector
was found to be fractured.
PRODUCT Giant Lumen and Sherpa brand Guiding Catheters. Recall
#Z-577/578-2.
CODE Model No. Lot No. Model No. Lot No.
(a) IM7021 14069 IM7021SH 14069
IM7027 14069 IM7028 14069
IM7032 14118 IM7033 14118
(b) IM7717 13989 IM7729 13954
IM7732SH 13954 IM7733SH 13967
IM7734 13987, 13988 IM7771SH 13966
IM7778 13987 IM7783 13965
IM8062SH 14311 IM8114 13941
IM8138SH 14311 IM8716 13972
IM8717 13985 IM8717SH 13924, 13925
IM8718 13972, 14026 IM8719 13852, 14050, 13951
IM8721SH 13974 IM8728 13901, 13963,
13970, 14008
IM8730 13974 IM8741 13974
IM8742SH 14008 IM8743 13974
IM8744SH 14026 IM8745SH 14048
IM8746 14077 IM8748 14050
IM8756SH 14050 IM8760 13892
IM8761 14077 IM8763SH 13963
IM8768SH 13963 IM8769SH 14050
IM8770 13892, 14040 IM8774SH 13984
IM8777 13970, 14026 IM877SH 13970
IM8783 14040 IM8786SH 13892
IM8838 13775 IM8839SH 13775
IM8843 13775 IM9001 14002
IM9715 14015 IM9715SH 13968
IM9728SH 14015 IM9741 13969
IM9770 13968 IM9778SH 13968, 13969, 14033
IM9780SH 14033 PA035 14168
PA036 14167, 14166 PA038 14166, 14167
14168 PA039 14166, 14168
PA040 14166, 14168 PA042 14167.
MANUFACTURER Medtronic Interventional Vascular, Inc., Danvers,
Massachusetts.
RECALLED BY Manufacturer, by letter February 12, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 648 catheters were distributed.
REASON The sterility of the devices may be compromised due to a void
in the package seal.
PRODUCT LDS 17000 Series Adult Heated Anesthesia Circuits:
1. LDS-17340 (20/case) and LDS-17340E (1/case) Single Limb,
40";
2. LDS-17360 (20/case) and LDS-17360E (1/case) Single Limb,
60";
3. LDS-17372 (20/case) and LDS-17372E (1/case) Single Limb,
72";
4. LDS-17440 (20/case) and LDS 17440E (1/case) Circle, Dual
Wire, 40";
5. LDS-17441 (20/case) and LDS-17441E (1/case) Circle, Dual
Wire,
40", 40" extension Filter Flex II;
6. LDS-17450 (20/case) and LDS-17450E (1/case) Circle, Dual
Wire, 40";
7. LDS-17460 (20/case) and LDS-17460E (1/case) Circle, Dual
Wire, 60";
8. LDS-17470 (20/case) and LDS-17470E (1/case) Circle, Single
Wire,
60";
9. LDS-17480 (15/case) and LDS-17480E (1/case) Circle, Dual
Wire, 80";
10. LDS-17490 (15/case) and LDS-17490E (1/case) Circle, Single
Wire,
72";
11. LDS-17499-108 (10/case) and LDS-17499-108 (1/case)
Ventilator
Single Wire, 72";
12. LDS-17630 (20/case) and LDS-17630E (1/case) Ventilator,
Dual Wire,
60";
13. LDS-17640 (20/case) and LDS-17640E (1/case) Ventilator
Single Wire,
60";
14. LDS-17641 (20/case) and LDS-17640E (1/case) Ventilator
Single Wire,
60" with 10" Nebulizer;
15. LDS-17642 (20/case) and LDS-17642E (1/case) Ventilator
Single Wire,
60" with 20" Nebulizer;
16. LDS-17648-271 (10/case) and LDS-17648-271E (1/case)
Ventilator
Single Wire, 60" with Low Flow Cannister, Filter Flex II;
17. LDS-17651 (20/case) and LDS-17651E (1/case) Ventilator
Single Wire,
60" with 10" Water Trap;
18. LDS-17652 (20/case) and LDS-17652E (1/case) Ventilator
Single Wire,
60" with 20" Water Trap;
19. LDS-17660 (20/case) and LDS-17660E (1/case) Ventilator
Dual Wire,
60";
20. LDS-17661 (20/case) and LDS-17661E (1/case) Ventilator
Dual Wire,
60" with 10" Nebulizer;
21. LDS-17730 (20/case) and LDS-17730E (1/case) Ventilator
Dual Wire,
72" with 20" Water Trap;
22. LDS-17740 (20/case) and LDS-17740E (1/case) Ventilator
Single Wire,
72";
23. LDS-17741 (15/case) and LDS-17741E (1/case) Ventilator
Single Wire,
72" with 10" Nebulizer;
24. LDS-17742 (15/case) and LDS-17742E (1/case) Ventilator
Single Wire,
72" with 20" Nebulizer;
25. LDS-17748-271 (10/case) and LDS-17748-271E (1/case)
Ventilator
Single Wire, 72" with Low Flow Cannister, Filter Flex II;
26. LDS-17751 (20/case) and LDS-17751E (1/case) Ventilator
Single Wire,
72" with 10" Water Trap;
27. LDS-17752 (20/case) and LDS-17752E (1/case) Ventilator
Single Wire,
72" with 20" Water Trap;
28. LDS-17760 (15/case) and LDS-17760E (1/case) Ventilator
Dual Wire,
72";
29. LDS-17761 (10/case) and LDS-17761E (1/case) Ventilator
Dual Wire,
72";
30. LDS-17764 (15/case) and LDS-17764E (1/case) Ventilator
Dual Wire,
72" with 2 Port Wye. Recall #Z-579/608-2.
CODE Lot numbers 136001 through 208000.
MANUFACTURER Life Design Systems, a Division of Bird Medical Technologies,
Inc., Carrollton, Texas.
RECALLED BY Manufacturer, by letter February 14, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 18,548 units were distributed.
REASON The corrugated plastic tubing of the heated wire circuits may
melt when used with Marquest SCT2000 or SCT3000 Humidifiers.
PRODUCT Transconjunctival Diathermy (TCD) Device, used in the
application of retinal detachment, retinal tears, retinopathy,
and hemostasis of hemorrhage prone vessels. Recall #Z-613-2.
CODE All codes to include:
T22 Jabbour Transconjunctival Electrode;
TR4070 Return path handle with switch and adult speculum;
TR4071 Return path handle with switch and pediatric speculum;
TR4060 Return path handle switchless, with adult speculum;
TR4061 Return path handle switchless, with pediatric speculum.
MANUFACTURER Mira, Inc., Waltham, Massachusetts.
RECALLED BY Manufacturer, by letter March 4, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Lebanon, Japan, Greece, Brazil, Argentina, Italy,
Hong Kong, Guam, England.
QUANTITY 12 units were distributed.
REASON Device has been marketed without an approved 510(k) Premarket
Notification.
PRODUCT Major Quality Single Use Syringe 1/2 cc, 28 g x 1/2"; Major
Quality Single Use Syringe 1 cc, 28 g x 1/2". Both products
are packaged in cellophane packets of 10 syringes per packet
which are packaged in boxes of 10 packets or 100 total
syringes per box. Recall #Z-614-2.
CODE Lot numbers: 910706 of the 1/2 cc syringes; 910428 of the 1
cc syringes.
MANUFACTURER Shina, Yoksamdong, Kangnamku, Seoul, Korea.
RECALLED BY Medicrat Division of Mediverse, Inc., St. Paul, Minnesota, by
FAX January 22, 1992, by telephone January 23, 1992 followed
by letter January 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Illinois, Kentucky, Florida, California, Michigan.
QUANTITY 2,085 boxes of lot 910428 and 5,675 boxes of lot 910706 were
distributed.
REASON Multiple syringe defects were found in the above lots.
PRODUCT Foot Pump, part of the Chick Model 703 Orthopedic Surgical
Operating Table. Recall #Z-617-2.
CODE Serial numbers: TBL1018, TBL1020, TBL1022, TBL1023, TBL1014,
TBL1021, TBL1016, TBL1019.
MANUFACTURER Midmark Corporation, Versailles, Ohio.
RECALLED BY Manufacturer, by telephone on or about March 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION California, Missouri, Montana, New Jersey, Ohio, Pennsylvania,
Tennessee, Washington state.
QUANTITY 9 units were distributed.
REASON The operating surface of the surgical table can descend
unexpectedly.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS III
PRODUCT Sterile Operating Room Towels, packed 12 towels per package.
Recall #Z-501-2.
CODE Reorder #712-B, lot #8475.
MANUFACTURER South Mountain Medical, Inc., Division Medical Action
Industries, Inc., Asheville, North Carolina.
RECALLED BY Manufacturer, by letter January 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Georgia, Texas, Arizona, Kentucky.
QUANTITY 300 cartons (6 packages per carton) were distributed.
REASON Openings in the seal of the sterile packages, which
compromises the sterility of the product.
PRODUCT Simplastin Excel - 300 Tests, an in-vitro diagnostic reagent
used in a modified one-stage prothrombin time test. Recall
#Z-553-2.
CODE Lot #101847 EXP 11/93.
MANUFACTURER Organon Teknika Corporation, Durham, North Carolina.
RECALLED BY Manufacturer, by letter dated December 4, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Mexico, Puerto Rico.
QUANTITY 4,241 units were distributed.
REASON Some packages of the product did not contain both the reagent
and diluent in correct combination.
PRODUCT Model PB100 Renaissance Spirometry System including a hand
held spirometer and a printer base station, a full pulmonary
function test device. Recall #Z-561-2.
CODE All units with version "A" software only.
MANUFACTURER Puritan-Bennett Corporation, Mervire, Galway, Ireland.
RECALLED BY Puritan-Bennett Corporation, Boston Division, Wilmington,
Massachusetts, by letter February 4, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 541 spirometers and 453 printer base stations were distributed.
REASON Due to software errors the %FEV1 (Forced Expiratory Volume in
1 sec) predicated value printed on the report will be
approximately 55% lower if Knudson's adult Standard Normals
are selected when testing a female either 18 or 19 years old;
the PEF (Peak Expiratory Flow) predicated value will read
approximately 6.75% lower if Hsu's Pediatric Standard Normals
are selected when testing a female under 18 years old; and the
spirometer will lock up (cease to function), requiring the
power to be turned off and then on to restart, under certain
conditions.
PRODUCT Beckman Protein Buffer, part #663600, an in-vitro diagnostic
intended for use with the Beckman Immuno-chemistry Systems and
reagents for the quantitative determinations of components in
biological fluids, in 2000 ml bottles. Recall #Z-609-2.
CODE Lot #L104031 EXP 3/93.
MANUFACTURER Beckman Instruments, Naguabo, Puerto Rico.
RECALLED BY Beckman Instruments, Brea, California, by letters September
11-12, 1991 and October 18, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Hong Kong, Japan, Taiwan, Korea, New
Zealand.
QUANTITY 1,216 units were distributed; FDA estimates that little, if
any, recalled product remains on the market.
REASON The pH varies from specification.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
PRODUCT Rite's Knee Paint, 950 ml, under the Lannett label; Dr. Rile's
Leg Paint, in 1 gallon containers, under the Lannett label.
Recall #V-029-2.
CODE Lot numbers: 25916 EXP 11/93, 25483 EXP 6/92 (knee paint);
25508 EXP 6/92 (leg paint).
MANUFACTURER Lannett Company, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letter November 20, 1991, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON Lack of assurance that the product was manufactured in
accordance with current good manufacturing practice
regulations.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Hewlett-Packard Transesophageal Transducers (TEE):
(a) Model 21362A, Single-Plane Transducer;
(b) Model 21362B, Single-Plane Transducer with Adapter;
(c) Model 21362C, Single-Plane Transducer Enabeling Steerable
CW (continuous wave) Doppler;
(d) Model 21363A, Biplane Transducer Enabling Both Transverse
and Longitudinal Views, and CW Doppler. Safety Alert
#M-039/042-2.
CODE All lots.
MANUFACTURER (a-c) Oldelft, Delft, Holland; (d) Echo Ultrasound,
Reedsville, Pennsylvania.
ALERTED BY Hewlett-Packard Company, Andover, Massachusetts, by letter
February 11, 1992.
DISTRIBUTION Nationwide, Canada, Europe, Asia, Latin America.
QUANTITY (a & b) 1,781 units; (c) 145 units; (d) 414 units were
distributed.
REASON During probe insertion, the transesophageal echocardiography
probe tip may double over and become temporarily lodged in the
patient's esophagus, which could cause the esophagus to be
scraped, perforated, or otherwise damaged.
DISPOSITIONS: PROSECUTIONS
DEFENDANT Vitarine Pharmaceuticals, Inc., Springfield Gardens, New York,
and
St. Croix, Virgin Islands.
CHARGES AND Vitarine, a manufacturer of generic drug products, has pleaded
DISPOSITION guilty to four counts of shipping adulterated drugs in
interstate commerce and has been fined $2,000,000. The drugs
were adulterated in that falsifications had been made by
corporate officers in applications to FDA for drug approvals
and in manufacturing process production records. Vitarine
cooperated fully in the investigation and voluntarily ceased
distribution of all involved drugs.
FILED April 13, 1992 - U.S. District Court for the District of
Maryland; Criminal #HAR-92-0117; FDC #65710.
DEFENDANT John W. Bushlow, former Vice President for Manufacturing and
General Manager of St. Croix, V.I. facility; Vitarine
Pharmaceuticals, Inc., Springfield Gardens, New York, and St.
Croix, Virgin Islands.
CHARGES AND Mr. Bushlow plead guilty to one count of fraudulent failure to
DISPOSITION establish and maintain records of drug manufacture, was
sentenced, and is presently serving a sentence of four months
in prison and four months in a halfway house, without parole.
FILED September 6, 1991 - plea; February 21, 1992 - sentencing; U.S.
District Court for the District of Maryland; Criminal
#HAR-91-0330, FDC #66528.
DEFENDANT Steven Colton, former Vice President and Director of Research
and Development, Vitarine Pharmaceuticals, Inc., Springfield
Gardens, New York, and St. Croix, Virgin Islands.
CHARGES AND Dr. Colton was convicted of three counts of providing false and
DISPOSITION fraudulent information to the Food and Drug Administration in
order to obtain approval of various Vitarine products. He is
currently serving a 27 month sentence without parole in a
federal prison.
FILED September 6, 1991 - sentencing; U.S. District Court for the
District of Maryland, Criminal #HAR-91-0125R, FDC #66529.
-15-
END OF ENFORCEMENT REPORT FOR APRIL 29, 1992: BLANK PAGES MAY
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