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
02/27/1990
FDA Enforcement for the week of February 28, 1990
FDA ENFORCEMENT REPORT
FOR FEBRUARY 28, 1990
February 28, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Angel Teresa Raw Clementines from Spain, in 22 pound
cartons. Recall #F-410-0.
Code: MARKS "Angel Teresa Hnos S.A. Puig-Valencia."
-1-
Manufacturer: Unifruiti of America, Philadelphia, Pennsylvania (importer).
Recalled by: Importer, by telephone December 11-12, 1989. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 5,825 cases (22 pounds/case) were distributed; firm estimates
none remains on market.
Reason: Product contains B-chlorfenvinphos, a pesticide compound
not permitted for use on clementines.
----
Product: Two pudding mix products (Preparado Para Pudim):
(a) Nabisco Boca Doce-Chocolate labeled Nabisco Brands
Portugal Comericio a Industria Lda;
(b) Micau Touchino Do Ceu (egg pudding mix) labeled Micau
S.A.R.L. 2675 Odivelas, Portugal. Recall #F-427/428-0.
Code: All lots/All day codes.
Manufacturer: Portugal-America Import & Export Company, Inc.,
Newark, New Jersey (importer/distributor).
Recalled by: Importer/distributor, by visit October and November
1989. Firm-initiated recall ongoing.
Distribution: New Jersey, Pennsylvania, New York, Connecticut.
Quantity: (a) 200 cases (36 packages/case); (b) 6 cartons of
6 x 6 x 18 packages were distributed.
Reason: Products contain nonpermitted Red No. 2 and undeclared
FD&C Yellow No. 5. Products also lack required labeling
in English.
----
Product: Ralston brand Fruit Muesli Cereal containing raisins,
peaches and pecans, in 13.5 ounce boxes. Recall #F-431-0.
Code: Y128S through Y147S, Y170T through Y175T, Y186U through
Y212U, Y213V through Y237V, Y261W through Y265W, Y282X
through Y286X, Y324Y through Y326Y, Y338Z.
Manufacturer: Ryt-Way Packaging Corporation, Northfield, Minnesota
(contract packager).
Recalled by: Ralston Purina Company, St. Louis, Missouri, by letter
January 22-23, 1990 followed by telephone and visit.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 229,705 cases (12 boxes/case) were distributed.
Reason: Product contains undeclared sulfites.
----
Product: Perrier Sparkling Water (mineral water), regular and
flavored, in glass and metal containers, all sizes
(23 ounces, 11 ounces and 6.5 ounces):
(a) Regular (Unflavored) Mineral Water;
(b) Berry Flavored Mineral Water;
(c) Lemon Flavored Mineral Water;
(d) Lime Flavored Mineral Water;
(e) Orange Flavored Mineral Water. Recall #F-432/436-0.
Code: All lots.
-2-
Manufacturer: Source Perrier, Paris, France (spring at Vergaza, France).
Recalled by: The Perrier Group (a holding company also known as The
Perrier Group of America, Greenwich, Connecticut, by
telephone February 9, 1990 followed by letter February 10,
1990. Firm-initiated recall ongoing. See also FDA talk
paper T90-11, February 9, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and U.S. territories.
Quantity: Firm estimates 0.5 million cases remain on market.
Reason: Product is contaminated with benzene.
----
Product: Kencraft/Ikes Candy Company brand Santa's Candy Canes,
packed 12 each in a cellophane wrapped retail display
carton: (a) Blueberry Flavor; (b) Pina Colada Flavor;
(c) Minted Chocolate Flavor; (d) Butterscotch Flavor;
(e) Peppermint Flavor; (f) Wintergreen Flavor.
Recall #F-437/442-0.
Code: Not coded -- All flavors listed are under recall.
Manufacturer: Kencraft/Ikes Candy Company, Salt Lake City, Utah.
Recalled by: Kencraft, Inc., Alpine, Utah, by letter January 31, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 7,176 cases (36 cartons/case) were distributed; firm
estimates less than 10 percent remains on market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Extra Crunchy Nu Nut Peanut Butter, in 80 ounce brown
plastic pail with orange lid. Recall #F-408-0.
Code: Oct 10, 1990.
Manufacturer: Golden Boy Foods, Burnaby, B.C., Canada.
Recalled by: Nalley's Fine Foods, Tacoma, Washington, by letter
January 10, 1990. Firm-initiated recall ongoing.
Distribution: California, Idaho, Oregon, Utah.
Quantity: 2,400 pails were distributed.
Reason: Product is contaminated with metal fragments.
----
Product: Flora brand Wine Vinegar, in 32 ounce glass bottles.
Recall #F-409-0.
Code: Not coded.
Manufacturer: DeNigris, Afragola, Italy.
Recalled by: Flora Distributors, Inc., Pompano Beach, Florida, by
letter January 5, 1990. Firm-initiated recall ongoing.
-3-
Distribution: Florida.
Quantity: 7,908 cases (12 bottles/case) were distributed; firm
estimates less than 5 percent remains on market.
Reason: Product contains undeclared sulfites.
----
Product: De Choix brand Spanish Sherry-Wine Vinegar, in 750 ml.
glass bottles. Recall #F-430-0.
Code: All lots.
Manufacturer: Palomino & Vergara, Jerez, Spain.
Recalled by: De Choix Specialty Foods Company, Division of Amazon Coffee
& Tea Company, Inc., Woodside, New York (importer/
distributor), by letter December 29, 1989. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: Approximately 80,000 bottles were distributed; firm
estimates 1,500 bottles remain on market.
Reason: Product contains undeclared sulfites.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Zimmer Arthroscopy Systems Sterile Hose, components used
to extend the hookup of the ATS (Automatic Tourniquet
System) 1500 or ATS 500 and the tourniquet cuff,
(a) Single Hose; (b) Dual Hose. Recall #Z-409/410-0.
Code: Catalog No. Lot No.
(a) 60-4009-001 A098941;
(b) 60-1812-001 A098933.
Manufacturer: Zimmer Arthroscopy Systems, Englewood, Colorado.
Recalled by: Manufacturer, by letter December 21, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Sweden, France.
Quantity: (a) 44 cases; (b) 25 cases (20 units/case) were distributed.
Reason: The luer connections do not effect an air tight seal.
----
-4-
Product: Puritan-Bennett T15000 Companion 2800 Portable Ventilator,
220 Volt Model, used to provide support for ventilator
dependent patients in both the hospital and home care
settings. Recall #Z-411-0.
Code: Serial numbers: 4115, 4116, 4117, 4205, 4206, 4207, 4208,
4390, 4392.
Manufacturer: Precision Power Systems, Inc., Longmont, Colorado
(component).
Recalled by: Puritan-Bennett, Boulder, Colorado, by telefax
January 22, 1990. Firm-initiated recall ongoing.
Distribution: Canada, United Kingdom, Spain, Italy.
Quantity: 9 units were distributed.
Reason: The device had a transformer with an incompletely cured
varnish coating.
----
Product: Cobe Oxygen Filter (Stand Alone):
(a) COBE Oxygen Filters (Stand-Alone),
(b) COBE Perfusion Packs;
(c) COBE CML Packs. Recall #Z-412/414-0.
Code: Catalog Nos. Lot Nos.
(a) 029029000 09T0436, 11T0214, 11T0313, 12T0148,
12T0204;
(b) 020366012 09T0026, 10T0025, 11T0325, 12T0355
020384016 11T0317
020401010 09T0412
020401016 12T0326
020428114 10T0393
020428115 12T0281, 12T0362, 12T0441;
020430108 10T0130, 12T0241, 12T0393
020440105 10T0109, 12T0278
020444107 11T0115
020520106 09T0051, 10T0164, 10T0394
020529107 10T0351
020545004 01U0048, 09T0143, 11T0017, 11T0219,
12T0317
020547105 01U0167
020586003 11T0318, 12T0367
020614106 01U0028, 12T0262, 12T0472
020631004 12T0237
020656008 11T0052
020656106 11T0037, 12T0257, 12T0373
020661104 11T0338
020671108 11T0160, 11T0161
020678002 11T0031, 12T0219
020693108 11T0053
020725103 11T0066, 12T0363
020736005 11T0111
020745103 11T0054, 11T0278, 12T0158, 12T0477
020773101 12T0251
020808106 11T0162
020811104 11T0191
-5-
020816106 11T0299, 12T0248
020816107 12T0382
020900109 12T0127
020900110 12T0466
020935007 09T0424
020935008 10T0317
020935009 11T0072, 12T0259
020940004 01U0096
020962101 11T0229
020994101 11T0116
021783031 12T0292
024389015 12T0254, 12T0376
024393011 01U0232
024421015 01U0001, 12T0234
024482022 10T0172
024515010 10T0095, 12T0239
025209402 12T0498
025222402 12T0329
025237408 10T0093, 12T0151, 12T0178
025238402 12T0481
025246403 12T0482
025262402 12T0411
025263402 12T0410
026233012 11T0310
026965012 09T0341, 11T0314, 12T0371
027105204 10T0207, 12T0265
028453020 11T0081, 12T0252, 12T0380
028523028 12T0005, 12T0335, 12T0349
028565015 11T0336
028565016 12T0245, 12T0388
020072203 12T0223
020116105 10T0153, 10T0115, 12T0356
020139203 11T0178, 12T0097
020150107 11T0258, 12T0401
020151106 10T0271, 12T0392
020188203 11T0138
020197102 12T0499
020214204 10T0228
020236106 09T0086, 10T0081, 12T0273
020253107 11T0255, 11T0328, 12T0351
020254113 10T0123
020254114 11T0164
020257205 10T0284, 11T0277
020257206 12T0190
020266105 12T0244, 12T0389
020275012 10T0131, 10T0227, 12T0091, 12T0231
020289103 12T0122
020290007 11T00320, 12T0365
020303202 10T0411
020303203 12T0008
020304202 10T0412
020322006 01U0003, 09T0282, 11T0036
-6-
020337201 11T0288, 12T0408
020354109 10T0011, 10T0083, 12T0242, 12T0390
020355018 11T0080, 12T0353
020356003 11T0167
020358004 11T0061
020361004 11T0172
020361109 09T0139, 10T0374
(c) 032471004 10T0391
032472002 10T0392
032523006 12T0275A
032531004 09T0428, 10T0342, 11T0136, 12T0138
032532005 12T0013
032544002 11T0224, 11T0255
050547105 12T0425
(NOTE: Lot numbers assigned by the manufacturer/vendor of
the oxygen filter are 20071989 and 20102089.)
Manufacturer: Cobe Laboratories, Inc., Arvada, Colorado.
Recalled by: Manufacturer, by telephone January 15, 1990 with follow-up
letter January 16, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, United Kingdom.
Quantity: (a) 905, (b) 6,106; (c) 282 units were distributed.
Reason: Devices may have partially or totally occluded ports.
----
Product: Marquest nonconductive disposable anesthesia circuits
(adults): (a) Product Codes GS 321 LV and GS 321 SC - For
Gas and/or Temperature Monitors;
(b) Product Codes GI 321T and GI 327T - Internal Gas
Sampling. Recall #Z-415/416-0.
Code: Lot numbers: 22374, 22235, 23695, 21946, 23403, 26049.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by telephone May 10, 1989. Firm-
initiated recall complete.
Distribution: Massachusetts, Maryland, California.
Quantity: Approximately 364 cases (20 units/case) were distributed.
Reason: The gas sampling line was occluded at the luer connector.
----
Product: 3M brand Heyman Afterloading Source (or applicator),
a Cesium (CS)-137 radiation source routinely used for
the treatment of endometrial cancer. Recall #Z-419-0.
Code: All serial numbers.
Manufacturer: Medical Device Division, 3M Health Care, New Brighton,
Minnesota.
Recalled by: Medical Device Division, 3M Health Care, St. Paul,
Minnesota, by letter January 15, 1990 followed by
telephone February 1, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Italy, Mexico.
Quantity: 1,287 units were distributed.
-7-
Reason: The Cesium-137 source capsules have separated from the
guidewire handle.
----
Class III -
Product: Fenestrated Sterile Field Drape, size 18 inches x 26 inches,
item #70-606N. Recall #Z-408-0.
Code: 30281 S, 30581 S, 30681 S.
Manufacturer: Graham Medical Products, Holyoke, Massachusetts.
Recalled by: Graham Medical Products, Division of Little Rapids
Corporation, Green Bay, Wisconsin, by letter January 8, 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 242 cases (300 drapes/case) were distributed.
Reason: The pouch labeling did not indicate that the product is
fenestrated.
----
Product: Eskalab-ECS Cal Set Calibrator, for use with the Na+
K+ Module of the Eskalab-ECS, an in-vitro diagnostic
product. Recall #Z-417-0.
Code: Product #33120 (boxes), #33130 (cases); lot numbers:
M 812037 EXP 30 JUN 90, M 901133 EXP 31 JUL 90.
Manufacturer: Smithkline Diagnostics, Inc., Carlsbad, California.
Recalled by: Smithkline Diagnostics, Inc., San Jose, California, by
telephone June 13, 1989. Firm-initiated recall complete.
Distribution: Nationwide, Puerto Rico.
Quantity: 58 cases of lot M812037 and 13 cases of lot M901133 were
distributed.
Reason: The vials may leak during shipment or storage due to
inconsistent hand tightening of the cap on the bottle,
resulting in vials being short filled.
----
Product: Beckman CX Multi Calibrator, Part #442600, an in-vitro
diagnostic product. Recall #Z-418-0.
Code: Part #442600, lot numbers: M903010 EXP 10/90,
M905078 EXP 12/90.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
letter December 18, 1989. Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: 1,620 units were distributed.
Reason: The calibrator lost phosphorus activity, which may have
resulted in incorrect elevated phosphorus patient values.
----
-8-
Product: Myocardial Temperature Probes, used with the Shiley
Temperature Monitor to monitor the temperature of the
heart during surgery: (a) Model DPM with 15 mm needle;
(b) Model DPML with 30 mm needle. Recall #Z-420/421-0.
Code: Lot numbers: (a) 8901043900 and below;
(b) 8901014900 and below.
Manufacturer: Shiley, Inc., Irvine, California.
Recalled by: Manufacturer, by letter November 28, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 174,376 units were distributed.
Reason: The probe's needle may separate from its hub.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Pioneer brand Medicated Pig Starter, in 50 pound
bags. Recall #V-031-0.
Code: 037-89, 083-89, 097-89, 136-89, 193-89, 242-89, 341-89.
Manufacturer: Burdic Feed, Inc., Kent, Washington.
Recalled by: Manufacturer, by telephone January 18, 1990. Firm-
initiated recall ongoing.
Distribution: Idaho, Washington state.
Quantity: 449 bags were distributed.
Reason: The product was found to be grossly deficient in
sulfamethazine, chlortetracycline and penicillin. In
addition, all lots manufactured between March 24, 1989 and
December 7, 1989, were labeled to contain sulfamethazine when
they actually contained sulfathiazole.
----
Class III -
NONE