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
05/27/1992
RECALLS AND FIELD CORRECTIONS: MAY 27, 1992
FOODS -- CLASS I
92-22
PRODUCT Maplenut Ice Cream, in 1/2 gallon brick style cartons. Recall
#F-300-2.
CODE All lots.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letters of March 13 and 25, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio, Maryland.
QUANTITY Approximately 100 cases (2 units/carton) were distributed.
REASON Product contains undeclared peanuts.
PRODUCT Various chocolate flavored ice cream and ice milk products,
packaged in pint cartons, 8 per case; half-gallon round
cardboard cartons, 6 per case; and 3 gallon bulk containers:
(a) Chocolate Ice Cream, under Breyers, Albertsons and Knudsen
labels;
(b) Neapolitan Ice Cream, under Breyers, Albertsons, Knudsen
and Stater Bros. Markets labels;
(c) Heavenly Hash Ice Cream, under Albertsons label;
(d) Chocolate Chip Ice Cream, under Breyers label;
(e) Rocky Road Ice Cream, under Knudsen and Stater Bros.
Markets labels;
(f) Rocky Road with Marshmallow Sauce and Walnuts Ice Cream,
under Albertsons label;
(g) Mocha Almond Fudge Ice Cream, under Stater Bros. Markets
label;
(h) Nice "N" Light Chocolate Ice Milk, under Knudsen label;
(i) Nice "N" Light Neapolitan Ice Milk, under Knudsen label;
(j) Nice "N" Light Rocky Road Ice Milk, under Knudsen label.
Recall #F-302/311-2.
CODE Lot numbers: (a) 13JUN92, 28SEP92, 13JUN92 (Bryers); 10JAN93,
20DEC92 (Albertsons); 13AUG92 (Knudsen);
(b) 28SEP92, 22AUG92 (Breyers); 02DEC92, 24DEC92, 19SEP92
(Albertsons); 24DEC92, 08AUG92 (Knudsen); 09JUL92, 16JUL92,
08JAN93, 13DEC92, 08AUG92, 02DEC92, 10JUL92 (Stater Bros.
Markets);
(c) 28MAY92, 09JAN93; (d) 28SEP92, 13JUN92; (e) 12AUG92,
07JAN93, (Knudsen); 16JUL92, 27DEC92, 18JUN92, 28MAY92 (Stater
Bros. Markets); (f) 12JUN92, 16SEP92, 26DEC92; (g) 02JUL92,
03JUL92; (h) 11JUN92, 25DEC92; (i) 24DEC92; (j) 23DEC92.
MANUFACTURER Kraft General Foods, Inc., Los Angeles, California.
RECALLED BY Kraft General Foods, Inc., Glenview, Illinois, by letter April
21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Arizona, California, Colorado, Hawaii, Idaho, New
Mexico, Nevada, Oklahoma, Oregon, Montana, Texas, Utah,
Washington state, Wyoming.
QUANTITY 63,463 cases were distributed; firm estimates that 33 percent
of the product remains on the market.
REASON Products contain undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Dicyclomine HCl Capsules, USP, 10 mg, in bottles of 100 and
1,000, an Rx antispasmodic. Recall #D-352-2.
CODE Lot #0A128FH EXP 2/94.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter dated May
7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 22,583 bottles of 100 and 1,435 bottles of 1,000
capsules were distributed.
REASON Subpotency.
PRODUCT Hydrogen Peroxide Solution USP 3%, packed in 16 fluid ounce
brown plastic bottles, may be used as a mouthwash or as a
gargle, under the following labels: Albertson's, Dominick's,
Marquee, May's and Medical Center. Recall #D-353-2.
CODE Lot #2041BD1.
MANUFACTURER Hunt Products Company, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letter dated April 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, Pennsylvania, Missouri, Tennessee, Texas.
QUANTITY 1,134 cases (12 bottles per case) were distributed.
-2-
REASON Presence of trace quantities of isopropyl alcohol.
PRODUCT Promotional Pamphlets for Pro-Woman brand All-Natural
Multivitamin and Multimineral Supplements. Pamphlets are
titled "PMS: Understanding and Dealing with Premenstrual
Syndrome" and "Pro-Woman Natural Vitamin-Mineral-Supplement
Winning the Monthly Battle." Recall #D-354-2.
CODE All copies distributed.
MANUFACTURER Biokin Company, Inc., Arlington, Texas (distributor).
RECALLED BY Distributor, by letter October 1, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON Promotional material serves to misbrand the product.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets. Recall #B-288-2.
CODE Units numbers: 07J49087, 07J49088, 07J49093, 07J49094,
07J49098, 07J49103, 07J49015, 07J49111.
MANUFACTURER American Red Cross Blood Services, Tucson, Arizona.
RECALLED BY Consignee notified firm by telephone May 18, 1991 and follow-up
letter May 31, 1991. Recall complete.
DISTRIBUTION Arizona.
QUANTITY 8 units.
REASON Blood products labeled with incorrect expiration date were
distributed.
PRODUCT Red Blood Cells. Recall #B-296-2.
CODE Unit #J16947.
MANUFACTURER Texoma Regional Blood Center, Sherman, Texas.
RECALLED BY Consignee notified firm by telephone November 7, 1991. Recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to hepatitis B core antigen (Anti-HBc), was
distributed.
PRODUCT Platelets, Pheresis. Recall #B-297-2.
CODE Unit #7798070.
MANUFACTURER The Blood Center for Southeast Louisiana (BCSL), New Orleans,
Louisiana.
RECALLED BY Consignee notified firm by telephone December 5, 1991. Recall
complete.
DISTRIBUTION Louisiana.
QUANTITY 1 unit.
-3-
REASON Blood product labeled with the incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Diagnostic X-Ray Control Generators, Models MS 325 and MS 525,
control console used to control the supply of electrical energy
to the x-ray tube. Recall #Z-460/461-2.
CODE All of the manuals for this device.
MANUFACTURER Control X, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter March 4, 1992. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide, Canary Islands, Zimvablov, Israel, Canada.
QUANTITY 35 units were distributed.
REASON Noncompliance with the performance standard for x-ray products
in that the instruction manual for these devices list the
coefficient of variation for linearity and reproductibility as
greater than 0.05.
PRODUCT Clinac Medical Linear Accelerators with Accessory Mounts:
(a) CL 2100; (b) CL 1800; (c) CL 2500; (d) CL 6/100;
(e) CL 4/100; (f) CL 600C; (g) CL 18; (h) CL 20; (i) CL 12/10.
Recall #Z-474/482-2.
CODE Serial numbers: (a) 1-60; (b) 1-234; (c) 2-31; (d) 1 417;
(e) 1-77; (f) 1-3; (g) 1-169, 901, 905-908;
(h) 1-72, 324; (i) 1-10.
MANUFACTURER Varian Associates, Inc., Palo Alto, California.
RECALLED BY Manufacturer, by Service Technical Bulletin, July 29, 1991.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, International.
QUANTITY 1,078 units were distributed.
REASON Accessories can fall out of the accessory mount as the "safety
notch tends to deform and fail".
PRODUCT Puritan-Bennett 7200 Series Microprocessor Ventilator, used for
the delivery of volumes of gas to patients dependent on
artificial respiration. Recall #Z-484-2.
CODE All models and all serial numbers ventilators shipped from
4/23/83 to 1/10/92.
MANUFACTURER Puritan Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by letter dated January 10, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe.
QUANTITY 20,416 units were distributed.
REASON A design problem may cause the error code 9905 indicating
"failed pressure transducer" to be generated during weather
conditions that exhibit high atmospheric pressure. This will
cause the device to stop ventilating and alarms will sound.
-4-
PRODUCT Fixed Wing Huber Needle Set, a non-coring needle administration
set with a "Y" site, 19 ga, 20 ga, and 22 ga and two needle
lengths (3/4 inch and 1 inch). Recall #Z-485-2.
CODE Lot numbers: 1A161, 1A191, 1A211.
MANUFACTURER Nipro Medical Industries, Ltd., Tatebayashi, Gumma, Japan.
RECALLED BY ACB Medical Suppliers, Inc., Medina, New York, by telephone
April 3, 1992, followed by letter April 21, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Canada.
QUANTITY 19,200 units were distributed.
REASON Cannula separation can occur.
PRODUCT Huber Infusion Set, Fixed Wing, with non-coring, 90 degree bend
needle, used in the treatment of cancer: Product Codes --
(a) 26940; (b) 26941; (c) 26944; (d) 26945; (e) 26946;
(f) 26948; (g) 26949; (h) 26950. Recall #Z-486/493-2.
CODE Lot numbers: 91A21, 91B19, 91B28, 91D22, 91D29, 91D18, 91E07,
91B25, 91B13.
MANUFACTURER Nissho Corporation, Osaka, Japan.
RECALLED BY Excel International, Inc., Culver City, California, by letter
April 9, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 52,450 sets were distributed.
REASON Cannula separation can occur.
PRODUCT Bard Cardiopulmonary division/TMP brand Extracorporeal Tube
Packs, Rx, sterile, single-use, custom perfusion tubing pack
used in heart bypass surgery:
(a) Catalog #401284-I; (b) Catalog #H-3767-H;
(c) Catalog #H-3792-H; (d) Catalog #H-7049-B;
(e) Catalog #H-7312-E;
CODE Lot numbers: (a) 28IBX154; (b) 28IBX165; (c) H 28IBX202;
(d) 28IBX167; (e) 28HBX162. Recall #Z-494/498-2.
MANUFACTURER Surgimedics, Inc./TMP, The Woodlands, Texas.
RECALLED BY Manufacturer, by memorandum October 29, 1991. Firm-initiated
recall complete.
DISTRIBUTION California, Kentucky.
QUANTITY None. Unknown.
REASON The sterility of the devices may be compromised due to
defective seals.
PRODUCT Vista 0.5T Magnetic Resonance Imaging Systems equipped with
surface coil interface boxes. Recall #Z-499-2.
CODE MFE, MF1, MF3-13, MF16, MF19, MF22-25, MF27-44, MBI-11,
MB13-17, MF20, MB12.
MANUFACTURER Picker International, Inc., Solon, Ohio.
RECALLED BY Picker International, Inc., Highland Heights, Ohio.
Firm-initiated recall ongoing.
-5-
DISTRIBUTION Nationwide and international.
QUANTITY 74 units were distributed.
REASON During MRI scanning induced currents may be generated in
surface coil connectors or the interface box, causing heating
of the component which may result in burns to patients.
PRODUCT Bard Electrophysiology Intracardiac Electrode Catheters, used
for intracardiac procedures:
(a) Catalog No. 200056, 5F; 1 cm; Cournand;
(b) Catalog No. 200060, 5F; 5 mm; Josephson;
(c) Catalog No. 200150, 4F; 2, 5, 2 mm; Cournand;
(d) Catalog No. 200151, 4F; 2, 5, 2 mm; Josephson;
(e) Catalog No. 200152, 4F; 1 mm; Cournand;
(f) Catalog No. 200153, 4F; 1 mm; Josephson;
(g) Catalog No. 200472, 6F; 2 mm; Cournand;
(h) Catalog No. 200473, 6F; 2 mm; Josephson.
Recall #Z-646/653-2.
CODE Lot numbers: (a) 27AC0064, 27JB6687, 27CC0102;
(b) 27HB9183, 27KB0654, 27AC0065, 27JB7481;
(c) 27HB3800, 27HB9770, 27AC0069;
(d) 27IB9599, 27AC0076; (e) 27AC0077;
(f) 27LB0114, 27AC0078; (g) 27AC0039, 27BC0047, 27CC0096;
(h) 27AC0040, 27BC0048.
MANUFACTURER Bard Ventures Division, Bard Electrophysiology, C.R. Bard,
Inc., Billerica, Massachusetts.
RECALLED BY Bard Ventures Division, Bard Electrophysiology, C.R. Bard,
Inc., Tewksbury, Massachusetts, by letter April 3, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Ireland, France.
QUANTITY Approximately 437 units were distributed.
REASON The electrode pin cable assembly was incorrectly labeled, in
that the electrode pairs labeled as 1, 2, 3, 4 are actually 3,
4, 1, 2 respectively.
PRODUCT 10F Judkins Left Coronary Guiding Catheters, used for guiding
and supporting the DVI Simpson Coronary Atherocath Catheters
utilized in percutaneous transluminal coronary atherectomy, and
for guiding and supporting commercial percutaneous coronary
angioplasty dilation catheters. Recall #Z-654-2.
CODE Catalog Nos. Lot Nos.
GC-1080-JL4.0SH 120151
GC-1080-JL4.5SH 120221
GC-1080-JLGRFSH 120081.
MANUFACTURER Devices for Vascular Intervention, Inc., Temecula, California.
RECALLED BY Devices for Vascular Intervention, Inc., Redwood City,
California, by letter February 20, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 7,095 units were distributed.
-6-
REASON Observed kinks or indentions on the inside curve of the guiding
catheter, near the side holes may prevent the advancement of
the atherectomy catheter through the guiding catheter.
PRODUCT 11F Judkins Left 4.0 Coronary Guiding Catheter, used for
guiding and supporting the DVI Simpson Coronary Atherocath
Catheters utilized in percutaneous transluminal coronary
atherectomy, and for guiding and supporting commercial
percutaneous coronary angioplasty dilation catheters. Recall
#Z-699-2.
CODE Catalog #CG-1190-JL4.OSH, lot numbers 112881, 113112.
MANUFACTURER Devices for Vascular Intervention, Inc., Temecula, California.
RECALLED BY Devices for Vascular Intervention, Inc., Redwood City,
California, by visit and by letter January 2, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 125 units were distributed.
REASON There is circumferential urethane cracking in the tip shape on
the inner radius of the distal, curved portion and brittle
bending behavior of the catheter.
UPDATE Corpak Bower PEG Feeding with Internal Retention Balloon with
Elastic Foam, Recall #Z-622/625-2 which appeared in the May 6,
1992 Enforcement Report should read:
CODE: Any lots produced after A48BA, A03BP, A01BH, A07BD
respectively, are not affected. Lots affected are:
(a) Reorder #30-5020, lot nos. A01BA through A48BA
(b) Reorder #30-4020, lot nos. A01BP through A03BP
(c) Reorder #30-6020, lot nos. A01BH
(d) Reorder #30-5520, lot nos. A01BD through A07BD.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT CKMB Isoenzyme Control (Human), a calibration control for an
in-vitro immunoinhibition test for the Creatine Kinase
isoenzyme specific to human heart muscle. Recall #Z-698-2.
CODE Catalog #102-S, lot #1004S.
MANUFACTURER Cala Diagnostics, Los Osos, California.
RECALLED BY Manufacturer, by letter July 18, 1991, followed by telephone.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,564 kits were distributed.
REASON Portions of the precautionary statements were omitted from the
package insert.
-7-
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Alukart Hemoperfusion Cartridge Devices, used in dialysis:
(a) Alukart Hemoperfusion Cartridge Device, Catalog #01-6003-6;
(b) HemoKart Hemoperfusion Cartridge Device, Catalog #01-6004-4;
(c) HemoKart Ped (Pediatric) Hemoperfusion Cartridge Device,
Catalog #01-6006-9. Safety Alert #M-054/056-2.
CODE All lots.
MANUFACTURER National Medical Care, Rockleigh, New Jersey.
ALERTED BY Manufacturer, by letter February 27, 1992.
DISTRIBUTION Unknown.
QUANTITY Unknown.
REASON Devices may contain an ether residue.
SEIZURES:
PRODUCT CMPK Injection (91-624-693/694).
CHARGES Misbranded - The product is a veterinary prescription drug that
does not bear the required prescription legend, "Caution:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian." The product's label also fails to bear
adequate directions for use since it fails to indicate all the
conditions and purposes for which the drug is intended.
FIRM Turlock Dairy Supply, Turlock, California.
FILED January 29, 1992 - U.S. District Court for the Eastern District
of California; Civil #CV F92 5050REC, FDC #66330.
SEIZED February 5, 1992 - veterinary drugs, valued at approximately
$1,160.
PRODUCT Caldex CMPK Injection (91-625-203).
CHARGE Misbranded - The product is a veterinary
prescription drug that does not bear the required
prescription legend, "Caution: Federal law
restricts this drug to use by or on the order of a
licensed veterinarian."
FIRM Veterinary Pharmaceuticals, Inc., Hanford, California.
FILED December 19, 1991 - U.S. District Court for the Eastern
District of California; Civil #CV F-91-285, FDC #66267.
SEIZED December 19, 1991 - veterinary drugs, valued at approximately
$3,550.
PRODUCT Oxygen, USP (92-619-154).
CHARGE Adulterated - The methods used in, and the facilities or
controls used for, their manufacture, processing, packing, and
holding do not conform to and are not operated and administered
in conformity with current good manufacturing practice
regulations.
FIRM Atlantic Sales and Repair, Myrtle Beach, South Carolina.
FILED March 25, 1992 - U.S. District Court for the District of South
Carolina, Florence Division; Civil #4-92-0888-21, FDC #66368.
-8-
SEIZED May 13, 1992 - oxygen, in cylinders, valued at approximately
$1,600.
PRODUCT Oxygen, USP (92-632-250).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, their processing, packing, and holding do
not conform to and are not operated and administered in
conformity with current good manufacturing practice regulations.
FIRM Concept Care Services, Inc., Trenton, New Jersey.
FILED April 29, 1992 - U.S. District Court for the District of New
Jersey; Civil #92-1831, FDC #66417.
SEIZED May 12, 1992 - bulk oxygen, and filled and empty liquid and
gaseous oxygen cylinders, valued at approximately $40,000.
PRODUCT "Sea-Band" accupressure wristbands (92-609-775).
CHARGE Adulterated - The products are class III devices which do not
have in effect the required approved premarket approval
application.
Misbranded - The labeling fails to bear adequate directions for
use for the purposes for which the products are intended
because adequate directions cannot be written for such
purposes. In addition, a premarket notification covering the
device was not filed as required by regulation.
FIRM Sportsman's Market, Inc., Batavia, Ohio.
FILED May 11, 1992 - U.S. District Court for the Southern District of
Ohio, Western Division; Civil #C-1-92-397, FDC #66422.
SEIZED May 14, 1992 - "Sea-Band" accupressure wristbands, valued at
approximately $5,500.
PRODUCT Sensor Pad, a round latex rubber bladder that contains
silicone, a medical grade lubricant, and is sold
over-the-counter for use as an aid in performing breast
self-examination (92-673-358).
CHARGE The sensor pad is a class III medical device which does not
have in effect the required approved premarket approval
application.
FIRM Inventive Products, Incorporated, Decatur, Illinois; and Health
Services Medical Corporation, Baldwinsville, New York.
FILED May 5, 1992 - U.S. District Court for the Northern District of
New York, Civil # 92-CV-581, FDC #66420.
SEIZED May 13, 1992 - sensor pads, valued at $1,000.
MASS SEIZURE:
PRODUCT Cervical Dilators (91-612-926).
FIRM Gynotech, Inc., Middlesex, New Jersey.
-9-
CHARGE Adulterated - The products are class III devices which do not
have in effect the required approved premarket approval
application for the devices, and for any subsequent change
affecting the safety or effectiveness of the devices. In
addition, the methods used in, and the facilities and controls
used for, their manufacture, packing, and storage are not in
conformity with current good manufacturing practice regulations.
Misbranded - The labeling fails to bear adequate directions for
use; and, information required by the Medical Device Reporting
regulation was not submitted.
FILED May 11, 1992 - U.S. District Court for the District of New
Jersey; Civ # 91-1894(DRD), FDC #66325.
SEIZED May 12, 1992 - cervical dilators and in-process raw materials,
valued at approximately $1,800,000.
-10-
END OF ENFORCEMENT REPORT FOR MAY 27, 1992. BLANK PAGES MAY FOLLOW.
###