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
03/29/1995
Recalls and Field Corrections: Foods -- Class I -- 03/29/1995
March 29, 1995 95-13
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Various Potato Salads, pasta salads and cole slaws:
Country Maid American Potato Salad, 10 lbs. and 2 x 5 lbs.
Country Maid Golden American Potato Salad, 16 oz., 3 lbs., 5
lbs., 2 x 5 lbs. and 10 lbs.
Country Maid German Potato Salad, 16 oz. and 10 lbs.
Country Maid French Potato Salad, 10 lbs.
Country Maid Creamy Bacon Potato Salad, 10 lbs.
Country Maid Zesty Potato Salad, 10 lbs.
Country Maid Golden Classic Potato Salad, 10 lbs.
Country Maid Sour Cream & Dill Red Potato Salad, 5 lbs.
Country Maid Creamy Chopped Cole Slaw, 14 oz. and 10 lbs.
Country Maid Creamy Shredded Cole Slaw, 10 lbs.
Country Maid Sweet and Sour Cole Slaw, 10 lbs.
Country Maid Macaroni Salad, 16 oz. and 10 lbs.
Country Maid Creamy Pasta Salad, 10 lbs.
Country Maid Gourmet Salad Base, 10 lbs.
Country Maid Vegetable Pasta Base, 10 lbs.
Country Maid Pasta Lite Salad, 16 oz. and 10 lbs.
Country Maid Mostaccholi Salad, 5 lbs.
Country Maid Pasta Florentine Salad, 5 lbs.
Products listing Mega Food Center, Oak Creek, WI as the
responsible firm:
Pick 'n Save American Potato Salad, 16 oz.
Pick 'n Save German Potato Salad, 16 oz.
Pick 'n Save Creamy Chopped Cole Slaw, 14 oz.
Pick 'n Save Macaroni Salad, 16 oz.
Products listing Piggly Wiggly, Sheboygan, WI as the firm
the products are manufactured for:
Piggly Wiggly Classic Potato Salad, 16 oz.
German Potato Salad, 16 oz.
Golden American Potato Salad, 16 oz.
Creamy Chopped Cole Slaw, 14 oz.
Macaroni Salad, 16 oz.
Products listing Fleming Companies, Waukesha, WI as the
responsible firm:
Homestyle American Egg Potato Salad, 10 lbs.
Homestyle German Potato Salad, 10 lbs.
Homestyle Macaroni Salad, 10 lbs.
Products listing Meurer Food Service, West Allis, WI as the
distributor:
French Potato Salad, 10 lbs.
Meurer German Style Potato Salad, 10 lbs.
Gourmet Red Potato Salad, 5 lbs.
Traditional American Potato Salad, 10 lbs.
Meurer Homestyle Cole Slaw, 10 lbs.
Meurer Creamy Macaroni Salad, 10 lbs.
Golden American Potato Salad, 5 lbs., manufactured for
Village Pantry, Richmond, IN. Recall #F-531/567-5.
CODE Sell by dates of 2/6/95 or earlier.
MANUFACTURER Country Maid, Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone on December 30, 1994, and January
4, 1995, followed by letter sent on January 9, 1995. Firm-
initiated recall complete. Wisconsin Department of
Agriculture issued press release January 3, 1995.
DISTRIBUTION Illinois, Indiana, Iowa, Minnesota, Wisconsin.
QUANTITY The amounts of the products on the market at time of recall
initiation: 85,000 pounds of potato salads; 20,000 pounds
of cole slaw; (c) 20,000 pounds of pasta salads.
REASON The products are contaminated with Listeria monocytogenes or
were manufactured under conditions in which they may have
been contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Publix Instant Oatmeal Variety Pack, 10 packets per box.
Recall #F-525-5.
CODE Case code - 8777 with pack date of 12/2/94 and the code on
individual variety pack boxes is 8/29/95 Y4.
MANUFACTURER Quaker Oats, St. Joseph, Missouri.
RECALLED BY Publix Super Markets, Inc., Lakeland, Florida by sending E-
Mail message on January 24, 1995. A joint press release
issued via AP from Lakeland, Florida on January 27, 1995 by
Quaker Oats and Publix. Firm-initiated recall complete.
DISTRIBUTION Florida, Georgia.
-2- QUANTITY 1,500 cases (12 boxes per case) were distributed.
REASON Product contains undeclared sulfites and milk-based
products.
_______________
PRODUCT La Preferida Nectars in 12 ounce cans, 24 cans per case, in
the following flavors: (a) Pear; (b) Peach;
(c) Apricot; (d) Papaya/Pineapple; (e) Tamarindo; (f) Mango;
(g) Guava. Recall #F-569/575-5.
CODE All product manufactured in Mexico.
MANUFACTURER Industrial de Alimentos del Norte, S.A. de C.V., Mexicali,
Mexico.
RECALLED BY La Preferida, Inc., Chicago, Illinois, by visit February 2-
24, 1995; by E-Mail on February 24, 1995; by fax February
25, 1994; and by memoranda dated February 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Arizona, California, Colorado, Florida, Georgia,
Iowa, Indiana, Maryland, Minnesota, Mississippi, New Mexico,
New York, Ohio, Tennessee, Texas, Wisconsin.
QUANTITY 12,366 cases were distributed.
REASON Products contain excessive levels of lead.
_______________
PRODUCT Paraguay Tea, in one 25-pound bulk bag and in individual
plastic bags. Recall #F-576-5.
CODE None.
MANUFACTURER Ecuadorean Tropical Products, Inc., doing business as Bonita
Foods, Maspeth, New York (importer).
RECALLED BY Importer, by posting notice in family owned store on March
24, 1994. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 bulk bag and 5 cases (24 units per case) or 120 individual
plastic bags were distributed; firm estimates none remains
on the market.
REASON Product contains belladonna alkaloids.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Thompson brand Stress Formula Vitamins + Zinc 60 Tablet.
Recall #F-526-5.
CODE Lot #20349
MANUFACTURER Rexall-Sundown, Boca Raton, Florida.
RECALLED BY Manufacturer, by telephone July 19, 1994, followed by letter
July 20, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 784 bottles were distributed.
REASON Product labeled "Rexall Stress Formula Vitamins + Zinc," Lot
#20349 contained a Woman's Multi Vitamins and Mineral
Formulation.
-3- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Monoject Hypodermic Needles, single use, epoxy needle
attachment, polypropylene hub, luer lock hub, 19 ga. x 1-
1/2". Recall #Z-455-5.
CODE Lot numbers: 237593 and 238057.
MANUFACTURER Sherwood Medical Company, Deland, Florida.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letter
dated December 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 642,600 needles of lot 237593 and 276,900 needles of lot
238057 were distributed.
REASON The needles may contain a coating of silicone oil in the
interior of the needle hub. This can cause difficulty in
firmly seating the needle to the luer-slip syringes.
_______________
PRODUCT Chemspor Biological and Chemical Indicator, a BI for
monitoring steam sterilization processes in wet
environments. Recall #Z-516-5.
CODE All lots within expiration date.
MANUFACTURER AMSCO International, Inc., Apex, North Carolina.
RECALLED BY American Sterilizer Company, Pittsburgh, Pennsylvania, by
letter February 22, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 9,988 boxes of product were distributed.
REASON The device is labeled for 48-hour incubation and 510(k)
clearance is for 7 days. The firm was not able to validate
the 48-hour or 7-day incubation claim for steam processing.
_______________
PRODUCT Proof Flash Self-Contained Biological and Chemical
Indicator, a BI for monitoring steam 270xF Steam gravity
sterilization cycles. Recall #Z-517-5.
CODE All lots within expiration date.
MANUFACTURER AMSCO International, Inc., Apex, North Carolina.
RECALLED BY American Sterilizer Company, Pittsburgh, Pennsylvania, by
letter February 22, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 25,462 cases (50 vials per box) were distributed.
REASON The product is labeled for a 24-hour or 48-hour incubation
period. The firm was not able to validate the 24-hour or
48-hour incubation claim for steam processing.
_______________
PRODUCT Saxon Gold Ultra Spermicidal Lubricated Latex Condoms with
Nonoxynol-9, packed in plastic film. Recall #Z-518-5.
CODE Lot #35039 EXP 12/95.
MANUFACTURER Safetex, Division of Aladan Corporation, Colonial Heights,
Virginia.
RECALLED BY Manufacturer, by telephone on or about September 21, 1994.
Firm-initiated recall complete.
-4- DISTRIBUTION New York, Kansas.
QUANTITY 20 gross were distributed; firm estimates none remains on
the market.
REASON Condoms were found to have a lower concentration of the
spermicide, Nonoxynol-9, than was represented in the
device's labeling and premarket notification.
_______________
PRODUCT MRINNERVU Disposable Endorectal Coils for MRI Imaging for
the colon and cervix:
(a) Cervix Coil Model BCR-15; (b) Colorectal Coil
Model PCC-15. Recall #Z-540/541-5.
CODE (a) Serial numbers 1110 through 1214;
(b) Serial numbers 0001 through 1399.
MANUFACTURER Medrad, Inc., Indianola, Pennsylvania.
RECALLED BY Manufacturer, by telephone January 31, 1995, followed by
letters dated February 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately (a) 812 units; (b) 915 units were distributed.
Firm estimated that 334 Rectal units and 252 Cervical units
remained on market at time of recall initiation.
REASON The packaged devices had broken shafts.
_______________
PRODUCT Coveen Urisheath/Uriliner, male external catheters:
(a) Pediatric/Geriatric Catheter, product #5120H-25mm;
(b) Large Catheter, Product #5135H, 35mm.
Recall #Z-542/543-5.
CODE Lot numbers: (a) 86764; (b) 86811.
MANUFACTURER Coloplast A/S, Humlebaek, Denmark.
RECALLED BY Coloplast, Inc., Marietta, Georgia, by letter January 31,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,500 units of lot 86811 and 200 units of lot 86764 were
distributed.
REASON The labeling incorrectly identifies the product as non-latex
product.
_______________
PRODUCT Adult, Child, and Infant CPR Resuscitator Bags, single
patient use, disposable, with related accessories (mask,
peep valve, peep adapter and manometer port.
Recall #Z-545/547-5.
CODE Part Numbers: 055106, 055107, 055111, 055113, 055115,
055117, 055121, 055122, 055124, 055126, 055129, 055229,
055234, 552335, 055241, 055242, 055251, 055252, 055255,
055259, 055260, 055264, 055160, 055200, 055203, 055204,
055213, 055214, 055217, 055218, 055223, 055224, 055226,
055133, 055138, 055139, 055142, 055144, 055145, 055146,
055150, 055155, 055156, 055158, 055018, 055025, 055027,
055028, 055029, 055031, 055034, 055037, 055047, 055103,
-5- 055104, 055000, 055002, 055003, 055004, 055006, 055007,
055008, 055012, 055014, 055015, and 055016.
MANUFACTURER Plaxtron Industrial (M) SDN. BHD, Taiwan and Malaysia.
RECALLED BY Mercury Medical, Clearwater, Florida, by letter August 29,
1994, and September 19, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 23,610 units were distributed.
REASON The devices have excess glue around the intake valve on the
interior of the bag. Device defect presents a moderate risk
of life-threatening adverse health consequences including
death.
_______________
PRODUCT Transflator II Balloon Inflation Syringes: (a) Transflator
Balloon Inflation Syringe, Catalog #05-0802; (b) Transflator
II Balloon Syringe with PTCA Accessory Kit,
Catalog #05-0804. Recall #Z-548/549-5.
CODE All product shipped prior to May 5, 1994.
MANUFACTURER Surgical Technologies, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter February 2, 1995, followed by
telephone on or about March 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Belgium, Canada, Italy, The Netherlands, United
Kingdom.
QUANTITY 1,732 units were distributed; firm estimates none remains on
the market.
REASON Devices have broken transmitting LED solder joints which may
result in loss of transmission and the "signal Lost" read-
out on the monitors.
_______________
PRODUCT Medical Research Laboratory DPD Defibrillator, sold under
Datascope Part #0998-00-0004, used in conjunction with
Datascope Passport Patient Monitoring System.
Recall #Z-550-5.
CODE All serial numbers.
MANUFACTURER Medical Research Laboratories, Buffalo Grove, Illinois.
RECALLED BY Datascope Corporation, Paramus, New Jersey, by letters dated
March 2, 1995 on MRL's letterhead, with an accompanying
letter from Datascope dated March 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 656 units were distributed.
REASON There is a potential of the devices -- when used in the
synchronous mode with the Datascope Passport Monitor for the
purpose of cardioversion -- to discharge as late as
approximately 160 ms after the peak of the R wave of the
electrocardiogram. This delay may cause the device to
discharge during the T wave period of the ECG complex which
could produce a life-threatening ventricular fibrillation.
-6- _______________
PRODUCT Encore Orthopedic Foundation brand Knee Tibial Insert, 13mm
size 4. Recall #Z-558-5.
CODE Catalog #350-13-004, Lot #6703.
MANUFACTURER Encore Orthopedics, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone October 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION New York, Oklahoma, Pennsylvania, South Carolina, Utah,
Texas, Washington state.
QUANTITY 15 inserts were distributed; firm estimates none remain on
market.
REASON The label on the interior pouch may incorrectly identify the
insert thickness as 15mm, however, the actual thickness is
13mm which is correctly identified on the exterior box
label.
_______________
PRODUCT Slit Rotation Knob on the Retroskop CS, an illumination
module (microscope attachment). Recall #Z-559-5.
CODE Catalog #302560, Serial #A.1/A.2.
MANUFACTURER Carl Zeiss, Inc., Thornwood, New York.
RECALLED BY Manufacturer, by letter mailed the week of February 6, 1995,
and by E-Mail February 7, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 80 attachments were distributed.
REASON The knob, originally designed to be removable so it could be
sterilized, has the potential to loosen and fall off from
the Retroskop after being sterilized.
_______________
PRODUCT D4600 Air Exchange Line, sterile/single patient use, an
accessory for ophthalmic use. Recall #Z-565-5.
CODE 28391 33302C 1331C 1611C 1651C 0982D
1782D 2522D 2932D 3352E 0323D 1413E
1603E 2213E 2643E 2923E 1943E 3333E
0244D 0534D 0704E 0964D 1374E 1524E
10391 10491 10492 10791.
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter November 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,213 boxes (10 pouches per box) were distributed.
REASON Due to a packaging deficiency, the pouches were improperly
sealed, therefore compromising sterility.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT MMI Barium Enema Kits, for use in x-ray diagnosis of the
lower gastrointestinal tract: (a) Catalog #354-00 assembled
Empty Barium Enema Kit; (b) Catalog #381-00 assembled Filled
Barium Enema Kit. Recall #Z-442/443-5.
-7- CODE Lot numbers: (a) 45918; (b) 946987.
MANUFACTURER Ridge Products, Lakewood, New Jersey.
RECALLED BY MMI, Inc., Southfield, Michigan, by telephone May 20, 1994,
followed by letter May 23, 1994. Firm-initiated recall
complete.
DISTRIBUTION New York, Florida, Michigan.
QUANTITY (a) 242 kits (b) 48 kits were distributed.
REASON Devices may have a fracture in the seal at the base of the
bag which could result in leakage.
_______________
PRODUCT MDT McKesson "Desert Air Plus" Dental Air Compressors:
(a) Model 301862, Single head, 115 V
(b) Model 301863, Single head, 230 V
(c) Model 301864, Twin head, 230 V
(d) Model 301865, Triple head, 230 V. Recall #Z-502/505-5.
CODE Serial numbers: (a) AN0001-KN0122 and A00127;
(b) BN0001-GN0064; (c) AN0001-KN0164 and B00165;
(d) CN0001-KN0015 and LN0016 and LN0017.
MANUFACTURER MDT Diagnostic Company, North Charleston, South Carolina.
RECALLED BY Manufacturer, by visit beginning June 10, 1994. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 124 units; (b) 65 units; (c) 166 units; (d) 18 units
were distributed.
REASON The nylon coalescing filter bowl may break apart due to
vibrational fatigue.
_______________
PRODUCT MDT McKesson "Desert Air Plus" Dental Air Compressors:
(a) Model 301862, Single head, 115 V
(b) Model 301863, Single Head, 230 V
(c) Model 301864, Twin head, 230 V
(d) Model 301865, Triple head, 230 V. Recall #Z-506/509-5.
CODE Serial numbers: (a) AN0001-KN0122; (b) BN0001-GN0064;
(c) AN0001-KN0164; (d) CN0001-KN0015.
MANUFACTURER MDT Diagnostic Company, North Charleston, South Carolina.
RECALLED BY Manufacturer, by letter December 6, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 123 units; (b) 65 units; (c) 165 units; (d) 16 units
were distributed.
REASON The clear styrene desiccant enclosure may explode.
_______________
PRODUCT Bausch & Lomb Gold Medalist Toric Visibility Tinted contact
lenses labeled with the following parameters:
(a) Blister Lot Number SY009541, BC 8.6, SPH +2,00, CYL -
125, AX 90; (b) Blister Lot Number SY009430, BC 8.3, SPH -
4.00, CYL -1.75, AX 170. Recall #Z-551/552-5.
CODE Carton Lot Numbers as follows:
(a) SZ064942 THROUGH SZ064956, SZ069065, SZ065693,
-8- SZ066011, SZ065748, SZ066017, SZ066019, SZ065751, SZ066022,
SZ066263, SZ065749, SZ065752, SZ065757, SZ065759
(b) SZ064968, SZ064972, SZ064973, SZ064974, SZ064977,
SZ064978, SZ065265, SZ065490, SZ065231, SZ065232, SZ065648,
SZ065549, SZ065267, SZ065271, SZ065490.
MANUFACTURER Bausch & Lomb, Inc., Sarasota, Florida.
RECALLED BY Bausch & Lomb, Inc., Rochester, New York, by telephone and
fax on January 24 and 25, 1995. Firm-initiated recall
complete.
DISTRIBUTION Alaska, Kansas, Minnesota, Virginia, California, Florida,
Georgia, Illinois, Iowa, Missouri, New Jersey, New York,
Ohio, Oregon, Wisconsin, Canada, Australia, Ireland.
QUANTITY (a) 66 lenses; (b) 71 lenses were distributed.
REASON An unidentified number of lenses are labeled with the
incorrect base curve, sphere, cylinder, and axis parameters.
_______________
PRODUCT Dade Alcohol and Ammonia Control Level I - Normal and Level
II - High. Recall #Z-560-5.
CODE Catalog No. Lot No. EXP Date
B5118-AM4 PAC-34 2/8/95
B5188-AM5 PAC-35 10/9/95
B5188-S PAC-34/35 2/8 & 10/9/95
B5118 PAC-36 12/25/95.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter August 1994. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 29,022 units were distributed.
REASON The labeling was misleading as to the ranges listed in the
package insert.
_______________
PRODUCT Dade Immunoassay Controls, Tri Level, Level I, Level II, and
Level III: (a) Catalog #B5700-5; (b) Catalog #B5700-6;
(c) Catalog #B5700-7; (d) Catalog #B5700-8.
Recall Z-561/564-5.
CODE Lot numbers: (a) IACK-22M; (b) IAC1-112M;
(c) IAC2-212M; (d) IAC3-312M.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter on or about October 20, 1994. Firm-
initiated field correction complete.
DISTRIBUTION Texas, Michigan, California, Wisconsin, Florida, New York.
QUANTITY 35 kits were distributed.
REASON The labeling is misleading as the results for the Free T4
Clinical Assays 2 Step (Cal535A) and Direct (Cal535S) were
reversed on the clinical assay sheets provided with the test
kits.
-10- SEIZURES:
=================================================================
_______________
PRODUCT Frozen Scallops (95-710-318).
CHARGE Adulterated - The article consists in whole or in part of
decomposed scallops.
LOCATION Continental Freezer of Illinois, Chicago, Illinois.
FILED March 22, 1995; U.S. District Court for the Northern
District of Illinois; Civ. #95C 1767; FDC #67074.
SEIZED March 22, 1995 - goods valued at approximately $9,320.
_______________
PRODUCT Frozen Peeled Shrimp and Imitation Breaded Shrimp (94-681-
944/5).
CHARGE Adulterated - The articles consist in whole or in part of a
decomposed substance by reason of the presence therein of
decomposed shrimp.
LOCATION Seaboard Cold Storage, Inc., Tampa, Florida.
FILED January 30, 1995; U.S. District Court for the Middle
District of Florida, Tampa Division; Civ. #95-129-CIV-T-23B;
FDC #67053.
SEIZED March 9, 1995 - goods valued at approximately $9,500.
-10-
END OF ENFORCEMENT REPORT FOR MARCH 29, 1995. BLANK PAGES MAY
FOLLOW.
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