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
01/29/1991
FDA Enforcement for the week of January 29, 1991
FDA ENFORCEMENT REPORT
FOR JANUARY 29, 1991.
January 30, 1991
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.
Product: (a) Fresh Crabmeat, in 1 pound plastic containers;
(b) Machine Picked Claw Crabmeat, in 1 pound plastic bags.
Recall #F-115/116-1.
Code: Lot numbers: (a) 270; (b) 290.
Manufacturer: RCV Seafood Corporation, Morattico, Virginia.
Recalled by: Manufacturer, by telephone November 13, 1990. Firm-
initiated recall ongoing.
Distribution: Virginia, Washington, D.C.
Quantity: (a) 290 pounds; (b) 100 pounds were distributed.
Reason: Product contaminated with Listeria monocytogenes.
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-1-
Product: Canned Chili beans, red kidney beans, and pinto beans:
(a) Grade A Fancy Happy Harvest Mexican Style Hot Chili
Beans, in 15 ounce cans, distributed by Aldi Inc.;
(b) Our Family chili Beans in Chili Gravy, in 15 ounce
cans, distributed by Nash Finch Company;
Hy-Vee Chili Style Beans, in 15 ounce cans, distributed
by Hy-Vee Food Stores;
(c) Hy-Vee Red Kidney Beans, in 20 ounce cans, distributed
by Hy-Vee Food Stores;
(d) Raggedy Ann Dark Red Kidney Beans, in 30 ounce cans,
distributed by Certified Grocers Midwest, Inc.;
Old Time Kidney Beans, in 30 ounce cans, distributed by
Roundy's, Inc.;
(e) La Preferida Pinto Beans/Frijoles Pintos, in 50 ounce
cans, distributed by La Preferida, Inc;
La Criolla brand Pinto Beans/Frijoles Pintos, in 50 ounce
cans, distributed by La Criolla, Inc.;
Supremo Frijoles Pintos Pinto Beans, in 50 ounce cans,
distributed by V & V Food Products, Inc.
Recall #F-144/148-1.
Code: Lot numbers: (a) 123FO/290A, 123FO/290B, 123FO/298A,
123FO/298B; (b) 123FO/290A; (c) 17OFO/309B;
(d) 160FO/295B; (e) 201FO/284A.
Manufacturer: Faribault Foods, Inc., Faribault, Minnesota.
Recalled by: Manufacturer, by telephone November 28, 1990 followed
by letter. Firm-initiated recall ongoing.
Distribution: Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska,
North Dakota, South Dakota, Wisconsin.
Quantity: 17,352 cases of 15 ounce cans (24 cans/case);
294 cases of 20 ounce cans (24 cans/case);
625 cases of 30 ounce cans (12 cans/case);
2,980 cases of 50 ounce cans (12 cans/case) were
distributed.
Reason: Potential Clostridium botulinum toxin hazard.
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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: Micro-Flora, a concentrated liquid form of viable organisms
designed to assist in the replacement and maintenance of
favorable intestinal bacterial growth, in 16 ounce bottles
whose labels identify firm's address as "Camarillo,
California. Recall #F-708-0.
Code: Batch #0573 on boxes, bottles are uncoded.
Manufacturer: Cosmetic Development Systems, Inc., Newbury Park, California.
-2-
Recalled by: Micro-Flora Corporation, Camarillo, California, by
telephone on or about May 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 18,960 bottles were distributed; firm estimates less than
500 bottles left at retail level.
Reason: Possible Clostridium botulinum contamination.
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Product: Lemonade Drink, in 10 ounce paper carton and a one
gallon plastic jug. Recall #F-114-1.
Code: Not coded.
Manufacturer: Carolina Dairy, Inc., Shelby, North Carolina.
Recalled by: Manufacturer, by verbally informing each route driver
on December 14, 1990 to place a sticker on each lemonade
container. Firm-initiated field correction ongoing.
Distribution: North Carolina, South Carolina.
Quantity: Firm estimates 100 gallons remain on market.
Reason: Product contained undeclared FD&C Yellow No. 5.
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Product: Various vegetable sprouts under the The Sprouters, Inc. and
Sprouters Northwest, Inc labels:
(a) Alfalfa Sprouts, in 5 ounce, and 8 ounce plastic
containers, in 1 and 2 pound bulk plastic bags, 2 pound
4 pound, and 5 pound living trays;
(b) Salad Sprouts, in 8 ounce, 5 ounce plastic containers,
and in 5 pound living trays;
(c) Clover Sprouts, in 5 ounce plastic containers and in
5 pound living trays;
(d) Munchies (3 bean salad), in 6 ounce plastic containers,
and in 2 pound plastic bags;
(e) Radish Sprouts, in 4 ounce, 5 ounce plastic containers
and in 1 pound plastic bags;
(f) Sunflower Greens, in 3 ounce plastic containers
and in 2 pound bulk plastic bags;
(g) Sprouted Lentils in 6 ounce plastic containers and in
4 pound trays;
(h) Sprouted Peas, in 6 ounce plastic containers;
(i) Alfalfa/Onion Sprouts, in 5 ounce plastic containers;
(j) Alfalfa Seeds, in 6 ounce plastic containers;
(k) Assorted Seeds, in 6 ounce plastic containers.
Recall #F-117/127-1.
Code: Not coded.
Manufacturer: Sprouters Northwest, Inc., Kent, Washington.
Recalled by: Manufacturer, by telephone December 19, 1990 followed
by letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 45,000 pounds were distributed; firm
estimates 22,500 pounds remain on the market.
-3-
Reason: Product is contaminated with salmonella.
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Product: (a) 12/15 Count Oriental Style Cleantail Butterfly
Hand Breaded Shrimp, in 3 pound waxed paperboard boxes,
packed 4 three pound boxes per case, labeled
GFS Gordon Food Service;
(b) 12/15 Count Oriental Style Round Breaded Shrimp, in
3 pound waxed paperboard boxes, packed 4 three pound boxes
per case. Boxes are labeled Gulf City Fisheries.
Recall #F-134/135-1.
Code: Lot numbers: (a) Product code 1232GFS, lot #332061;
(b) Product code 0422GC, lot #333065.
Manufacturer: Gulf City Seafood, Inc., Pascagoula, Mississippi.
Recalled by: Manufacturer, by telephone and by letter December 7, 1990.
Firm-initiated recall ongoing.
Distribution: Michigan, Illinois, Alabama.
Quantity: (a) 49 cases; (b) 22 cases were distributed;
Reason: Product is contaminated with salmonella.
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Product: (a) Family Thrift Center French Bread, 1 pound loaf;
(b) Prairie Market French Bread, 1 pound loaf.
Recall #F-136/137-1.
Code: Lot #06DEC90.
Manufacturer: Family Thrift Center West, Rapid City, South Dakota.
Recalled by: Nash Finch Company, Rapid City, South Dakota, by
telephone beginning December 5, 1990 and by press release
December 7, 1990. Firm-initiated recall complete.
Distribution: South Dakota.
Quantity: 60 loaves of bread were distributed.
Reason: Product may contain a piece or pieces of a metal blade.
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CORRECTION: ICAPS Plus, a vitamin and mineral supplement which
appeared in the January 23, 1991 Enforcement Report
should read:
Product: ICAPS Plus, a vitamin and mineral supplement,
in 120 softgel capsule and 12 softgel capsule
bottles, distributed by La Haye Laboratories.
Recall #F-717-0.
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CORRECTION: Candy Cake Decorations, Recall #F-036-1 which appeared
in the January 9, 1991 Enforcement should be amended
to state: "Manufactured prior to 1987 and should not be
be confused with currently manufactured product.
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-4-
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Rich's Chocolate Signature Cream Pie, 38 ounces, frozen.
Recall #F-128-1.
Code: Lot #0242.
Manufacturer: Rich Products Corporation, Buffalo, New York.
Recalled by: Manufacturer, by telephone December 21, 1990 followed by
letter December 28, 1990. Firm-initiated recall ongoing.
Distribution: Massachusetts.
Quantity: 549 cases (6 pies/case) were distributed; firm estimates
121 cases at the retail level.
Reason: Product was short weight.
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Product: Old Fashioned brand Sharp Chedder Cold Pack Cheese,
in 8 ounce plastic containers. Recall #F-131-1.
Code: All lots.
Manufacturer: Old Fashioned Foods, Inc., Mayville, Wisconsin.
Recalled by: Manufacturer, by telephone November 30, 1990 followed by
visit. Firm-initiated recall complete.
Distribution: Minnesota, Wisconsin.
Quantity: Approximately 200 cases were distributed.
Reason: Product is short weight.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Platelets. Recall #B-047-1.
Code: Unit #12KT17259, 12KM43402.
Manufacturer: American Red Cross Blood Services, Charlotte, North Carolina.
Recalled by: Manufacturer, by telephone March 16, 1990 and April 30, 1990.
Firm-initiated recall complete.
Distribution: North Carolina.
Quantity: 2 units.
Reason: Product was labeled and distributed with incorrect
expiration date.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-061/063-1.
Code: Unit #17P79988.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone July 19,1990 followed by letter
July 26, 1990. Firm-initiated recall complete.
Distribution: Minnesota.
Quantity: 1 unit of each component.
Reason: Blood components collected from donor who engaged in high
risk behavior were distributed.
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Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: ALPHA III MGF 100 Mammographic X-Ray System.
Recall #Z-063-1.
Code: All serial numbers.
Manufacturer: Instrumentarium Corporation, Helsinki, Finland.
Recalled by: Instrumentarium Imaging, Inc., Milwaukee, Wisconsin.
FDA approved the firm's corrective action plan
October 5, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 157 units were distributed.
Reason: Noncompliance with performance standard for x-ray
products.
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Product: Curved Arterial Cannula in Custom Perfusion Pack:
(a) Catalog #020355-006; (b) Catalog #020355-005.
Recall #Z-096/097-1.
Code: Lot numbers: (a) 11P0836; (b) 01R0034, 11P0029.
Manufacturer: Cobe Laboratories, Inc., Cardiovascular Division,
Arvada, Colorado; DLP Inc., Grand Rapids, Michigan
(Cannula).
Recalled by: Manufacturer, by telephone September 27, 1990
followed by letter September 29, 1990. Firm-initiated
recall ongoing.
Distribution: New York.
-6-
Quantity: 71 units were distributed.
Reason: The curved plastic cannula tip may fracture at its base.
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Product: Gambro blood line sets, packaged in tyvek:
(a) Gambro Blood Line Set for Hemodialysis, G Series
except G-514;
(b) Hospal Blood Line Set for Hemodialysis, H710 and
H700 Series;
(c) Gambro Blood Line and Ultrafiltrate Adapter for
A-V Hemofiltration, G-514 Series. Recall #Z-176/178-1.
Code: All sequential lot numbers starting with and inclusive of
0-1523-N-11 to 0-1630-N-11 for the G series and H series
bloodlines. This includes products having catalogue numbers
printed on the label as follows:
G-500 G-525 G-540 G-555 G-571
G-501 G-530 G-542 G-558 G-575
G-506 G-533 G-544 G-565 H-710
G-514 G-538 G-553 G-566 H-700.
The catalogue numbers and lot numbers are printed at the top
of the label beside "CAT. NO." and "LOT. NO."
Manufacturer: Gambro-Hospal, Inc., Newport News, Virginia.
Recalled by: Cobe/Gambro/Hospal, Lakewood, Colorado, by letter
November 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, South America.
Quantity: (a & b) 698,393 sets; (c) 67 sets were distributed.
Reason: Cracks may occur in the luer connectors because the
PVC compound used to mold the luers does not possess
the tensile strength needed for the amount of stress
applied to the luers during treatment.
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Product: Model PVS-30M Mammmography X-Ray Unit, a Bennett X-ray
Corporation x-ray system. Recall #Z-179-1.
Code: Serial numbers of tubestand assembly: B-12085, B-10364,
B-11451, B-11688, B-12003, B-13566, B-11936, B-12293,
B-11018, B-9643, B-7649, B-10799, B-11262, B-16372, B-11884,
B-7259, B-11854, B-15045, B-12227, B-7665 plus three (3)
additional units that were installed by Detroit Radiographic
but not sold by them and the serial number of the tubestand
assembly is unknown.
Manufacturer: Bennett X-ray Corporation, Copiague, New York.
Recalled by: Detroit Radiographic Systems, Mt. Clemens, Michigan
(assembler), by letter December 5, 1990. Firm-iniitated
field correction ongoing.
Distribution: Michigan and 1 distributed in Ohio.
Quantity: 24 systems were distributed.
-7-
Reason: The wall anchors used by the assembler during the
installation of these x-ray units may fail and the unit
may pull loose from the drywall and fall.
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Product: (a) ZMS Intramedullary Fixation Driver, product #2237-14,
a surgical instrument used in driving fracture
rods through the medullary canal in femur/tibia fracture
fixation procedures;
(b) ZMS Intramedullary Fixation Locking Bolt, Small,
product #2237-11, a surgical instrument which is
also used in driving fracture fixation rods through the
medullary canal in femur/tibia fracture fixation
procedures. Recall #Z-180/181-1.
Code: Lot numbers: (a) 71501100; (b) 71364500.
Manufacturer: Tuco Instruments Company, Canton, Massachusetts.
Recalled by: Zimmer, Inc., Warsaw, Indiana, by letter November 28, 1990.
Firm-initiated recall ongoing.
Distribution: Arizona, California, Florida, Indiana, Illinois, Kansas,
Massachusetts, Michigan, Mississippi, North Carolina,
New York, Ohio, South Carolina, Tennessee, Texas, Utah,
Virginia, Wisconsin.
Quantity: (a) 57 units; (b) 63 units were distributed.
Reason: The C-shaped clip that fastens the locking chuck (which
fastens to the locking bolt) on the shaft of the driver
may break or bend during use or disassembly; and the bolt
may break at the threaded end which is inserted in the
grip guide and impacts the nail.
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Product: Skan 9000 Model Laser Barcode Scanner. Recall #Z-183-1.
Code: Serial numbers: 0043, 0042, 0051, 0049, 0062, 0046, 0057,
0044, 0050, 0041, 0036, 0063, 0061.
Manufacturer: Lazerdata Corporation, Orlando, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan November 28, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 13 units were distributed.
Reason: Noncompliance with performance standards for laser
products due to inadequate labeling and lack of beam
attenuators.
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Product: Spectrum RD-1200 Lasermedic Q-Switched Ruby Laser.
Recall #Z-184-1.
Code: Serial numbers: P1081A, P1091, P1092, P1093, P1094.
Manufacturer: Laser Applications, Inc., Orlando, Florida.
-8-
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan December 4, 1990. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Massachusetts, Texas.
Quantity: 5 units were distributed.
Reason: Noncompliance with the performance standards for laser
products due to inadequate user manuals and inadequate
warning logotype.
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Product: SD-2000 Series Ellipsometer, a laser device.
Recall #Z-185-1.
Code: Serial numbers: Undetermined.
Manufacturer: PLASMO GmbH, Munich, West Germany.
Recalled by: C.V.C. Products, Inc., Rochester, New York. FDA
approved the firm's corrective action plan December 5,
1990. Firm-initiated field correction ongoing.
Distribution: Vermont, California.
Quantity: 2 units were distributed.
Reason: Noncompliance with performance standards for laser products
due to inadequate labels, inadequate warning statements and
failure to submit required reports.
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Class III -
Product: Stayfree Deodorant Maxi Pads Sanitary Napkin.
Recall #Z-105-1.
Code: Product code 1067, lot numbers: 0066 (case), individual
poly bags are not coded.
Manufacturer: Johnson and Johnson Hemisferica S.A., Arroyo, Puerto Rico.
Recalled by: Johnson and Johnson, San Juan, Puerto Rico, by visit
beginning May 17, 1990. Firm-initiated recall complete.
Distribution: Puerto Rico.
Quantity: 59 cases (14 poly bags/case, 27 pads per bag) were
distributed.
Reason: The adhesive strip on the sanitary napkin is reversed
(attached backwards), which may result in a tearing of the
napkin when the release paper is peeled off.
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VETERINARY PRODUCTS
NONE