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
01/08/1991
FDA Enforcement for the week of January 9, 1991
FDA ENFORCEMENT REPORT
FOR JANUARY 9, 1991
January 9, 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: Various types of Fresh and Frozen Crabmeat in 16 oz.
plastic tubs:
(a) Fresh Jumbo Lump Crabmeat; (b) Fresh Regular Lump
Crabmeat; (c) Fresh Special White Crabmeat; (d) Fresh
Regular Claw Crabmeat; (e) Fresh Fingers Crabmeat;
(f) Fresh Jumbo Claw Crabmeat; (g) Frozen Regular Claw
Crabmeat, Recall #F-667/672-0.
Code: Lot Nos. 00718 through 00829, distributed between July
18, 1990 and August 29, 1990.
Manufacturer: Gulf Tex Seafood, San Leon, Texas.
Recalled by: Manufacturer, by telephone August 29, 1990. Firm-
initiated recall ongoing.
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Distribution: Maryland, Texas.
Quantity: (a-f) 36,827 pounds of fresh crabment; (g) 1,760 pounds
were distributed.
Reason: Product contaminated with Listeria monocytogenes.
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Product: Various Aloe Vera Gel Drinks: (a) Aloe Vera Gel Drink
(b) Naturally Aloe Vera Gel Drink; (c) Premium 99.6% Aloe
Vera Gel Drink; (d) Hydroponically Cultivated Aloe Vera
Drink, Recall #F-058/061-1.
Code: All lots.
Manufacturer: Superior Product Company, Dallas, Texas.
Recalled by: Manufacturer, by letter October 9, 1990. Firm-
initiated recall ongoing.
Distribution: Florida, New Hampshire, Pennsylvania, Texas, Canada.
Quantity: 834/8 fluid ounce bottles; 2,439/16 fluid ounce bottles;
2,923/32 fluid ounce bottles and 165/128 fluid ounce jugs
were distributed.
Reason: Undeclared sulfites in excess of 10 mg. per serving.
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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: Candy Cake Decorations, each packet contains candy
decorations that spell out "HAPPY BIRTHDAY".
Recall #F-036-1.
Code: Not coded.
Manufacturer: Decco Inc., Sandusky, Ohio, and Pioneer Products, Ocala,
Florida.
Recalled by: Odd's -n- Ends's, Buffalo, New York by memorandum dated
September 14, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 79/144 units per case were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Mint Chip Ice Cream in half gallon paper tubs, and three
and half gallon square cardboard tubs, Recall #F-037-1.
Code: Not coded.
Manufacturer: Sweets, Treats and Cream Inc., Plymouth, Michigan.
Recalled by: Manufacturer by representative visit November 7, 1990.
Firm-initiated recall ongoing.
Distribution: Michigan.
Quantity: Firm estimates approximately 80 half gallons of mint
ice cream remain on market.
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Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Various flavored powdered gelatin dessert mixes in
plastic laminated pouches, 12/24 oz/case and 6/4 lb. 8 oz.
(72 oz.)/case:
(a) Artificially Flavored Orange Gelatin Dessert
i) Code brand, Dist. by Code, Inc., Pittsburgh, PA
24 oz., item #19398, lot 092601
ii) Nifda brand (case: Nifda Valu-Gel), Dist. by Nifda, Inc.,
Atlanta, GA, 24 oz., item # 13227, lot 092601
iii) generic (case: Valu-Gel), The Park Corporation,
Barrington, IL, 72 oz., item #19729, lot 092701
iv) Embassy's Lucky Boy, Dist. by Embassy Food Service Corp.,
Pittsburgh, PA, 72 oz., item #16147, lot 092701
(b) Code Assorted Citrus Gelatin Dessert, with the case
containing 4 pouches each of Code brand Lemon, Lime and
Orange gelatins, 24 oz., item #19489, lot 092601
(c) Artificially Flavored Raspberry Gelatin Dessert
(i) Nifda brand (case: Nifda Valu-Gel), Dist. by Nifda, Inc.,
Atlanta, GA, 24 oz., item #13268, lot 092602
ii) Nifda Nifda-Jel, Dist. by Nifda Inc., Atlanta, GA
72 oz., item #14209, lot 092701
iii) generic (case: Valu-Gel), The Park Corporation,
Barrington, IL, 72 oz., item #19778, lot 092702
iv) Code brand, Dist. by Code, Inc., Pittsburgh, PA,
72 oz., item #16576, lot 092702
(d) Artificially Flavored Cherry Gelatin Dessert
i) Code brand, Dist. by Code, Inc., Pittsburgh, PA
24 oz., item #16808, lot 092602
ii) Nifda brand (case: Nifda Valu-Gel), Dist. by Nifda, Inc.,
Atlanta, GA, 24 oz., item #13276, lot 092602
iii) generic (case: Valu-Gel), The Park Corporation,
Barrington, IL, 72 oz., item #19737, lot 092702
(e) Artificially Flavored Strawberry Gelatin Dessert
i) Nugget brand, Dist. by Nugget Distributors, Inc.,
Stockton, CA, 24 oz., item #18929, lot 092602
ii) Nifda brand (case: Nifda Valu-Gel), Dist. by Nifda, Inc.,
Atlanta, GA, 72 oz., item #13334, lot 092702
iii) Embassy's Lucky Boy, Dist. by Embassy Food Service
Corp., Pittsburgh, PA, 72 oz., item #16287, lot 092702
iv) Code brand, Dist. by Code, Inc., Pittsburgh, PA
72 oz., item #16568, lot 092702
(f) Assorted Reds Gelatin Dessert, with the case containing
4 pouches each of Cherry, Strawberry and Raspberry gelatins
(i) generic (case: Valu-Gel), The Park Corporation,
Barrington, IL, 24 oz., item #18424, lot 092602
(ii) Nugget brand, Dist. by Nugget Distributors, Inc.,
Stockton, CA, 24 oz., item #18986, lot 092602
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iii) Nifda Nifda-Jel, Dist. by Nifda, Inc., Atlanta, GA
24 oz., item #14266, lot 092801
iv) Code brand, Dist. by Code, Inc., Pittsburgh, PA,
24 oz., item #16691, lot 092802. Recall #F-040/045-1.
Code: Lot numbers: 092601, 092602, 092701, 092702, 092801, 092802.
Manufactirer: The Park Corporation, Barrington, Illinois.
Recalled by: Manufacturer, by telephone September 28, 1990 followed by
letter October 2, 1990. Firm-initiated recall complete.
Distribution: Illinois, Wisconsin, Tennessee, Maine, Florida, Indiana,
Kentucky, Iowa, Oregon, West Virginia.
Quantity: 426 cases were distributed; firm estimates none remains
on the market.
Reason: The gelatin was contaminated with metal wire fragments.
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Product: Dextrose Powder used as an ingredient, Recall #F-046-1
Code: BDOJ244X, BDOJ274X, BDOH274Y, BD91494T, BDOJ243X, BDOJ243Y,
BDOJ243Z, BDOJ243Z5, BDOJ253X, BDOJ2535X5, BDOJ253Y,
BDOJ253Z, BDOJ263Y5, BDOJ263Y, BDOJ263Z, BDJO263Z5,
BDOJ273X, BDOJ272X, BDOJ241X.
Manufacturer: A. E. Staley Manufacturing Company, Decatur, Illinois.
Recalled by: Manufacturer by letter and by telephone September 28, 1990
and October 1, 1990. Firm-initiated recall ongoing.
Distribution: New Jersey, California, New York, Pennsylvania, Tennessee,
North Carolina, Minnesota, Texas, Georgia, Massachusetts,
Michigan, Missouri, Ohio, Iowa, Canada.
Quantity: 1,156,620 pounds were distributed; firm estimates 80 percent
remains on the market.
Reason: Product contains wire metal fragments.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Aloe Vera Gel Drinks. Recall #F-062/070-1.
Code: All lots.
Manufacturer: Superior Product Company, Dallas, Texas.
Recalled by: Manufacturer by letter October 9, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, New Hampshire, Pennsylvania, Texas, Canada.
Quantity: 120/16 fluid ounce bottles, 419/32 fluid ounce bottles,
216/64 fluid ounce bottles and 3,151/128 fluid ounce jugs
were distributed.
Reason: Product contains undeclared sulfites.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model 1D/2D Soft Laser Scanning Densitometer, used
for biomedical research. Recall #Z-424-0.
Code: Serial numbers: Undetermined.
Manufacturer: Biomed Instruments, Inc., Fullerton, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 5, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 177 units were distributed.
Reason: Noncompliance with performance standard for laser products
in that labeling procedures and quality control plans were
inadequate.
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Product: Model HI-C1000 Yag Laser System-Marker. Recall #Z-598-0.
Code: Serial numbers: Undetermined.
Manufacturer: Intel Corporation, Chandler, Arizona.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 24, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide and international.
Quantity: 18 units were distributed.
Reason: Noncompilance with performance standard for laser products
in that the design failed to incorporate a required
redundant interlock system.
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Product: DFP-50A Digital Fluorography Apparatus, X-ray control.
Recall #Z-668-0.
Code: Serial numbers: Undetermined
Manufacturer: Toshiba Corporation, Tokyo, Japan.
Reclled by: Toshiba America Medical Systems, Inc., Tustin, California.
FDA approved the firm's corrective action plan September 26,
1989. Firm-initiated field correction ongoing.
Distribution: Nationwide.
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Quantity: 23 units were distributed.
Reason: Noncompliance with performance standards for x-ray products
in that the device emitted or caused the emission of
electronic product radiation, which was unnecessary to
the accomplishment of its primary purpose, creating a
risk of injury.
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Product: Helium Neon Laser Heads and Power Supplies. Recall #Z-697-0.
Code: Serial numbers: Undetermined.
Manufacturer: Meredith Instruments, Glendale, Arizona.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan June 18, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 36 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that it lacked beam attenuators, the required
labels and adequate instructions for assembly.
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Product: Beam Master Laser Projection System. Recall #Z-731-0.
Code: Serial numbers: Undetermined.
Manufacturer: Entertainment Technology Industries, Anaheim, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan June 29, 1990. Firm-initiated field correction
ongoing.
Distribution: California.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for laser
products in that the device did not have a certification
label, identification label, adequate safety interlocks or
a beam attenuator.
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Product: Marquest Medical Trach Swivel Adaptor with port, a component
of the Marquest Water Trap Breathing Circuit Assembly, and
also distributed individually in cases of 50 or 6 units
per case. Recall #Z-116/117-1.
Code: Product codes beginning with 17 are individual or case
labeled units. Product codes beginning with 09 are
Custom Breathing Circuits which contain the affected Trach
Swivel Adaptor.
Product Code Lot Number:
178799 36359, 36744
178800 35880, 35881, 36150, 36149, 37215,
37217, 37584
178830 35883, 36153, 36570, 36792, 37223,
37587
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095289 39073
095300 37867, 37476, 38598, 38883
098196 39075
098355 36748, 37733, 37855, 37978, 38304
098470 37309, 39244
098675 37310, 38073, 38333, 38600
098788 37765, 38074, 39433
099026 37480, 36980, 38523
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Redcalled by: Manufacturer by letter October 22, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 1,500 cases remain on the market.
Reason: Suction cap restraining straps on the dual trach swivel
elbow may break due material stress, which may allow
the cap to pop off as the breathing circuit is pressurized.
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Product: Philips Diagnost 53 Radiographic/Floroscopic X-ray
Table with Spotfilm Device, a table designed for a full
range of x-ray diagnostics. Recall #Z-175-1.
Code: Model #9804-310-3...7, Lot #0-2.
Manufacturer: Philips Medical Systems, North American Company,
Shelton, Connecticut.
Recalled by: Manufacturer by field correction June, 1990. Firm-
initiated field correction complete.
Distribution: Nationwide.
Quantitiy: 182 units were distributed.
Reason: The compression counterweight cables may break
causing the spotfilm device to fall on the table
or patient.
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Class III -
NONE
VETERINARY PRODUCTS
NONE
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