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.

February 12, 1997 97-07

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Raw Shellstock Oysters, packed 38 pounds in
plastic bags and then waxed cardboard boxes.
Recall #F-207-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Ameri-Pure Oysters, Port Sulphur, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and ISSC
statement dated January 9, 1997.
DISTRIBUTION New York.
QUANTITY 22 boxes were distributed. Firm estimates
none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus._______________
PRODUCT (a) Raw Shellstock Oysters, in 100 count
boxes; (b) Shucked Oysters, in gallon plastic
containers. Recall #F-208/209-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Battistella's Seafood, Inc., New Orleans,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Mississippi, California, New Mexico, Indiana,
New York.
QUANTITY (a) Approximately 10 100-count boxes; (b) 36
plastic gallon containers were distributed;
firm estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-210-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Bayou Express Seafood, Violet, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Alabama.
QUANTITY Approximately 255 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias,

-2- Lake Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled wooden
boxes. Recall #F-211-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Carlo Oysters, Inc., Amite, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Mississippi.
QUANTITY 30 30-pound boxes were distributed. Firm
estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shucked Oysters, in plastic gallon
containers. Recall #F-212-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Bill's Seafood, Chalmette, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Mississippi.
QUANTITY Approximately 42 gallons were distributed;
firm estimates none remains on the market.

-3-REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-213-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Cyril's Ice House and Supplies, St. Bernard,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement issued January 9, 1997.
DISTRIBUTION Louisiana, Mississippi.
QUANTITY Approximately 1,027 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-214-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Eddie's Quality Oysters, Port Sulphur,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana

-4- Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION North Carolina, Florida, Maryland, Alabama,
Louisiana.
QUANTITY Approximately 3,285 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-215-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Gulf Island Seafood, Hopedale, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Alabama, Virginia, Maryland.
QUANTITY Approximately 1,535 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT (a) Raw Shucked Oysters in Plastic containers
and glass jars; (b) Raw Half Shell Oysters in
waxed cardboard cases. Recall #F-216/217-7.

-5-CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997. (a) Shucked oysters in
gallon and 1/2 gallon containers have the
"date shucked" on them. Shucked oysters in
one quart buckets, 2 lb. containers, 10 oz.
cups, 8 oz. cups, and 10 oz. jars have a "Sell
By" date on them two weeks from the date they
were shucked.
(b) 1/2 shell oysters in cardboard cases do
not have a code but have the harvest tag.
MANUFACTURER Joey Oysters, Inc., Amite, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Mississippi, Texas, Tennessee, Arkansas.
QUANTITY a) Approximately 1322 cases of 12/10 ounce
containers of shucked oysters
b) Approximately 587 cases of 6/1 quart
containers of shucked oysters
c) Approximately 155 cases of 12/2 pound
containers of shucked oysters
d) Approximately 125 cases of 12/8 ounce
containers of shucked oysters
e) Approximately 68 cases of 6/1 gallon
containers of shucked oysters
f) Approximately 53 cases of 2/half gallon
containers of shucked oysters
g) Approximately 100 cases of 12/10 ounce
glass jars of shucked oysters
h) Approximately 55 cases of 7/1 dozen bags
of half shell oysters
i) Approximately 345 cases of 100 count half
shell oysters.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw In-Shell Oysters in burlap sacks.
Recall #F-218-7.

-6-CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER LA Seafood Exchange, Jefferson, Louisiana.
RECALLED BY Manufacturer, by telephone on January 6, 1997.
Completed recall resulted from a memorandum
dated January 3, 1997, issued by the State of
Louisiana Department of Health and Hospitals
Office of Public Health. See also FDA and the
ISSC statement dated January 9, 1997.
DISTRIBUTION Mississippi and Missouri.
QUANTITY 24 sacks, 19 5-gallons were distributed; firm
estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw In-Shell Oysters in burlap sacks.
Recall #F-219-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Median LLC, Gretna, Louisiana.
RECALLED BY Manufacturer, by telephone on January 7, 1997.
Completed recall resulted from a memorandum
dated January 3, 1997, issued by the State of
Louisiana Department of Health and Hospitals
Office of Public Health. See also FDA and the
ISSC statement dated January 9, 1997.
DISTRIBUTION Alabama and Mississippi.
QUANTITY 521 packs were distributed; firm estimates
none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

-7-_______________
PRODUCT Raw In-Shell Oysters in burlap sacks.
Recall #F-220-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Melerine Seafood, Delacroix Island, Louisiana.
RECALLED BY Manufacturer, by telephone on January 8, 1997.
Completed recall resulted from a memorandum
dated January 3, 1997, issued by the State of
Louisiana Department of Health and Hospitals
Office of Public Health. See also FDA and the
ISSC statement dated January 9, 1997.
DISTRIBUTION Mississippi and Alabama.
QUANTITY 475 sacks were distributed; firm estimates
none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shucked Oysters in one gallon plastic
containers. Recall #F-221-7.
CODE "Date Shucked" is on container. Oysters were
harvested from waters of Plaquemines or St.
Bernard Parishes, Louisiana, between December
22, 1996 and January 3, 1997.
MANUFACTURER New Orleans Fish House, New Orleans,
Louisiana.
RECALLED BY Manufacturer. Completed recall resulted from
a memorandum dated January 3, 1997, issued by
the State of Louisiana Department of Health
and Hospitals Office of Public Health. See
also FDA and the ISSC statement dated January
9, 1997.
DISTRIBUTION Mississippi.
QUANTITY 17 gallons were distributed.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.
-8-_______________
PRODUCT Raw In-Shell Oysters in burlap sacks.
Recall #F-222-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Pace Oysters & Seafood, Inc., Buras,
Louisiana.
RECALLED BY Manufacturer, by telephone on January 7, 1997.
Completed recall resulted from a memorandum
dated January 3, 1997, issued by the State of
Louisiana Department of Health and Hospitals
Office of Public Health. See also FDA and the
ISSC statement dated January 9, 1997.
DISTRIBUTION Florida.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shucked Oysters in gallons of 4 pounds, 5
pounds and 7 pounds and half shell Oysters in
boxes. Recall #F-223/224-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Pearl Reef Oyster Company, Broussard,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Louisiana and Texas.
QUANTITY 180 4-pound buckets, 222 5-pound buckets, 24
7-pound buckets of shucked oysters and 291
boxes 1/2 shell oysters were distributed; firm
estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe,

-9- Bay Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shucked Oysters in plastic gallon
containers. Recall #F-225-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Po-Boys Oysters, St. Bernard, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION North Carolina.
QUANTITY Approximately 60 gallons were distributed.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-226-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Port Sulphur Fisheries, Inc., Port Sulphur,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Alabama and California.
QUANTITY Approximately 1,535 100-pound sacks were
distributed.

-10-REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-227-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER R & A Oysters, Inc., Pointe-a-la-Hache,
Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Florida, Georgia, Louisiana.
QUANTITY Approximately 2,227 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-228-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Robin Seafood, Inc., Yscloskey, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
-11-DISTRIBUTION Mississippi, North Carolina, Texas, Oklahoma.
QUANTITY Approximately 280 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-229-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Shamrock Seafood, Inc., Raceland, Louisiana.
RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION North Carolina.
QUANTITY 30 40-pound sacks and 15 100-pound sacks were
distributed; firm estimates none remains on
the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Raw Shellstock Oysters in unlabeled burlap
sacks. Recall #F-230-7.
CODE None. Oysters were harvested from waters of
Plaquemines or St. Bernard Parishes,
Louisiana, between December 22, 1996 and
January 3, 1997.
MANUFACTURER Southern Foods Cajun Cuisine, Yscloskey,
Louisiana.

-12-RECALLED BY Manufacturer, by telephone. Completed recall
resulted from a memorandum dated January 3,
1997, issued by the State of Louisiana
Department of Health and Hospitals Office of
Public Health. See also FDA and the ISSC
statement dated January 9, 1997.
DISTRIBUTION Florida, Alabama, Virginia.
QUANTITY 1,316 100-pound sacks were distributed; firm
estimates none remains on the market.
REASON Oysters harvested from waters of Plaquemines
and St. Bernard Parishes, Louisiana
(specifically Black Bay, Lake Machias, Lake
Fortuna, California Bay, Bay Crabe, Bay
Gardene, American Bay and Bay Lafourche)
between December 22, 1996, and January 3,
1997, have been associated with an outbreak of
gastrointestinal illnesses caused by Norwalk
virus.

_______________
PRODUCT Italia Cappuccino Truffles, sold as bulk and
labeled with ingredients and firm name, no net
wt. statement (40 units/approx. 20 oz.), and
in boxes labeled:
"Choco-Lit Series *** 15 pieces Net Wt. 8 oz."
"The Choco-lit Companion... a complete refill
that slips into our classic best seller ** Net
Wt. 8 oz."
"Truffle 4 Pack Milk Chocolate Sampler ** Net
Wt. 2.4 oz." Recall #F-235-7.
CODE None.
MANUFACTURER Moonstruck Chocolatier, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated January 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,000 truffles were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III ======
_______________
PRODUCT TLC Hospital Lotion, in 3.5 fluid ounce
bottles. Recall #F-206-7.
CODE Lots numbers: 5776A, 5777A, 5717A, 5717B,
5718A.
MANUFACTURER Polychem Corporation, New Haven, Connecticut.
RECALLED BY Manufacturer, by letter on November 22, 1996,
by fax followed by telephone on December 5,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.

-13-QUANTITY 40,416 bottles of lot 5776A; 41,376 bottles of
lot 5777A; 18,336 bottles of lot 5717A; 2,400
bottles of lot 5717B; 21,120 bottles of lot
5718A were distributed.
REASON Some bottles may be labeled as TLC Mouth
Rinse.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Oxygen, USP Compressed (gas), Rx, in aluminum
cylinders, size M-6 (180 liters); D (415
liters); and E (680 liters).
Recall #D-094-7.
CODE Lot numbers: 1069701 filled 1/6/97; 1089701
and 1089705 filled 1/8/97.
MANUFACTURER Tech Med I.V., Inc., Portland, Maine.
RECALLED BY Manufacturer, by telephone on January 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Maine.
QUANTITY 161 cylinders were distributed.
REASON Good manufacturing practice deficiencies.

_______________
PRODUCT Cefaclor, USP; Clindamycin Phosphate; and,
Minocycline HCl, Rx active pharmaceutical
ingredients. Recall #D-113/115-7.
CODE All lots distributed since 1993.
MANUFACTURER Biochimica Opos, Italy, a wholly-owned
subsidiary of Roussel Uclaf.
RECALLED BY Roussel Corporation, Montvale, New Jersey, by
letter dated November 19, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Cefaclor - 80,645.3kg; Clindamycin -
17,758.6kg; Minocycline - 21,269.1kg.
REASON Discrepancies between the filed and actual
manufacturing process (Roussel has voluntarily
withdrawn their application).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Dihistine and Phenhist Cough Suppressant,
decongestant, and expectorant (Codeine
Phosphate, 10 mg, Pseudoephedrine
Hydrochloride, 30 mg, and Guaifenesin, 100 mg,
in 1 pint and 4 fluid ounce jars, under the
Barre and Rugby labels. Recall #D-092-7.

-14-CODE Lot numbers: RL6623 EXP 6/98; RJ6420 EXP
9/98; RJ6468 EXP 7/98; RH6352, EXP 6/98;
RF6267, EXP 5/98; RD6220 EXP 4/98; RB6055 EXP
4/98; RS5835 EXP 3/98; RS5836 EXP 3/98; RP5735
EXP 12/97; RN5638 EXP 11/97; VJ5417 EXP 7/97;
VC5185 EXP 6/97; VD5227 EXP 6/97; VB5081 EXP
6/97.
MANUFACTURER Alpharma (Barre-National), Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated January 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 236,376 units were distributed; firm estimated
that 9,922 units of the 4-ounce and 5,530
units of the 16-ounce units remained on market
at time of recall initiation.
REASON Product is not stable; failing potency assay
for codeine phosphate at the 12-month
stability timepoint (88%; SPEC is 90-110%).

_______________
PRODUCT Guiatuss DAC, a sugar-free cough suppressant,
decongestant, and expectorant (codeine-
phosphate, 10 mg; Pseudoephedrine
Hydrochloride, 30 mg, and Guaifenesin, 100
mg), in one pint jars, under the following
labels Barre-National, Rugby, Schein, URL.
Recall #D-093-7.
CODE Lots numbers and EXP dates: RA5029 01/97,
RB5090 03/97, RC6180 03/98, RD5320 05/97,
RL5606 09/97, RJ5430 07/97, VP5744/ 12/97.
MANUFACTURER Alpharma (Barre-National, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter on January 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 257,604 units were distributed; firm estimated
that 19,470 units remained on the market at
time of recall initiation.
REASON Product is not stable; failing potency assay
for codeine phosphate at the 18-month
stability timepoint (89%; SPEC is 90-110%).

_______________
PRODUCT Lidocaine Hydrochloride Oral Topical Solution
USP 2% (Viscous) in 100 ml bottles, indicated
for the production of topical anesthesia of
irritated or inflamed mucous membranes of the
mouth and pharynx, and is also useful for
reducing gagging during the taking of x-ray
pictures and dental impression, under the
following labels: Moore, Barre, Rugby,
Schein. Recall #D-095-7.

-15-CODE All lots within expiration date to include:
RA4023, EXP 4/97, RA4024, EXP 4/97
RF4314, EXP 6/97, RH4393, EXP 7/97
RK4524, EXP 10/97, RN4662, EXP 11/97
RS4788, EXP 12/97, VS4825, EXP 4/98
VH5350, EXP 8/98, VJ5437, EXP8/98
RL5571, EXP 9/98, RN5664, EXP 11/98
RP5752, EXP 12/98, RA6019, EXP 1/99
RB6062, EXP 3/99, RC6136, EXP 4/99
RC6181, EXP 4/99, RF6316, EXP 7/99.
MANUFACTURER Alpharma (Barre-National), Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter on January 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,806,492 units were distributed; firm
estimated that 26,027 units remained on market
at time of recall initiation.
REASON Product fails specification for viscosity on
stability at the 18-month timepoint (523CPS;
SPEC is 650CPS - 6000CPS).

_______________
PRODUCT Esimil, Guanethidine Monosulfate, USP, 10 mg,
Hydrochlorothiazide, USP, 25 mg 100
tablets/bottle, a prescription
antihypertensive-diuretic combination drug
product for oral administration in the
treatment of hypertension. CIBA also markets
the active ingredients in Esimil tablets as
monotherapy under the brand names Ismelin 10
mg (Guanethidine Monosulfate, USP) tablets and
Esidrix 25 mg (Hydrochlorothiazide USP)
tablets. Recall #D-097-7.
CODE LOT # 1T175538 EXP MAY 00.
MANUFACTURER CIBA Pharmaceuticals, Suffern, New Jersey.
RECALLED BY CIBA Pharmaceuticals, Summit, New Jersey, by
letter mailed on September 13, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,767 bottles were distributed.
REASON Product fails dissolution for
Hydrochlorothiazide at the 12-month stability
timepoint (55%; SPEC is not less than 60%
after 30 minutes).

_______________
PRODUCT Thorazine (Chlorpromazine) Syrup, 10 mg/5 ml
Oral Liquid, in 4 ounce amber glass bottles,
indicated for the management of manifestations
of psychotic disorders. Recall #D-098-7.
CODE Lot #X1-5T72J EXP 3/31/97.

-16-MANUFACTURER SmithKline Beecham Pharma, Inc., Cidra, Puerto
Rico.
RECALLED BY Manufacturer, by letter dated January 10,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,439 bottles were distributed.
REASON Dissolution failure of potency specification
at the 18-month stability timepoint (94.8%;
SPEC is 95-105%).

_______________
PRODUCT Butisol Sodium (butabarbital sodium) Tablets,
100 mg, Rx indicated for use as a
sedative/hypnotic. Recall #D-099-7.
CODE Lot numbers: 3E02T and 3E02U (common bulk lot
3E02).
MANUFACTURER Wallace Laboratories, Decatur, Illinois.
RECALLED BY Carter-Wallace, Inc., Cranbury, New Jersey, by
telephone starting August 6, 1996, followed by
fax. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,560 bottles were distributed; firm estimates
none remains on the market.
REASON Failure at the 6-month stability timepoint
(67%; SPEC is not less than 75%).

_______________
PRODUCT Augmentin (Amoxicillin Trihydrate 200 mg and
Clavulanate Potassium 28.5 mg) Chewable
Tablets, 20 tablets per pack, Rx
antibacterial. Recall #D-100-7.
CODE Lot #DC2981 EXP 9/31/97.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Bristol,
Tennessee.
RECALLED BY SmithKline Beecham Pharmaceuticals,
Philadelphia, Pennsylvania, by letter dated
December 31, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 19,440 packages were distributed.
REASON Product is not stable due to a poor seal on
the blister pack (amoxicillin may be as low as
84% at the 6-month stability timepoint;
Clavulanate may be as low as 0% at the 6-month
stability timepoint).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Single Donor Plasma.
Recall #B-020/021-7.
CODE Unit numbers: 53GZ79878, 53LJ13015,
53FK24253, 53T28161, 53T28162, 53T28156.
-17-MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated September 19,
1995. Firm-initiated recall complete.
DISTRIBUTION Maryland, District of Columbia.
QUANTITY 6 units.
REASON Blood products, corresponding to a unit of
pooled platelets which were implicated in a
transfusion reaction, were distributed.

_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma.
Recall #B-342/343-7.
CODE Unit #S70114.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone on March 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested positive for anti-Kell
antibodies were labeled as negative.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-333/334-7.
CODE Unit numbers: (a) 2188164, 3806384, 3805747;
(b) 2188164, 3805747.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated June 6, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana and Missouri.
QUANTITY (a) 3 units; (b) 2 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-335-7.
CODE Unit #26146-3074.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by letter dated September 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for CMV antibody
was labeled as negative.

_______________
PRODUCT Platelets, Pheresis. Recall #B-347-7.
CODE Unit 53P64249.
MANUFACTURER American Red Cross, Baltimore, Maryland.

-18-RECALLED BY Manufacturer, by letter dated August 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for CMV antibody
was labeled as negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Plasma. Recall #B-336-7.
CODE Unit #42FR50761.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on August 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON A unit of plasma frozen within 24 hours of
collection was incorrectly labeled as fresh
frozen plasma.

_______________
PRODUCT Red Blood Cells. Recall #B-337-7.
CODE Unit #21GF72588.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated May 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON A unit of leukodepleted red blood cells failed
quality control specifications for residual
white blood cell count.

_______________
PRODUCT Platelets, Pooled. Recall #B-338-7.
CODE Unit #LP21948.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by telephone on March 12, 1995,
followed by letter dated April 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Twelve units of platelets were pooled using a
filter which should be used for a maximum of
ten units.

_______________
PRODUCT Platelets, Pheresis. Recall #B-340-7.
CODE Unit #55FP00736.

-19-MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on July 26, 1996,
followed by letter dated July 31, 1996. Firm-
initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-341-7.
CODE Unit #55P23354.
MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on June 16, 1996,
followed by letter dated June 19, 1996. Firm-
initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS I ==========
_______________
PRODUCT Ventritex Tiered Therapy
Cardioverter/Defibrillator: (a) Model No.
V-110 Ventritex Tiered Therapy
Cardioverter/Defibrillator, Cadence;
(b) Model No. V-112 Ventritex Tiered Therapy
Cardioverter/Defibrillator, Cadence.
Recall #Z-232/233-7.
CODE Model V-110 and V-112.
MANUFACTURER Ventritex, Sunnyvale, California.
RECALLED BY Manufacturer, by letter on January 13, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,606 units have been implanted and 4 units
were in distribution channels at time of
recall initiation.
REASON Crystal oscillators are defective, and can
cause Central Processing Unit (CPU) timing
problems, which in turn can lead to rapid
pacing and lethal ventricular fibrillation.

-20-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Medtronic Indura Model 8703W Intraspinal
Catheter, intended for use with Medtronic
SynchroMed Programmable Pumps, for the
intraspinal infusion of parenteral drugs.
Recall #Z-223-7.
CODE Lot Numbers: 40841, 40843, 40844, 40845,
40846, 40847, 40848, 41007, 41008, 41009,
41010, 41011, 41012, 41427, 41428, 41429,
41430, 41431, 41432, 41433, 41434, 41435,
41436, 41523, 41526, 41527, 41528, 41529,
41531, 41562.
MANUFACTURER Medtronic, Inc., Neurological Division,
Minneapolis, Minnesota.
RECALLED BY Medtronic, Inc., Neurological Division,
Columbia Heights, Minnesota, by letter dated
January 6, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY 1,108 catheters were distributed.
REASON The radiopaque component (barium sulfate,
BaSO4) of the distal catheter segment is
insufficient to visualize the catheter using
the diagnostic methods of fluoroscopy or
x-ray.

_______________
PRODUCT One Touch Test Strips, used in conjunction
with Lifescan meters for blood glucose
monitoring. Recall #Z-241-7.
CODE Lot #609816A.
MANUFACTURER Lifescan, Inc., Milpitas, California.
RECALLED BY Manufacturer, by telephone on October 11,
1996, and by fax on October 17, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,623 units were distributed.
REASON The lot of glucose test strips was labeled
with an incorrect calibration code which
causes glucose results to be inaccurately
high.

_______________
PRODUCT Mobilaire MLP Portable Oxygen Units and
Mobilaire MLB Liquid Oxygen Reservoirs, used
by home patients for oxygen therapy:
(a) Mobilaire MLP Portable Oxygen Units;
(b) Mobilaire MLB Liquid Oxygen Reservoirs,.
Recall #Z-242/243-7.
CODE (a) Serial numbers beginning with 93K through
95H; (b) Serial numbers beginning with 93K
through 95F.
-21-MANUFACTURER Invacare Corporation, Sanford, Florida.
RECALLED BY Manufacturer, by letter dated November 22,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,131 units are subject to recall.
REASON The contents gauge may fail to properly
indicate the contents of the oxygen unit or
oxygen reservoir.

_______________
PRODUCT Elbow with gas sampling port included in
various anesthesia breathing circuits:
(a) Kendall's Anesthesia Breathing Circuits;
(b) Bain Breathing Circuits;
(c) Pediatric Anesthesia Breathing Circuits;
(d) SafeTrak Anesthesia Breathing Circuits;
(e) Customer Special Anesthesia Breathing
Circuits. Recall #Z-244/248-7.
CODE All inventory of the following product codes:
02346 6791 6926 10109 10154
02436 6794 6927 10111 10155
02490 6797 6928 10112 10156
02492 6798 6929 10113 10160
04412 6803 6931 10114 10162
04413 6814 6933 10115 10163
2435 6866 6935 10116 10165
2444 6872 6936 10117 10166
2447 6875 7145 10118 10168
2449 6876 8624 10119 10172
2450 6877 8627 10120 10173
2451 6878 8632 10121 10174
2453 6879 8634 10123 10175
2491 6881 8664 10124 10176
2494 6883 8667 10125 10178
2498 6886 8683 10126 10179
4936 6887 8684 10127 10181
4937 6888 8686 10128 10185
4938 6889 8687 10132 10189
4941 6893 8688 10133 10190
4942 6894 8824 10134 10191
4944 6895 8826 10135 10192
4945 6896 8827 10137 10197
4948 6908 8828 10138 10199
6909 9424 10139 10200
6679 6911 9425 10141 10206
6777 6912 9521 10142 10207
6778 6913 10101 10143 10212
6780 6915 10103 10145 10214
6785 6916 10105 10146 10215
6787 6917 10106 10151 10217
6788 6919 10107 10152 24499
6790 6925 10108 10153.
-22-MANUFACTURER Especialidades Medicals, Kenmex, Tijuana,
Mexico.
RECALLED BY Kendall Healthcare Products Company,
Mansfield, Massachusetts, by letter November
16, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 55,000 - 60,000 circuits were
distributed.
REASON Each device contains an Elbow (with gas
sampling port only) which may be partially or
totally occluded, thus interfering with the
ability to adequately ventilate or administer
anesthesia to patients.

_______________
PRODUCT Padgett Electro Dermatome Power Pak for use
with the Model B Padgett Electro Dermatome,
for use in cutting skin grafts.
Recall #Z-249-7.
CODE Serial numbers (which can be found on both the
power pack and the Dermatome):
1-1919 1-6268 1-9054 1-9101 1-9130
1-9168 1-1941 1-7324L 1-9055 1-9102
1-9131 1-9169 1-3609L 1-7419 1-9056
1-9103 1-9132 1-9170 1-36561 1-7587
1-9057 1-9104 1-9133 1-9171 1-3799L
1-7942 1-9058 1-9105 1-9134 1-9172
1-3909 1-8008 1-9059 1-9106 1-9135
1-9173 1-3960 1-8450 1-9060 1-9110
1-9136 1-9174 1-4058 1-8972 1-9061
1-9111 1-9137 1-9175 1-4060 1-9008
1-9072 1-9112 1-9138 1-9176 1-4074
1-9010 1-9073 1-9113 1-9139 1-9177
1-4270 1-9024 1-9074 1-9114 1-9140
1-9178 1-4276 1-9028 1-9075 1-9115
1-9141 1-9179 1-4317 1-9029 1-9076
1-9116 1-9142 1-9202 1-4449A 1-9030
1-9077 1-9117 1-9143 1-9203 1-4644
1-9031 1-9078 1-9118 1-9144 1-9206
1-4863 1-9032 1-9079 1-9119 1-9145
1-9207 1-5045 1-9033 1-9080 1-9120
1-9146 1-9208 1-5152 1-9034 1-9081
1-9121 1-9147 1-5225 1-9035 1-9092
1-9122 1-9148 1-5391A 1-9036 1-9094
1-9123 1-9149 1-5594 1-9037 1-9095
1-9124 1-9150 1-5922 1-9038 1-9096
1-9125 1-9151 1-6023 1-9040 1-9097
1-9126 1-9152 1-6132 1-9051 1-9098
1-9127 1-9165 1-6224 1-9052 1-9099
1-9128 1-9166 1-6225 1-9053 1-9100
1-9129 1-9167.
MANUFACTURER Dadson Manufacturing Company, Grain Valley,
Missouri. (contract manufacturer)
-23-RECALLED BY Padgett Instruments, Inc., Kansas City,
Missouri, by letter dated December 13, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 129 Dermatome power packs containing the 1/2
amp circuit breaker were distributed; 18 power
paks have been corrected.
REASON The power paks may have a circuit breaker that
will trip inadvertently and turn off the
dermatome.

_______________
PRODUCT St. Jude Medical Aortic Valve Graft with
Meadox Hemashield Woven Double Velour Graft,
Model GAVG-404, a replacement aortic valve and
graft used with the aortic valve and the
ascending aorta must be replaced.
Recall #Z-251-7.
CODE Serial numbers: 10026548, 10026549, 10026552,
10026553, 10026554, 10026558, 10026559,
10026560, 10026563, 10026564, 10026568, and
10026573.
MANUFACTURER St. Jude Medical, Inc., St. Paul, Minnesota
(aortic replacement valve with graft);
Meadox Medical, Inc., Subsidiary of Boston
Scientific Corporation, Oakland, New Jersey
(Hemashield Graft).
RECALLED BY St. Jude Medical, Inc., St. Paul, Minnesota,
by telephone on January 7, 1997, followed by
letter dated January 9, 1997. Firm-initiated
recall complete.
DISTRIBUTION California, Colorado, Illinois, Kansas,
Kentucky, Missouri, New York, Pennsylvania,
Texas, Australia.
QUANTITY 12 valves with grafts were distributed.
REASON A change in manufacturing process by the
vascular graft supplier permitted a residue of
collagen to be deposited on the valve
prosthesis.

-24-

END OF ENFORCEMENT REPORT FOR FEBRUARY 12, 1997. BLANK PAGES MAY FOLLOW.

####

End of Enforcement Report for