FDA

Enforcement Report

May 26, 1999                               99-21

RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS I
________
PRODUCT
Austin Whole Wheat and Cheddar Cracker Sandwiches, 7.4 ounces.  Recall 
#F-421-9.
CODE
JUN2099bk.
MANUFACTURER
Austin Quality Foods, Cary, North Carolina.
RECALLED BY
Manufacturer, by E-mail on January 12, 1999, and by press release on 
January 15, 1999, followed by visit.  Firm-initiated recall complete.
DISTRIBUTION
Connecticut, Massachusetts, Rhode Island.
QUANTITY
100 8-pack cases were distributed.
REASON
Some packages labeled as "Whole Wheat and Cheddar Cracker Sandwiches" 
actually contain "Cheese Peanut Butter Cracker Sandwiches."


________
PRODUCT
Shredded Monterey Jack Cheese, net weight 30 pounds.
Recall #F-422-9.
CODE
Lot #2029074.
MANUFACTURER
Beatrice Cheese, Inc., Fredericksburg, Iowa.
RECALLED BY
Beatrice Cheese, Inc., Waukesha, Wisconsin, by return authorization 
issued on March 29, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
200 30-pound cases.
REASON
Product was contaminated with Listeria monocytogenes.

________
PRODUCT
Heinz 3 Broccoli, Carrots & Cheese Junior Baby Food, in 6 ounce glass 
jars.  Recall #F-423-9.
CODE
P3388EA.
MANUFACTURER
Heinz USA, Pittsburgh, Pennsylvania.
RECALLED BY
Manufacturer, by letters and press release on March 29, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide, Singapore, Uruguay.
QUANTITY
5,269 cases (24 jars per case) were distributed.
REASON
Product is contaminated with pieces of hard plastic.


RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS II
________
PRODUCT
Italian Cookies, packaged in rigid plastic containers, 
16 ounces.  Recall #F-385-9.
CODE
None.
MANUFACTURER
96 Vreeland Street Corporation, doing business as Rosa Maria Bakery, 
Staten Island, New York.
RECALLED BY
Manufacturer, by telephone on November 16, 1998.  Completed field 
correction (relabeling) resulted from sample analysis and follow-up by 
the New York State Department of Agriculture and Markets.
DISTRIBUTION
New Jersey.
QUANTITY
Approximately 50 packages were distributed.
REASON
Product contains undeclared FD&C Yellow No. 5, FD&C Yellow #6, FD&C Red 
No. 3, and FD&C Blue No. 1.

________
PRODUCT
Matouk's Hot Chow, in 9 ounce and 13.4 ounce jars.  Product of 
Trinidad.  Recall 
#F-420-9.
CODE
None.
MANUFACTURER
Matouk International, Ltd., Trinidad, West Indies.
RECALLED BY
La Preferida, Inc., Bronx, New York, by letter dated November 4, 1998.  
Completed field correction (relabeling) resulted from sample analysis 
and follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
Massachusetts, New Jersey, New York, Ohio.
QUANTITY
20 cartons (12 jars per carton) of each product were imported.
REASON
Product contains undeclared FD&C Yellow No. 5.


RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS III
________
PRODUCT
Fat Free Cottage Cheese packaged under the Shop 'n Save label, in 24-
ounce plastic containers, (12 containers per case).  Recall #F-398-9.
CODE
Jun 02 3947.
MANUFACTURER
Tamarack Farms Dairy, Newark, Ohio.
RECALLED BY
Manufacturer, by telephone on April 30, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
348 cases (4,176 containers) were distributed.
REASON
Product is misbranded because the label identifies it as "Fat Free 
Cottage Cheese" when it in fact is regular small curd cottage cheese.

________
PRODUCT
The recall involves the firm's own brands and styles of pasteurized, 
not-from-concentrate (single strength) and from concentrate orange 
juice as well as numerous "private label" pasteurized not-from-
concentrate and from concentrate orange juice.  Product is either 
packed into a laminated paper carton or a plastic container.
Recall #F-418-9.
CODE
The following products are Lykes Pasco brands (Sunkist and 
Floridagold) including Lot Numbers:
a) Sunkist Premium Orange Juice Not From Concentrate (both with pulp 
and without pulp), 64 oz. and 96 oz. cartons and jugs - All Codes With 
Pull Dates of "March 10" through "April 7".
b) Sunkist Growers' Blend Orange Juice From Concentrate, Both With Pulp 
And Pulp Free, 64 fl. oz. and 96 oz. - All Codes With Pull Dates of 
"March 24" through "April 28".
c) Floridagold Premium, Not From Concentrate Orange Juice, Both With 
Pulp And Without Pulp, 64 and 96 fl. oz. - All Codes With Pull Dates Of 
"March 24" through "April 21".
d) Floridagold Original From Concentrate Orange Juice, 64 oz. and 96 
oz. With Pull Dates of "March 24" through "April 28".  The following 
products and lot numbers under recall are "private labels" packed under 
contract for various brokers/grocery store chains. Note:  All product 
codes for the following products with pull dates of "MARCH 24" 
through "APRIL 21" are under recall:
e) America's Choice Premium Orange Juice Pasteurized Not From 
Concentrate, distributed by Compass Foods, Montvale, NJ, 64 fl. oz. 
f) Albertson's Orange Juice, Premium, Not From Concentrate, 32 and 64 
oz., distributed by Albertson's, Inc. Boise, Idaho 83726.
g) BI LO Orchard Harvest Premium And Country Style Pasteurized Orange 
Juice Not From Concentrate, distributed by BI-LO, Inc., Mauldin, SC 
29662, 64 and 96 fl. oz.
h) Bel-Air Homestyle Premium Squeezed Orange Juice Not From 
Concentrate, net 64 fl. oz., distributed by Safeway Inc. Oakland, CA.
i) Best Yet Orange Juice Not From Concentrate, 64 fl. oz., Packed for 
Scrivner, Inc. Oklahoma City, OK 73126.
j) Buehler's Premium Orange Juice Not From Concentrate Regular and 
Country Style with Juicy Bits of Orange, 64 and 96 fl. oz. distributed 
by Buehler's,'Inc. Wooster, Ohio.
k) Cub Foods Orange Juice Pasteurized Not from Concentrate 64 fl. oz. 
distributed by Cub Foods Stillwater, MN 55082.
l) C-town Orange Juice Not from Concentrate 64 fl oz. distributed. by 
Alplha I Marketing Corp., White Plains, NY 10604.
m) Dominick's Premium Orange Juice Not From Concentrate, 96 fl. oz. 
distributed by Dominick's Finer Foods, Inc. Northlake, IL 60164
n) Finast Orchard Harvest Premium Pasteurized Orange Juice Not from 
Concentrate, Regular and Country Style, 64 and 96 fl. oz. distributed 
by Foodhold, USA, Inc., Atlanta, GA 30326.
o) Food Club Premium "Groves Best" Extra Pulp Added Orange Juice Not 
From Concentrate, 64 fl oz. and Food Club Premium Orange Juice Pulp 
Added Not from Concentrate 8 oz. and 64 fl. oz., distributed by Topco 
Assoc., Inc, Skokie, IL 60077.
p) Food Lion Premium Orange Juice Not From Concentrate, Also Includes 
the Label with "Country Style", 8, 32, 64, and 96 fl. oz., distributed 
by Food Lion, Inc., Salisbury, NC 28144.
q) Flavorite Premium Orange Juice Not From Concentrate, 64 fl. oz., 
distributed by Preferred Products, Inc., Eden Prairie, MN 55344.
r) Four Winds Farm Premium Florida Squeezed Orange Juice Not From 
Concentrate, 64 and 96 fl. oz., distributed by Staff Supermarket 
Associates, Norcross, GA. 30092.
s) Giant Eagle Orange Juice Premium Not From Concentrate, 64 and 96 fl. 
oz., distributed by Giant Eagle Inc. Pittsburgh, PA 
t) Golden Flow Premium Orange Juice Not From Concentration, 32 and 64 
fl. oz., distributed by Upstate Dairy Farm Corp., Brooklyn, NY 11205.
u) Grand Union Premium Orange Juice Not From Concentrate, and Grand 
Union Premium Orange Juice Country Style, Not From Concentrate. 64 oz. 
and 96 oz., distributed by Grand Union Co., Wayne, NJ. 07470.
v) Great Value Premium Florida Squeezed Orange Juice Not From 
Concentrate, 64 oz., Marketed by Wal Mart Stores, Inc., Bentonville, AR 
72716.
w) Hyde Park Florida Squeezed Orange Juice, Not From Concentrate, 64 
fl. oz., distributed by Fleming Co., Oklahoma City, OK 73126.
x) IGA Premium Orange Juice, Not From Concentrate, 64 fl. oz., 
distributed by IGA, Inc., Chicago, IL 60631.
y) Jitney Gold Original Not from Concentrate Orange Juice, Both 
"Original" in 64 and 96 oz. Containers and "Country Style" Not From 
Concentrate Orange Juice 64 oz. Container, "Packed Exclusively For:" 
Jitney Jungle Stores of America, 
Jackson, MS 39204.
z) Jus D'orange, Co-op, non Fait De Concentre, 1.89 Liter, Prepared for 
Interprovincial Coop, Ltd., Saskatoon, Canada.
aa) Kn'k Preferred Premium Original Orange Juice Not From Concentrate 
and Also Kn'k Preferred Premium More Pulp Orange Juice Not from 
Concentrate, 64 oz. proudly distributed by Kash n'Karry Tampa, FL.
bb) Kash n' Karry Premium Orange Juice Not From Concentrate, 96 fl. 
oz., proudly distributed by Kash n' Karry, Tampa, FL.
cc) Key Food Premium Orange Juice 64 fl. oz., Not From Concentrate, 
distributed by Key Food Stores Brooklyn, NY 11236.
dd) King Kullen Premium Orange Juice Not From Concentrate and King 
Kullen Premium Orange Juice Not From Concentrate with More Pulp, 32 and 
64 fl. oz. distributed by King Kullen Grocery Co, Inc. Westbury, NY 
11590.
ee) Lakewood Farms Orange Juice Not From Concentrate 64 fl. oz. Upstate 
Dairy Farms Corp, Brooklyn, NY Distributor.
ff) La Fe Orange Juice Pasteurized Not From Concentrate 64 fl. oz., 
distributed by G & T Foods Inc., North Bergen, NJ 07047.
gg) Meijer Orange Juice Florida Premium Not From Concentrate, 64 and 96 
fl. oz., distributed by Meijer, Inc. Grand Rapids, MI 49544.
hh) Nature's Nectar Premium Orange Juice 64 fl oz., distributed by 
Aldi, Inc., Batavia, IL 60510.
ii) Our Family Orange Juice Not From Concentrate 64 fl oz., distributed 
by Nash Finch Co., Minneapolis, MN 55435.
jj) Old Fashioned Master Choice Orange Juice Not From Concentrate, 64 
fl. oz., distributed by Complass Foods, Montvale, NJ.
kk) Old South Premium Orange Juice Not From Concentrate, both the 
regular and the "Country Style" 8 and 64 oz. distributed by Lykes Pasco 
Co., Dade City, FL 
ll) Orchard Hill Orange Juice Not From Concentrate 1.89L
mm) Pathmark, Premium Orange Juice 64 fl oz. packed by Pathmark Stores, 
Inc. Woodbridge NJ 07095
nn) Piggly Wiggly Orange Juice Not From Concentrate 64 fl. oz. 
distributed by Piggly Wiggly Corp, Memphis, TN 38101.
oo) Premium Choice Smooth and Also with Juicy Orange Bits Style, Orange 
Juice From Oranges Not From Concentrate 1 Liter, Power Supermarkets, 
produced for PC Brand, Gresham House Dublin and Belfast Ireland.
pp) Nature's Best Premium Orange Juice past. Not From Concentrate, 64 
fl. oz. distributed by Preferred Products, Inc. Eden Prairie, MN 55344
qq) Private Selection Country Style and Regular Style Orange Juice Not 
From Concentrate, 64 oz., distributed by Ralph's Grocery Co., Los 
Angeles, CA 90054.
rr) Pueblo Orange Juice Homestyle Extra Pulp Not From Concentrate, 64 
fl oz. distributed by Pueblo Intern. Carolina PR.
ss) Richfood Fine Beverages, Premium Orange Juice, 64 fl. oz. 
distributed by Richfood Inc., Richmond, VA 23261.
tt) River Valley Premium Orange Juice Not From Concentrate, 64 and 96 
fl. oz. packed for River Valley Foods, Inc., Syracuse, NY 13221.
uu) Roundy's Premium Orange Juice Not From Concentrate, 64 and 96 fl 
oz. distributed by Roundy's Inc, Milwaukee, WI 53201.
vv) Safeway Homestyle Orange Juice with Juicy Orange Bits Not from 
Conc. And Also Regular Style Orange Juice Not from Conc., 64 oz., 
distributed by Safeway, Inc. Pleasanton, CA 94566.
ww) Scwegmann Premium Orange Juice Not from Concentrate 64 fl oz., 
packed for Schwegmann Giant Super Markets New Orleans, LA 70126.
xx) Seaway Premium Florida Squeezed Orange Juice Not From Concentrate 
64 fl oz., distributed by American Seaway Foods, Inc. Cleveland, OH.
yy) Shoprite Premium Orange Juice Both the Regular and Country Style 
(With Pulp) Not from Concentrate, 64 fl. oz., distributed by Wakefem 
Food Corp. Elizabeth, NJ 07207.
zz) Shurfresh Brand Premium Orange Juice Not From Concentrate 64 fl. 
oz. distributed by Shurfine Intern., Inc. Northlake, IL 60164.
aaa) Smith's Premium Pasteurized Orange Juice 64 and 96 fl. oz., 
distributed by Smith's Food and Drug Centers, Salt Lake City, UT 84104
bbb) Southern Home Regular Style and Also Country Style with Added Pulp 
64 and 96 fl. oz., distributed by Southern Home Birmingham, AL 35201
ccc) Super a Premium Orange Juice Not from Concentrate Both Regular and 
Country Style (With Added Pulp), 64 fl oz. distributed by Associated 
Food Stores Inc., Jamaica, Long Island, NY
ddd) Thrifty Jus D'Orange Juice 1.89 Liter, prepared for Jace Holding 
Ltd., Victoria BC Canada
eee) Tops Pure Premium Orange Juice Original in 64 and 96 fl. oz. Sizes 
and Homestyle in 64 oz., distributed by Tops Market, Inc., Buffalo, NY 
14240.
fff) Ukrop's Premium Orange Juice Original Not From Concentrate, 64 fl. 
oz., proudly Offered by Ukrop's Super Markets, Inc. Richmond, VA 23236
ggg) Ultimate Choice Premium Orange Juice Not From Concentrate 64 fl. 
oz., distributed by SII, Northlake, IL 60164.
hhh) Western Beef Original Premium Orange Juice, 64 fl. oz. distributed 
by Western Beef Supermarkets, Inc. Ridgewood, NY 11385.
iii) Western Classics Premium Orange Juice 2.84 L prepared for Western 
Family Foods, Vancouver, BC Canada
jjj) World Classics, Premium Orange Juice Not From Concentrate, 64 fl. 
oz. and 96 fl. oz. distributed by World Brands, Inc. Skokie, IL 60076.
MANUFACTURER
Lykes Pasco Packing Company, Dade City, Florida.
RECALLED BY
Lykes Brothers, Inc., Tampa, Florida, by telephone beginning on 
February 16, 1999, followed by letter.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
Approximately 200,000 cases of various branded orange juice products 
were distributed.
REASON
Product is unfit for food due to fermentation.

________
PRODUCT
Cranberry Raspberry Diet Snapple Fruit Drink, in 16 fluid ounce glass 
bottles.  Recall #F-419-9.
CODE
JX06A9.
MANUFACTURER
Southeast Atlantic Beverage, Jacksonville, Florida (responsible 
contract manufacturer/bottler).
RECALLED BY
Snapple Beverage Corporation, Valley Stream, New York, by fax on 
February 8, 1999.  Completed recall resulted from sample analysis and 
follow-up by The State of Florida Department of Agriculture and 
Consumer Services.
DISTRIBUTION
Florida, South Carolina, Virginia, Tennessee, Georgia, North Carolina.
QUANTITY
1,244 cases were distributed.
REASON
Product may have been contaminated with mold.


RECALLS AND FIELD CORRECTIONS:
BIOLOGICS -- CLASS II
________
PRODUCT
Source Plasma.  Recall #B-784-9.
CODE
Unit numbers:  G6491-017, G6374-017, G6295-017.
MANUFACTURER
Plasma Biologicals Services, Owensboro, Kentucky (collection facility).
RECALLED BY
Interstate Blood Bank, Inc., Memphis, Tennessee, by letter dated March 
20 & 30, 1998, and June 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from an unsuitable donor.

________
PRODUCT
a) Red Blood Cells, Leukocytes Removed; b) Fresh Frozen Plasma.  Recall 
#B-785/786-9.
CODE
Unit #4166588.
MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY
Manufacturer, by letter dated October 22, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Alaska.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug Proscar.

________
PRODUCT
Red Blood Cells.  Recall #B-787-9.
CODE
Unit #4448886.
MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY
Manufacturer, by telephone on or about March 23, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled as CMV negative was not tested for CMV in 
accordance with the test kit manufacturer's instructions.

_______
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. 
Recall #B-788/789-9.
CODE
Unit numbers: 6007932, 6008397, 6009089, 4168205.
MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY
Manufacturer, by letter dated November 17 or 18, 1998, or by fax on 
November 19, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Alaska.
QUANTITY
4 units of each component were distributed.
REASON
Blood products were collected from a donor taking the drug Proscar.

________
PRODUCT
Whole Blood.  Recall #B-792-9.
CODE
Unit #1214312.
MANUFACTURER
Houchin Community Blood Bank, Bakersfield, California.
RECALLED BY
Manufacturer, by telephone on November 4, 1996.  Firm-initiated recall 
complete.
DISTRIBUTION
California.
QUANTITY1 unit was distributed.
REASON
Blood product was not labeled as having tested positive for CMV 
antibodies.


RECALLS AND FIELD CORRECTIONS:
BIOLOGICS -- CLASS III
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-783-9.
CODE
Unit #16KJ02628.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone on March 9, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASONBlood product was inappropriately prepared from 
a potentially traumatic collection.


RECALLS AND FIELD CORRECTIONS:
DEVICES -- CLASS II
________
PRODUCT
Carpal Tunnel Release System Handpiece.  Recall #Z-916-9.
CODE
Catalog #81014, All Serial numbers 3106 through 3288, and 3400 through 
3519, inclusive.
MANUFACTURER
3M Health Care, Irvine, California.
RECALLED BY
Microaire Surgical Instruments, Inc., Charlottesville, Virginia, by 
letter April 16, 1999, followed by telephone. Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide, France, Germany.
QUANTITY
196 units were distributed.
REASON
Units exhibited sticking trigger linkage pins due to rust.

________
PRODUCT
Chiron Diagnostics Rapidpoint 400 Blood Gas Analyzer System, critical 
care diagnostic information system that provides rapid blood analysis 
for bedside, near patient or alternate site testing.  Recall #Z-921-9.
CODE
Serial numbers.
02087, 02207, 02229, 02296, 02233, 02254, 02266, 02255, 02288, 02292, 
02297, 
02311, 02328, 02329, 02324, 02327, 02334, 02335, 02337, 02339, 02341, 
02345, 
02351, 02355, 02243. 
MANUFACTURER
Chiron Diagnostics Corporation, Medfield, Massachusetts.
RECALLED BY
Manufacturer, by letter on March 24, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
California, Florida, Georgia, Illinois, New York, 
New Hampshire, Oklahoma, Oregon, Texas and international.
QUANTITY
24 units were distributed.
REASON
Rapidpoint 400 measurement cartridges for pO2 may calibrate at an 
incorrect level and result in understating/overstating patient p02 
values.

________
PRODUCT
Yasargil Titanium Aneurysm Clips, Model FT728T, used for permanent 
occlusion of cerebral aneurysms.  Recall #Z-922-9.
CODE
All lot numbers--Blade length 7mm, Mini, Permanent, and 
Bayonet (all remaining patterns and sizes of the product 
are not affected).
MANUFACTURER
Aesculap AG & Company, KG, Germany.
RECALLED BY
Aesculap, Inc., South San Francisco, California, by letter and 
telephone on April 30, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
58 units were distributed.
REASON
Blades may have a potential for not being properly aligned 
(scissoring).

________
PRODUCT
E2608-6 Handswitching Suction Coagulator, intended for use in surgical 
procedures requiring controlled fluid evacuation coupled with 
electrosurgical coagulation.  Recall #Z-924-9. CODE
Lot Nos. 35831, 35832, 36117, 36940, 37526, 38179.
MANUFACTURER
Valleylab Inc., Boulder, Colorado.
RECALLED BY
Manufacturer, by letter on April 16, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
507 cases (25 units per case) were distributed.
REASON
The coagulator remained activated after the activation button was 
released.

________
PRODUCT
Modified Leveen Needle Electrode, Model LE3515.
Recall #Z-925-9.
CODE
Lot #012499.
MANUFACTURER
Radiotherapuetics Corporation, Mountain View, California.
RECALLED BY
Manufacturer, by letter dated April 27, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide, Italy, Japan.
QUANTITY
71 units were distributed.
REASON
Product has the potential to abrade the tissue.


END OF ENFORCEMENT REPORT FOR MAY 26, 1999.


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