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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
July 4, 2007
07-27
___________________________________
PRODUCT
a) Wilton Premium Dark Cocoa Candy Melts for Making Homemade Candy, packaged
in 12 oz.
plastic bags; UPC 0 70896 19411 4 and 0 70896 19456 5, Recall
# F-358-7;
b) Wilton Dark Cocoa Candy Melts, packaged in 14 oz. plastic bags; UPC 0 70896
19451 0 and
0 70896 19358 2, Recall # F-359-7;
c) Wilton Dark Cocoa Mint Flavored Candy Melts, packaged in 14 oz. plastic
bags;
UPC 0 70896 11920 9, Recall # F-360-7
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wilton Industries, Inc., Woodridge, IL, by press release,
telephone or e-mail beginning on April 20, 2007.
Manufacturer: Clasen Quality Coatings, Inc., Middleton, WI. Firm initiated
recall is complete.
REASON
The dark cocoa candy melts may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
1,787,662 packages
DISTRIBUTION
Nationwide, including PR and Canada
_________________________________
PRODUCT
Gurley's Golden Recipe All Natural Cranberry Trail Mix. Ingredients: raisins,
dates, peanuts, natural almonds, sunflower meats, pumpkin meats, cranberries,
cashews, peanut oil, sea salt, in 7.25-oz. packages. No preservatives added,
Recall # F-361-7
CODE
0508, 0608, 0618, 0678, 0758, 0888, 0898, 0938, 1158
RECALLING FIRM/MANUFACTURER
Willmar Cookie and Nut Co., Inc., Willmar, MN, by press release, letter, telephone
or email on May 8, 2007. Firm initiated recall is ongoing.
REASON
Golden Recipe Cranberry Trail Mix contains undeclared sulfites based on the
New York State Department of Agriculture and Markets’ analysis.
VOLUME OF PRODUCT IN COMMERCE
1,121 cases (8 pkgs/case)
DISTRIBUTION
AL, AR, MA, ME, MN, NC, OH, OR, SD, VA, VT, WA, WI, WV
___________________________________
PRODUCT
a) Dark Chocolate Clusters, The Ultimate Walnut Cherry Caramel Indulgence in
green and
cream striped boxes with a folded over top. Net wt 6 oz
(170 g). SKU 109000,
Recall # F-362-7;
b) Dark Chocolate Clusters, The Ultimate Peanut & Peanut Butter Indulgence
in red and cream
striped boxes with a folded over top. Net wt 6 oz (170 g).
SKU 108980, Recall # F-363-7;
c) Dark Chocolate Clusters, The Ultimate Pecan Cranberry Caramel Indulgence
in dark red
and cream striped boxes with a folded over top. Net wt 6
oz (170 g). SKU 108997,
Recall # F-364-7;
d) Whole Almond Confection in brown and white striped boxes with a folded over
top.
Net wt 6 oz (170 g). SKU 109024, Recall # F-365-7;
e) Whole Cashew Confection in dark red and cream striped boxes with a folded
over top.
Net wt 6 oz (170 g). SKU 109031, Recall # F-366-7
CODE
All lot codes up to and including expiration code 'BEST BEFORE 071123';
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bear Creek Operations, Inc. DBA Harry and David, Medford, OR,
by e-mail on April 3, 6, and 13, 2007, and by press release on April 6, 2007.
Manufacturer: Cherrydale Farms Inc., Allentown, PA. Firm initiated recall
is complete.
REASON
Products contain undeclared tree nuts and peanuts.
VOLUME OF PRODUCT IN COMMERCE
30,086 boxes of clusters
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Standard Sweets and Snacks brand Mango Burfee, Net Wt. 14 OZ. Product is packaged
in a clear, plastic container and has a red, blue and white stick-on label
with the following ingredients listed: milk, sugar, oil, yellow, green color,
Recall # F-381-7
CODE
No code
RECALLING FIRM/MANUFACTURER
Standard Sweets Corp, South Ozone Park, NY, by Consumer Alert, on January 10,
2007 and by visit beginning on January 15, 2007. Firm initiated recall is complete.
REASON
The product contained undeclared almonds based on sampling, analysis, and inspectional
findings by New York State Department of Agriculture and Markets. This product
also contained undeclared colors, FD&C Yellow 5 and FD&C Blue 1.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY City
___________________________________
PRODUCT
Fortune Star brand Dried Lily Bulb, 10 oz. (283 g +- 5 g). The product is packaged
in a sealed plastic bag. The front of package is labeled in red and black print
in part as follows: "*** DRIED LILY BULB *** 10 oz (283 g +-5 g) *** PRODUCT
OF CHINA *** 6 64460 10443 4 *** Nutrition FACTS Serving Size 5.3 (150g) ---
Servings Per Container 1 ***". The product is also labeled in Chinese.
UPC bar code 6 64460 10443 4, Recall # F-382-7
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ho's Trading, Inc., Brooklyn, NY, by press release on February 5, 2007. Firm
initiated recall is complete.
REASON
The product contains undeclared sulfites (836 ppm) based on sampling & analysis
by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
11 cases (10 oz. x 50 bags)
DISTRIBUTION
NY, FL, GA, KS, KY, MA, NH, MN, NC, TN, TX, VA, & WI
___________________________________
PRODUCT
Ying Feng Foodstuffs brand Melon Candy, Net Wt. 12 oz. The product is packaged
in plastic tray within a plastic bag. Front of package is labeled, "YING
FENG FOODSTUFFS *** MELON CANDY *** Net Wt: 12oz (340g) *** YING FENG FOODSTUFFS
CO. LTD." Back of package is labeled in part, " ** PRODUCT
OF P.R.C., *** Expirationo: 24Months *** Nutrition Facts: Serving Size 1oz(28g)
--- Servings Per Container 6g ***" UPC barcode # 6 911749 380619, Recall
# F-383-7
CODE
UPC coding only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fine Land Corp., Brooklyn, NY, by Consumer Alert, on January
24, 2007.
Manufacturer: Ying Feng Foodstuffs Co., LTD, Jiangmen, China. Firm initiated
recall is complete.
REASON
The product contains undeclared sulfites (682 ppm) based on sampling & analysis
by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
42 cases (60 x 5.3 oz. packages)
DISTRIBUTION
NY City area
___________________________________
PRODUCT
a) Deluxe Potato Salad, packaged in two sizes; Net Wt. 16 oz. in clear plastic
tub, 12 tubs per case
and Net Wt. 8 lbs. size packaged in plastic bag, 4 bags
per case; Ingredients: potatoes, eggs,
salad dressing, etc. Consumer labels under the following
brands: Midwest Pride (UPC 33147 00007),
Coborns and Cashwise (UPC 33147 00013). The master carton
label has DBC Foods on Coborns
& Cashwise cases; All labels – Distributed by
J & B Group, Recall # F-384-7;
b) Homestyle Potato Salad, packaged in two sizes; Net Wt. 16 oz. in clear plastic
tub, 12 tubs
per case and Net Wt. 8 lbs. size packaged in plastic bag,
4 bags per case; Ingredients: potatoes,
salad dressing, water, sugar, etc. Consumer labels under
the following brands: Midwest Pride
(UPC 33147 00007), Coborns and Cashwise (UPC 33147 00013);
Coborns & Cashwise cases;
All other labels have Distributed by J & B Group. UPDATE:
The firm expanded the recall to
include all lots of potato salad on 3/20/07. This added
an additional label: Aunt Mabels
(UPC 33147 00001) sold in 2 lb tubs, 6-2lbs containers per
case. The master carton label has
Dist. by: DBC Foods on Aunt Mabel’s label, Recall
# F-385-7
CODE
The recall includes lots 7057011 through 7075020 (lots are in numerical order).
RECALLING FIRM/MANUFACTURER
Coborn’s, Inc., Saint Cloud, MN, by letters on March 15, 2007, telephone
on March 15, 2007 and March 20, 2007, media advisory on March 20, and by press
release on March 16, and March 23, 2007. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes based on sampling and
analysis by the Minnesota Department of Agriculture..
VOLUME OF PRODUCT IN COMMERCE
3,428 lbs.
DISTRIBUTION
IA, MN, MI, NE, ND, SD, WI
___________________________________
PRODUCT
a) Ballard’s Farm Egg Salad, 12 ounce clear plastic cups, packed 6 cups/case;
Food City 'Premium' Egg Salad, 12 ounce clear plastic cups,
packed 12 cups/case;
Valu Time Egg Salad, 11 ounce clear plastic cups, packed
12 cups/case, Recall # F-428-7;
b) Ballard’s Farm Cole Slaw, 12 ounce clear plastic cups, packed 12 cups/case
and 2 lb. tubs
packed 6 tubs/case; and Ballard’s Farm Amish Sweet
Slaw, in 24 ounce clear plastic cups,
6 cups/case. Recall # F-429-7;
c) Ballard’s Farm Amish Macaroni Salad, in 24 ounce clear plastic cups,
6 cups/case,
Recall # F-430-7
CODE
All date codes prior to expiration date code 12/14/06
RECALLING FIRM/MANUFACTURER
Ballard, Wayne, WV, by press releases and faxes on October 17, October 21,
and October 25, 2006. Firm initiated recall is complete.
REASON
North Carolina Department of Agriculture and Consumer Services analyzed egg
salad, slaw, and macaroni salad products collected from retail shelves and
found the products contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
12,000 cases
DISTRIBUTION
WV, OH, PA, NY, NJ, VA, NC, SC, TN, GA, MI, KY, IN, AL, DE, IL, and FL
____________________________________
PRODUCT
a) Del Destino Brand Green Cerignola Olives glass jars Net Drained Weight 13.04
oz. (370g).
Product of Italy; UPC 0 71270 35520 6; Product number 055979,
Recall # F-326-7;
b) Bonta di Puglia Italian Green Cerignola Olives 3 kg pouch. Product of Italy,
Product # 057502,
Recall # F-327-7;
c) Del Destino Black Cerignola Olives 2.5 kg tin. Product of Italy, Product
# 057598,
Recall # F-328-7;
d) Del Destino Red Cerignola Olives 2.5 kg tin. Product of Italy, Product #
057597,
Recall # F-329-7;
e) Del Destino Brand Green Cerignola Olives 2.5 kg tin. Product of Italy, Product
code 057887,
Recall # F-330-7;
f) Del Destino Brand Cerignola Red Olives 3.1 ltr. glass jar, Product of Italy,
Product code 057596,
Recall # F-331-7
CODE
All lots starting with G (indicates 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atalanta Corp., Elizabeth, NJ, by letter on April 20,
2007.
Manufacturer: Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy.
Firm initiated recall is complete.
REASON
The product was manufactured under conditions whereby it may have been rendered
hazardous to health. It may not be adequately processed to prevent the growth
of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
a) 61 cases of 6 x 13/4 oz. glass jars;
b) 10 cases of 2 x 3 kg pouches;
c) 12 cases of 4 x 2.5 kg tins;
d) 3 cases of 4 x 2.5 kg tins;
e) 12 cases of 4 x 2.5 kg tins;
f) 45 cases of 2 x 3.1 ltr glass jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Product is Lemon Bar (no product label) to be sold in retail store bakery
case.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates.
Product is delivered to retail store in sheet pan and sliced
by retail store for sale to consumer.
Recall # F-367-7;
b) Product is Marionberry Pie (no product label) to be sold in retail store
bakery case.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates.
Product is delivered as whole pie in tin pie plate, and
is sliced by retail store for sale to consumer.
Recall # F-368-7;
c) Product is Apple Pie (no product label) to be sold in retail store bakery
case.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates.
Product is delivered as whole pie in tin pie plate, and
is sliced by retail store for sale to consumer.
Recall # F-369-7;
d) Product is Blueberry Pie (no product label) to be sold in retail store bakery
case.
Ingredient list is supplied with order and states
'Greenleaf Baked Desserts Fine Chocolates.
Product is delivered as whole pie in tin pie plate,
and is sliced by retail store for sale to
consumer. Recall # F-370-7;
e) Product is Espresso Chip Brownies (no product label) to be sold in retail
store bakery case.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates.
Product is cut/sliced and delivered in covered container
to retail store. Retail store places
cut/sliced brownies on glass plate store for sale to consumer,
Recall # F-371-7;
f) Product is Chocolate Fudge Cake (no product label), two tiered cake packed
in cardboard
box for delivery. Whole cake is placed on glass plate and
sliced for sale by individual pieces
to consumer in retail store bakery case. Ingredient list
is supplied with order and states
'Greenleaf Baked Desserts Fine Chocolates, Recall # F-372-7;
g) Product is Peanut Butter Dreams (no product label) to be sold in retail
store bakery case.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates.
Product is peanut butter filled chocolate cups in paper
'candy cups'. Product is delivered in
covered container to retail store. Retail store places 'candy
cups' onto display tray for individual
sale to consumer. Recall # F-373-7;
h) Product is Grand Marnier Chocolate Truffle (no product label) to be sold
individually or in
boxes containing 4, 8, 16, or 32 truffles in retail store
bakery case. Retailer boxes truffles as needed.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates,
Recall # F-374-7;
i) Product is Amaretto Chocolate Truffle (no product label) to be sold individually
or in boxes
containing 4, 8, 16, or 32 truffles in retail store bakery
case. Retailer boxes truffles as needed.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates,
Recall # F-375-7;
j) Product is Kahlua Chocolate Truffle (no product label) to be sold individually
or in boxes
containing 4, 8, 16, or 32 truffles in retail store bakery
case. Retailer boxes truffles as needed.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates,
Recall # F-376-7;
k) Product is Rum Chocolate Truffle (no product label) to be sold individually
or in boxes
containing 4, 8, 16, or 32 truffles in retail store bakery
case. Retailer boxes truffles as needed.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates,
Recall # F-377-7;
l) Product is All Chocolate Truffle (no product label) to be sold individually
or in boxes
containing 4, 8, 16, or 32 truffles in retail store bakery
case. Retailer boxes truffles as needed.
Ingredient list is supplied with order and states 'Greenleaf
Baked Desserts Fine Chocolates,
Recall # F-378-7
CODE
No codes are used on product.
RECALLING FIRM/MANUFACTURER
Green Leaf Chocolates, by telephone on March 29, 2007 and by press release
on April 2, 2007. Firm initiated recall is complete.
REASON
Misbranded. Undeclared allergen, milk not declared as source ingredient for
butter.
VOLUME OF PRODUCT IN COMMERCE
16 bars; 3 pies; 25 individual brownies; 1 cake; 60 candy cups; 152 truffles
DISTRIBUTION
WA
___________________________________
PRODUCT
Valle Verde brand Cotija cheese, distributed as wheels packed in plastic bags
(approx 60 LBS ea.), cut portions wrapped in plastic (approx. 1 LB ea.), and
grated packed in plastic bags (approx 3 5 LBS ea.), all further packed in
labeled cardboard shipping cartons. FOODS KEEP REFRIGERATED, Recall # F-380-7
CODE
Hand written on shipping cartons '380-40', '380', and unidentified cartons.
'380' represents a sequential production batch number. '40' is the number of
approximate 60 LB cheese wheels produced under lot number 380. Unidentified
cartons are included in the recall because the firm does not consistently identify
each carton with a production code. The finished product has an approximate
6 month shelf life.
RECALLING FIRM/MANUFACTURER
Green Valley Foods Products, Inc. dba Valle Verde Foods, Barstow, CA,
by letter on March 21, 2006. Firm initiated recall is ongoing.
REASON
Staphylococcus aureus was found in sample at levels up to 110,000 MPN / gram.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,400 pounds
DISTRIBUTION
WA, OR, and CA
___________________________________
PRODUCT
a) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
brand name Oroweat and include:
Potato Bread, 100% Whole Wheat Bread, Oatnut Bread, Wheatberry
Bread, Buttermilk Bread,
Wide Pan Raisin Bread, Country White Bread, Healthnut Bread,
Country 100% Whole Wheat Bread,
Whole Grain White Bread, Whole Grain Oat Bread, Seven Grain
Bread, and 12 Grain Bread –
all 24 oz in plastic bag; Jewish Rye Bread, Russian Rye
Bread, Swarzwalder Dark Rye Bread –
all 16 oz wrapped in plastic film; 6-pack Sour Dough Muffins,
12.5 oz plastic bag; 6-pack Raisin
Muffin, 14.5 oz plastic bag; 6-pack Extra Crisp Muffin,
12.5 oz plastic bag; Double Pack Country
Potato Bread, and Double Pack Stoneground Wheat Bread --
both 48 oz in plastic bag; Onion Buns
Hamburger Buns, Golden Egg Hamburger Buns, and Cracked Wheat
Hamburger Buns –
all 8-pack, 21 oz. in plastic bags; 100% Whole Wheat Muffins,
6-pack 12.5 oz in plastic bag;
Muffin Healthnut, 6-pack 14 oz in plastic bag; Gourmet Sesame
Hot Dog Buns, 14-oz. in
plastic bag; 7 Grain Hamburger Buns 4-pack; and Oatnut Hamburger
Buns, 4-pack, both 11-oz.
in plastic bags. Orowheat Brand products sold only to institutions:
Jasons Deli Rye Bread, 32-oz.;
Sliced Sour Dough Bread, 40-oz.; Round Top White Bread,
24-oz; 4-inch Special Hamburger Buns,
6-pack, 16-oz; and Brannola Wheat Bread, 24-oz -- all in
plastic bags, Recall # F-386-7;
b) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
brand name Francisco and include
the following: Sliced Square Sour Dough Bread, 24 oz; 6-pack
French Rolls, 17 oz.;
10-pack 3-inch French Rolls, 12 oz.; 6-pack 6-inch Whole
Grain Rolls, 17 oz.; and Whole Grain
Bread, 16 oz -- all in plastic bags, Recall # F-387-7;
c) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at
that facility on December 23, 2006. Products involved have
the Mrs. Baird’s brand name,
a Best By date of 1/5/2007, and include the following: 12-pack
Junior Hamburger Buns, 21.75 oz;
Honey 7-Grain Bread, 1-1/2 lb. Split Top Wheat Bread, 1-1/2
lb. 100% Wheat Round Top Bread,
1-1/2 lb. Honey Wheat Bread, 1-1/2 lb. Xtra-Thin Bread,
1-1/2 lb. Large Bread, 1-1/2 lb.
Texas Slice Bread, and Harvest Select 100% Whole Grain Bread;
-- all 24-oz. in plastic bags;
Sugar Free 100% Wheat Bread, and 1 lb. Small Bread, both
16-oz in plastic bags; Home Bake
Rolls, 12-oz. in plastic bag; 8-pack Coneys (Hot Dog Bun),
11.75 oz. in plastic bag; 8-pack
4 Inch Hamburger Buns, 14 oz.; 8-pack 4-1/2 Inch Hamburger
Buns, 18.25 oz.; 8-pack 4-1/2 Inch
Sesame Seed Hamburger Buns, 18.25 oz.; 20-pack 4-1/2 Inch
Premium Sesame Seed Hamburger
Buns, 47 oz. all in plastic bags; 6-pack 4.5 Inch Honey
7-Grain Bun, 11 oz.; 6-pack 4.5 Inch
100% Whole Grain Bun, 16 oz; 100% Whole Grain Dinner Rolls,
16.5-oz.; and Whole Grain
White Dinner Rolls, 16.5 oz. all in plastic bags. Additional
products involved have the
Mrs. Baird’s brand name, a Best By date of 1/7/2007
and include the following: Cluster
Cinnamon Rolls, 13 oz.; Powdered Sugar Donut Bag, 19.5 oz;
20-pack Snack Bag Powder
Donut, 10 oz.; 20-pack Snack Bag Chocolate Donut, 11.25
oz; and 20-pack Snack Bag
Cinnamon Donut, 10 oz.. all in plastic bags.; 5-pack Boxed
Apple Pies, 16.25 oz; 5-pack
Boxed Cherry Pies, 16.25 oz; Powder Sugar Donut Dots, 12-oz.;
Classic Donut Plain, 8.5 oz.;
Multi-pack Strawberry Pie, 16.3 oz.; and 3-Count Snack Donut
Powdered, 9 oz. all in boxes,
Recall # F-388-7;
d) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Entenmanns’s brand name, a Best By
date of January 5, 2007, and include the following: 8-pack
Frosted Chocolate Donuts, 19 oz.;
8-pack Glazed Butter Milk Donuts, 18 oz.; 8-pack Rich Frosted
Donuts Chocolate, 16-oz.;
Danish Twist Raspberry, 15-oz.; Danish Ring Pecan, 12-oz.;
Three Pack Cinnamon Roll, 12 oz.;
12-pack Donut Softee Variety, 22 oz.; 8-pack Variety Pack
Donuts, 16 oz.; Cheese Filled Crumb
Strip Danish, 16 oz.; Danish Twist Cheese, 16 oz.; Cheese
Topped Coffee Cake, 18 oz.; 5-pack
Little Bites Muffin Blueberry, 8.75 oz.; 5-pack Little Bites
Brownie, 11 oz.; 5-pack Little Bite
Chocolate Chip Mini Muffin, 8.75 oz.; New York Crumb Coffee
Cake, 16 oz.; Snack Bag Powder
Popettes (Mini Donuts), 10-oz.; and Snack Bag Chocolate
Popettes (Mini Donuts), 11.5oz. –
all in boxes, Recall # F-389-7;
e) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Thomas brand name, a Best By date
of January 5, 2007, and include the following: 6-pack English
Muffin Honey Wheat, 12 oz.;
6-pack New York Bagel Cinnamon, 22 oz.; 6-pack New York
Bagel Blueberry, 22 oz.;
6-pack New York Bagel Multi Grain, 22 oz.; 6-pack English
Muffin Sour Dough, 12 oz.;
6-pack English Muffin White, 12 oz.; 6-pack English Muffin
Raisin, 13 oz.; 6-pack New York
Bagel White, 22 oz.; 6-pack New York Bagel Cinnamon Raisin,
22 oz.; 6-pack English Muffin
Hearty Grains 100% Whole Wheat, 13 oz.; 6-pack Hearty Grains
Multi Grain Muffin, 12 oz.;
100% Whole Wheat Bagel, 22 oz.; 100% Whole Wheat Mini Bagel,
20 oz.; Mini Bagel
Cinnamon, 20 oz.; Mini Bagel Plain, 20 oz.; Lite Multi Grain
Muffin, 12 oz.; 6-pack Whole
Grain English Muffin, 12 oz.; 6-pack Whole Grain Bagel,
22 oz.; 6-pack Plain Bagel Square,
22 oz.; 6-pack Everything Bagel Square, 22 oz.; 6-pack Whole
Wheat Bagel Square, 22 oz.;
and 6-pack 100 Calorie Muffin, 12 oz. -- all in plastic
bags, Recall # F-390-7;
f) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Boboli brand name, a Best By date
of January 31, 2007, and include the following: Single 12-inch
pizza crust, 16 oz.;
Pizza Sauce Large, 15 oz.; and Thin Crust 12-inch pizza
crust, 10 oz.; and 2-pack 8-inch
Crust Twin, 10 oz. -- all in plastic bags, Recall # F-391-7;
g) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received
at that facility on December 23, 2006. Products involved
have the Tia Rosa brand name,
a Best By date of January 10, 2007, and include the following:
10-pack Tortilla Premium Flour,
17.6 oz.; 8-pack Tortilla Burrito Flour, 20 oz.; 12-pack
Homestyle Tortilla Flour, 18 oz.;
36-pack Tortilla White Corn, 30 oz.; 24-pack Tortilla Yellow
Corn, 20 oz.; 10-pack Tortilla
98 Fat Free Whole Wheat, 16 oz.; and 90-pack Tortilla Family
Pack White Corn, 82.5 oz –
all in plastic bags, Recall # F-392-7;
h) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Bimbo brand name, a Best By date of
January 5, 2007, and include the following: 8-pack 4-inch
Cluster Sesame Hamburger Buns,
12 oz.; and 8-pack Hot Dog Buns, 12 oz. -- both in plastic
bags, Recall # F-393-7;
i) All baked products shipped to Bimbo Bakeries Kansas City distribution
center, received at that
facility on December 23, 2006. Products involved have the
Old Country brand name, a Best By
date of January 5, 2007, and include the following: 18-inch
French Stock White Bread, 16 oz.;
Restaurant and Institutional Hearth Rye Bread, 32 oz.; 2-pack
12-inch French Stick Bread, 15 oz.;
and 6-pack 5-inch Kaiser White Hamburger Buns, 18 oz. --
all in plastic bags. All of these products
are sold only to restaurants and institutions, Recall #
F-394-7;
j) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Market Pantry brand name, a Best By
date of January 5, 2007, and include the following: White
Bread Large, 24oz.; White Sandwich
Bread, 24 oz.; Wheat Sandwich Bread, 24 oz.; Old Fashion
Wheat Bread, 24 oz.; 8-pack Hamburger
Buns, 12 oz.; 8-pack Hot Dog Buns, 12 oz.; Whole Wheat Bagels,
20 oz.; Plain Bagels, 20 oz.;
Cinnamon Raisin Bagels, 20 oz.; Plain English Muffins, 12.5
oz.; and Whole Wheat English Muffins,
12.5 oz. -- all in plastic bags. The Market Pantry brand
products are sold to only one customer,
Recall # F-395-7;
k) All baked products shipped to Bimbo Bakeries Kansas City distribution center,
received at that
facility on December 23, 2006. Products involved have the
Archer Farms brand name,
a Best By date of January 5, 2007, and include the following:
Multi Grain Bread, 24 oz.;
100% Whole Wheat Bread, 24 oz.; Buttermilk Bread, 24 oz.;
Honey Oatmeal Bread, 24 oz.;
Honey Whole Wheat Bread, 24 oz.; and Potato Bread, 24 oz.
-- all in plastic bags.
The Archer Farms brand products were sold to only one customer,
Recall # F-396-7;
CODE
a), b), d) Best By January 5, 2007
c) Best By January 5, 2007; and Best By January 7, 2007.
e), h), i), j), and k) Best By 1/5/2007
f) Best By 1/31/2007
g) Best By 1/10/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bimbo Bakeries USA, Inc., Fort Worth, TX, by letter on
December 28, 2006.
Manufacturer: Bimbo Bakeries USA Inc., Montebello, CA. Firm initiated
recall is ongoing.
REASON
Product is contaminated with hydrocarbon vapors from floor sealant used in
the plant.
VOLUME OF PRODUCT IN COMMERCE
20,519 units
DISTRIBUTION
KS and MO
___________________________________
PRODUCT
a) 100% Orange Juice Mix Ratio 3 + 1, packaged in 2 and 3 gallon containers (256
fl. oz. and
384 fl. oz.), manufactured by JUS-MADE, LP., Dallas, TX 75220,
under the following
brand names: Jus-Made Naturals, Fruit Drinks, Kahlua Bay,
Clifford Distribution, Frullati Cafe,
and Subway Natural, Recall # F-397-7;
b) 100% Orange Juice, Mix Ratio 4 + 1, packaged in 1 gallon (123 fl. oz.) and
3 gallon (384 fl. oz.)
containers, manufactured under the following brand names:
Jus-Made, Harvest Fresh Juice,
Shur-Flow (Austin), Shur-Flow (San Antonio), Blue Duck, B & Q
Distributing, and Wild
Tropics, Recall # F-398-7;
c) 100% Orange Blend (80% orange juice / 20% pineapple), Mix Ratio 4 + 1, packaged
in a
3-gallon container, manufactured under the brand name Best
Juice Distributors, Recall # F-399-7;
d) 100% Orange Blend Juice, Mix Ratio 4 + 1, packaged in 1.32 gallon (169 fl.
oz) 5 Liter
containers, manufactured by Jus-Made, Dallas TX 75220 under
the brand name of Vitaflo,
Recall # F-400-7;
e) 100% Orange Juice and Orange Blend, Mix Ratio 5 + 1, packaged in 1/2 gallon
containers
(64 fl. oz.) 1.8925 liters, manufactured under the following
brand names: Sunbeam Foods, Inc.
and Marvel Products, Recall # F-401-7;
f) 100% Juice Orange Mango, Mix Ratio 5 + 1, packaged in 1/2 gallon containers
(64 fl. oz.)
1.8925 Liters, manufactured by JUS-MADE, LP., Dallas, TX 75220,
under the brand name
Tropical Flurry, Recall # F-402-7;
g) 100% Orange Strawberry Banana Blend Juice, Mix Ratio 5 + 1, packaged in 1/2
gallon containers
(64 fl. oz.) 1.8925 Liters, manufactured under the Sunbeam
Foods, Inc. brand name,
Recall # F-403-7;
h) 100% Apple Juice, Mix Ratio 3 + 1, packaged in 3 gallon containers, manufactured
under
the Frullati Cafe brand name, Recall # F-404-7;
i) 100% Apple Juice, Mix Ratio 4 + 1, packaged in 3 gallon containers (384
fl. oz.) 11.355 Liters,
manufactured under the Blue Duck brand name, Recall # F-405-7;
j) 100% Green Apple Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon containers
(64 fl. oz.)
1.8925 Liters, manufactured under the Tropical Flurry brand
name, Recall # F-406-7;
k) 100% Apple Blend Juice, Mix Ratio 4 + 1, packaged in 1.32 (169 fl. oz.) 5
Liters and 3 gallon
(384 fl. oz.) 11.355 Liters containers, manufactured under
the Vitaflo brand name,
Recall # F-407-7;
l) 100% Apple Blend Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter
and 3 gallon (384 fl. oz.) 11.355 Liter containers, manufactured
under the following brand names:
Marvel Products, Sunbeam Foods, Inc., Harvest Fresh Juice,
Blue Duck, and Best Juice
Distributors, Recall # F-408-7;
m) 100% Cran-Apple Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl.oz.)
1.8925 Liter
containers, manufactured under the Sunbeam Foods brand name,
Recall # F-409-7;
n) 100% Grape Juice, Mix Ratio 4 + 1, packaged in 3 gallon (384 fl. oz.) 11.355
Liter containers,
manufactured under the following brand names: Blue Duck and
Harvest Fresh Juice,
Recall # F-410-7;
o) 100% Concord Grape Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl.
oz.) 1.8925 Liter
containers, manufactured under the following brand names:
Sunbeam Foods, Inc., Tornado Slush,
and Tropical Flurry, Recall # F-411-7;
p) 100% White Grape Juice, Mix Ratio 4 + 1, packaged in 3 gallon (384 fl. oz.)
11.355 Liter
containers, manufactured under the Vitaflo brand name, Recall
# F-412-7;
q) 100% White Grape Juice and White Grape Blend, Mix Ratio 5 + 1, packaged in
1/2 gallon
(64 fl. oz.) 1.8925 Liter containers, manufactured under the
following brand names:
Marvel Products and Sunbeam Foods, Inc., Recall # F-413-7;
r) 100% Strawberry Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter containers,
manufactured under the following brand names: Tornado Slush
and Tropical Flurry,
Recall # F-414-7;
s) 100% Strawberry-Kiwi Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl.
oz.) 1.8925 Liter
containers, manufactured under the Tornado Slush brand name,
Recall # F-415-7;
t) 100% Strawberry-Banana Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64
fl. oz.) 1.8925 Liter
containers, manufactured under the Tropical Flurry brand name,
Recall # F-416-7;
u) 100% Lemon Lime Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter
containers, manufactured by JUS-MADE, LP., Dallas, TX 75220,
under the Tornado Slush
brand name, Recall # F-417-7;
v) 100% Lemonade Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter containers,
manufactured under the Tornado Slush brand name, Recall #
F-418-7;
w) 100% Cherry Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.) 1.8925
Liter containers,
manufactured under the Tornado Slush brand name, Recall #
F-419-7;
x) 100% Clear Cherry Juice and Clear Cherry Blend, Mix Ratio 5 + 1, packaged
in 1/2 gallon
(64 fl. oz.) 1.8925 Liter containers, manufactured under the
following brand names:
Marvel Products and Sunbeam Foods, Inc., Recall # F-420-7;
y) 100% Blue Raspberry Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl.
oz.) 1.8925 Liter
containers, manufactured under the Tornado Slush and Tropical
Flurry brand names,
Recall # F-421-7;
z) 100% Mixed Berry Juice, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter containers,
manufactured under the Sunbeam Foods, Inc. brand name, Recall
# F-422-7;
aa)100% Prune Juice, Mix Ratio 3 + 1, packaged in 3 gallon (384 fl. oz.) 11.355
Liter containers,
manufactured under the Blue Duck and Wild Tropics brand
names, Recall # F-423-7;
bb) 100% Berry Punch, Mix Ratio 4 + 1, packaged in 1 gallon (128 fl. oz.) 3.785
Liter containers,
Recall # F-424-7;
cc) 100% Citrus Punch, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.) 1.8925
Liter containers,
manufactured under the Tornado Slush brand name, Recall
# F-425-7;
dd) 100% Punch, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.) 1.8925 Liter
containers,
manufactured under the Sunbeam Foods, Inc. brand name,
Recall # F-426-7;
ee) 100% Clear Fruit Punch, Mix Ratio 5 + 1, packaged in 1/2 gallon (64 fl. oz.)
1.8925 Liter
containers, manufactured under the Sunbeam Foods Inc.
and Marvel Products brand names,
Recall # F-427-7
CODE
a) Lot numbers: 61109108, 61116186, 70205009, 61003021, 61116186, 70205009, 61031359,
and 70206031;
b) Lot numbers: 61012116, 61109093, 61113132, 61127232, 70205009;
c) Lot number 61113132;
d) Lot numbers: 61106029, 61106032, 61228185, and 70111175;
e) Lot numbers: 61019204, 61121223, 61215057, 70103054, and 70130333;
f) Lot numbers 70109122 and 70115202;
g) Lot numbers 70103055, 61024242, and 61215069;
h) Lot number 70102028;
i) Lot number 61106029;
j) Lot numbers: 61121212, 70109125, and 70115201;
k) Lot numbers: 61106029, 61227166, and 70111172;
l) Lot numbers: 70103049, 61109096, 61026249, 70102018, 61016156, 61109082,
70103051,
70129324, 61023218, 61113159, and 61215058;
m) Lot numbers 61023221, 61215059, and 70104058;
n) Lot numbers: 61204001, 61113773, 61026252, and 70102019;
o) Lot numbers: 61023222, 61113162, 70104057, 70105084, and 61121212;
p) Lot number 61228181;
q) Lot numbers: 61109085, 70103053, 70129327, 61023225, 61026272, 61113165, and
61215070;
r) Lot numbers: 61027317, 70102026, 70109124, 70115200 and 70126305;
s) Lot numbers: 61009089, 61027316, 61106019, 70105085, and 70131338;
t) Lot number 61011111;
u) Lot numbers: 61009088, 61103002, 61226149, and 70131337;
v) Lot numbers 61103003 and 70122269;
w) Lot numbers 61106018 and 70131339;
x) Lot numbers: 61016157, 61109083, 70129325, 61023219, 61113160, 61215055 and
70103056;
y) Lot numbers: 61009087, 61027315, 61106017, 61226147, 70105083, 70122267, 70102027,
70109123, 70115199, 70126304, and 70131341;
z) Lot numbers 61023223, 61113163, and 70104078;
aa) Lot numbers: 70102005 and 61027293;
bb) Lot 61219101;
cc) Lot numbers 61103004 and 61226148;
dd) Lot numbers: 61023224, 61113164, and 70104077;
ee) Lot numbers 61023220, 61109084, 70103052, 70129326, 61113161, and 61215056
RECALLING FIRM/MANUFACTURER
Jus Made, Inc., Dallas, TX, by letter on March 26, 2007. Firm initiated recall
is ongoing.
REASON
Manufacturer failed to produce juice under requirements of Hazard Analysis and
Critical Control Point (HACCP) 21 CFR Part 120.
VOLUME OF PRODUCT IN COMMERCE
15,859 units
DISTRIBUTION
LA, TX, TN, FL, NV, MN, IA, KS, and PR
___________________________________
PRODUCT
Margaret Holmes brand Seasoned Turnip Greens, Heat-N-Serve, Product is packed
in 27oz (1 lb. 11 oz) cans, Recall # F-379-7
CODE
TURN3 K10GY, Best by Nov2009
RECALLING FIRM/MANUFACTURER
McCall Farms, Inc., Effingham, SC, by press release and letter on May 18, 2007and
by telephone on May 18th and 19th, 2007. Firm initiated recall is ongoing.
REASON
Analysis of the product by the State of North Carolina found low concentrations
of diesel fuel in the product.
VOLUME OF PRODUCT IN COMMERCE
1,755 cases/12 cans per case
DISTRIBUTION
AL, GA, FL, NC, SC, TN, and VA
___________________________________
PRODUCT
Listerine Agent Cool Blue Plaque-Detecting Rinse, Glacier Mint Flavor, 250
mL and 500 mL bottles, Recall # D-823-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil PPC, Inc., Morris Plains, NJ, by press release on April
11, 2007 and letters on April 13, 2007.
Manufacturer: McNeil PPC, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Firm’s testing confirmed microbial contamination in some bottles, including
gram negative organisms.
VOLUME OF PRODUCT IN COMMERCE
9,500,000 bottles
DISTRIBUTION
Nationwide including PR
___________________________________
PRODUCT
Listerine Agent Cool Blue Plaque-Detecting Rinse, Bubble Blast Flavor, 250
mL and 500 mL bottles, Recall # D-824-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil PPC, Inc., Morris Plains, NJ, by press release on April
11, 2007 and letters on April 13, 2007.
Manufacturer: McNeil PPC, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Product may be contaminated with gram negative microorganisms.
VOLUME OF PRODUCT IN COMMERCE
9,500,000 bottles
DISTRIBUTION
Nationwide including PR
___________________________________
PRODUCT
a) Colgate Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube,
Regular, Recall # D-825-2007;
b) Colgate Toothpaste, Sodium Monoflorophosphate 1.1%, 5 oz (100ml) tube,
Herbal, Colgate Herbal, Recall # D-826-2007
c) Colgate Toothpaste, 0.76% Sodium, Monoflorophosphate 0.10% sodium
fluoride, 5 oz (100ml) tube Colgate Gel, Recall # D-827-
2007;
d) Colgate Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube,
Triple with Germ Defense, Recall # D-828-2007
CODE
a) Regular 3400 2008 UPC 6 001067 066613;
b) Herbal: MNF 04 2005 OB EXP 04 2008 UPC 6 001067 021452;
c) Gel: 50712A10 UPC 6 001067 066293;
d) All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: MS USA Trading, Inc., North Bergen, NJ, by telephone
and visits beginning June 13, 2007.
Manufacturer: Colgate Palmolive (PTY) LTD, Boskburg, South Africa. Firm
initiated recall is ongoing.
REASON
Toothpaste may contain Diethylene Glycol
VOLUME OF PRODUCT IN COMMERCE
122 cases (144 tubes per case)
DISTRIBUTION
MD, NJ, NY and PA
___________________________________
PRODUCT
a) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719
Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge,
Dual Port; Item #1719-A –
Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I
Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open
End; Item #1719-S
Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual
Port, Smooth.
For use in cataract surgical procedures, Recall # Z-0740-2007;
b) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720
Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge,
Dual Port; Item #1720-A –
Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I
Disposable Bimanuals Irrigation/Aspiration Set 20g, Open
End; Item #1720-S
Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual
Port, Smooth.
For use in cataract surgical procedures, Recall # Z-0741-2007;
c) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721
Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge,
Dual Port; Item #1721-A –
Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I
Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open
End; Item #1721-S
Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual
Port, Smooth.
For use in cataract surgical procedures, Recall # Z-0742-2007
CODE
a) Item #1719: DB0l05A,DB0I06B,DB0605A,DB0605D,DB0705A,DB0804A,DB0804A;
Item #1719-A: DB1004E;
Item #1719-I: DB0505A,DB0505A,DB0605C,DB0705H,DB1004D,DB1004E;
Item #1719-S: DB0106C, DB0305A, DB0605B, DB0605E;
b) Item #1720: DB0105B, DB0l06A, DB0605F, DB0705J, DB0705J, DB0804B,
DB0804B, DB1005A, DB1104H, DB1104I;
Item #1720-A: DB1004I;
Item # 1720-I: DB0105D, DB0305A, DB0305A, DB0705B, DB0705I,
DB1004H;
Item #1720-S: DB0505B, DB0505B, DB0605G, DB0705K, DB1205C;
c) Item #1721: DB0105C,DB0105C,DB0605H,DB0705E, DB0804C,DB0804C,
DB0905C,DB0906B,DB1104G,DB1104J;
Item #1721-A: DB1004G;
Item # 1721-I: DB0105E, DB0105E, DB0705G,DB1004F;
Item #1721-S: DB06051,DB0705F, DB0805B, DB0906A, DB1205B,
DB1205D
RECALLING FIRM/MANUFACTURER
Oasis Medical Inc., Glendora, CA, by letter on April 9, 2007. Firm initiated
recall is ongoing.
REASON
Plastic shavings are coming from the product handle during irrigation. Use
of this product may leave plastic shavings in the patient's eyes.
VOLUME OF PRODUCT IN COMMERCE
3,050 sets
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip
Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices,
Recall # Z-0968-2007
CODE
Lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiac Surgery Technologies, Minneapolis, MN,
by letter on February 8, 2007.
Manufacturer: Medtronic Mexico EG, Empame, Sonora, Mexico. Firm initiated recall
is ongoing.
REASON
Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled.
The nose cone attachment to the body of the removal tool does not contain sufficient
adhesive which can cause the nose to separate from the body of the device.
VOLUME OF PRODUCT IN COMMERCE
187 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A,
HC431SLL, HC431SLM & HC431SLS. CPAP masks,
Recall # Z-0969-2007;
b) Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A &
900HC401. CPAP masks, Recall # Z-0970-2007;
c) Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A,
HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL
& HC407U. CPAP masks, Recall # Z-0971-2007;
d) Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A
& HC481SL. CPAP masks, Recall # Z-0972-2007;
e) Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451,
900HC451T, HC451A, HC452A & HC452F. CPAP masks,
Recall # Z-0973-2007;
f) Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202
(Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve),
400HC209
(Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask
no headgear),
400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481
mask base),
400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask
no headgear),
900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask
no headgear),
900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser
and swivel) &
900HC463 (HC451 flexitube kit). CPAP masks, Recall # Z-0974-2007
CODE
a) Lot numbers for Part Numbers 431A (lot #s: 031120 to 051121),
HC431SLL (lot #s: 050607 to 051028),
HC431SLM (lot #s: 050609 to 051107) &
HC431SLS (lot #s: 050609 to 051107);
b) Lot numbers for Part Numbers: HC401A (lot #s: 020521 to 060217) &
900HC401 (lot #s: 010829 to 020517)
c) Lot numbers for Part Numbers: HC405A (lot #s: 020930 to 060410) ,
HC405SL (lot #s: 040225 to 040325),
HC405U (lot #s: 030922 to 060217),
HCHC406A (lot #s: 050830 to 060123),
HC406SL (lot #s: 051021 to 051220),
HC407A (lot #s: 031124 to 060207),
HC407SL (lot #s: 040921 to 060202) &
HC407U (lot #s: 040407 to 060113);
d) Lot numbers for Part Numbers: HC481A (lot #s:050128 to 060506) &
HC481SL (lot #s: 050608 to 060327);
e) Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016),
900HC451T (lot #s: 011024 to 020517),
HC451A (lot #s: 020523 to 040907),
HC452A (lot #s: 031215 to 060503) &
HC452F (lot #s: 040719 to 041102);
f) Lot Numbers for Part Numbers: 400HC202 (lot #s: 040802 to 051222),
400HC203 (lot #s: 040719 to 051103),
400HC209 (lot #s: 041108 to 050920),
400HC502 (lot #s: 040825 to 060201),
400HC503 (lot #s:040830 to 051028),
400HC505 (lot #s: 050223 to 050726),
400HCHC510 (lot #s: 051007 to 051028),
900HC402 (lot #s: 010918 to 060203),
900HC405 (lot’s: 030924 to 030925),
900HC406 (lot #s: 031110 to 060403),
900HC412 (lot #s: 020108 to 060203),
900HC441 (lot #s: 031110 to 060424) &
900HC463 (lot #s: 020108 to 040604)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fisher & Paykel Healthcare Inc, Irvine, CA, by letter
on December 4, 2006.
Manufacturer: Fisher & Paykel Healthcare Ltd, Auckland, New Zealand. Firm
initiated recall is ongoing.
REASON
Plastic tabs incorporated into the connector components of these CPAP masks
may break off if they are not cleaned in accordance with the Instructions for
Use. In the event of a tab breaking off, it may enter the CPAP system air path
and there is an extremely remote possibility that the broken tab may then enter
the patient's nasal cavity or mouth. Masks manufactured since April 2006 do
not feature tab connectors and are not affected by this recall.
VOLUME OF PRODUCT IN COMMERCE
815,239
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771, Recall # Z-0976-2007
CODE
(Foreign) 116, 117, 135, 171,175, 208, 209, 212, 215, 156, 106, 214, 211, 120,
169, 125, 119, 210, 126, 124, 139, 196, 140, 218, 121, 197, 213, 216, 170,
217, 185, 195, 152, 174, 130, 173, 138 (USA) 155, 167, 172, 176, 182, 051,
101, 118, 122, 123, 127, 128, 129, 131, 132, 133, 134, 136, 137, 141-151, 153,
154, 157-166, 177-181, 183, 184, 186-194, 198-207, 219
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated
May 24, 2007.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall
is ongoing.
REASON
GE Healthcare has become aware of the absence of thread-locking compound associated
with the C-arm fasteners of your Diamond mammographic x-ray system that may
impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
106 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas
e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no.
11875116122. in vitro diagnostic, Recall # Z-0977-2007
CODE
Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08;
and 17733202, exp. 2/29/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated
May 15, 2007.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall
is ongoing.
REASON
The test is not as sensitive, or as precise between runs, as claimed in the
labeling. Low concentrations are observed only in saliva samples.
VOLUME OF PRODUCT IN COMMERCE
6,051 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LINAC Scapel Treatment Planning System, incorporating FastPlan software versions
4.0, 5.0, 5.0.1, 5.1, 5.1.1., Recall # Z-0978-2007
CODE
S/Ns: HZ30001 HZ30020 HZ30021 HZ30033 HZ30054 HZ30061 HZ30108 HZ30139 HZ30144
HZ30167 HZ30171 HZ30178 HZ30207 HZ30208 HZ30224 HZ30230 HZ30251 HZ30265 HZ30280
HZ30283 HZ30293 HZ30294 HZ30299 HZ30312 HZ30330 HZ30342 HZ30349 HZ30368 HZ30398
HZ30403 HZ30404 HZ30407 HZ30422 HZ30426 HZ30460 HZ30461 HZ30462 HZ30485 HZ30495
HZ30507 HZ30508 HZ30509 HZ30511 HZ30513 HZ30520 HZ30531 HZ30537 HZ30540 HZ30556
HZ30557 HZ30571 HZ30572 HZ30573 HZ30574 HZ30588 HZ30604 HZ30612 HZ30617 HZ30620
HZ30640 HZ30646 HZ30649 HZ30656 HZ30670 HZ30674 HZ30675 HZ30681 HZ30684 HZ30698
HZ30703 HZ30727 HZ30731 HZ30740 HZ35070 HZ39020 HZ39066 HZ39071 HZ39165 HZ39997
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Inc., Palo Alto, CA, by letter
dated March 9, 2007.
Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA. Firm
initiated recall is ongoing.
REASON
A software anomaly in a medical device used for patient treatment could result
in accidental or unintended radiation exposure. The tilt rotation compensation
algorithm does not adequately compensate for the tilt rotation.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Proximate PPH, Procedure for Prolapse and Hemorrhoids Set, REF PPH03. Each
set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular
anal dilator, and 1 purse string suture anoscope, Recall # Z-0980-2007
CODE
C4ER8H, C4ET81, C4ET82, C4ET91, C4ET83, C4ET92, C4EU22, C4EU23, C4EU2U, C4EU4M,
C4EU4N, C4EU2V, C4EV7K, C4EV7L, C4EV7J, C4EV9D, C4EV9E, C4EW2A, C4EW2W, C4EV9C,
C4EW58, C4EW59, C4EW57, C4EW6T, C4EW6U, C4EW8T, C4EW8R, C4EX9V, C4EX9T, C4EY41,
C4EY42, C4EY43, C4EX9U, C4EY82, C4EY81, C4EY83, C4EZ1D, C4F01P, C4F01R, C4F01T,
C4F03D, C4F03C, C4F05G, C4F114, C4F116, C4F115, C4F12K, C4F12L, C4F12M, C4F143,
C4F142, C4F303, C4F14C, C4F31T, C4F33F, C4F34W, C4F34X, C4F35N, C4F380, C4F406,
C4F41E, C4F422, C4F407, C4F42L, C4F433, C4F432, C4F44G, C4F44F, C4F456, C4F455,
C4F56C, C4F56D, C4F583, C4F58J, C4F58H, C4F60N, C4F60M, C4F62Y, C4F58T, C4F62Z,
C4F630, C4F694, C4F695, C4F72Y, C4F715, C4F850, C4F852, C4F84Z, C4F851, C4F86Z,
C4F86W, C4F86X, C4F853, C4F854, C4FD16, C4FD17, C4FD5P, C4FD5R, C4FD9X, C4FD9Y,
C4FE58, C4FE59, C4FE7C, C4FE7D, C4F851, C4FF43, C4FF4Y, C4FF4Z, C4FF8N, C4FF8P,
C4FG20, C4FG6K, C4FH11, C4FH12, C4FH2P, C4FH2R, C4FH7F, C4FH8X, C4FH8Y, C4FJ00,
C4FH7G, C4FJ92, C4FJ8K, C4FK05, C4FL05, C4FK9U, C4FL00, C4FM02, C4FM01, C4FM18,
C4FN0L, C4FN0G, C4FN80, C4FN78, C4FN5X, C4FN8P, C4FP0N, C4FP0P, C4FP2W, C4FP2X,
C4FP5X, C4FR1V, C4FP9V, C4FR3C, C4FM2R, C4FR79, C4FT0G, C4FR7A, C4FT0F, C4FM2T,
C4FT1K, C4FT23, C4FT24, C4FT25, C4FT37, C4FT4D, C4FT38, C4FT5D, C4FU70, C4FV36,
C4FV2L, C4FU71, C4FV6Y, C4FV7T, C4FV7V, C4FW0N, C4FW0M, C4FW13, C4FW35, C4FW3P,
C4FW3M, C4FW34, C4FW3N, C4FW6P, C4FW6T, C4FX0N, C4FX22, C4FY0A, C4FY0D, C4FY0C,
C4FY6F, C4FY6M, C4FY6G, C4FZ1L, C4FZ1K, C4FZ2G, C4FZ3D, C4FZ3E, C4FZ4C, C4FZ1L,
C4G001, C4FZ9Z, C4G000, C4G04E, C4G04G, C4G04F, C4G06T, C4G06R, C4G086, C4G108,
C4G085, C4G107, C4G12E, C4G148, C4G12F, C4G20Y, C4G20X, C4G23W, D4G34J, D4G34K,
D4G34L, D4G37V, D4G37W, D4G460, D4G45Z, D4G483, D4G492, D4G494, D4G484, D4G482,
D4G493, D4G49T, D4G63A, D4G63D, D4G63C, D4G851, D4G864, D4G86U, D4G87Y, D4G88Z,
D4G890, D4G986, D4G987, D4G985, D4GA22, D4GA23, D4GA21, D4GD5T, D4GD5R, D4GD5U,
D4GE16, D4GE17, D4GE6L, D4GE6K, D4GG09, D4GG0A, D4GG0C, D4GG6A, D4GG6C, D4GG8H,
D4GG8J, D4GH0Y, D4GH1J, D4GJ0F, D4GH8F, D4GH8D, D4GJ3H, D4GJ3G, D4GJ49, D4GJ5W,
D4GJ48, D4GJ7K, D4GJ7P, D4GJ7R, D4GK4D.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters
dated April 2, 2007 and April 3, 2007.
Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V., Cd. Juarez, Chihuahua,
Mexico. Firm initiated recall is ongoing.
REASON
The adhesive used to bond the casing of the device may have migrated to the
staple driver. While the device still fires, it may result in audible and tactile
feedback at the midpoint of the firing cycle which may be interpreted by some
surgeons as a completed firing cycle, which may cause the surgeon to prematurely
stop firing the device and result in incomplete staple formation or cut line.
VOLUME OF PRODUCT IN COMMERCE
23,966 sets
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Gyroscan MRI, Recall # Z-0981-2007;
b) Intera MRI, Recall # Z-0982-2007;
c) Achieva MRI, Recall # Z-0983-2007;
d) Panorama 1.0T MRI, Recall # Z-0984-2007
CODE
a) Site numbers: 6662, 6841, 6947, 10367, 10409, 13020, 13056, 13334, 13338,
13408, 13413,
13532, 13538, 13606, 13730, 13748, 13753, 13754, 13864,
13894, 13932, 13947, 13948, 13965,
3966, 13967, 13976, 13977, 14065, 14117, 14128, 14134, 14144,
16745, 17280, 17336, 17394,
17410, 17421, 17459, 17481, 17482, 17483, 17533, 17544,
17585, 17648, 17664, 17683, 17688,
25958, 25966, 25969, 25986, 26011, 26074, 26119, 26133,
26135, 26149, 26150, 26178, 26201,
26219, 26224, 26269, 34694, 35172, 35362, 35394, 35452,
35491, 37911, 37938, 37941, 37979,
37986, 37996, 37997, 38111, 38143, 38189, 38257, 38303,
38304, 38345, 38415, 38420, 38438,
38441, 38650, 38651, 38652, 38661, 38749, 38797, 38865,
38893, 38966, 38984, 40314, 40903,
40904, 40975, 41064, 41147, 41250, 41333, 41342, 41345,
41346, 41362, 41392, 41440, 41459,
44268, 44793, 44813, 44832, 44876, 44891, 44892, 44952,
44994, 45006, 45009, 45016, 45036,
45037, 45046, 45063, 45065, 45071, 46628, 46846, 47043,
47058, 50009, 50042, 50226, 50309,
50336, 50378, 50390, 50402, 50407, 50411, 50412, 50426,
50430, 50432, 59236, 59252, 59357,
59384, 59427, 59428, 59435, 59475, 59483, 59488, 59556,
59637, 59648, 59707, 59712, 62450,
62457, 62658, 62659, 62801, 62953, 67523, 68196, 73894,
73920, 73974, 76320, 76321, 76341,
76352, 76358, 76402, 76475, 76477, 76480, 76807, 76847,
76848, 78104, 82506, 82546, 82547,
82580, 82582, 82583, 82610, 82627, 82668, 82837, 83044,
83071, 83615, 83708, 83876, 85156,
91351, 91649, 100444, 100463, 101131, 101581, 101930, 102440,
104349, 104455, 105607,
250030, 250082, 250210, 250320, 250451, 250473, 250502,
504244, 504250, 504741, 504897,
521535, 531705, 531862, 532988, 533079, 533741, 534571,
534942, 534943, 536929, 536979,
537591, 538075, 540134, 541042, 542669, 543170, 543400,
543845, 544503, 545176, X0003,
X0034, X0054, X0067, X0161, X0162, X0164, X0165, X0214,
X0592, X0599, X0608, X0707,
X0708, X0716, X0717, X0885, X0940, X0942, X1019, X1042,
X1080, X1081, X1083, X1084,
X1085, X1086, X1179, X1188, X1231, X1270, X1271, X1272,
X1348, X1352, X1353, X1373,
X1577;
b) Site numbers: 10009, 10353, 10432, 13057, 13058, 38134, 38317, 41391, 41441,
62832, 63046,
76919, 82507, 82534, 82678, 83051, 83080, 83301, 83303,
83306, 83325, 83395, 83396, 83616,
83631, 83802, 83804, 83916, 83940, 83941, 83946, 83995,
84418, 84433, 84477, 84478, 84484,
84700, 84820, 84860, 84861, 84887, 84899, 85023, 85119,
85139, 85141, 85157, 85158, 85172,
85433, 85436, 85442, 85443, 85500, 85684, 85685, 85686,
85688, 86012, 86019, 86020, 86056,
86080, 86082, 86083, 86085, 86121, 86147, 86148, 86184,
86236, 86248, 86250, 86280, 86281,
86287, 86292, 86293, 86313, 86316, 86317, 86334, 86335,
86368, 86379, 86380, 86381, 86404,
86406, 86407, 86408, 86409, 86410, 86413, 86555, 86556,
86557, 86558, 86559, 86560, 86570,
86595, 86596, 86597, 86925, 86968, 87010, 87011, 87018,
87019, 87033, 87034, 87036, 87038,
87053, 87062, 87067, 87135, 87145, 87146, 87147, 87148,
87161, 87168, 87183, 87188, 87309,
87310, 87311, 87355, 87526, 87527, 87604, 87605, 87607,
100214, 100323, 100449, 100459,
100460, 100461, 100462, 100469, 100478, 100629, 100679,
100745, 100785, 100786, 100826,
100832, 100886, 100916, 101056, 101070, 101084, 101111,
101138, 101162, 101165, 101206,
101313, 101347, 101408, 101412, 101416, 101420, 101423,
101425, 101429, 101431, 101432,
101477, 101551, 101560, 101561, 101572, 101584, 101585,
101595, 101608, 101780, 101874,
101877, 101878, 101934, 101946, 101953, 101976, 102003,
102004, 102018, 102095, 102101,
102110, 102137, 102157, 102194, 102353, 102492, 102497,
102524, 102547, 102548, 102561,
102569, 102571, 102614, 102617, 102671, 102698, 102699,
102709, 102718, 102724, 102786,
102827, 102889, 102907, 102933, 102975, 102978, 102980,
103041, 103062, 103064, 103065,
103068, 103098, 103099, 103101, 103126, 103135, 103136,
103142, 103143, 103149, 103151,
103166, 103171, 103207, 103215, 103243, 103247, 103249,
103258, 103286, 103291, 103324,
103333, 103347, 103351, 103373, 103416, 103417, 103450,
103509, 103530, 103540, 103544,
103547, 103552, 103579, 103580, 103582, 103592, 103611,
103620, 103631, 103647, 103665,
103688, 103697, 103703, 103704, 103770, 103779, 103782,
103808, 103811, 103817, 103818,
103847, 103904, 103907, 103909, 103911, 103946, 104019,
104022, 104027, 104032, 104054,
104069, 104070, 104079, 104082, 104095, 104102, 104124,
104134, 104138, 104144, 104193,
104336, 104340, 104343, 104378, 104392, 104393, 104446,
104467, 104531, 104532, 104635,
104639, 104765, 104800, 104808, 104871, 104880, 104886,
104887, 104897, 104900, 104901,
104912, 104918, 104919, 104928, 104942, 105148, 105252,
105271, 105290, 105303, 105311,
105313, 105314, 105315, 105317, 105348, 105358, 105368,
105373, 105424, 105471, 105486,
105487, 105488, 105509, 105657, 105664, 105679, 105687,
105695, 105720, 105741, 105925,
105926, 105929, 105938, 225313, 250033, 250050, 250122,
250156, 250180, 250229, 250293,
250498, 250890, 500007, 500009, 500010, 500034, 500051,
504243, 504249, 504298, 504335,
504342, 504346, 504349, 504350, 504351, 504353, 504400,
504403, 504409, 504412, 504527,
504531, 504543, 504608, 504628, 504653, 504662, 504670,
504738, 504793, 504866, 504899,
504927, 504952, 504954, 504974, 504979, 505007, 505021,
505049, 505050, 505275, 505337,
505399, 505400, 505490, 505514, 505568, 505678, 505682,
505688, 505689, 505777, 505785,
505815, 505914, 505940, 505941, 505943, 506034, 506044,
506120, 506183, 506188, 506190,
506203, 506219, 506296, 506324, 506385, 506570, 506670,
506691, 506777, 506784, 519129,
519133, 519147, 519525, 519545, 519569, 519765, 519890,
520002, 520113, 520176,520190,
520354, 520355, 520579, 520662, 520679, 520700, 520708,
520709, 520754, 520765, 521228,
521415, 521429, 521432, 521524, 521678, 521751, 521908,
521911, 521927, 521939, 522297,
522419, 522421, 522441, 530363, 530364, 530366, 530651,
531652, 531712, 531766, 531767,
531925, 531934, 532282, 532463, 532705, 532709, 532710,
532711, 533489, 533682, 533953,
534643, 534676, 534684, 534686, 534695, 534765, 534777,
535327, 535328, 535329, 535330,
535486, 535505, 536126, 536262, 536318, 536482, 536589,
536885, 537391, 537690, 537980,
538077, 538253, 538429, 538800, 538841, 539236, 539276,
539280, 539281, 539531, 539585,
539597, 539644, 539882, 540285, 540412, 540454, 540793,
540794, 540945, 541125, 541441,
541442, 541575, 541740, 541819, 541827, 541973, 542116,
542270, 542275, 542580, 543118,
543119, 543280, 543293, 543724, 543824, 543892, 543966,
543976, 544085, 544112, 544116,
545008, 545084, 545255, 545541, 545573, 545832, 545842,
545940, 545952, 545965, 545980,
546177, 546970, 547066, 547075, 547235, 547261, 547587,
547903, 547934, 547953, 547979,
547985, 548050, 548065, 548320, 549239, 549243, 549429,
549592, 549858, 550035, 550057,
550060, 550085, 550256, 550391, 550422, 550909, 551037,
551689, 552498, 552508, X1215,
X1216, X1281, X1412, X1523, X1562, X1593, X1594, X1595,
X1602, X1648, X1649, X1662,
X1664, X1668, X1669, X1670, X1693, X1730, X1739, X1740,
X1741, X1742, X1743, X1744,
X1753, X1756, X1759;
c) Site numbers: 102114, 103789, 104087, 104163, 104658, 104879, 104924, 105291,
105475, 105624,
500036, 500045, 504634, 505045, 505046, 505048, 505357,
505705, 505879, 506389, 506390,
506798, 506842, 519120, 519124, 519127, 519216, 519522,
519552, 519892, 519933, 520007,
520191, 520315, 520429, 520432, 520667, 520690, 520966,
521002, 521097, 521130, 521134,
521150, 521152, 521159, 521465, 521466, 521509, 521513,
521518, 521526, 521529, 521536,
521542, 521689, 521718, 521737, 521772, 521804, 521902,
521929, 521932, 521934, 522010,
522264, 522368, 522422, 528928, 530362, 530395, 530422,
530423, 530426, 530427, 530680,
530771, 530774, 530776, 530790, 531765, 531786, 532068,
532410, 532417, 532418, 532470,
532491, 532537, 532643, 532809, 532840, 532851, 532980,
532981, 533063, 533076, 533082,
533086, 533116, 533320, 533393, 533403, 533588, 533743,
533744, 533746, 533747, 533759,
533859, 534069, 534165, 534301, 534344, 534503, 534561,
534587, 534636, 534671, 534693,
534700, 534715, 534721, 534732, 534778, 534838, 534841,
534845, 534925, 534929, 534935,
534944, 534961, 535001, 535189, 535208, 535211, 535222,
535247, 535288, 535289, 535290,
535331, 535353, 535392, 535394, 535404, 535487, 535839,
536597, 536649, 536651, 536652,
536675, 536679, 536804, 536943, 537033, 537063, 537133,
537176, 537461, 537508, 537729,
537736, 537795, 537832, 537871, 537880, 538007, 538300,
538452, 538463, 538491, 538525,
538526, 538779, 538789, 538941, 539180, 539183, 539216,
539271, 539327, 539420, 539477,
539550, 539583, 539591, 539703, 539938, 539945, 540015,
540243, 540444, 540469, 540490,
540707, 540999, 541084, 541147, 541200, 541267, 541404,
541491, 541613, 541637, 541797,
541876, 541888, 542595, 542970, 543247, 543278, 543286,
543321, 543696, 543697, 543699,
543888, 543917, 543944, 543992, 544006, 544027, 544563,
544565, 544585, 544640, 544659,
544667, 544704, 544736, 544792, 544911, 545018, 545154,
545219, 545236, 545291, 545294,
545711, 545879, 545914, 545932, 545943, 545999, 546004,
546010, 546015, 546019, 546055,
546096, 546104, 546553, 546570, 546600, 546610, 546637,
546649, 546669, 546730, 546774,
546848, 546864, 546941, 547018, 547023, 547160, 547162,
547228, 547310, 547389, 547585,
547639, 547640, 547698, 547724, 547785, 547788, 547792,
547899, 547941, 547957, 548008,
548010, 548012, 548037, 548359, 548634, 548689, 548729,
548745, 548758, 548760, 548792,
548918, 549009, 549024, 549371, 549373, 549412, 549541,
549666, 549819, 549923, 549936,
550040, 550044, 550195, 550208, 550276, 550279, 550344,
550364, 550366, 550373, 550410,
550731, 550831, 550876, 550926, 550972, 551271, 551401,
551403, 551587, 551656, 551658,
551674, 551872, 551873, 551874, 551875, 551876, 551877,
551878, 551879, 551880, 552183,
552189, 552516, 552539, 552588, 552591, 552602, 552604,
552622, 552645, 552805;
d) Site #’s: 521810, 533745, 533860, 533900, 534276, 534278, 535230,
535273, 535664, 536972,
537852, 538574, 538616, 539265, 539374, 539514, 540482,
541065, 541851, 542236, 542244,
543822, 544039, 544148, 544696, 544723, 545034, 545143,
545732, 545902, 545918, 545981,
546206, 546594, 546654, 546722, 546728, 547843, 547897,
548040, 548041, 548064, 549389,
549909, 550324, 550358, 550398, 550439, 550449, 550621,
551025, 551583, 552453, 552526,
552609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA,
by letter dated April 25, 2007
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is ongoing.
REASON
Potential for gaseous helium to improperly vent, resulting in rupture of the
magnet vessel and venting of helium into the MRI site.
VOLUME OF PRODUCT IN COMMERCE
287 Gyroscan, 640 Intera, 350 Achieva, 55 Panorama 1.0T
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software,
Recall # Z-0985-2007;
b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software,
Recall # Z-0986-2007
CODE
a) Serial numbers: 80G0543625,
80G0543628, 80G0543636, 80G0543637, 80G0543639, 80G0543640,
80G0543643, 80G0543644, 80G0543645, 80G0583727, 80G0583728,
80G0583730, 80G0583731,
80G0593773, 80G0593785, 80G0593786, 80G0593789, 80G0593790,
80G0593791, 80G0593792,
80G0593793, 80G0593794, 80G05X3837, 80G05X3839, 80G05X3852,
80G05X3853, 80G05X3854,
80G05X3855, 80G05Y3866, 80G05Y3867, 80G05Y3870, 80G05Y3871,
80G05Y3872, 80G05Y3873,
80G05Y3874, 80G05Y3883, 80G05Y3884, 80G05Y3887, 80G05Y3889,
80G05Y3890, A1627001,
A1627002, A1627003, A2532207, A2532209, A2532210, A2532211,
A2542221, A2542223, A254224,
A2542225, A2542228, A2542229, A2542230, A2542232, A2542234,
A2542235, A2542236, A2552260,
A2552261, A2552262, A2552297, A2552298, A2552299, A2562305,
A2562307, A2562309, A2592415,
A2592420, A2602427, A2602430, A2602432, A2602435, A2602436,
A2602437, A2602438, A4583197,
B3522582, B3532463, B3532464, B3532533, B3532534, B3532602,
B3532603, B3542624, B3542625,
B3542626, B3542627, B3542628, B3542629, B3552647, B3552648,
B3552649, B3552651, B3552667,
B3552669, B3552672, B3552673, B3562677, B3562678, B3562679,
B3562680, B3562681, B3562694,
B3562697, B3562700, B3572727, B3572732, C3592781, C3592783,
C3592784, C3602834, C3602836,
C3612855, C3612856, C3612857, C3612870, C36l 2872, C3612874,
C3612875, C361 2877, C3612882,
C3612883, C3612885, C3612886, C3612887, C3612888, C3612889,
C3612891, C3612892, C3612893,
C3612894, C3622938, C3622939, D3622940, D3622945, D3622947,
D4532657, D4532658, D4532660,
D4532663, D4533034, D4533038, D4533039, D4533041, D4533042,
D4533043, D4533044, D4533048,
D4533051, D4533052, D4533054, D4533055, D4533056, D4543084,
D4543085, D4543086, D4543088,
D4543091, D4543092, D4543093, D4553108, D4553109, D4553111,
D4553112, D4553121, D4553123,
D4553124, D4553125, D4553126, D4563136, D4563141, D4563142,
D4563143, D4573166, D4573167,
D4573168, D4573169, D4573170, E4583194, E4583195, E4583196,
E4583198, E4583201, E4583202,
E4583206, E4583207, E4583208, E4583211, E4593250, E4593254,
E4593255, E4593262, E4593263,
E4593264, E4593267, E4593268, E4593270, E4593273, E4593274,
E4593276, E4593278, E4593281,
F4603311, F4603314, F4603317, F4613337, F4613338, F4613339,
F4613341, F4613342, F4613343,
F4613344, F4613351, F4613352, F4613353, F4613356, F4623375,
F4623377, F4623378, F4623380,
F4623381, F4623382, F4623383, F4623388, F4623389, F4623391,
F4623392, F5513431, F5513433,
F5513437, F5513439, F5513445, F5513446, F5513448, F5513449,
F5513450, F5513452, F5513455,
F5513460, F5513461, F5513462, F5513463, F5513464, F5513467,
F5513459, G5522743, G5523512,
G5523513, G5523514, G5523519, G5523541, G5523544, G5523558,
G5523559, G5523562, G5523563,
G5523564, G5523565 & G5523567;
b) Serial numbers: B2622263, B2622264, B2622265, B2622267, B2622269, B3522364,
B3522365,
B3522366, B3522369, B3522370, B3522372, B3522373, B3522402,
B3522403, B3522404, B3522405,
B3552542, B3552557, B3552558, B3552560, B3562595, B3562599,
B3582672, B3582673, B3582674,
C3592771, C3592772, C3592773, C3592774, D4553251, D4553252,
D4553253, D4563327, D4563329,
E4593563, E4593564, F4603654, F4603655, F4603656, F4613730,
F4613731, F4613732, F5513813,
G5523871 & G5523875
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters
on February 2, 2007.
Manufacturer: Toshiba Medical Systems Corp., Tokyo, Japan. Firm initiated recall
is ongoing.
REASON
When using the LV measurement function and making numerous measurements the
value displayed on the image screen may on occasion not update correctly. The
values that are stored in MDA (measurement display area) are correct and no
issue has been reported with these values.
VOLUME OF PRODUCT IN COMMERCE
305 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JULY 4, 2007
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