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FDA Enforcement Report
FDA
Enforcement Report
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
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I
_________________________________
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) 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
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
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
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III
___________________________________
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
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
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
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
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
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
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
MedWatch
Rocephin (ceftriaxone sodium) for Injection
Audience: Neonatologists, pediatricians, infectious disease specialists, hospital administrators, other healthcare professionals
[Posted 07/05/2007] Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone.
For further information see Prescribing Information at: http://www.fda.gov/medwatch/safety/2007/rocephin_PI_may2007.pdf
See also, Dear Healthcare Professional Letter at: http://www.fda.gov/medwatch/safety/2007/rocephin_DHCP_june2007.pdf
Invanz (ertapenem sodium) Injection
Audience: Infectious disease specialists, hospital administrators and pharmacists, other healthcare professionals
[Posted 07/05/2007] Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
For further information see Dear Healthcare Professional Letter at: http://www.fda.gov/medwatch/safety/2007/INVANZ_DHCP.pdf
Xolair (omalizumab)
Audience: Pulmonary healthcare professionals, asthmatic patients
Indications and Usage: for treatment of adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.
[UPDATE 07/02/2007] Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for Xolair was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for Xolair is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, Xolair should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each Xolair injection.
[Posted 02/21/2007] FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab). Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the Xolair label and provide a MEDICATION GUIDE for patients to strengthen the existing warning for anaphylaxis.
For further information see FDA's Healthcare Professional Information at: http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm
See also, Prescribing Information at: http://www.fda.gov/cder/foi/label/2007/103976s5102lbl.pdf
The Medication Guide is found at: http://www.fda.gov/cder/foi/label/2007/103976s5102mg.pdf
Finally, see FDA's previous (February 21, 2007) documents:
Drug Information Page at: http://www.fda.gov/cder/drug/infopage/omalizumab/default.htm
News Release at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01567.html
Colistimethate (marketed as Coly-Mycin M and generic products)
Audience: Pulmonologists, respiratory therapists, compounding pharmacists, other healthcare professionals, cystic fibrosis patients
[Posted 06/28/2007] FDA notified healthcare professionals and cystic fibrosis patients that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF). Colistimethate is FDA approved for intravenous or intramuscular injection for the treatment of acute or chronic infections due to sensitive strains of certain Gram-negative bacilli, particularly sensitive strains of Pseudomonas aeruginosa which are a significant problem for patients with CF and for patients with neutropenia, and/or immune system compromise. The product is not FDA approved for use as a liquid to be inhaled via nebulizer. In this case, the drug was prepared by a pharmacy and dispensed as prescribed in premixed unit dose ready-to-use vials. Once Colistimethate is mixed into a liquid form, the product breaks down into other chemicals that can damage lung tissue.
Healthcare professionals who choose to prescribe Colistimethate to treat patients with CF should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of the product. Patients should discard any unused pre-mixed liquid forms of Colistimethate.
For further information see FDA's Healthcare Professional Information Sheet at: http://www.fda.gov/cder/drug/InfoSheets/HCP/colistimethateHCP.htm
See also FDA's Public Health Advisory at: http://www.fda.gov/cder/drug/advisory/colistimethate.htm
Propofol (marketed as Diprivan and generic products)
Audience: Surgeons, anesthesiologists, healthcare professionals
[Posted 06/15/2007] FDA informed healthcare professionals about several clusters of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. Multiple vials and several lots of propofol used in patients who experienced these symptoms were tested and there was no evidence that the propofol vials or prefilled syringes used were contaminated with bacteria or endotoxins. Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. To minimize the potential for bacterial contamination, propofol vials and prefilled syringes should be used within six hours of opening and one vial should be used for one patient only. Patients who develop fever, chills, body aches or other symptoms of acute febrile reactions shortly after receiving propofol should be evaluated for bacterial sepsis. Healthcare professionals who administer propofol for sedation or general anesthesia should carefully follow the recommendations for handling and use in the product's full prescribing information.
For further information see FDA's Drug Information Page at: http://www.fda.gov/cder/drug/infopage/propofol/default.htm
RotaTeq (Rotavirus, Live, Oral, Pentavalent) Vaccine
Audience: Pediatric healthcare professionals, consumers
[Posted 06/15/2007] FDA informed healthcare professionals of changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.
Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.
For further information see FDA's Information Page at: http://www.fda.gov/cber/label/rotateqLBinfo.htm
See also Label at: http://www.fda.gov/cber/label/rotateqLB.pdf
Abbott Laboratories Architect Stat Troponin-1 Immunoassay
Audience: Hospital Risk Managers, hospital administrators, clinical laboratories, healthcare professionals
[Posted 06/08/2007] Abbott Laboratories and FDA notified healthcare professionals of a Class I Recall of the Architect Stat Troponin-1 Immunoassay. Doctors use this test in diagnosing damage to the heart and/or a heart attack in people who have had chest pain. The product was recalled after a small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-1 (i.e., less than 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. Laboratories are advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels.
For further information see FDA's Recall Notice at: http://www.fda.gov/cdrh/recalls/recall-030807.html
Texas Tech University Health Sciences Center, Department of Safety Services, 3601 4th Street MS 9020, Lubbock, TX 79430
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