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U.S. Department of Health and Human Services

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Enforcement Report for December 28, 2011

 

December 28, 2011                                                                                                11-52
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Front Row Produce Grape Tomatoes packaged in 10-oz. plastic clamshell containers (12/case), Product of Mexico. The tomatoes are also packaged in 10-lb. bulk boxes labeled only with the pack/lot number and no other identifying information. Recall # F-0441-2012
CODE
10-oz. containers cases - 2310802, 2310405, and 2510401 (the lot number is only found on the cases, not on the retail packages.) 10-lb. bulk - 2310801
RECALLING FIRM/MANUFACTURER
Front Row Produce LLC, Saint Louis, MO, by fax on November 26, 2011 and via telephone on November 29&30, 2011. Firm initiated recall is ongoing.
REASON
The product tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
91/12/1-pt. clamshell container cases and 30/10-lb. bulk boxes
DISTRIBUTION
MO and IL
___________________________________
PRODUCT
1) Race Trac brand, Chicken Quarter Pounder, 7.8 ounce packages. Recall # F-0442-2012;
 
2) Race Trac brand, Chicken Quarter Pounder with Tomatoes, 8.8 ounce packages. Recall # F-0443-2012;
 
3) Race Trac brand, Ham Quarter Pounder, 7.38 ounce packages. Recall # F-0444-2012;
 
4) Race Trac brand, Ham Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-0445-2012;
 
5) Race Trac brand, American Sub that have 10.17 ounce packages. Recall # F-0446-2012;
 
6) Race Trac brand, Turkey Quarter Pounder, 7.38 ounce packages. Recall #F-0447-2012;
 
7) Race Trac brand, Turkey Quarter Pounder with Tomatoes, 9.05 ounce packages. Recall # F-0448-2012
CODE
Sell Thru Dates 10/11/11-11/30/11
RECALLING FIRM/MANUFACTURER
Flying Food Group, LLC, Lawrenceville, GA, by email and telephone on November 21, 2011 and a press release on December 3, 2011. FDA initiated recall is ongoing.
REASON
Product was found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
808 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Raw Cheddar cheese is a aged product. It is vacuum packaged in clear plastic. A stick-on label on the back of the package reads: "864" The product is portioned in various weights, between .25 - .50 pounds. A stick-on label reads in part: "Raw Cheddar Raw Unpasteurized Whole Milk, Salt, Culture, Vegetable Rennet, r-BST free***Keep Refrigerated***Natural handcrafted cheese produced by the Jensen ladies." 864 This code refers to the actual consecutive batch number of cheese ever made at this firm since its beginning in 2004. Recall # F-0452-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Jensen Family Dairy and Creamery, LLC, Bow, WA, by telephone on November 7, 2011 and by press release on November 8, 2011. Washington initiated recall is ongoing.
REASON
The Washington State Department of Agriculture collected a surveillance sample of raw cheddar cheese and it was found positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approximately 34 pounds
DISTRIBUTION
WA
___________________________________
PRODUCT
1) The butter is packaged in plastic tubs with a stick-on label on the lid that reads: "Northwest Mushroom Trio Butter Pasteurized cream, Lobster, Oyster and Chanerelle mushrooms, salt. keep refrigerated 4 oz. MILK Natural handcrafted cheese produced by the Jensen ladies." Code "767" is on the top label. It is a batch code. Recall # F-0453-2012;
 
2) The butter is packaged in plastic tubs with a stick-on label on the lid that reads: "Herbes de Provence Butter Pasteurized cream, Rosemary, Savory, Oregano, Basil, Thyme and salt. Keep Refrigerated 4 oz. MILK Natural handcrafted cheese produced by the Jensen ladies." The three digit code, 767, on the top label is a batch code. Code "767" is on the top label. It is a batch code. Recall # F-0454-2012;
 
3) The butter is in a single 15 pound box (plastic bag inside box) with a stick-on label that reads: Unsalted Farmstead Butter Pasteurized cream Keep Refrigerated, 15 lbs. MILK Natural handcrafted cheese produced by the Jensen ladies." The three digit code, 756, on the top label is a batch code. Recall # F-0455-2012
CODE
1) Use by 1/20/12 or 1/27/12;  
2) Use by 1/6/12 or Use by 1/27/12;
3) Use by 12/8/11
RECALLING FIRM/MANUFACTURER
Jensen Family Dairy and Creamery, LLC, Bow, WA, by telephone on December 2, 2011 and by press release on December 3, 2011. Washington initiated recall is ongoing.
REASON
A surveillance sample of Northwest Mushroom Trio butter, collected and analyzed by the Washington State Department of Agriculture (WSDA), was found positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1 - 15 lb case of Unsalted butter, 21 - 4 ounce containers of Herbes de Provence butter and 68 - 4 ounce containers of Northwest Mushroom Trio butter
DISTRIBUTION
WA
___________________________________
PRODUCT
Assi Brand Korean Cake, item #20649D, Net Weight 8 oz. retail packages, 25 packages/case, packages labeled in part ***UPC 0 8165220649 1. Recall # F-0457-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhee Brothers Inc., Hanover, MD, by visit starting on December 3, 2011.
Manufacturer: Cho & Son Inc., Philadelphia, PA. New York initiated recall is ongoing.  
REASON
Product contains eggs which are undeclared on the label.
VOLUME OF PRODUCT IN COMMERCE
37 cases
DISTRIBUTION
CA, NY, VA, TN, OK, OH, NC, MN, MI. LA, KS, IN, FL, and AR
___________________________________
PRODUCT
1) Fair Oaks Farms Fine Cheese, Cheddar, 4 YR, clear plastic package, ~ 0.5 lbs. Recall # F-0458-2012;
 
2) Fair Oaks Farms Fine Cheese, Habanera Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0459-2012;
 
3) Fair Oaks Farms Fine Cheese, Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0460-2012;
 
4) Fair Oaks Farms Fine Cheese, Havarti Pepper, clear plastic package, ~ 0.5 lbs. Recall # F-0461-2012;
 
5) Fair Oaks Farms Fine Cheese, Havarti Dill, clear plastic package, ~ 0.5 lbs. Recall # F-0462-2012;
 
6) Fair Oaks Farms Fine Cheese, Sweet Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0463-2012;

 
7) Fair Oaks Farms Fine Cheese, Veggie Havarti, clear plastic package, ~ 0.5 lbs. Recall # F-0464-2012;
 
8) Fair Oaks Farms Fine Cheese, Havarti Onion, clear plastic package, ~ 0.5 lbs. Recall # F-0465-2012;
 
9) Fair Oaks Farms Fine Cheese, Hickory Smoked Sweet Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0466-2012;
 
10) Fair Oaks Farms Fine Cheese, Aged Gouda, clear plastic package, ~ 0.5 lbs. Recall # F-0467-2012;
 
11) Fair Oaks Farms Fine Cheese, Asiago, clear plastic package, ~ 0.5 lbs. Recall # F-0468-2012;
 
12) Fair Oaks Farms Fine Cheese, Mozzarella, clear plastic package, ~ 0.5 lbs. Recall # F-0469-2012;
 
13) Fair Oaks Farms Fine Cheese, Calico, clear plastic package, ~ 0.5 lbs. Recall # F-0470-2012;
 
14) Fair Oaks Farms Fine Cheese, Cheddar Curd, clear plastic package, ~ 0.5 lbs. Recall # F-0471-2012;  
 
15) Fair Oaks Farms Fine Cheese, Cheddar-1 YR, clear plastic package, ~ 0.5 lbs. Recall # F-0472-2012;
 
16) Fair Oaks Farms Fine Cheese, Cheddar-2 YR clear plastic package, ~ 0.5 lbs. Recall # F-0473-2012;
 
17) Fair Oaks Farms Fine Cheese, Cheddar-3 YR clear plastic package, ~ 0.5 lbs. Recall # F-0474-2012;
 
18) Fair Oaks Farms Fine Cheese, Cheddar-5 YR clear plastic package, ~ 0.5 lbs. Recall # F-0475-2012;
 
19) Fair Oaks Farms Fine Cheese, Cheddar-Mild, clear plastic package, ~ 0.5 lbs. Recall # F-0476-2012;
 
20) Fair Oaks Farms Fine Cheese, Emmenthaler, clear plastic package, ~ 0.5 lbs. Recall # F-0477-2012;
 
21) Fair Oaks Farms Fine Cheese, Farmers, clear plastic package, ~ 0.5 lbs. Recall # F-0478-2012;
 
22) Fair Oaks Farms Fine Cheese, Lacy Swiss, clear plastic package, ~ 0.5 lbs. Recall # F-0479-2012;
 
23) Fair Oaks Farms Fine Cheese, Muenster, clear plastic package, ~ 0.5 lbs. Recall # F-0480-2012;
 
24) Fair Oaks Farms Fine Cheese, Provolone, clear plastic package, ~ 0.5 lbs. Recall # F-0481-2012;
 
25) Fair Oaks Farms Fine Cheese, Smoked Gouda, clear plastic package, ~ 0.5 lbs. Recall # F-0482-2012;
 
26) Fair Oaks Farms Fine Cheese, Butterkase, clear plastic package, ~ 0.5 lbs. Recall # F-0483-2012;
 
27) Fair Oaks Farms Fine Cheese, Gouda clear plastic package, ~ 0.5 lbs. Recall # F-0484-2012
CODE
No expiration, no code 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fair Oaks Dairy Products, LLC, Fair Oaks, IN, by telephone and e-mail on December 5, 2011 and by press release on December 7, 2011.
Manufacturers: Land O Lakes Inc., Kiel, WI;  
Edelweiss Graziers Cooperative, Monticello, WI. Indiana initiated recall is ongoing.
REASON
Possible Listeria monocytogenes contamination.
VOLUME OF PRODUCT IN COMMERCE
23, 341.57 pounds (46, 782 packages)
DISTRIBUTION
IN, IL, and TX
___________________________________
PRODUCT
1) Pangasinan Smoked Mackerel (Hasa Hasa); 6 oz plastic package (170 g) Product of the Philippines; Keep Chilled, Cook Before Serving. Recall # F-0495-2012;
 
2) Pangasinan Smoked Round Scad, (Tinapang Galunggong); 6 oz plastic package (170 g) Product of the Philippines; Keep Chilled, Cook Before Serving. UPC: 2239257451. Recall # F-0496-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Camtrade Enterprises, Inc., Union City, CA, by letter on November 5, 2011.
Manufacturer: Fitrite Inc., Quezon City, Philippines. Firm initiated recall is ongoing.  
REASON
Uneviscerated fish has the potential to be contaminated with Clostridium botulinum, a bacteria which can cause life-threatening illness or death.
VOLUME OF PRODUCT IN COMMERCE
1) 3 cases; 2) 27 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Barbecue sauce packaged in 18 oz and 34 oz capacity glass bottles and 1 gallon plastic containers. Recall # F-0497-2012;
 
2) Japeno Barbecue sauce packaged in 18 oz and 34 oz capacity glass bottles and 1 gallon plastic containers. Recall # F-0498-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Herbadashery LLC, Casper, WY, by letters on November 25, 2011. Firm initiated recall is complete.
REASON
The firm's products do not include anchovies as a sub ingredient in the barbecue sauce ingredient statements. The anchovies are contained in the Worcestershire sauce used to manufacture the product.
VOLUME OF PRODUCT IN COMMERCE
1) 516 x 18 oz; 120 x 34 oz; 16 x 1 gallon; 2) 924 x 18 oz; 300 x 34 oz; 58 x 1 gallon
DISTRIBUTION
CA, CO, IA, ID, IN, KS, MI, MO, OR, SD, TX, WA, WI and WY
___________________________________
PRODUCT
Rising Moon Organic Mediterranean Garlic & Herb Ravioli, 8 oz. frozen. Recall # F-0501-2012
CODE
Sell by Apr 05 2012 printed on front label
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blue Marble Brands, N Providence, RI, by letter on December 12, 2011 and by press release on December 14, 2011.  
Manufacturer: Carmel Food Group, Inc., Hayward, CA. Firm initiated recall is ongoing.
REASON
The product contains undeclared soy.
VOLUME OF PRODUCT IN COMMERCE
540 cases (6/cs)
DISTRIBUTION
US-Eastern & Central region
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Hampton Farms Smooth Peanut Butter, 12 and 18 oz plastic jars, UPC: 8186400040 and 8186400042, Product numbers: 866, 878, 1274-A and 1275-A. Recall # F-0440-2012
CODE
Best Buy Dates: 9/27/2012, 9/30/2012, 10/01/2012 and 10/19/2012
RECALLING FIRM/MANUFACTURER
Northhampton Peanut Co., Severn, NC, by email, telephone, and letter on November 23, 2011. FDA initiated recall is ongoing.
REASON
Product was not manufactured under Good Manufacturing Processes
VOLUME OF PRODUCT IN COMMERCE
154,656 lbs 
DISTRIBUTION
IL, MI, MO and NV
___________________________________
PRODUCT
1) Product of Centroamerica El Puro Queso Duro Blando El Sabor Original de Tu Tierra Hard Cheese INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, and Salt. Net Wt/PESO NETO 16 oz (1 Lb.) 454 g. Recall # F-0449-2012;
 
2) Alumbrando al Mundo con el Sabor de tu Tierra Queso Emanuel Hard Cheese Net Wt/PESO NETO 16 oz (1 lb.) 454 g. INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, Salt. Keep Refrigerated. Recall # F-0450-2012;
 
3) Alumbrando al Mundo con el Sabor de tu Tierra Queso Rallado Grated Cheese Net Wt/PESO NETO 16 oz (1 lb.) 454 g; INGREDIENTS: Pasteurized Milk to 3% of FAT, Calcium, Chloride, Lactic Cultures, Curdle, Salt. Keep Refrigerated. Recall # F-0451-2012
CODE
No Codes
RECALLING FIRM/MANUFACTURER
Emanuel Distributors, Irving, TX, by letter on November 15, 2011. Firm initiated recall is ongoing.
REASON
The firm's product declared unpasteurized milk as pasteurized milk on the ingredient statement and possible adverse health effects from pathogens that may survive a 66-day aging process in products made from unpasteurized milk.
 
VOLUME OF PRODUCT IN COMMERCE
248 units of the Queso Rallado (1 lb), 2500 units of the El Puro Queso Duro Blando (1 lb), and 2000 units of the Queso Emanuel Hard Cheese (1 lb)
DISTRIBUTION
AR and TX
___________________________________
PRODUCT
365 Everyday Value Organic Cashews mislabeled as 365 Everyday Value Organic Walnuts halves & pieces; USDA ORGANIC NET WT 12 OZ (340g); Product would have shipped in a case for cashews. UPC: 0 99482 43428 1. Recall # F-0485-2012
CODE
Lot Code: 10/12/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by e-mail on November 29, 2011.
Manufacturer: Golden Boy Foods Limited partnership, Burnaby, Canada. Firm initiated recall ongoing.  
REASON
Undeclared cashews. There are 365 Cashews which are mislabeled as 365 Organic Walnuts. The product would have shipped in a case for cashews.
VOLUME OF PRODUCT IN COMMERCE
1241 retail units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Cranberry Apricot Nut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00322 9. The product is labeled in part: "***MACRINA BAKERY***cranberry apricot nut crostini***Unbleached white wheat flour, natural sour starter, filtered water, dried unsulphured apricots, cranberries, pecans, walnuts, organic wheat flour, salt, anise, cloves, olive oil, garlic, contains wheat***". Recall # F-0486-2012;
 
2) Herb Wheat Walnut Crostini has a 9 oz (225 g) net weight. The UPC is 8 91886 00321 2. The product is labeled in part: "***MACRINA Bakery Cafe***HERB WHEAT WALNUT CROSTINI***Unbleached white wheat flour, natural sour starter, filtered water, walnuts, organic whole wheat flour, assorted fresh herbs (parsley, thyme, rosemary, sage, oregano), olive oil, garlic, contains wheat***". Recall # F-0487-2012
CODE
Sell By 11/18 through 12/2
RECALLING FIRM/MANUFACTURER
Mac & Co. dba Macrina Bakery and Café, Seattle, WA, by telephone on November 22, 2011. FDA initiated recall is ongoing.
REASON
Product contains walnut and it is declared in the Ingredient Statement. However, walnut is not declared in the Contains allergen statement.
VOLUME OF PRODUCT IN COMMERCE
359 - 9 ounce bags of Cranberry apricot nut crostinis and 34 - 9 ounce bags of Herb wheat walnut crostinis
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Seafood salad, under the brand name: Noelle's . Product labeling reads in part: "SEAFOOD SALAD Ingredients: Imitation Crab, Mayonnaise***Net Weight 5lb ***0 87709 01840 6. Recall # F-0488-2012;
 
2) Linguine/Artichoke Salad, under the brand name: Noelle's. Product labeling reads in part: "LINGUINE/ARTICHOKE SALAD INGREDIENTS: Rotini Pasta, Linguine Pasta***Mayonnaise***Net Weight 5lb ***0 87709 01869 7. Recall # F-0489-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Nasco Gourmet Foods, Corona, CA, by letters via combination of email, visit, and telephone, on December 8, 2011. FDA Initiated recall is ongoing.
REASON
During a FDA inspection of the firm, it was discovered that the firm's products contained undeclared soybean oil in a sub-ingredient.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Strawberry Cakes. Product is sold under brand name Pander El Angel. Individual piece of strawberry cake are wrapped as a single unit in a transparent plastic container. Each unit is approximately 7 inches by 7 inches and weight approximately 1 pound. There is no UPC on package. The product is labeled in parts: "***Pastel 3 Leches***Milk Egg, Sugar, Flour, Royal, Oil, Conservatives, Chantilli. Recall # F-0490-2012;
CODE
None
RECALLING FIRM/MANUFACTURER
Panaderia El Angel, Arlington, WA, by visit on December 2, 2011. FDA initiated recall is ongoing.
REASON
Assorted Mexican Pastries contain undeclared FD&C Red No. 3.
VOLUME OF PRODUCT IN COMMERCE
576 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Dell'Alpe Sport Peppers; packaged in an 8 fl. oz. (236 mL) glass jar, 12 jars per case; UPC 0 75462 02033 0. Recall # F-0492-2012;
 
2) Vienna Sport Peppers; packaged in a 12 fl. oz. (355 mL) glass jar, 12 jars per case; UPC 0 70723 55252 0. Recall # F-0493-2012
CODE
1) All jars with a four digit code on the front panel of the label;
2) Best By dates 012810 through 100413
RECALLING FIRM/MANUFACTURER
Rubinelli Inc., Bolingbrook, IL, by fax on November 14, 2011 and follow-up letters on November 17, 2011. Firm initiated recall is ongoing.
REASON
The sport peppers contain undeclared color - FD&C Yellow #5 which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
22,128 cases
DISTRIBUTION
CA, IL, IN, WI
___________________________________
PRODUCT
Vitamin E Oil, UPC 005368533962 --- Uses: Moisturizes and conditions by helping to restore the skin's essential nutrients. Each 5 drops supplies 100 International Units of Vitamin E in a natural base of heat germ and vegetable oils. Recall # F-0499-2012
CODE
Lot codes: 601673, 603717, 605603, 901284, 801284, 802284
RECALLING FIRM/MANUFACTURER
Hi-Tech Pharmacal Co., Inc., Amityville, NY, by letter on September 10, 2010 and September 22, 2010. Firm initiated recall is ongoing.
REASON
Vitamin E Oil was recalled as it did not meet the specifications for microbial limits, specifically for yeast and mold.
VOLUME OF PRODUCT IN COMMERCE
47,172 bottles
DISTRIBUTION
GA
___________________________________
PRODUCT
Maruchan Ramen Noodle Soup, Picante Beef Flavor, Net Wt. 3 oz (85g). 24 packages per case. Recall #F-0500-2012
CODE
Lot #040313 AV, 040313 BV, 040313 CV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maruchan, Inc., Irvine, CA, by letter on November 9, 2011
Manufacturer: Maruchan Virginia Inc., Richmond, VA. Firm initiated recall is ongoing.
REASON
The Ramen Noodle Soup Picanted Beef Flavor contains an incorrect flavor, Picante Chicken, which has dehydrated celery stalk.
VOLUME OF PRODUCT IN COMMERCE
5,304 cases
DISTRIBUTION
TN, MI, GA, MO, and FL
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Assorted Mexican Pastries and Cookies with red frosting and/or gel. Product is sold under brand name Panaderia El Angel. Pastries are distributed in bulk on a metal tray wrapped with cellophane. Each tray contains 50 units total but 4 units contain and are observed with a red-pink color frosting and 3 units are observed with a red-pink color filling gel. Trays are distributed to consignees without an affixed label. A label is provided to the consignee separately and then it is placed on the bakery display case. There is no net quantity nor UPC on the label. The product is labeled in parts: "***Wheat flour bleached & unbleached granulated, Vegetable bakes margarine (non-dairy), all purpose shortening, partially hydrogenated soybean oil, sugar, water, salt, margarine (partially hydrogenated), vegetable shortening***, eggs, 2% milk, butter, soy bean oils, yeast, melted barley flour***Yellow (5), Yellow (6) Citric Acid, ***artificially colored with beta-carotene. Recall # F-0491-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Panaderia El Angel, Arlington, WA, by visit on December 2, 2011. FDA initiated recall is ongoing.
REASON
Assorted Mexican Pastries and Cookies contain undeclared FD&C Red No. 3.
VOLUME OF PRODUCT IN COMMERCE
9,800 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Mother Murphy's Natural Pina Colada Flavor, 1 gallon, 2114490-1G. Recall # F-0494-2012
CODE
Lot numbers: 234738, 237035, 238814, 240725, 239480, 239985 and 241061
RECALLING FIRM/MANUFACTURER
Mother Murphy’s Laboratory, Greensboro, NC, by e-mail on December 16, 2011. Firm initiated recall is ongoing.
REASON
The product does not list coconut as an ingredient; however, there is allergy information on the label.
VOLUME OF PRODUCT IN COMMERCE
95 gallons
DISTRIBUTION
TX
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
 
PRODUCT
1) Ondansetron Hydrochloride Tablets, 4 mg, 1 Card x 3 Tablets per carton, Rx only, Manufactured in Israel By: Teva Pharmaceutical IND. Ltd., Jerusalem, 91010, Israel; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-0233-33.
 
2) Ondansetron Hydrochloride Tablets, 8 mg, 1 Card x 3 Tablets per carton, Rx only, Manufactured in Israel by: Teva Pharmaceutical IND. Ltd., Jerusalem, 91010, Israel; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7236-33.
CODE
1) Lot # Y04033, Exp 12/12;
2) Lot # Y05037, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel
REASON FOR RECALL
Labeling: Incorrect or Missing Package Insert: Packages contain out-dated product inserts.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) Cyclafem(TM) 7/7/7, (norethindrone and ethinyl estradiol Tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7525-49) and 6 cards (NDC 0603-7525-17), Rx only. Recall # D-1117-2012;
 
2) Cyclafem(TM) 1/35, (norethindrone and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7521-17), Rx only. D-1118-2012;
 
3) Emoquette(TM), (desogestrel and ethinyl estradiol tablets USP, 0.15 mg and 0.03 mg USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7521-49) and 6 cards (NDC 0603-7540-17), Rx only. Recall # D-1119-2012;
 
4) Gildess(R) FE 1.5/30, (norethindrone acetate and ethinyl estradiol Tablets USP and ferrous fumarate tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7608-17), Rx only. Recall # D-1120-2012;
 
5) Gildess(R) FE 1/20, (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate, USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7609-17), Rx only. Recall # D-1121-2012;
 
6) Orsythia(TM), (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP), 28 Day Regimen, packaged in boxes of 3 cards (NDC 0603-7634-49) and 6 cards (NDC 0603-7634-17), Rx only. Recall # D-1122-2012;
 
7) Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7642-17), Rx only. D-1123-2012;
 
8) Tri-Previfem(R), (norgestimate and ethinyl estradiol tablets USP), 28 Day Regimen, packaged in boxes of 6 cards (NDC 0603-7663-17), Rx only. Recall # D-1124-2012
CODE
All lots within expiry.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, by press release on September 15, 2011, by letter on September 16, 2011. 
Manufacturer: Patheon, Inc., Toronto Region Operations, Mississauga Ontario, Canada.
Firm Initiated recall is ongoing.
REASON
Contraceptive Tablets Out of Sequence; blister cards were rotated 180 degrees, reversing the weekly tablet orientation.
VOLUME OF PRODUCT IN COMMERCE
3,220,845 cards
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Nostrilla Nasal Decongestant, (Oxymetazoline HCl), 0.5 fl. oz. (15 mL) bottle, NDC 63736-730-01. Recall # D-1130-2012
CODE
Lot # 11G075
RECALLING FIRM/MANUFACTURER
Recalling Firm: Insight Pharmaceuticals, Corp., Langhorne, PA, by letter on September 15, 2011 and by press release on October 19, 2011.  
Manufacturer: Ultra-Seal Corp., New Paltz, NY. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Product; product found to contain Bulkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
34,092 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
FLUOXETINE Capsules USP, 10 mg, 1000-count Capsules per bottle, Rx only, NDC 50111-647-03. Recall # D-1125-2012
CODE
Lot: 35201238A, exp 05/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 30, 2011. 
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Firm's laboratory investigation was not performed in accordance with strict adherence to the "FDA Guidance for Industry Investigating Out-of-Specification Test Results for Pharmaceutical Production."
VOLUME OF PRODUCT IN COMMERCE
1,199 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tetracycline Hydrochloride Capsules USP, 500 mg, packaged in a) 10-count capsules per blister pack (NDC 0172-2407-00) packaged in 100 Unit-Dose Capsules (10 x 10) blister packs per box (NDC 0172-2407-10); and b) 1000-count bottles (NDC 0172-2407-80), Rx only. Recall # D-1127-2012
CODE
a) Lot 34002104A, Exp. 04/13; b) Lot 34002104C, Exp. 04/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on October 20, 2011. 
Manufacturer: Barr Laboratories, Inc. (div. of Teva), Forest, VA. Firm initiated recall is ongoing. 
REASON
CGMP Deviations: Product is being recalled due to an Out-of-Specification for particle size.
VOLUME OF PRODUCT IN COMMERCE
2,572 boxes and bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tetracycline Hydrochloride Capsules USP, 500 mg, 1000-count capsules per bottle, Rx only, NDC 0172-2407-80. Recall # D-1128-2012
CODE
Lot # 34002105B, exp 4/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 21, 2011.
Manufacturer: Barr Laboratories, Inc. (div. of Teva), Forest, VA. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
1,204 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Metformin Hydrochloride Tablets, USP, 1000 mg, 100-count tablets per bottle, Rx only, NDC 65862-010-01. Recall # D-1126-2012
CODE
Lot MTSC10038-A; Exp. Date August 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurolife Pharma LLC, Dayton, NJ, by letter on January 6, 2011.
Manufacturer: Aurobindo Pharma Ltd., Polepally(v) Jadcherla, India. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-up: Some bottles of Metformin Tablets 1000 mg were mislabeled as 500 count instead of 100 count.
VOLUME OF PRODUCT IN COMMERCE
21, 624 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0299-12
CODE
W0423110016433
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Billings, MT, by electronic notification on October 24, 2011 and by letter dated November 15, 2011.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, CA
___________________________________
PRODUCT
SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1 when used with SoftScape GUI versions: 1.2.0.7 - 1.2.0.15 and 1.3.0.4 - 1.3.0.5. Recall # B-0321-12
CODE
SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, through SCC Soft Computer's proprietary Task Management System on May 9, 2011. Firm initiated recall is ongoing.
REASON
SCC Soft Computer, SoftBank II versions: 23.0, 23.1, 23.2, 25.0, 25.1 when used with SoftScape GUI versions: 1.2.0.7, 1.2.0.15 and 1.3.0.4, 1.3.0.5, with a glitch or defect, were distributed.
VOLUME OF PRODUCT IN COMMERCE
136
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2. Recall # B-0322-12
CODE
SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, through SCC Soft Computer's proprietary Task Management System on September 16th, 2011. Firm initiated recall is ongoing
REASON
SCC Soft Computer, SoftBank II versions: 23.2.0.1-23.2.0.5, 25.0.0.3-25.0.0.5, and 25.1.0.1-25.1.0.2, with a glitch or defect, were distributed.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0298-12
CODE
W0423110016433
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Billings, MT, by electronic notification on October 24, 2011 and by letter dated November 15, 2011.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, CA
___________________________________
PRODUCT
1) Cancellous Particles: "***PUROS ALLOGRAFT augmentation material***REF***Cancellous Particles***Rx only*** STERILE***". All sizes are subject to recall: REF 68209 - Cancellous Particles W= 0.25 - 1 mm Qty 2.0 cc RTI: ZCN012 REF 68210 - Cancellous Particles W= 0.25 - 1 mm Qty 0.5 cc RTI: ZCN010 REF 68211 - Cancellous Particles W= 0.25 - 1 mm Qty 1.0 cc RTI: ZCN011 REF 68212 - Cancellous Particles W= 1-2 mm Qty 0.5 cc RTI: ZCN020 REF 68213 - Cancellous Particles W= 1-2 mm Qty 1.0 cc RTI: ZCN021 REF 68214 - Cancellous Particles W= 1-2 mm Qty 2.0 cc RTI: ZCN022. Recall # B-0369-12;
 
2) Cortical Particles: "***PUROS ALLOGRAFT augmentation material***REF***Cortical Particles***Rx only***STERILE***". All sizes subject to recall: REF 68271 - Cortical Particles W= 0.25 - 1 mm Qty 0.5 cc RTI: ZCR010 REF 68272 - Cortical Particles W= 0.25 - 1 mm Qty 1.0 cc RTI: ZCR011 REF 68273 - Cortical Particles W= 0.25 - 1 mm Qty 2.0cc RTI: ZCR012 REF 68274 - Cortical Particles W= 1 - 2 mm Qty 0.5 cc RTI: ZCR020 REF 68275 - Cortical Particles W= 1 - 2 mm Qty 1.0cc RTI: ZCR021 REF 68276 - Cortical Particles W= 1 - 2 mm Qty 2.0cc RTI: ZCR022. Recall # B-0370-12
CODE
1) All sizes. 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RECALLING FIRM/MANUFACTURER
RTI Biologics, Inc., Alachua, FL, by letter the week of July 26, 2010 and July 27, 2010. Firm initiated recall is complete.
REASON
Bone allografts, packaged with a lack of assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9,011 units
DISTRIBUTION
Nationwide, PR, Canada, and Latin America
___________________________________
PRODUCT
LABScreen MICA Single Antigen-Group 1; Product Number: LSMICA001. Recall # B-0402-12
CODE
Lot number 002, 003, 004 Expiration Date: 06/2008, 08/2011, 07/2013
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA, by letter on July 18, 2011. Firm initiated recall is ongoing.
REASON
LABScreen MICA Single Antigen - Group 1, in which a false reaction may be observed with the MICA19 antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
390 units
DISTRIBUTION
Nationwide, Canada, Saudi Arabia, Egypt, United Kingdom, France, Germany, Greece, Italy, Bosnia Herzegovina, Austria, Netherlands, Korea, Spain, China, India, Japan, Mexico, Philippines, and Taiwan
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
1) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 3/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3000A. Recall # Z-0247-2012;
 
2) SKYLight Gamma Camera System; SKYLIGHT 8 FT, 5/8" SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2161-3001A. Recall # Z-0248-2012;
 
3) SKYLight Gamma Camera System; SKYLIGHT, 3/8", SPECT. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3000A 4535-600-66661. Recall # Z-0249-2012;
 
4) SKYLight Gamma Camera System; SKYLIGHT, 5/8", SPECT; The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2160-3001A. Recall # Z-0250-2012;
 
5) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3000B 4535-602-46831. Recall # Z-0251-2012;
 
6) SKYLight Gamma Camera System; SKYLIGHT, AZ, 8 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2161-3001B 4535-602-55271. Recall # Z-0252-2012;
 
7) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3000B, 4535-602-46641. Recall # Z-0253-2012;
 
8) SKYLight Gamma Camera System; SKYLIGHT, AZ, 9 FT, 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model number: 2160-3001B. Recall # Z-0254-2012;
 
9) Precedence System; SYST, PRECEDENCE, 16 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3001A 4535-602-50861. Recall # Z-0255-2012;
 
10) Precedence System; SYST, PRECEDENCE, 16 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3000A 4535-602-50851. Recall # Z-0256-2012;
 
11) Precedence System; SYST, PRECEDENCE, 6 Slice 3/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3002A 4535-602-53551. Recall # Z-0257-2012;
 
12) Precedence System; SYST, PRECEDENCE, 6 Slice 5/8. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. Model numbers: 2169-3003A 4535-602-53561. Recall # Z-0258-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, San Jose, CA, by letter dated September 27, 2011. 
Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm Initiated recall is ongoing.
REASON
A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
VOLUME OF PRODUCT IN COMMERCE
658
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***" Labeling on product: "***1C0101 and K0061014***". A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis, post-operative conditions, degenerative joint disease, Parkinson's disease or other neuromuscular disorders. Recall # Z-0270-2012
CODE
Lot No. 1C0101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Uplift Technologies Inc., Dartmouth, Canada, by fax, telephone or letter dated June 27, 2011.
Manufacturer: Maxhealth Corp., Taipei, Taiwan. FDA initiated recall is ongoing.  
REASON
The plastic seat does not meet manufacturing specifications. The seat may not fit the unit properly and may interfere with the unit's normal locking mechanism.
VOLUME OF PRODUCT IN COMMERCE
219 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall #Z-0329-2012;
 
2) Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. Recall # Z-0330-2012
CODE
1) H630164 H630703 H630727 H630756 H630787 H630810 H630829 H630850 H630868 H630888 H630165 H630705 H630728 H630757 H630789 H630811 H630832 H630851 H630869 H630889 H630168 H630706 H630729 H630758 H630790 H630812 H630833 H630852 H630870 H630891 H630170 H630711, H630732 H630760 H630792 H630813 H630834 H630854 H630871 H630892 H630205 H630712 H630733 H630764 H630793 H630814 H630835 H630855 H630872 H630895 H630206 H630713 H630736 H630769 H630794 H630815 H630837 H630857 H630877 H630896 H630210 H630714 H630737 H630771 H630795 H630817 H630839 H630858 H630878 H630897 H630211 H630716 H630739 H630774 H630798 H630818 H630841 H630859 H630879 H630898 H630214 H630718 H630741 H630776 H630801 H630820 H630842 H630860 H630880 H630901 H630215 H630719 H630744 H630777 H630802 H630822 H630843 H630863 H630881 H630902 H630216 H630720 H630747 H630778 H630804 H630825 H630845 H630864 H630884 H630903 H630219 H630721 H630749 H630781 H630807 H630826 H630847 H630866 H630885 H630904 H630701 H630722 H630753 H630784 H630809 H630828 H630848 H630867 H630886;
 
2) Units: H630164 H630703 H630727 H630756 H630787 H630810 H630829 H630850 H630868 H630888 H630165 H630705 H630728 H630757 H630789 H630811 H630832 H630851 H630869 H630889 H630168 H630706 H630729 H630758 H630790 H630812 H630833 H630852 H630870 H630891 H630170 H630711 H630732 H630760 H630792 H630813 H630834 H630854 H630871 H630892 H630205 H630712 H630733 H630764 H630793 H630814 H630835 H630855 H630872 H630895 H630206 H630713 H630736 H630769 H630794 H630815 H630837 H630857 H630877 H630896 H630210 H630714 H630737 H630771 H630795 H630817 H630839 H630858 H630878 H630897 H630211 H630716 H630739 H630774 H630798 H630818 H630841 H630859 H630879 H630898 H630214 H630718 H630741 H630776 H630801 H630820 H630842 H630860 H630880 H630901 H630215 H630719 H630744 H630777 H630802 H630822 H630843 H630863 H630881 H630902 H630216 H630720 H630747 H630778 H630804 H630825 H630845 H630864 H630884 H630903 H630219 H630721 H630749 H630781 H630807 H630826 H630847 H630866 H630885 H630904 H630701 H630722 H630753 H630784 H630809 H630828 H630848 H630867 H630886
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 6, 2011. Firm initiated recall is ongoing.
REASON
The Product Models 1 & 2 has a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities. Recall # Z-0331-2012
CODE
Last Four Digits of Lot #2408, 2064, 2851, 2076, 2081, 2804, 2109, 2100, 2519, 2521, 2008, 3063, 2537, 2350, 2382, 2834, 3030, 3043, 3250, 3194, 2105, 2938, 2063, 2148, 2187, 2313, 2324, 2330, 2331, 2424, 2284, 2692, 2067, 2416, 2802, 3294, 2846, 2852, 2901, 3011, 3075, 3167, 2590, 2591, 2462, 3044, 2305, 3155, 3066, 3102, 3290, 3188, 2176, 2781, 3293, 2117, 3308, 3309, 2862, 2321, 2225, 2235, 2238, 3041, 7003, 7004, 2502, 2599, 3317, 2246, 2272, 2217, 3330, 3048, 2954, 3341, 2391, 2835, 2557, 2303, 2294, 2440, 2348, 2597, 3003, 2369, 2500, 2070, 2613, 2299, 2301, 2216, 3146, 3166, 3110, 2262, 2040, 2675, 3064, 2097, 2145, 3203, 2870, 2306, 2750, 2776, 2691, 2410, 7005, 2930, 2494, 2052, 2244, 2245, 2457, 3345, 2683, 2152, 2995, 2970, 2816, 2763, 2593, 2708, 2674, 2744, 2547, 2966, 2967, 2730, 2836, 2843, 2844, 2845, 2643, 2751, 2261, 2373, 2697, 2559, 2405, 2565, 3189, 2121, 3134, 2821, 3195, 2157, 2158, 2206, 3193, 3285, 3350, 2841, 2401, 2503, 2863, 2534, 2140, 2530, 3355, 3262, 3307, 2581, 2736, 2982, 2418, 2280, 2281, 3149, 2353, 2456, 2346, 2349, 2091, 2343, 3213, 2815, 2857, 2909, 2973, 3049, 3047, 2544, 2688, 3060, 2315, 2308, 2676, 2961, 3176, 2760, 3187, 2267, 2504, 2908, 2738, 2007, 3156, 3373, 3380, 2354, 2524, 2190, 2250, 3173, 3197, 3349, 2470, 2178, 2174, 2785, 3022, 3371, 3108, 2394, 3352, 2383, 2824, 2574, 2659, 2789, 2782, 2788, 2498, 2614, 2975, 2398, 3150, 2620, 2752, 3319, 2445, 2501, 2837, 2737, 2801, 2194, 2213, 2513, 2558, 2957, 2984, 2204, 3123, 2395, 2478, 2595, 2921, 3325, 2399, 3074, 3087, 3181, 2900, 2538, 3314, 2082, 3236, 2814, 2095, 3200, 3055, 3056, 2022, 3178, 2310, 3093, 2198, 2096, 2268, 3305, 2952, 2628, 2994, 2427, 2655, 2989, 2374, 2447, 3378, 3198, 3346, 2362, 2455, 2721, 3261, 2423, 2439, 2569, 2682, 3177, 3233, 2104, 2871, 2876, 2073, 2316, 2128, 3336, 3427
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated October 3, 2011. 
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  
REASON
The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being transferred may fall from the tabletop.
VOLUME OF PRODUCT IN COMMERCE
300 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Model H48: Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floor stand devices. The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions. Recall # Z-0332-2012
CODE
Code numbers: HZ50004 HZ70169 HZ70426 HZ70617 HZ70743 HZ72001 HZ72037 HZ72064 HZ72089 HZ73039 HZ77007 HZ50468 HZ70181 HZ70460 HZ70620 HZ70762 HZ72002 HZ72038 HZ72067 HZ72090 HZ73041 HZ77010 HZ50567 HZ70182 HZ70465 HZ70629 HZ71001 HZ72003 HZ72039 HZ72068 HZ72091 HZ73042 HZ77011 HZ50671 HZ70190 HZ70466 HZ70640 HZ71002 HZ72004 HZ72040 HZ72069 HZ72094 HZ73044 HZ77027 HZ59006 HZ70223 HZ70486 HZ70646 HZ71003 HZ72005 HZ72041 HZ72070 HZ72095 HZ73046 HZ77040 HZ59011 HZ70231 HZ70495 HZ70649 HZ71004 HZ72006 HZ72042 HZ72071 HZ72096 HZ73047 HZ77062 HZ59014 HZ70258 HZ70500 HZ70656 HZ71005 HZ72007 HZ72043 HZ72072 HZ72098 HZ73049 HZ77069 HZ59016 HZ70273 HZ70507 HZ70670 HZ71006 HZ72008 HZ72046 HZ72073 HZ72101 HZ73050 HZ77077 HZ59017 HZ70274 HZ70508 HZ70674 HZ71007 HZ72009 HZ72047 HZ72074 HZ72103 HZ73053 HZ77081 HZ59018 HZ70283 HZ70509 HZ70675 HZ71008 HZ72012 HZ72048 HZ72075 HZ72107 HZ73055 HZ78330 HZ59020 HZ70293 HZ70513 HZ70681 HZ71009 HZ72013 HZ72049 HZ72077 HZ72108 HZ73059 HZ79012 HZ59139 HZ70294 HZ70537 HZ70684 HZ71011 HZ72015 HZ72052 HZ72080 HZ72125 HZ73060 HZ79020 HZ59997 HZ70299 HZ70540 HZ70696 HZ71013 HZ72016 HZ72054 HZ72081 HZ72126 HZ73062 HZ79113 HZ59998 HZ70351 HZ70548 HZ70698 HZ71014 HZ72023 HZ72055 HZ72082 HZ72190 HZ73064 HZ79144 HZ70044 HZ70355 HZ70550 HZ70703 HZ71017 HZ72026 HZ72056 HZ72083 HZ73020 HZ75070 HZ79185 HZ70050 HZ70368 HZ70557 HZ70712 HZ71019 HZ72027 HZ72057 HZ72084 HZ73021 HZ75480 HZ79998 HZ70061 HZ70398 HZ70585 HZ70725 HZ71021 HZ72029 HZ72058 HZ72085 HZ73022 HZ76066 HZ70083 HZ70403 HZ70594 HZ70731 HZ71022 HZ72030 HZ72060 HZ72086 HZ73026 HZ76118 HZ70108 HZ70404 HZ70603 HZ70737 HZ71023 HZ72033 HZ72061 HZ72087 HZ73030 HZ77002 HZ70154 HZ70405 HZ70612 HZ70740 HZ71024 HZ72036 HZ72062 HZ72088 HZ73031 HZ77003
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 4, 2011. Firm initiated recall is ongoing.
REASON
An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.
VOLUME OF PRODUCT IN COMMERCE
205 Kits (each kit contains 4 Head Ring Posts or 820 HRP's
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. Recall # Z-0333-2012
CODE
domestically is version 1.05; internationally is version 2.04; version 7.1
RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corp., Saint Paul, MN, by letter dated October 2011.  Firm initiated recall is ongoing.
REASON
Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the measured value that prompted the alert is not displayed. Similarly, out-of-range impedance measurements are not plotted on programmer or LATITUDE trending graphs. Boston Scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue.
VOLUME OF PRODUCT IN COMMERCE
25,300 (14,700 Nationwide, 10,600 Internationally)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Dual Incu i (Atom Infant Incubator Model 100). Usage: A combination incubator and warmer for infants. Recall #Z-0337-2012;
 
2) Incu i (Atom Infant Incubator Model 101). Usage: An incubator for infants. Recall #Z-0338-2012;
 
3) Rabee Incu i (Atom Infant Incubator Model 102). Usage: An incubator for infants. Recall #Z-0339-2012;
 
4) Infa Warmer i (Atom Infant Warmer Model 103). Usage: A warmer for infants. Recall # Z-0340-2012
CODE
All lots on the market.
RECALLING FIRM/MANUFACTURER
Atom Medical Corp., Bunkyo-Ku, Japan, by letter dated August 18, 2011. Firm initiated recall is ongoing.
REASON
The caster with lock on the radiant-warming open type incubator may become loose or break.
VOLUME OF PRODUCT IN COMMERCE
453 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process. Recall # Z-0342-2012
CODE
Units: G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated October 20, 2011. 
Manufacturer: Elekta Oncology Systems (Fmrl Philipp’s), Crawley, West Sussex,   
UK. Firm initiated recall is ongoing.
REASON
A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide, PR
___________________________________
PRODUCT
1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473. Recall # Z-0343-2012;
 
2) Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. Recall # Z-0344-2012
CODE
1) Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237;
2) Serial Numbers: 7229, 7231, 7232, 7234, 7236, 7238, 7241, 7243, 7245, and 7246
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated October 28, 2011. Firm initiated recall is ongoing.
REASON
In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of these PET/CT system units.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag. Recall # Z-0508-2012
CODE
Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Orthopedics, Inc., Warsaw, IN, by letters on November 9, 2011.
Manufacturer: Symmetry Medical New Bedford Inc., New Bedford, MA. Firm initiated recall is ongoing.  
REASON
DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.
VOLUME OF PRODUCT IN COMMERCE
890 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0444-2012
CODE
SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter on July 26, 2011. Firm initiated recall is ongoing.
REASON
A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.
VOLUME OF PRODUCT IN COMMERCE
265 units
DISTRIBUTION
Nationwide and Canada
 
END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2011
 
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