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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 16, 2011

February 16, 2011                                                                                        11-07

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Kroger Value Semi Sweet Chocolate Chips, 12 oz. UPC 11110-86603. Recall # F-0411-2011
CODE
All Best By dates ending in 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Barry Callebaut LLC, Saint Albans, VT, by telephone and e-mail on January 8, 2011 and by press release on January 14, 2011.
Manufacturer: Barry Callebaut Canada Inc., Saint-Hyacinthe, Canada. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
16,494 cases (12/cs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
FROZEN CAPELIN ("IMURA" KOMOCHI SHISHAMO); UPC/Bar Code: 4-954559-197055, 4-954559-197062, 4-954559-197079, 4-954559-197086, 4-954559-197093, 4-954559-197116, and 4-954559-197123; Sizes(20 trays per case): 7L 8P 20/6.17 Z, 7L 5P 20/3.87 Z, 6L 10P 20/6.52 Z, 6L 8P 20/5.29 Z, 6L 5P 20/3.35 Z, 5L 10P 20/5.46 Z, 5L 8P 20/4.40 Z. Recall # F-0412-2011
CODE
Lot Numbers: P214, P215 and P218
RECALLING FIRM/MANUFACTURER
Recalling Firm: JFC International, Los Angeles, CA, by press release and e-mail on December 17, 2010 and by press release on December 23, 2010.
Manufacturer: Vietnam Rich Beauty Food Co Ltd, Thai Binh Province, Vietnam. New York initiated recall is ongoing.
REASON
The recall was initiated because the un-eviscerated Frozen Capelin has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
VOLUME OF PRODUCT IN COMMERCE
330 cases (20 trays per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oaxaca String Cheese "La Original"; 17.63 ounce (500 gr); clear plastic package marked- Oaxaca String Cheese, "La Original de Oaxaca"; UPC Code: 8 90512 00104 2. Recall # F-0414-2011
CODE
Lot # 1360912, Expiration Date: 01/09/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guelaguetza Foods, South Gate, CA, by telephone on January 9, 2011, press release on January 10, 2011 and by letter on January 11, 2011.
Manufacturer: Exportadores Del Sabor Oaxaqueno Sa De Cv, Elsa Santa Rosa Panzaco, Mexico. FDA initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Listeria monocytogenes and Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
840 kg
DISTRIBUTION
CA
___________________________________
PRODUCT
Valu Time Salt & Vinegar Potato Chips Net wt 5 oz (141g), Unit UPC: 11225-03388, Item #18882, Ingredients: potatoes, sunflower oil and/or corn oil, lactose, sodium diacetate, salt, malic acid, sodium citrate, spice extractive. Recall # F-0415-2011
CODE
All Best By before 05MAY2011
RECALLING FIRM/MANUFACTURER
Barrel O' Fun Snack Foods, Inc., Perham, MN, by press release and letter dated January 19, 2011. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk protein. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
882 cases (15/case)
DISTRIBUTION
VA, NB, KS
___________________________________
PRODUCT
1) Tuna Rotini Pasta Salad, in an 8 oz plastic container, with a red and green label with black print, UPC 5484800445. Recall # F-0416-2011;

2) Krab Pasta Salad, in an 8 oz plastic container, with a red and green label with black print, UPC 5484800446. Recall # F-0417-2011;

3) Classic Potato Salad, in an 8 oz clear plastic container and 10 pound bulk plastic containers, with a red and green label with black print, Gourmet Salads. Recall # F-0418-2011;

4) Spinach and Artichoke Dip, in an 8 oz clear plastic container and 10 pound bulk plastic container, with a red and green label with black print, UPC 5484800434. Recall # F-0419-2011;

5) Creamy Tortillini Salad, in an 8 oz clear plastic container and 10 pound bulk plastic container, with a red and green label with black print, Gourmet Salads. Recall # F-0420-2011;

6) Tuna Macaroni Pasta Salad, in an 8 oz clear plastic container and 10 pound bulk container, with a red and green label with black print, UPC 5484800481. Recall # F-0421-2011
CODE
Manufacture date 12/28/2010 through 01/10/2011
RECALLING FIRM/MANUFACTURER
California Pasta Shops, Inc., Clinton Twp, MI, by visit on January 11, 2011. Firm initiated recall is ongoing.
REASON
The labels for the salads do not include an ingredient statement for the presence of "egg" which is an ingredient in the Mayonnaise and Fat Free Salad dressing.
VOLUME OF PRODUCT IN COMMERCE
305.5 pounds
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Jeram Brand Fruity Pudding (Assorted Fruit Flavors); 120 g (25.2 oz) x 6 pcs; plastic cups; Flavors include Strawberry, Honey Dew, Apple, Mango, Papaya, and Durian. Recall # F-0396-2011
CODE
BEST BEFORE 18/11/2011 (November 18th, 2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: CNS Trading Inc., Maspeth, NY, by letter on January 5, 2011.  
Manufacturer: Jaram Coconut Sdn, Selangor, Malaysia. FDA initiated recall is ongoing.
REASON
The labels do not include the presence of Ponceau 4R, an unapproved color additive and Brilliant Blue FCF, certifiable as FD&C Blue # 1, in the product.
VOLUME OF PRODUCT IN COMMERCE
1,600 cases
DISTRIBUTION
MD, NJ, NY
___________________________________
PRODUCT
Italian style sub sandwich, 5.5 oz wrapped in clear plastic with green stick on label, UPC 8428000002. Recall # F-0398-2011
CODE
Best by 10/27/2010
RECALLING FIRM/MANUFACTURER
Fiesta Gourmet and Deli, Dearborn, MI, by visit on October 23, 2010. FDA initiated recall is ongoing.
REASON
Sandwiches contain yellow banana peppers containing yellow # 5. The ingredient label for the sandwiches does not list yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Submarine Sandwich, Super Submarine 16 oz. and Mini Submarine 3oz, in clear plastic wrap with a red and black sticker label, UPC 729810500608 and 729810991253. Recall # F-0399-2011;

2) Italian Submarine Sandwich, 5 oz, wrapped in clear plastic with a red and black sticker label, UPC 729810500509. Recall # F-0400-2011
CODE
All dates up to NOV 3
RECALLING FIRM/MANUFACTURER
Scotty's, Inc., Detroit, MI, by visit beginning October 19, 2010. FDA initiated recall is ongoing.
REASON
The firm manufactures sandwiches that contain sliced yellow banana peppers. The banana peppers contain yellow # 5 which is not declared on the sandwich label.
VOLUME OF PRODUCT IN COMMERCE
9,730 submarines
DISTRIBUTION
MI, OH
___________________________________
PRODUCT
Home 360 Baby Strawberry Pediatric Drink , Net 8 fl. oz Polypropylene bottle with a screw cap UPC code: 7-25439-96848-5. Recall # F-0401-2011
CODE
Lot Code: 0264SR334 Best By: 2011 DE 21 K
RECALLING FIRM/MANUFACTURER
Recalling Firm: PBM Nutritionals, LLC, Georgia, VT, by telephone on January 21, 2011.
Manufacturer: Kerry (Quebec) Inc., Sainte-Claire, Canada. Firm initiated recall is ongoing.
REASON
Pediatric nutritional drink labeled as vanilla flavor contains strawberry flavor.
VOLUME OF PRODUCT IN COMMERCE
5,880 bottles
DISTRIBUTION
NC, SC
___________________________________
PRODUCT
1) EAS� Peak" Fruit Power, 16 ounce bottles, Stock # 56598 & 56598E. Recall # F-0402-2011;
2) EAS� Peak" Orange Spark, 16 ounce bottle, Stock Code, 56592 & 56592E. Recall # F-0403-2011;
3) EAS� Peak" Peach Surge, 16 ounce bottle, Stock Code, 56596 & 56596E. Recall # F-0404-2011
CODE
1) Lot #: 91006TP00, 91011TP00, 91012TP00, 91019TP00, 91020TP00, 91021TP00, 91023TP00, Exp. Date 1-Aug-11;

2) Lot #: 90005TP00, Exp. Date 1-Jul-11; Lot # 91013TP00, 91013TP10, 91014TP00, 91015TP00, 91016TP00, 91017TP00 & 91018TP00, Exp. Date 1-Aug-11;

3) Lot #: 90004TP00, Exp. Date 7/1/2011; Lot #, 91007TP00, 91007TP10, 91008TP00, 91009TP00, 91010TP00, 91024TP00, 91025TP00 & 91008TP00, Exp. Date 1-Aug-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ross Products Division, Abbott Laboratories, Columbus, OH, by letter, telephone and/or email on October 7, 2010.
Manufacturer: Kan-Pak LLC, Arkansas City, KS. Firm initiated recall is ongoing.
REASON
The product does not meet quality standards. Following a consumer complaint, quality tests were conducted on additional lots of EAS Peak beverage products and results indicate the presence of mold.
VOLUME OF PRODUCT IN COMMERCE
1)  98,120/16 oz bottles; 2) 73,320/16 oz bottles; 3) 49,760/16 oz bottles
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) SWAD Best Taste in Town Gulabjamun, Soft cheese balls flavored with cardamom in sugar syrup, Serve Hot; Net Contents 35.30 oz (1 kg), No. of pieces: 20, Drained Weight: 17.65 oz (500 g), 12 cans per case; Item 30052, UPC 0 51179 30052 1. Recall # F-0405-2011;

2) SWAD Best Taste in Town Rossogolla/Rasgulla, Soft cheese balls in sugar syrup, Serve Chilled; Net Contents 35.30 oz (1 kg), No. of pieces: 20, Drained Weight: 17.65 oz (500 g), 12 cans per case; Item 30054, UPC 0 51179 30054 5. Recall # F-0406-2011;

3) SWAD Best Taste in Town Rajbhog, Soft cheese balls in sugar syrup, Serve Chilled; Net Contents 35.30 oz (1 kg), No. of pieces: 10, Drained Weight: 16 oz (454 g), 12 cans per case; Item 30093, UPC 0 51179 30093 4. Recall # F-0407-2011;

4) SWAD Best Taste in Town Cham Cham, Soft cheese balls in sugar syrup, Serve Chilled; Net Contents 35.30 oz (1 kg), No. of pieces: 10, Drained Weight: 16 oz (454 g), 12 cans per case; Item 30055, UPC 0 51179 30055 2. Recall # F-0408-2011;

5) SWAD Best Taste in Town Rasbhari, Soft cheese balls in sugar syrup, Serve Chilled; Net Contents 35.30 oz (1 kg), No. of pieces: 30, Drained Weight: 16 oz (454 g), 12 cans per case; Item 30091, UPC 0 51179 30091 0. Recall # F-0409-2011;

6) SWAD Best Taste in Town Rasmalai, Soft milk patty in sugar syrup, Serve Chilled; Net Contents 35.30 oz (1 kg), No. of pieces: 10, Drained Weight: 16 oz (454 g), 12 cans per case; Item 30057, UPC 0 51179 30057 6. Recall # F-0410-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raja Foods, L.L.C., Skokie, IL, by letters dated December 1, 2010 and December 8, 2010.
Manufacturer: Good-Day Foods Ltd., Thane, India. FDA initiated recall is ongoing.
REASON
The products contain wheat flour that was declared as "flour" in the ingredients statement and wheat was not included in the allergen statement.
VOLUME OF PRODUCT IN COMMERCE
14,497 cases
DISTRIBUTION
Nationwide, Grand Cayman Island, Aruba, Colombia and Jamaica
___________________________________
PRODUCT
El Latino Arepas de choclo with Cheese, packed frozen in bulk shipping boxes each containing 36 arepas. Keep Frozen. Ingredients: Corn, Cheese, (Milk, Salt, Rennet) sugar, wate, and salt. Cooking instructions: Thaw arepas to room temperature, then bake at 300 for 7 minuets or until cheese melts, UPC 1 08 33911 00301 6. Recall # F-0413-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intermark Foods Corp., Miami, FL, by telephone on November 23, 2010.
Manufacturer: Dona Arepa, Inc., Miami, FL. FDA initiated recall is ongoing.
REASON
Product contains undeclared color additives and wheat.
VOLUME OF PRODUCT IN COMMERCE
160 boxes
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Marx Hot Bagels brand plain, whole wheat, half & half, and garlic bagels packaged in clear flexible plastic bags with six bagels per bag; Net wt. 18 oz, UPC# 021571600017. Recall # F-0422-2011;

2) Marx Hot Bagels brand pumpernickel, combo, and onion bagels packaged in clear flexible plastic bags with six bagels per bag; Net wt. 18 oz, UPC# 021571600017. Recall # F-0423-2011;

3) Marx Hot Bagels brand sour dough rye, orange cranberry, honey wheat, and oat bran bagels packaged in clear flexible plastic bags with six bagels per bag; Net wt. 18 oz, UPC# 021571600024. Recall # F-0424-2011;

4) Marx Hot Bagels brand fiber, jalapeno, banana nut, and raisin wheat bagels packaged in clear flexible plastic bags with six bagels per bag; Net wt. 18 oz. UPC# 021571600024. Recall # F-0425-2011;

5) Marx Hot Bagels brand apple cinnamon, raisin, and blueberry bagels packaged in clear flexible plastic bags with six bagels per bag; Net wt. 18 oz, UPC# 021571600024. Recall # F-0426-2011;

6) Marx Hot Bagels brand miniature bagels packaged in clear flexible plastic bags with twelve bagels per bag; Net wt. 14 oz, UPC# 021571600055. Colored day dot sticker according to date the firm picks the item up for credit from the consignee, which is two days from the date of manufacture. Recall # F-0427-2011
CODE
Colored day dot sticker according to date the firm picks the item up for credit from the consignee, which is two days from the date of manufacture.
RECALLING FIRM/MANUFACTURER
Hot Bagel Factory Inc., Cincinnati, OH, by telephone and letter on December 8, 2010. FDA initiated recall is ongoing.
REASON
The presence of wheat in several varieties of bagels with no declaration of wheat on the product labels.
VOLUME OF PRODUCT IN COMMERCE
Regular size: 175 dozen (350/6 count bags); Miniature size: none (all 20 dozen miniatures manufactured were sold in the firm's retail store).
DISTRIBUTION
OH, KY
___________________________________
PRODUCT
1) Proteinex-15, (1 oz.), (8 oz.), (16 oz.), and (30 oz.) packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz.) size reads in part: PROTEINEX, 54859-515-01, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 15g of Protein and 60 Calories Per Dose, 1 Fl. oz. (30 mL), K, UPC 354859515018. Product labeling for (8 oz.) size reads in part: PROTEINEX, 54859-515-08, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 15g of Protein and 60 Calories Per Dose, 8 Fl. oz. (236.5 mL), K, UPC 354859515087. Product labeling for (16 oz.) size reads in part: PROTEINEX, 54859-515-16, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 15g of Protein and 60 Calories Per Dose, 16 Fl. oz. (473 mL), K, UPC 354859515162. Product labeling for (30 oz.) size reads in part: PROTEINEX, 54859-515-30, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 15 GRAMS, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 15g of Protein and 60 Calories Per Dose, 30 Fl. Oz. (887 mL), K, UPC 35485951530. Nutritional Panel for (1 oz.) , (8 oz.), (16 oz.), and (30 oz.) size reads: L-Arginine 1200 mg, L-Histidine 110 mg, L-Isoleucine 200 mg, L-Leucine 450 mg, L-Lysine 650 mg, L-Methionine 110 mg, L-Phenylalanine 350 mg, L-Threonine 300 mg, L-tryptophan 66 mg, L-Valine 139 mg. Other Ingredients for (1 oz.), (8 oz.), (16 oz.) and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, Sucrose, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Natural and Artificial Flavors. Recall # F-0428-2011;

2) Proteinex-18 Grape (1oz.), and (30 oz.) size packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz.) size reads in part: PROTEINEX, 54859-530-01, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, New Improved Flavor, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 72 Calories Per Dose, 1 Fl. oz. (30 mL), Grape, K, UPC 354859530011. Product labeling for (30 oz.) size reads in part: PROTEINEX, 54859-530-30, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, New Improved Flavor, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 72 Calories Per Dose, 30 Fl. oz. (887 mL), Grape, K, UPC 354859553030. Nutritional Panel for (1 oz.) and (30 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-tryptophan 66 mg, L-Valine 167 mg. Other Ingredients for (1 oz.) and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Sucralose Neotame, Malic Acid, Methylparaben, Propylparaben, Grape Flavor. Recall # F-0429-2011;

3) Proteinex-18 Grape (1oz.), and (30 oz.) size packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz.) size reads in part: PROTEINEX, 54859-530-01, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, New Improved Flavor, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 72 Calories Per Dose, 1 Fl. oz. (30 mL), GRAPE, K, UPC 354859530011. Product labeling for (30 oz.) size reads in part: PROTEINEX, 54859-530-30, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, New Improved Flavor, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 72 Calories Per Dose, 30 Fl. oz. (887 mL), Grape, K, UPC 354859553030. Nutritional Panel for (1 oz.) and (30 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-tryptophan 66 mg, L-Valine 167 mg. Other Ingredients for (1 oz.) and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Sucralose Neotame, Malic Acid, Methylparaben, Propylparaben, Grape Flavor. Recall # F-0430-2011;

4) Proteinex-18, Black Cherry, (1 oz.), (8 oz.) , (16 oz.) , and (30 oz.) size packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling reads in part for (1 oz.) size: PROTEINEX, 5459-525-16, Liquid Predigested Protein, No Fat, Sorbitol, Carbohydrates, Phosphorous, 18 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provide 18g of Protein and 72 Calories Per Dose, 1 FL. Oz. (30 mL), Black Cherry, K, UPC 354859525017. Product labeling reads in part for (8 oz.) size: PROTEINEX, 54859-525-08, Liquid Predigested Protein, No Fat, Sorbitol, Carbohydrates, Phosphorous, 18 GRAMS, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provide 18g of Protein and 72 Calories Per Dose, 8 Fl. oz. (236.5 mL), Black Cherry, K, UPC 354859525086. Product labeling reads in part for (16 oz.) size: PROTEINEX, 54859-525-16, Liquid Predigested Protein, No Fat, Sorbitol, Carbohydrates, Phosphorous, 18 GRAMS, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provide 18g of Protein and 72 Calories Per Dose, 16 Fl. oz. (473 mL), Black Cherry, K, UPC 354859525161. Product labeling reads in part for (30 oz.) size: PROTEINEX, 54859-525-30, Liquid Predigested Protein, No Fat, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provide 18g of Protein and 72 Calories Per Dose, 16 FL. Oz. (473 mL), Black Cherry, K, UPC 354859525307. Nutritional Panel for (1 oz.), (8 oz.), (16 oz.), and (30 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-Tryptophan 66mg. Other Ingredients for (1 oz.), (8 oz.), (16 oz.), and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Black Cherry Flavor. Recall # F-0431-2011;

5) Proteinex-18, Lemon Lime, (1 oz.), (8 oz.), (16 oz.) (30 oz.) size packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling reads in part for (1 oz.) size: PROTEINEX, 54859-535-01, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, Contains the highest Amount of protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 1 Fl. oz. (30 mL), Lemon Lime, K, UPC 354859535016. Product labeling reads in part for (8 oz.) size: PROTEINEX, 54859-535-08, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, Contains the highest Amount of protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 8 Fl. oz. (236.5 mL), Lemon Lime, K, UPC 354859535085. Product labeling reads in part for (16 oz.) size: PROTEINEX, 54859-535-16, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 GRAMS, Contains the highest Amount of protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 16 Fl. oz. (473 mL), Lemon Lime, K, UPC 354859535160. Product labeling reads in part for (30 oz.) size: PROTEINEX, 54859-535-30, Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 Grams, Contains the highest Amount of protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 30 Fl. oz. (877 mL), Lemon Lime, K, UPC 354859535306. Nutritional Panel for (1 oz.), (8 oz.), (16 oz.), and (30 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-Tryptophan 66mg. Other Ingredients for (1 oz.), (8 oz.), (16 oz.), and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Lemon Lime Flavor. Recall # F-0432-2011;

6) Proteinex-100, (1 oz.), (30 oz.) size Black Cherry, packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz) size reads in part: PROTEINEX, 54859-545-01, Liquid Predigested Protein, No Fat, Sorbitol, Phosphorus, 100 Calories, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 100 Calories Per Dose, 1 Fl. oz. (30 mL), Black Cherry, K, UPC 354859545015. Product labeling for (30 oz.) size reads in part: PROTEINEX, 54859-545-30, Liquid Predigested Protein, No Fat, Sorbitol, Phosphorus, 100 Calories, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 100 Calories Per Dose, 30 Fl. oz. (887 mL), Black Cherry, K, UPC 354859545305. Nutritional Panel for (1 oz.) and (30 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-tryptophan 66 mg Other Ingredients for (1 oz.), and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, Sucrose, L-Tryptophan, Propylene Glycol, Potassium Sorbate, Calcium Saccharin, Methylparaben, Propylparaben, Natural and Artificial Flavors. Recall # F-0433-2011;

7) Proteinex-100, (16 oz.), Black Cherry, packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling reads in part: PROTEINEX, 54859-545-16, Liquid Predigested Protein, No Fat, Sorbitol, Phosphorus, 100 Calories, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18g of Protein and 100 Calories Per Dose, 16 Fl. oz. (473 mL), Black Cherry, K, UPC 354859545169, Nutritional Panel for (16 oz.) size reads: L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-tryptophan 66 mg, L-Valine 167 mg. Other Ingredients for (16 oz.) size reads: Purified Water, Hydrolyzed Collagen, Sucrose, L-Tryptophan, Propylene Glycol, Potassium Sorbate, Calcium Saccharin, Methylparaben, Propylparaben, Natural and Artificial Flavors. Recall # F-0434-2011;

8) Proteinex-Wound Care (1 oz.), and (30 oz.) size, packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz.) size reads in part: PROTEINEX, 54859-555-01, Proteinex- Wound Care, WC, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, Added L-Arginine, L-Glutamine, Vitamin C, Zinc and Copper, For Patients that Require Additional Protein Supplementation, Provides 22g of Protein and 107 Calories Per Dose, Shake Well Before Using, 1 Fl. oz. (30 mL), GRAPE, K, UPC 354859555014. Product labeling for (30 oz.) size reads in part: PROTEINEX, 54859-555-30, Proteinex- Wound Care, WC, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, Added L-Arginine, L-Glutamine, Vitamin C, Zinc and Copper, For Patients that Require Additional Protein Supplementation, Provides 22g of Protein and 107 Calories Per Dose, Shake Well Before Using, 30 Fl. oz. (887 mL), GRAPE, K, UPC 354859555304. Nutritional Panel for (1 oz.) and (30 oz.) size reads: L-Arginine 6200 mg, L-Histidine 110 mg, L-Isoleucine 200 mg, L-Leucine 450 mg, L-Lysine 650 mg, L-Methionine 110 mg, L-Phenylalanine 350 mg, L-Threonine 300 mg, L-tryptophan 66 mg, L-Valine 139 mg. Other Ingredients for (1 oz.) and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan,L-Arginine, L-Glutamine, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Citric Acid, Sucrose, Xanthan Gum, Ascorbic Acid, Zinc Sulfate, Copper Sulfate, Natural and Artificial Flavors. Recall # F-0435-2011;

9) Aminorip-15 Liquid, (1oz.), and (30 oz.) size packaged in PET, amber plastic bottles, Storage requirements room temperature (59-86 F). Product labeling for (1 oz.) size reads in part: Liquid Predigested Protein, No Fat, No Sugar, No Sorbitol, No Carbohydrates, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Individuals that Require Additional Protein Supplementation, Provides 15 g of Protein and 60 Calories Per Dose, Dietary Supplement, 1 FL. oz. (30 mL), UPC 854581002027 Product labeling for (30 oz.) size read in part: Liquid Predigested Protein, No Fat, No Sugar, No Sorbitol, No Carbohydrates, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Individuals that Require Additional Protein Supplementation, Provides 15 g of Protein and 60 Calories Per Dose, Dietary Supplement, 30 Fl. oz. (887 mL), UPC 854581002010 Nutritional Panel for (1 oz.) and (30 oz.) size reads: L-Arginine 1200 mg, L-Histidine 110 mg, L-Isoleucine 200 mg, L-Leucine 450 mg, L-Lysine 650 mg, L-Methionine 110 mg, L-Phenylalanine 350 mg, L-Threonine 300 mg, L-Tryptophan 66 mg, L-Valine 139 mg. Other Ingredients for (1 oz.) and (30 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Natural and Artificial Flavors. Recall # F-0436-2011;

10) Proteinex, Liquid Predigested Protein 15 Grams, Pouch Product labeling for (1 oz.) size reads in part: Liquid Predigested Protein, No Fat, No Sugar, No Sorbitol, No Carbohydrates, No Phosphorus, 15 Grams, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 15 g of Protein and 60 Calories Per Dose, 1 Fl. oz. (30 mL), UPC 3 54859 51510 0. Directions for (1 oz.) size reads: As a food supplement, 2 tablespoons (30ml) daily. Provides 15 g of protein hydrolysate. L-Arginine 1200 mg, L-Histidine 110 mg, L-Isoleucine 200 mg, L-Leucine 450 mg, L-Lysine 650 mg, L-Methionine 110 mg, L-Phenylalanine 350 mg, L-Threonine 300 mg, L-Tryptophan 66 mg, L-Valine 139 mg. Other Ingredients for (1 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Natural and Artificial Flavors. Recall # F-0437-2011;

11) Proteinex, Liquid Predigested Protein 18 Grams, Pouch, Lemon Lime. Product labeling for (1 oz.) size reads in part: Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 g, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 1 Fl. oz. (30 mL), UPC 3 54859 53510 8. Directions for (1 oz.) size reads: As a food supplement, 2 tablespoons (30ml) daily. Provides 18 g of protein hydrolysate. L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-Tryptophan 66 mg. Other Ingredients for (1 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Lemon Lime Flavor. Recall # F-0438-2011;

12) Proteinex, Liquid Predigested Protein 18 Grams, Pouch, Black Cherry. Product labeling for (1 oz.) size reads in part: Liquid Predigested Protein, No Fat, Sugar, Sorbitol, Carbohydrates, Phosphorus, 18 g, Contains the Highest Amount of Protein Per Dose and All Indispensable Amino Acids, For Patients that Require Additional Protein Supplementation, Provides 18 g of Protein and 72 Calories Per Dose, 1 Fl. oz. (30 mL), UPC 3 54859 52510 9. Directions for (1 oz.) size reads: As a food supplement, 2 tablespoons (30ml) daily. Provides 18 g of protein hydrolysate. L-Arginine 1440 mg, L-Histidine 132 mg, L-Isoleucine 240 mg, L-Leucine 540 mg, L-Lysine 780 mg, L-Methionine 132 mg, L-Phenylalanine 420 mg, L-Threonine 360 mg, L-tryptophan 66 mg. Other Ingredients for (1 oz.) size reads: Purified Water, Hydrolyzed Collagen, L-Tryptophan, Propylene Glycol, Calcium Saccharin, Methylparaben, Propylparaben, Black Cherry Flavor. Recall # F-0439-2011
CODE
1) (1 oz.) size: Lot # 081007, Lot # 090403, Lot # 090609, Lot # 090613, Lot # 0A03, Lot # 0C01, Lot # 0C02, Lot # 0D01, Lot # 0E06, Lot#8A11, Lot#8C02, Lot#8E02, Lot # 8L01, Lot # 9A01, Lot # 9B01, Lot # 9B02, Lot # 9D02, Lot # 9F04, Lot # 9G04, Lot # 9J03, Lot # 9L04, Lot # 9M04; (8 oz.) size: Lot # 081007, Lot # 090613, Lot # 091107, Lot # 091208, Lot # 0B04, Lot # 0C02, Lot # 0D01, Lot # 0F01, Lot # 0F02, Lot # 0G04, Lot # 7L17, Lot # 8A11, Lot # 8B13, Lot # 8C02, Lot # 8D14, Lot # 8L01, Lot # 9A01, Lot # 9B02, Lot#9C03, Lot # 9D03, Lot # 9E01, Lot#9E02, Lot#9G04, Lot # 9H04, Lot # 9K01, Lot # 9K04, Lot # 9M02, Lot # 0C04; (16 oz) size: Lot # 081105, Lot # 081107, Lot # 0C04, Lot # 081101, Lot # 081208, Lot # 081218, Lot # 090609, Lot # 090613, Lot # 091107, Lot # 0A04, Lot # 0B01, Lot # 0B05, Lot # 0D04, Lot # 0E03, Lot # 0F02, Lot # 0G03, Lot # 100301, Lot # 100404, Lot # 100710, Lot # 8A07, Lot # 8A11, Lot # 8B13, Lot # 8B14, Lot # 8C02, Lot # 8D14, Lot # 8D15, Lot # 8E02, Lot # 9A01, Lot # 9A02, Lot # 9A03, Lot # 9C01, Lot # 9C05, Lot # 9D01, Lot # 9D02, Lot # 9D03, Lot # 9D05, Lot # 9E01, Lot # 9F01, Lot # 9F04, Lot # 9G01, Lot # 9G04, Lot # 9H03, Lot # 9H04, Lot # 9J03, Lot # 9K03, Lot # 9K04, Lot # 9L01, Lot # 9L04, Lot # 9M03, Lot # 9M04, Lot # 7L17; (30 oz.) sizes: Lot # 0F02, Lot # 0A03, Lot # 0C02, Lot # 0C04, Lot # 0D01, Lot # 0E06, Lot # 9B02, Lot # 9G01, Lot # 9K01, Lot # 9M02;

2) (1 oz.) size: Lot#0G01; (30 oz.) size: Lot# 0G01;

3) (1 oz.) size: Lot # 0F06; (30 oz.) size: Lot # 0F06;

4) (1 oz.): size: Lot # 081003, Lot # 090210, Lot # 090315, Lot # 0B02, Lot # 0C03, Lot # 0D02, Lot # 0F03, Lot # 0H02, Lot # 100302, Lot # 9C02, Lot # 9H02, Lot # 9J02, Lot # 9K05, Lot # 9L02; (8 oz.) size: Lot # 0A02, Lot # 0D02, Lot # 9H02, Lot # 9K01, Lot # 9K05; (16 oz.) size: Lot # 090210, Lot # 090612, Lot # 0A02, Lot # 0C03, Lot # 0D02, Lot # 0E02, Lot # 0H02, Lot # 9J02, Lot # 9K05, Lot # 9L02; (30 oz.) size: Lot # 0F03, Lot # 081003, Lot # 090612, Lot # 0A02, Lot # 0C03, Lot # 0D02, Lot # 0E02, Lot # 0H02, Lot # 9E02, Lot # 9H02, Lot # 9J02, Lot # 9K05, Lot # 9L02;

5) (1 oz.) size: Lot # 090402, Lot # 090611, Lot # 0A01, Lot # 0E01, Lot # 100214; (8 oz) size: Lot # 0A01, Lot # 0E01, Lot # 100214; (16 oz) size: Lot # 090611, Lot # 091007, Lot # 0E01, Lot # 0F05, Lot # 100214; (30 oz) size: Lot # 090402, Lot # 0A01, Lot # 0E01, Lot # 0F05;

6) (1 oz.) size: Lot # 0B03, Lot # 9G02; (30 oz.) size: Lot # 9G02, Lot # 0E04, Lot # 0B03, Lot # 8K01;
7) (16 oz.) size: Lot # 9G02;
8) (1 oz.) size: Lot # 0D03, Lot # 9F02; (30 oz.) size: Lot # 9F02, Lot # 0D03;
9) (1 oz.) size: Lot # 0C01, Lot # 9L03; (30 oz.) size: Lot # 0E05, Lot # 9L03, Lot # 9L04;
10) Lot # 100710;
11) Lot # 100214, 091007;
12) Lot # 100302, 090612
RECALLING FIRM/MANUFACTURER
Recalling Firm: Llorens Pharmaceutical International Div., Miami, FL, by letter dated November 1, 2010.
Manufacturer: Abba Pharma, Inc., Tampa, FL. FDA initiated recall is ongoing.
REASON

Affected products are being recalled due to presence of varying amounts of phosphorus not declared as an ingredient on the product labeling.
VOLUME OF PRODUCT IN COMMERCE
893,554 bottles and pouches
DISTRIBUTION
Nationwide, Venezuela and Canada

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Ferrous Sulfate Drops, Iron Supplement Drops For Infants and Toddlers, Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) per 1 mL, alcohol 0.2% v/v, 50 mL ( 2/3 fl oz), NDC 0603-0762-47. Recall # F-0397-2011
CODE
Lot Numbers: 5881A, exp 02/12; 5882A, exp 02/12; and 5883A, exp 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by letter on November 2, 2010.
Manufacturer: Silarx Pharmaceuticals, Inc., Spring Valley, NY. Firm initiated recall is ongoing.
REASON
Product was reformulated, but the firm did not obtain a new NDC which caused confusion at the retail level.
VOLUME OF PRODUCT IN COMMERCE
8,511 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
1) Alcohol Swabs, Alcohol Prep Swabs, and Alcohol Prep Pads with Benzocaine for Pain Relief. Active ingredient: Isopropyl Alcohol 70% v/v and Benzocaine 6%. Made in USA. Packaged under the following brand names and are not labeled as sterile: 1) Triad Sting Relief Pads, 100 pads, Cat. No. 10-6400, NDC 50730-6400-0; 2) Care One, 80 individually foil wrapped wipes, UPC 41520-87570; 3) CVS/pharmacy, 80 individually wrapped foil packets, UPC 50428-10712; 4) Good Neighbor Pharmacy, 80 individually wrapped foil packets, UPC 87701-40352; 5) Kroger, 80 swabs, NDC 50730-1404-1, UPC 41260-35215; 6) Leader, 80 swabs, UPC 96295-11495; 7) Major, 80 individually wrapped pads, Reorder No. 006775. NDC 0904-5836-47, UPC 09045-83647; 8) The Medicine Shoppe, 80 individually wrapped swabs, UPC 91899-01877; 9) Premier Value, 80 individually wrapped pads, UPC 40986-02320; 10) ReliOn, 100 individually foil wrapped swabs NDC 50730-1450-1, UPC 05388-55828; 11) Rite Aid Pharmacy, 80 individually wrapped pads, UPC 11822-39578; 12) Sunmark, 80 individually foil wrapped packets, UPC 10939-30044; 13) TopCare, 80 individually wrapped pads, NDC 50720-1410-1, UPC 36800-19630; 14) up & up, 80 individually wrapped pads, UPC 50730-14131; 15) Value plus, 80 individually wrapped swabs, NDC 49736-140-91, UPC 72000-29329; 16) Walgreens, 60 individual foil packets, UPC 11917-08762. Recall # D-232-2011;

2) CVS/pharmacy Alcohol Prep Swabs Lavender oil masks alcohol odor, 80 individually wrapped foil packets, UPC 50428-10679, Active ingredient: Isopropyl Alcohol 70% v/v. Recall # D-233-2011;

3) Triad Plus sterile Alcohol Swabsticks. Active ingredient: Isopropyl Alcohol 70% v/v. Antiseptic for preparation of the skin prior to injection. Latex Free. Made in USA. For Hospital and Professional Use. Contents STERILE unless opened or damaged. -Cat. No.11-SA01, Sterile, One Alcohol Swabstick, NDC 50730-4301-8; Cat. No. 11-SA03, Sterile, Three Alcohol Swabsticks, NDC 50730-4300-8. Recall # D-234-2011;

4) Alcohol Swabsticks. Active ingredient: Isopropyl Alcohol 70% v/v. Antiseptic for preparation of the skin prior to injection. Latex Free. Made in USA. For Hospital and Professional Use. The following Brands are not labeled as sterile: 1) Triad, Alcohol Swabsticks (3s), Cat. No. 10-4300, NDC 50730-4300-3, 25 pouches 3 swabsticks per Pouch; 2) NovaPlus, Cat. No. V10-4300, NDC 50730-4300-9, Contains 25 pouches of 3 Swabsticks Each. Recall # D-235-2011;

5) Sterile Alcohol Swabs, Alcohol Prep Swabs, and Alcohol Prep Pads. Active ingredient: Isopropyl Alcohol 70% v/v. Antiseptic for preparation of the skin prior to injection. Latex Free. Made in USA. Packaged under the following Brands: 1) Triad, Cat. No. 10-3101, Sterile Medium, 200 Prep Pads, NDC 50730-3101-0, UPC 50730-31010; -Cat. No. 10-3103, Sterile Medium, 100 Prep Pads, NDC 50730-3101-0, UPC 50730-31030;  2) AmeriNet Choice, Reorder # AC-3101, Sterile Medium, 200 pads per box; 3) Boca Ultilet Sterile Medium, 200 sterile swabs; 4) Cardinal Health Allegiance, Cat. 40000-110, sterile Medium, NDC 63517-310-10, UPC 063014006399, box of 200; 5) Con Zellin, 100 Sterile Alcohol Swabs, No. 999-980, UPC 049500-305242; 6) Curad, 200 Sterile Swabs, UPC 8225-233300; 7) Medline, Sterile Medium, Reorder MDS090735, NDC 53329-802-09; 8) NovaPlus. -Sterile 2-Ply Medium, Cat. No. V9100 -Sterile 2-Ply large, Cat No. V9105; 9) Select medical products, -Sterile Medium, Reorder # 521, 200 Individually sealed pads, -Sterile Large, Reorder # 522, 200 Individually sealed pads; 10) Versa Pro, Sterile, #MS113411100, 200 Medium Prep Pads. Recall # D-236-2011;

6) Alcohol Swabs, Alcohol Prep Swabs, and Alcohol Prep Pads. Active ingredient: Isopropyl Alcohol 70% v/v. Antiseptic for preparation of the skin prior to injection. Latex Free. Made in USA. Packaged under the following Brands and not labeled as sterile: 1) Triad, Cat. No.10-3001, Medium, 200 prep pads, NDC 50730-3001-0; Cat No. 10-3002, Large, 100 pads, NDC 50730-3002-0, UPC 50730-30020, Cat No. 10-3003, 100 individual Packets, NDC 50730-3003-2, UPC 50730-300032; Cat. No. 10-3004. Medium, 300 pads, NDC 50730-3004-0; 2) Aeromed, Cat. No. 3001-SP; 3) Alco-Prep, H&W, -Reorder #600H, 100 Pre-injection skin cleansing swabs; -Reorder # 610H, Large, 100 Pre-injection skin cleansing swabs; -Reorder #10-3001H, Medium 200 Pre-injection skin cleansing swabs; -medium 500 Pre-injection skin cleansing swabs; 4) AmeriNet Choice, Reorder # AC-3001, Medium, NDC 50730-3001-7 - Reorder # AC-3002, Large; 5) Aurora Pharmacy, 100 Individually wrapped foil packets, NDC 6550-4404-23, UPC 65504-40423; 6) Be Smart, Medium Pad; 7) Best Choice, 100 individually wrapped pads, UPC 70038-62668; 8) Brooks, 100 individually foil wrapped swabs, UPC 84597-50138; 9) Cardinal Health Allegiance, -Cat. 40000-090, medium, box of 200, NDC 63517-300-10 -Cat. 40000-100, large, box of 200, NDC 63517-300-20; 10) CareOne, 100 individually foil wrapped wipes, UPC 41520-31367; 11) CVS/pharmacy, -100 swabs, UPC 50428-13034 -120 individual foil packets, UPC 50428-07522; 12) Dacogen; 13) Discount Drug Mart food Fair, 100 individually wrapped pads, NDC 50730-1059-1, UPC 93351-11413; 14) Eckerd, Eckerd Item 760272,120 individually wrapped wipes, UPC 34575-76027; 15) Equaline, 100 individual packets, NDC 41163-2833-4, UPC 41163-26334; equate 100 individually wrapped swabs, UPC 50730-01126;  17) exact, 100 individually wrapped swabs, UPC 60383-82505; 18) Exchange Select, 100 individually wrapped prep pads, UPC 14299-40256; 19) First Choice, CIN # 3017779, 100 Individually wrapped foil packets, UPC 39131-47128; 20) Fisher brand, Cat. No. 22-031-365, 200 pads; 21) Freds, 100 pads, UPC 84579-29196; 22) Good Neighbor Pharmacy, 100 Individual Foil Packets, NDC 24385-165-78, UPC 87701-69817; 23) GoodSense, 100 individual pads, UPC 80410-00046; 24) Health Care, 50 Individually wrapped foil packets, UPC 92215-99720; 25) Health Care America, 100 Individually Wrapped Pads, UPC 97807-11049; 26) Healthy Generations, 100 swabs, UPC 41130-50195; 27) H E B in Control, 100 alcohol Swabs, UPC 41220-03089; 28) IMCO, Reorder No. 3001B-IMC, 200 Individually Wrapped Pads, UPC 07415-68534; 29) Kroger, -100 swabs, UPC 11110-79449, -140 swabs, NDC 50730-1033-1, UPC 11110-38524;  30) Leader, 100 swabs, NDC 37285-6155-78, UPC 96295-10612; 31) Life, -100 Individually wrapped swabs, UPC 57800-06014, -200 Individually wrapped swabs, UPC 57800-16044; 32) Live Better, 100 individually wrapped packets, NDC 50730-1236-0, UPC 41310-62029; 33) Longs, 100 individually wrapped swabs, UPC 12333-94761; 34) Major, 100 individually wrapped pads, NDC 0904-4277-60, UPC 09045-27760; 35) Medic, 100 individually wrapped packets, UPC 21140-79333; 36) The Medicine Shoppe, 100 individually wrapped foil packets, UPC 91899-62278; 37) Meijer, -100 pads, UPC 41250-04080 -120 pads, UPC 19283-59475; 38) Medline, -Reorder: MDS090675, 100 each, Deluxe, Large, -Reorder: MDS 090725C, 200 pads, Medium Antiseptic, -Reorder:  DS090730, Medium -Reorder MDS 090730BR, 200 pads, Medium, UPC 80196-74509; 39) Moore Medical. -Reorder No. 68533, 100 Prep Pads, NDC 0839-6853-30, UPC 07415-68533 -Reorder No. 68534, 200 Prep Pads, NDC 0839-6854-40, UPC 07415-68534; 40) Option +, 100 Swabs individually wrapped, UPC 71290-00018; 41) Personnelle, 100 swabs individually wrappee, UPC 55989-25003; 42) Premier Value, 100 Individually wrapped pads, UPC 40986-01290; 43) Publix, 100 Individually sealed wipes, UPC 41415-30173; 44) Quality Choice, 100 Individually wrapped foil packets, UPC 35515-99989; 45) Remedys Rx, 100 Individually wrapped pads, UPC 73072-02701; 46) Rexall, 100 swabs individually wrapped, UPC 71058-04376; 47) Rite Aid Pharmacy, -100 individual foil packets, UPC 11822-33374, -120 individual foil packets, UPC 11822-80004, -120 Individually wrapped pads, UPC 11822-25372; 48) Safeway, 100 individually wrapped foil packets, UPC 21130-78063; 49) Select medical products, -Reorder # 523, 2 Ply Medium, 200 Individually sealed pads, -Reorder # 524, 2 Ply Large, 200 Individually sealed pads, -Reorder # 37260, 200 Individually sealed pads; 50) StarLine, Reorder No. 1780-02, retail carton states, 200 pads. Individual foil package; 51) Sunmark, 100 individually wrapped foil packets, UPC 10939-57933; 52) TopCare, 100 individually wrapped pads, UPC 36800-14624; 53) Target brand, -100 Individually wrapped pads, UPC 92450-70142, -120 Pads, UPC 50730-10130, -up & up, 100 individually wrapped pads, UPC 50730-01082; 54) Value plus, 100 individually wrapped swabs, NDC 49738-128-71, UPC 72000-29328,. Individually wrapped swab states Kmart Pharmacy; 55) Versa Pro, -#MS113410100, 200 Medium Prep Pads, -#MS113411010, 100 Large Pre Pads; 56) Walgreens, 100 individual foil packets, item 665266, UPC 11917-06104, -100 individual foil packets, item 595944, UPC 11917-07088, -100 + 20 FREE, 120 individual foil packets, item 665287, UPC 11917-06103 -120 individual foil packets, item 483832, NDC 50730-2115-1, UPC 11917-10940; 57) Walmart; 58) Western Family, 100 Individually wrapped foil packets, UPC 15400-65559. Recall # D-237-2011
CODE
All lot codes within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: H & P Industries, Inc., Hartland, WI, by letter beginning on January 3, 2011 and by press release on January 5, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. FDA initiated recall is ongoing.
REASON 
Microbial contamination; concerns of potential contamination of Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
975,922 cases
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
OSR#1 (Oxidative Stress Relief) N1, N3-bis (2-mercaptoethyl) isophthalamide OSR#1, a) 3g capsules are blister-packed in a paper carton; b) 9g powder pouches are packed in a paper carton; c) 250g powder bottles are packed in a plain white plastic bottle with a label. Store in a cool dry place. Recall # D-238-2011
CODE
a) Lot #090306-01 & 100121-01; b) lot #090862-01; c) lot #091203-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: CTI Science Inc., Lexington, KY, by letters on August 24, 2010.
Manufacturer: PCI Synthesis, Newburyport, MA; JLM Pharmatech, Inc., Seymour, IN; Maco Bag Corp., Newark, NY. FDA initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA:  product makes claims that affects the body's structures and functions.
VOLUME OF PRODUCT IN COMMERCE
58,710 - 3g capsule cartons; 4,193 - 9g powder pouches; 68 - 250g powder bottles
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, Egypt, Estonia, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Malta, New Zealand, Norway, Singapore, Slovenia, Spain, Sweden, Switzerland & United Kingdom
___________________________________
PRODUCT
1) Hyland's Teething Tablets: 125 tablets, UPC # 3 54973 75041 & UPC # 3 54973 75066. Recall # D-239-2011;
2) Hyland's Teething Tablets: 250 tablets, UPC # 3 54973 75042. Recall # D-240-2011;
3) Hyland's Teething Tablets: 50 tablets, UPC # 3 54973 75044. Recall # D-241-2011;
4) Hyland's Teething Tablets: 145 tablets, UPC # 3 54973 75121. Recall # D-242-2011;
5) Hyland's Teething Tablets: Clip Strip 6x125 tablets, UPC # 3 54973 35109. Recall # D-243-2011;
6) Hyland's Teething Tablets: T-6 Sample Packet. Recall # D-244-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Standard Homeopathic Company, Inc., Los Angeles, CA, by press release on October 23, 2010. Firm initiated recall is ongoing.
REASON 
Lack of Blend Uniformity  
VOLUME OF PRODUCT IN COMMERCE
963,789,242 tablets
DISTRIBUTION
Nationwide, Canada, Senegal, South Africa, and Pakistan
___________________________________
PRODUCT
Ibuprofen Tablets, USP 800 mg, RX only, 500 tablets, NDC 67877-121-05. Recall # D-245-2011
CODE
Lot number 10AL03A, Expiration Date 12/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ascend Laboratories LLC, Montvale, NJ, by letter on October 6, 2010.
Manufacturer: Shasun Chemicals & Drugs, Ltd., Pondicherry, India. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: Some bottles of 800 mg Ibuprofen tablets may contain one or more 400 mg Ibuprofen tablets.
VOLUME OF PRODUCT IN COMMERCE
785 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fentanyl Transdermal System, 25 mcg/hr, Rx only 5-count carton, NDC No. 0591-3198-72. Recall # D-246-2011
CODE
Lot No. 264085A Exp. 01/31/2012
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Inc., Salt Lake City, UT, by letter beginning November 24, 2010. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or Defective Delivery System: Defective product may result in decreased efficacy.
VOLUME OF PRODUCT IN COMMERCE
75,525 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) OB Complete 400; Prenatal Vitamin with DHA, Softgel capsules; 30 count package; Rx only; NDC: 68025-038-30. Recall # D-247-2011; 
2) UltimateCare ONE NF, 30 count, Rx Only, NDC # 13811-050-30. Recall # D-248-2011;
3) Zatean Pn Softgels, Rx only, Made in Canada, NDC #13811-580-30. Recall # D-249-2011;
4) Zatean Pn PlusSoftgels, Rx only, Made in Canada, NDC #13811-582-30. Recall # D-250-2011
CODE
1) Lot number: 20909140, Exp: 11/11; Lot number: 20911161, Exp: 1/12; Lot number: 21001139, Exp: 2/12; Lot number: 21001143, Exp: 1/12;
2) Lot number: 20904157, Exp: 4/11;
3) Lot number: 21004142, Exp: 4/12 Lot number: 21004142A, Exp: 4/12;
4) Lot number: 21005127, Exp: 5/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vertical Pharmaceuticals, Inc., Sayreville, NJ, by letters on December 21, 2010.  
Manufacturer: Viva Pharmaceutical Inc., Vancouver British Columbia, Canada. Firm initiated recall is ongoing.
REASON
Defective Delivery System: Product may contain leaking capsules.
VOLUME OF PRODUCT IN COMMERCE
248,363 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0201-11
CODE
Unit: W087609812990
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on September 7, 2010 and letter on October 5, 2010. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Source Plasma. Recall # B-0506-11
CODE
Units: 4920236465, 4920235054, 4920234461, 4920233851, 4920230254, 4920227934, 4920226199, 4920225967, 4920224624, 4920223990, 4920222976, 4920222380, 4920221444, 4920220610, 4920219836, 4920219089, 4920203609, 4920202397, 4920201120, 4920200439, 4920199502, 4920198968, 4920197887, 4920196390, 4920113068, 4920112440, 4920112072, 4920111389, 4920110747, 4920110210, 4920109567, 4920108637, 4920108278, 4920107584, 4920107081, 4920106471, 4920105756, 4920105250, 4920104628, 4920104126, 4920103508, 4920102445, 4920101931, 4920100191, 4920099746, 4920099111, 4920098137, 4920097990, 4920096797, 4920096156, 4920095039, 4920094761, 4920093637, 4920093279, 4920092341, 4920092050, 4920091303, 4920090911, 4920090209, 4920089845, 4920089189, 4920088825, 4920087043, 4920086602, 4920085955, 4920085659, 4920084811, 4920084184, 4920083851, 4920083272, 4920082925, 4920082281, 4920081892, 4920081278, 4920080969, 4920080326, 4920079818, 4920079036
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Springfield, OH, by letter dated December 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
IL, Germany, Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0742-11
CODE
Unit: 3224589
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by fax on August 8, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0756-11;
2) Plasma Frozen. Recall # B-0757-11
CODE
1) and 2) Unit: 1634387
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated April 24, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0794-11
CODE
Unit: 225579943
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone and facsimile on February 16, 2007. 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
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0795-11
CODE
Units: 0520349423, 0520347376, 0520346707, 0520344482, 0520344041, 0520342075, 0520341802, 0520349711
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Memphis, TN, by facsimile on April 25, 2005. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IL, NC, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-0796-11
CODE
Units: 0100682234, 0100676221, 0100675835, 0100674896
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Chattanooga, TN, by facsimile on February 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have an annual physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0799-11
CODE
Units: 5374610 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on December 20, 2007 and by letter dated January 8, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0802-11
CODE
Unit: 6039930
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 19, 2008 and by letter dated February 19, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0803-11
CODE
Unit: 9347849
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 29, 2008 and by letter dated February 29, 2008. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0804-11;
2) Plasma Frozen. Recall # B-0805-11
CODE
1) and 2) Unit: 5378213
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 28, 2008 and by letter dated February 28, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0816-11
CODE
Units: 0520357261, 0520356919, 0520355892, 0520355701, 0520355385, 0520354652, 0520354538, 0520353900, 0520353692, 0520353406, 0520353150, 0520352749, 0520352526, 0520351983, 0520351873, 0520351499, 0520351123, 0520350907, 0520350561, 0520350303, 0520349704, 0520349512, 0520349017, 0520348753, 0520348314, 0520347788, 0520347383, 0520347218, 0520346761
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Memphis, TN, by facsimile on September 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
NC, IL, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-0817-11
CODE
Units: 0520371585, 0520370625, 0520369960, 0520369625, 0520369161, 0520355254, 0520355116, 0520354648, 0520354460, 0520354088, 0520353760, 0520353305, 0520352923, 0520352720, 0520349670, 0520349205, 0520372020
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Memphis, TN, by facsimile on September 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC, KY, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-0818-11
CODE
Units: 0520348289, 0520348158, 0520347665, 0520347089, 0520346814, 0520346400, 0520346131, 0520345718, 0520345435, 0520345060, 0520344836, 0520344558, 0520344258, 0520343873, 0520343625, 0520343295, 0520343025, 0520342660, 0520342461, 0520341940, 0520341703, 0520341320, 0520341088, 0520340712, 0520340474, 0520340120, 0520340002, 0520339562, 0520339395, 0520339010, 0520338811, 0520338223, 0520338114, 0520337656, 0520337548, 0520336301, 0520335945, 0520335436, 0520335304, 0520334988, 0520334464, 0520334253, 0520333931, 0520333707, 0520332363, 0520332059, 0520331859, 0520331500, 0520331178, 0520330892, 0520330623, 0520330242, 0520330118, 0520329515
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Memphis, TN, by facsimile on November 8, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0819-11;
2) Recovered Plasma. Recall # B-0820-11
CODE
1) and 2) Units: 2669218, 1910800, 2677001, 2678675
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated September 13, 2005 or by facsimile on September 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom HIV re-entry testing was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0824-11
CODE
Unit: 3685019
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0825-11;
2) Fresh Frozen Plasma. Recall # B-0826-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0827-11;
4) Recovered Plasma. Recall # B-0828-11
CODE
1) and 2) Unit: 2837259;
3) and 4) Unit: 3706202
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated September 1, 2005 or by facsimile on September 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0829-11
CODE
Unit: 2566064
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated September 1, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0863-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0864-11
CODE
Unit: W226908920327
RECALLING FIRM/MANUFACTURER
Virginia Blood Services RMH Blood Center, Harrisonburg, VA, by telephone on September 7, 2010 and letter on September 30, 2010 and October 20, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0874-11
CODE
Unit: R17143 
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on February 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0876-11;
CODE
Unit: T25101
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter and telephone on May 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0878-11
CODE
Unit: 2675666
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated May 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0888-11
CODE
Unit: W115110010375C
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by facsimile on December 11, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0893-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0894-11
CODE
1) and 2) Unit: 192663676
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on June 8, 2007. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0009-11
CODE
Unit: X63118
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on September 7, 2010 and by letter on September 30, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0789-11
CODE
Units:  224716597 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on March 9, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0800-11
CODE
Units: 9235560, 5375922 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on December 20, 2007 and by letter dated January 8, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0822-11;
2) Plasma Frozen. Recall # B-0823-11
CODE
1) Units: 11FW42135, 11FW42231, 11FW42248, 11GY49828, 11GS02065, 11FS55566, 11FW42251, 11FW42253, 11FW42279, 11FY41431, 11GF60969, 11GF60970, 11GY49824, 11GY49841, 11LR08607, 11LR08608, 11LR08611, 11LR08614, 11LR08617, 11LR08620, 11LR08621;

2) Units: 49GE14094, 49GN56676, 49GN56713, 49KM18757, 49KM18760, 49KM18762, 49KQ21591, 49LG93145, 49GG28577, 49GH16234, 49GH16242, 49FL16541, 49GN56704 RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tulsa, OK, by facsimile on September 13, 2007 and September 19, 2007.  
Manufacturer: American National Red Cross SW Region – HT, Tulsa, OK. Firm initiated recall is complete.  
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
OK
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0877-11
CODE
Unit: T25101
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter and telephone on May 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I
___________________________________
PRODUCT
1) Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips. Recall # Z-0994-2011;

2) Abbott Diabetes Care Optium EZ Blood Glucose Test Strips. Recall # Z-0995-2011;

3) Abbott Diabetes Care, a) MediSense Optium Blood Glucose Test Strips; b) MediSense Optium Blood Glucose Electrodes. Recall # Z-0996-2011;

4) Abbott Diabetes Care, Optium Blood Glucose Test Strips. Recall # Z-0997-2011;

5) Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips. Recall # Z-0998-2011;

6) Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue Blood Glucose Test Strips. Recall # Z-0999-2011;

7) Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test. Recall # Z-1000-2011
CODE
1) Lot codes: 44535H, 44545H, 44565H, 445A5H, 44645H, 44665H, 446E5H, 44725H, 44755H, 44925H, 44945H, 44945H, 44975H, 44995H, 449A5H, 44A15H, 44A35H, 44A75H, 44A85H, 44C65H, 44C75H, 44CE5H, 44CH5H, 44CP5H, 44CR5H, 45025H, 45035H, 450A5H, 450C5H;

2) Lot codes: 45358, 45369, 45377, 45504, 45677, 45678, 45681, 45789, 45841, 45848, 45849, 45999, 46000, 46008, 46061, 46067, 46102, 46104, 46117, 46159, 46179, 46201, 46202, 46211, 46230, 46247, 46311, 46312, 46341, 46368, 46369, 46371, 46395, 46399, 46401, 46436;

3) a) Lot codes: 45001A159, 45001A195, 45001A228, 45001A233, 45001A236, 45001A243, 45001A247, 45001A249, 45001A250, 45001A255, 45001A279, 45001A285, 45001A295, 45001A298, 45001A306, 45001A317, 45001A318, 45001A327, 45001A346, 45001A398, 45001A449, 45001A469, 45001A578, 45001A693, 45001A697, 45001A747, 45001A790, 45001A795, 45001A839, 45001A917; b) 45001A133, 45001A137, 45001A226, 45001A252, 45001A257, 45001A277, 45001A285, 45001A817, 45001A835, 45001A921, 45001C001;

4) Lot codes: 45001A484, 45001A486, 45001A512, 45001A514, 45001A517, 45001A519, 45001A527, 45001A541, 45001A544, 45001A552, 45001A558, 45001A564, 45001A572, 45001A598, 45001A665, 45001A677, 45001A709, 45001A713, 45001A732, 45001A771, 45001A819, 45001A852 45455, 45516, 45708, 45709, 45737, 45738, 45777, 45778, 45783;

5) Lot codes: 45515, 45517, 45701, 45791, 45963, 45964, 46367;

6) Lot codes: 45001A330, 45001A467, 45001A481, 45001A482, 45001A483, 45001A487, 45001A488, 45001A496, 45001A497, 45001A499, 45001A500, 45001A503, 45001A505, 45001A506, 45001A510, 45001A511, 45001A513, 45001A519, 45001A520, 45001A521, 45001A530, 45001A532, 45001A534, 45001A536, 45001A537, 45001A545, 45001A556, 45001A565, 45001A566, 45001A568, 45001A573, 45001A577, 45001A584, 45001A594, 45001A595, 45001A597, 45001A605, 45001A607, 45001A608, 45001A609, 45001A613, 45001A614, 45001A626, 45001A634, 45001A637, 45001A641, 45001A644, 45001A645, 45001A656, 45001A660, 45001A664, 45001A669, 45001A670, 45001A671, 45001A677, 45001A678, 45001A682, 45001A685, 45001A694, 45001A700, 45001A705, 45001A706, 45001A707, 45001A709, 45001A712, 45001A730, 45001A732, 45001A739, 45001A742, 45001A744, 45001A751, 45001A753, 45001A757, 45001A762, 45001A777, 45001A778, 45001A786, 45001A788, 45001A790, 45001A798, 45001A806, 45001A814, 45001A815, 45001A816, 45001A820, 45001A840, 45001A842, 45001A847, 45001A852, 45001A856, 45001A860, 45001A861, 45001A872, 45001A876, 45001A882, 45001A910, 45001A912, 45001A914, 45001A918, 45001A920, 45001A921, 45001A940, 45001A947, 45001A948, 45001A949, 45001A971, 45001A976, 45001A979, 45001A982, 45001A983, 45001C008, 45001C011, 45001C012 45384, 45388, 45396, 45407, 45418, 45455, 45456, 45463, 45464, 45512, 45514, 45516, 45521, 45611, 45612, 45614, 45619, 45627, 45632, 45639, 45645, 45646, 45653, 45670, 45679, 45680, 45682, 45707, 45708, 45724, 45729, 45731, 45732, 45733, 45735, 45737, 45738, 45755, 45777, 45782, 45783, 45784 Precision Xtra Blood Glucose & Ketone Monitoring System: 01P107D, 01P128D, 01P139D, 02P140D, 01P153D, 02P201D, 02P223D, 02P229D, 03P107D, 03P155D, 03P158D, 03P194D, 03P209D, 03P222D, 03P223D, 03P242D, 04P154D, 04P194D, 04P201D, 04P315D, 05P106D, 05P107D, 05P127D, 05P130D, 05P138D, 05P139D, 05P140D, 05P152D, 05P201D, 06P180D, 06P322D, 07P141D, 08P106D, 08P138D, 08P279D, 09P106D, 09P140D; Precision G3b Smartblue Blood Glucose Test Strips: 45001A710;

7) Lot codes: 45358, 45369, 45377, 45379, 45466, 45504, 45511, 45608, 45613, 45641, 45642, 45644, 45672, 45674, 45675, 45676, 45677, 45721, 45734, 45736, 45739, 45742, 45743, 45789, 45790, 45800, 45801, 45840, 45841, 45849, 45850, 46008, 46009, 46061, 46067, 46069, 46072, 46103, 46105, 46148, 46201, 46202, 46214, 46215, 46232, 46313, 46332, 46336, 46338, 46341, 46368
RECALLING FIRM/MANUFACTURER
Abbott Diabetes Care, Inc., Alameda, CA, by press release and letters on December 22, 2010. Firm initiated recall is ongoing.
REASON
Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.
VOLUME OF PRODUCT IN COMMERCE
359 total lots, 1,000,000 strips per lot
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of preservative-free morphine sulfate sterile solution. " Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Preservative-free sterile saline, USP, can only be used to achieve the physician prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. "Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen injection)." Chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. Z-1060-2011;

2) Medtronic Synchromed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Recall # Z-1061-2011; 

3) Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual. Recall # Recall # Z-1062-2011
CODE
All units of these pump models are affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc. – Neuromodulation, Minneapolis, MN, by letter dated January 2011.
Manufacturer: Medtronic Puerto Rico Operations Co., Juncos, PR. Firm initiated recall is ongoing.
REASON
This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed� II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump. Please share this information with any of your staff that perform pump refills. From May 1996 to September 2010, Medtronic has received 351 reports worldwide related to the occurrence of pocket fills with the SynchroMed infusion system. Assuming pumps are refilled 6 times per year, the reported rate of occurrence per refill opportunity is as high as 1 per 10,000 refill opportunities (0.0101%). The actual occurrence rate is likely to be higher due to under reporting, but the extent of under reporting is unknown. Of the reported events there have been 8 deaths, 270 events requiring medical intervention (serious or life threatening injury), and 58 events not requiring medical intervention (no injury or non-serious injury). There were 15 events in which the patient severity was unknown.
VOLUME OF PRODUCT IN COMMERCE
91,369 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
___________________________________
PRODUCT
1) LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0942-2011;

2) GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0943-2011;

3) GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0944-2011;

4) GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0945-2011;

5) GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications. Recall # Z-0946-2011
CODE
Technical Reference Manual numbers 2351785-xxx and 2390935-xxx
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter beginning October 27, 2010. Firm initiated recall is ongoing.
REASON
Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the differences could be anywhere from 80% to 106% less dose if calculated manually via the TRM against the actual value.
VOLUME OF PRODUCT IN COMMERCE
1,450 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Varian High Energy Linear Accelerator; Model numbers: H14, H27, H29 and HCX; Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-1045-2011
CODE
Serial numbers: H140002 H140101 H140738 H140901 H270237 H270364 H270462 H270605 H270703 H270793 H270896 H140003 H140103 H140741 H140902 H270240 H270365 H270463 H270606 H270708 H270795 H270897 H140006 H140110 H140743 H140905 H270242 H270370 H270466 H270615 H270709 H270799 H270899 H140009 H140115 H140744 H270001 H270245 H270371 H270470 H270616 H270710 H270800 H271002 H140010 H140117 H140745 H270006 H270251 H270373 H270474 H270617 H270711 H270804 H271004 H140011 H140118 H140746 H270009 H270252 H270377 H270475 H270624 H270712 H270805 H271005 H140012 H140120 H140749 H270010 H270254 H270378 H270476 H270625 H270713 H270809 H271008 H140014 H140121 H140750 H270021 H270256 H270380 H270477 H270626 H270714 H270810 H271009 H140015 H140122 H140751 H270027 H270261 H270385 H270479 H270627 H270715 H270812 H271013 H140017 H140123 H140754 H270029 H270267 H270392 H270482 H270631 H270717 H270820 H271015 H140022 H140124 H140755 H270030 H270270 H270395 H270483 H270633 H270718 H270821 H271017 H140023 H140128 H140756 H270031 H270271 H270396 H270484 H270635 H270721 H270822 H271018 H140024 H140131 H140758 H270038 H270273 H270397 H270486 H270637 H270722 H270825 H271020 H140030 H140132 H140763 H270047 H270274 H270404 H270487 H270639 H270725 H270828 H271021 H140033 H140134 H140770 H270074 H270280 H270408 H270489 H270641 H270727 H270829 H271023 H140034 H140135 H140771 H270075 H270282 H270409 H270495 H270642 H270728 H270832 H271024 H140035 H140136 H140772 H270088 H270284 H270410 H270496 H270643 H270729 H270835 H271025 H140036 H140143 H140778 H270096 H270297 H270412 H270498 H270645 H270730 H270841 H271031 H140039 H140152 H140782 H270101 H270299 H270418 H270499 H270647 H270732 H270847 H271032 H140040 H140203 H140784 H270106 H270300 H270419 H270500 H270648 H270735 H270850 H271033 H140041 H140204 H140795 H270107 H270303 H270420 H270502 H270652 H270736 H270852 H271035 H140042 H140208 H140797 H270109 H270305 H270421 H270503 H270653 H270737 H270854 H271036 H140043 H140211 H140801 H270111 H270307 H270425 H270504 H270654 H270739 H270857 H271039 H140048 H140213 H140802 H270118 H270311 H270426 H270506 H270660 H270740 H270858 H271040 H140052 H140214 H140804 H270126 H270314 H270427 H270510 H270662 H270743 H270859 H271041 H140053 H140215 H140805 H270128 H270321 H270431 H270511 H270663 H270744 H270862 H271047 H140057 H140223 H140818 H270134 H270328 H270433 H270512 H270664 H270749 H270865 H271055 H140058 H140229 H140819 H270136 H270329 H270435 H270514 H270667 H270751 H270867 H271056 H140059 H140231 H140820 H270138 H270335 H270436 H270518 H270671 H270752 H270868 H271061 H140060 H140232 H140823 H270141 H270338 H270437 H270520 H270674 H270757 H270870 H271062 H140061 H140235 H140824 H270143 H270341 H270443 H270522 H270680 H270760 H270872 H271063 H140062 H140236 H140825 H270144 H270343 H270445 H270525 H270681 H270767 H270873 H271071 H140063 H140240 H140829 H270201 H270344 H270446 H270529 H270682 H270769 H270878 H271075 H140065 H140702 H140836 H270209 H270346 H270447 H270530 H270684 H270770 H270880 H271076 H140068 H140705 H140837 H270214 H270349 H270448 H270532 H270685 H270778 H270881 H271082 H140070 H140709 H140838 H270215 H270351 H270449 H270534 H270686 H270782 H270884 H271083 H140077 H140713 H140839 H270216 H270352 H270450 H270540 H270690 H270783 H270885 H271085 H140080 H140720 H140847 H270226 H270353 H270452 H270542 H270692 H270786 H270886 H271094 H140090 H140723 H140862 H270227 H270355 H270454 H270545 H270693 H270787 H270888 H271096 H140096 H140725 H140870 H270232 H270356 H270455 H270547 H270695 H270788 H270890 H271098 H140097 H140726 H140898 H270233 H270360 H270457 H270550 H270700 H270790 H270892 H271099 H140099 H140734 H140899 H270235 H270361 H270459 H270603 H270702 H270792 H270894 H271100 H271102 H271208 H271347 H271433 H271528 H271603 H271708 H271788 H271898 H271990 H272105 H271103 H271210 H271349 H271435 H271530 H271604 H271709 H271789 H271899 H271994 H272106 H271107 H271213 H271355 H271436 H271532 H271606 H271711 H271790 H271901 H271995 H272111 H271109 H271215 H271356 H271438 H271534 H271611 H271715 H271791 H271903 H271996 H272117 H271110 H271216 H271358 H271439 H271535 H271616 H271716 H271792 H271904 H272002 H272118 H271111 H271227 H271361 H271441 H271536 H271622 H271717 H271793 H271905 H272003 H272124 H271112 H271230 H271362 H271442 H271540 H271624 H271718 H271795 H271907 H272004 H272127 H271115 H271231 H271367 H271443 H271541 H271627 H271721 H271797 H271909 H272005 H272128 H271117 H271232 H271370 H271444 H271542 H271630 H271722 H271799 H271914 H272010 H272129 H271123 H271245 H271371 H271449 H271543 H271634 H271723 H271803 H271915 H272011 H272130 H271124 H271247 H271372 H271453 H271544 H271636 H271725 H271807 H271921 H272012 H272132 H271125 H271248 H271374 H271455 H271545 H271638 H271726 H271811 H271922 H272013 H272136 H271131 H271249 H271376 H271459 H271547 H271646 H271727 H271812 H271923 H272014 H272137 H271133 H271253 H271377 H271460 H271549 H271647 H271728 H271817 H271924 H272020 H272142 H271135 H271256 H271378 H271461 H271551 H271651 H271732 H271818 H271925 H272021 H272147 H271136 H271257 H271379 H271465 H271553 H271654 H271733 H271824 H271927 H272027 H272156 H271137 H271258 H271380 H271468 H271555 H271658 H271734 H271825 H271928 H272028 H272157 H271138 H271260 H271382 H271470 H271560 H271661 H271735 H271827 H271929 H272031 H272158 H271142 H271263 H271383 H271472 H271561 H271662 H271736 H271837 H271931 H272034 H272159 H271143 H271264 H271386 H271474 H271562 H271663 H271739 H271840 H271933 H272039 H272161 H271144 H271268 H271390 H271475 H271563 H271665 H271740 H271841 H271934 H272043 H272162 H271152 H271269 H271391 H271476 H271564 H271666 H271741 H271845 H271936 H272044 H272163 H271155 H271272 H271392 H271477 H271565 H271674 H271743 H271846 H271938 H272047 H272164 H271157 H271275 H271393 H271479 H271568 H271679 H271744 H271850 H271943 H272050 H272165 H271159 H271276 H271394 H271480 H271569 H271680 H271746 H271852 H271947 H272052 H272167 H271160 H271278 H271395 H271481 H271570 H271681 H271749 H271853 H271950 H272054 H272168 H271161 H271281 H271397 H271483 H271571 H271682 H271753 H271854 H271955 H272060 H272170 H271162 H271288 H271398 H271484 H271572 H271684 H271754 H271855 H271958 H272061 H272171 H271175 H271290 H271399 H271485 H271573 H271686 H271755 H271859 H271959 H272064 H272173 H271176 H271292 H271402 H271486 H271575 H271687 H271756 H271863 H271963 H272065 H272174 H271179 H271293 H271404 H271489 H271576 H271688 H271759 H271864 H271965 H272068 H272175 H271184 H271294 H271407 H271490 H271577 H271691 H271760 H271865 H271967 H272070 H272177 H271185 H271296 H271409 H271491 H271578 H271692 H271763 H271870 H271968 H272071 H272179 H271186 H271298 H271410 H271493 H271581 H271694 H271764 H271872 H271969 H272073 H272180 H271188 H271299 H271416 H271496 H271584 H271695 H271765 H271873 H271970 H272074 H272182 H271191 H271303 H271417 H271497 H271586 H271696 H271766 H271874 H271971 H272077 H272183 H271193 H271312 H271419 H271505 H271588 H271698 H271768 H271875 H271972 H272080 H272185 H271195 H271314 H271421 H271506 H271591 H271700 H271771 H271880 H271977 H272081 H272192 H271196 H271319 H271423 H271510 H271593 H271701 H271773 H271882 H271978 H272086 H272194 H271197 H271320 H271425 H271512 H271594 H271702 H271776 H271886 H271980 H272087 H272196 H271198 H271324 H271426 H271513 H271597 H271703 H271777 H271887 H271981 H272088 H272197 H271200 H271328 H271427 H271515 H271598 H271704 H271781 H271888 H271982 H272092 H272199 H271201 H271338 H271428 H271518 H271599 H271705 H271782 H271889 H271983 H272100 H272203 H271202 H271343 H271431 H271523 H271600 H271706 H271784 H271891 H271986 H272103 H272211 H271206 H271344 H271432 H271527 H271602 H271707 H271787 H271892 H271988 H272104 H272215 H272216 H272320 H272422 H272836 H272957 H273103 H290114 H290217 H290320 H290414 H291016 H272217 H272323 H272425 H272838 H272959 H273105 H290116 H290219 H290321 H290417 H291017 H272221 H272324 H272430 H272840 H272961 H273112 H290118 H290220 H290323 H290423 H291019 H272226 H272325 H272431 H272843 H272962 H273114 H290123 H290226 H290324 H290424 H291023 H272229 H272327 H272432 H272844 H272966 H273119 H290130 H290228 H290325 H290425 H291024 H272239 H272328 H272433 H272851 H272971 H273120 H290137 H290229 H290327 H290426 H291026 H272243 H272329 H272439 H272852 H272974 H273122 H290138 H290230 H290328 H290427 H291027 H272245 H272330 H272441 H272853 H272975 H273136 H290139 H290231 H290330 H290500 H291031 H272249 H272332 H272443 H272857 H272976 H273140 H290143 H290235 H290331 H290503 H291032 H272259 H272333 H272445 H272858 H272981 H273141 H290144 H290236 H290333 H290506 H291034 H272260 H272334 H272446 H272859 H272983 H273142 H290146 H290237 H290334 H290507 H291037 H272261 H272335 H272447 H272861 H272986 H273143 H290151 H290240 H290336 H290511 H291041 H272264 H272337 H272448 H272862 H272988 H273149 H290152 H290242 H290338 H290513 H291044 H272265 H272338 H272451 H272863 H272989 H273150 H290154 H290244 H290339 H290516 H291045 H272267 H272341 H272452 H272864 H272991 H273151 H290155 H290248 H290342 H290517 H291046 H272269 H272346 H272453 H272867 H272993 H273152 H290158 H290253 H290345 H290518 H291049 H272270 H272347 H272454 H272875 H272994 H273153 H290159 H290254 H290346 H290519 H291055 H272276 H272348 H272461 H272878 H273002 H273158 H290160 H290257 H290351 H290526 H291062 H272279 H272351 H272462 H272879 H273004 H273159 H290161 H290258 H290352 H290527 H291064 H272280 H272352 H272466 H272880 H273005 H273164 H290164 H290260 H290356 H290528 H291066 H272283 H272353 H272467 H272882 H273012 H273176 H290171 H290261 H290357 H290529 H291067 H272284 H272355 H272468 H272885 H273016 H273180 H290173 H290264 H290358 H290533 H291073 H272286 H272358 H272469 H272886 H273018 H273182 H290175 H290266 H290359 H290534 H291074 H272288 H272361 H272470 H272887 H273020 H273187 H290176 H290268 H290360 H290536 H291075 H272290 H272363 H272482 H272891 H273021 H273191 H290177 H290269 H290363 H290539 H291078 H272291 H272364 H272483 H272892 H273029 H273200 H290180 H290272 H290369 H290540 H291080 H272292 H272366 H272484 H272894 H273031 H273202 H290182 H290273 H290372 H290542 H291085 H272293 H272373 H272485 H272895 H273033 H273203 H290186 H290274 H290373 H290543 H291086 H272296 H272377 H272491 H272900 H273045 H273206 H290187 H290276 H290375 H290544 H291091 H272298 H272381 H272492 H272907 H273048 H273208 H290189 H290277 H290376 H290547 H291092 H272299 H272383 H272496 H272909 H273049 H273209 H290191 H290278 H290379 H290550 H291093 H272300 H272387 H272498 H272910 H273051 H290003 H290195 H290283 H290380 H290551 H291099 H272301 H272389 H272801 H272912 H273052 H290012 H290196 H290286 H290381 H290553 H291108 H272302 H272390 H272804 H272914 H273056 H290016 H290198 H290288 H290386 H290558 H291111 H272304 H272392 H272808 H272917 H273061 H290017 H290199 H290292 H290387 H290559 H291114 H272306 H272398 H272809 H272920 H273062 H290026 H290203 H290296 H290388 H290560 H291115 H272307 H272399 H272813 H272921 H273067 H290030 H290204 H290299 H290394 H290561 H291127 H272308 H272403 H272818 H272924 H273068 H290031 H290205 H290301 H290396 H290600 H291128 H272311 H272405 H272820 H272934 H273072 H290033 H290208 H290306 H290400 H291002 H291130 H272312 H272406 H272821 H272936 H273078 H290100 H290209 H290309 H290401 H291004 H291132 H272313 H272408 H272822 H272937 H273093 H290103 H290210 H290310 H290402 H291006 H291137 H272315 H272409 H272823 H272941 H273097 H290105 H290211 H290311 H290406 H291007 H291139 H272316 H272414 H272829 H272942 H273098 H290106 H290213 H290314 H290411 H291008 H291140 H272317 H272419 H272830 H272949 H273101 H290108 H290214 H290315 H290412 H291010 H291142 H272318 H272421 H272831 H272954 H273102 H290111 H290216 H290316 H290413 H291015 H291144 H291148 H293308 H293406 H293556 H293678 H293791 H293910 H294073 H294235 H294393 H291151 H293311 H293416 H293559 H293679 H293794 H293924 H294083 H294237 H294394 H291152 H293315 H293417 H293560 H293681 H293795 H293929 H294091 H294248 H294395 H291154 H293316 H293421 H293562 H293682 H293796 H293935 H294095 H294256 H294397 H291157 H293320 H293423 H293567 H293684 H293802 H293938 H294098 H294265 H294399 H291158 H293321 H293424 H293568 H293687 H293803 H293942 H294100 H294284 H294403 H291159 H293323 H293427 H293571 H293691 H293804 H293947 H294101 H294288 H294407 H291160 H293325 H293428 H293584 H293698 H293805 H293948 H294104 H294292 H294414 H291163 H293326 H293429 H293585 H293702 H293810 H293950 H294105 H294294 H294427 H291164 H293327 H293431 H293588 H293704 H293811 H293953 H294106 H294299 H294429 H291165 H293328 H293432 H293594 H293705 H293821 H293956 H294108 H294302 H294451 H291168 H293329 H293434 H293595 H293710 H293822 H293958 H294110 H294304 H294467 H291176 H293331 H293441 H293597 H293712 H293823 H293959 H294111 H294307 H294474 H291181 H293332 H293444 H293598 H293725 H293826 H293960 H294118 H294308 H294569 H291182 H293335 H293447 H293600 H293726 H293829 H293964 H294119 H294312 H294588 H291193 H293336 H293450 H293601 H293727 H293830 H293967 H294122 H294317 H294633 H291194 H293337 H293455 H293602 H293728 H293835 H293979 H294123 H294319 H294639 H291195 H293338 H293456 H293603 H293731 H293839 H293980 H294129 H294324 H294640 H291198 H293339 H293464 H293604 H293732 H293842 H293982 H294133 H294326 H294641 H291201 H293341 H293467 H293605 H293734 H293845 H293984 H294136 H294327 H294655 H291204 H293343 H293468 H293606 H293739 H293848 H293987 H294140 H294328 H294697 H291205 H293344 H293469 H293607 H293740 H293854 H293994 H294142 H294329 H294702 H291211 H293345 H293471 H293608 H293741 H293856 H293997 H294144 H294331 HCX4019 H291222 H293348 H293477 H293612 H293743 H293857 H293998 H294147 H294333 HCX4344 H291227 H293349 H293487 H293613 H293747 H293858 H293999 H294154 H294335 HCX4662 H291228 H293353 H293489 H293617 H293750 H293865 H294002 H294157 H294337 H291231 H293357 H293490 H293619 H293752 H293867 H294003 H294158 H294340 H291237 H293364 H293496 H293626 H293753 H293869 H294004 H294168 H294341 H291238 H293365 H293498 H293628 H293754 H293870 H294006 H294175 H294346 H291239 H293367 H293501 H293629 H293758 H293871 H294022 H294181 H294348 H291241 H293368 H293507 H293630 H293760 H293872 H294024 H294186 H294350 H291246 H293371 H293510 H293631 H293763 H293875 H294028 H294189 H294355 H291250 H293374 H293511 H293637 H293765 H293877 H294034 H294196 H294364 H291256 H293378 H293512 H293638 H293767 H293878 H294035 H294197 H294366 H291264 H293379 H293516 H293639 H293770 H293882 H294038 H294200 H294368 H291265 H293384 H293518 H293642 H293771 H293889 H294041 H294203 H294372 H291267 H293385 H293521 H293643 H293773 H293890 H294045 H294204 H294373 H291270 H293386 H293530 H293645 H293774 H293898 H294047 H294205 H294378 H291272 H293387 H293532 H293648 H293776 H293900 H294056 H294209 H294380 H293009 H293388 H293534 H293649 H293780 H293901 H294059 H294210 H294381 H293207 H293389 H293540 H293650 H293782 H293904 H294063 H294215 H294382 H293300 H293394 H293550 H293661 H293785 H293905 H294065 H294216 H294383 H293302 H293395 H293552 H293662 H293786 H293907 H294069 H294217 H294384 H293305 H293396 H293553 H293663 H293789 H293908 H294070 H294226 H294386 H293307 H293401 H293554 H293664 H293790 H293909 H294072 H294234 H294392
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on December 10, 2010. Firm initiated recall is ongoing.
REASON
An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.
VOLUME OF PRODUCT IN COMMERCE
1,882 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
1) Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0040. Recall # Z-1046-2011;

2) Omnifit M/S PSL Porous Coated Acetabular Shell 42MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0042. Recall # Z-1047-2011;

3) Omnifit M/S PSL Porous Coated Acetabular Shell 44MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0044. Recall # Z-1048-2011;

4) Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0046. Recall # Z-1049-2011;

5) Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0048. Recall # Z-1050-2011;  

6) Omnifit M/S PSL Porous Coated Acetabular Shell 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0050. Recall # Z-1051-2011;

7) Omnifit M/S PSL Porous Coated Acetabular Shell 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0054. Recall # Z-1052-2011;

8) Omnifit M/S PSL Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2017-0058. Recall # #1053-2011;

9) Omnifit M/S Dual Geom Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number 2035-0058. Recall # Z-1054-2011;

10) Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA46. Recall Z-1055-2011;

11) Omnifit PSL M/S 3-Hole Cup, 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA48. Recall # Z-1056-2011;

12) Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA50. Recall # Z-1057-2011;

13) Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA54. Recall # Z-1058-2011;

14) Omnifit PSL M/S 3-Hole Cup, 58MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis. Catalog number S-1790-HA58. Recall # Z-1059-2011
CODE
1) Lot # 68966701A;

2) Lot # 4C3070, 7E3030;

3) Lot # 7E3020, MHP9NP;

4) Lot7E3029, 7K3015, 7K3015A, 8K3048, *m3038, 8M3038A, MHMJW8;

5) Lot # 4S3088, 5H3020A, 6H3068, 7M3050A, 7M3050D, 7S3048, 8K3108, 8M3034, 8M3034A, 8N3045, 8N3045A;

6) Lot # 5L3074, 5T3024,5T30224C, 5V3057, 5V3057A, 7A3023, 7A3023C,7E3009C7K3007, 7K3020, 7S3014, 8K3107, 8K3107A, 8M3010, 8M3010A, 8M3010C, 8M3010D, 8M3010F, 8N3030, 8N3050A, 8N3050D, MET81K, MHNNM9, MHREMA;.

7) Lot # 5E3022, 5H3045C, 5M3000A, 5V3066A, 5V3066C, 6K3013A, 7C3083, 7E3132, 7H3022, 7K3011A, 7M3053, 7M3053A, 7N3026A, 7N3026D, 8K3051, 8M3033, 8M3033A, 8N3043, 8N3043A, MER9D2, MER9D8, MHHTTA, MHHTTM, MHL67L;

8) Lot # 4N3046, 4S3019, 5L3029, 5N3062, 7E3018, 7K3003, 7K3003A, 7K3004, 7M3052, 7M3052A, 8M3024 8M3024A, MER9DP, MER9EE, MHMW56;

9)  Lot # SS3034A;

10) Lot # MHNMJR, TA3077C;

11) Lot # 1C3008A, 4V3069, 6V3062, 7K3016, MHMW86, SE3007A;

12) Lot # 5T3016A, 5W3003, 6T3052A, 6T3052C, 7L3017, 7L3017A, 8N3086A, MER8D4, MHL5N6;

13) Lot # 6C3054, 6N3067, 6V3034, 7M3012, 7M3012A, MER0A9, MHDMHR, MHPA74;

14) Lot # 4V3066, 5E3023, 5T3025, MER9HJ, MHATV6, MHNPL8, TW3011A
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated August 2, 2010. Firm initiated recall is ongoing.  
REASON
Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
VOLUME OF PRODUCT IN COMMERCE
514 units
DISTRIBUTION
AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA, WI; and China, Hong Kong and Korea
___________________________________
PRODUCT
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens. Recall # Z-1063-2011
CODE
Unit: 6100-7001
RECALLING FIRM/MANUFACTURER
Inrad, Inc., Kentwood, MI, by letter dated December 20, 2010. Firm initiated recal is complete.
REASON
This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
VOLUME OF PRODUCT IN COMMERCE
250 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125. Intended use: medical charged-particle radiation therapy system . Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297. Recall # Z-1064-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters beginning July 30, 2009. Firm initiated recall is ongoing.
REASON
Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machines’ are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
VOLUME OF PRODUCT IN COMMERCE
151 units
DISTRIBUTION
Nationwide, Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa
___________________________________
PRODUCT
Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800. Intended for immunohistochemistry on paraffin-embedded tissue sections. Recall # Z-1065-2011
CODE
Lot numbers: 11279, 11297, 11315, 111604, 11693, and 11967
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL,  by letters dated November 16, 2010.
Manufacturer: Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, United Kingdom. Firm initiated recall is ongoing.
REASON
Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due to the DAB Part B component, which may give a false negative result.
VOLUME OF PRODUCT IN COMMERCE
653 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented self�contained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment. Recall # Z-1066-2011
CODE
Lot Number: 0396BC5 Boxes # 686 - 834 and # 665-685
RECALLING FIRM/MANUFACTURER
Abaxis Inc., Union City, CA, by letter dated November 19, 2010. Firm initiated recall is ongoing.
REASON
Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.
VOLUME OF PRODUCT IN COMMERCE
797 units
DISTRIBUTION
Nationwide, Kowloon and Germany
___________________________________
PRODUCT
Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope. Recall # Z-1067-2011
CODE
EPX-4400 - Catalog Number 5600092 4V395A279 4V395A438 4V395A441 4V395A442 2V395A005 2V395A007 2V395A018 2V395A019 2V395A084 4V395A558 4V395A294 4V395A454 2V395A257 2V395A258 2V395A263 2V395A267 2V395A283 4V395A039 2V395A033 4V395A306 2V395A228 4V395A174 4V395A264 4V395A309 4V395A163 4V395A166 4V395A179 4V395A124 2V395A078 4V395A262 4V395A278 4V395A378 4V395A431 4V395A432 4V395A433 4V395A435 4V395A446 4V395A447 4V395A479 4V395A492 4V395A495 4V395A503 4V395A506 4V395A511 4V395A572 4V395A577 4V395A691 4V395A692 4V395A697 4V395A720 4V395A733 4V395A736 4V395A752 2V395A111 2V395A245 4V395A507 2V395A083 4V395A223 2V395A001 4V395A168 2V395A106 4V395A361 4V395A742 4V395A749 4V395A571 4V395A295 2V395A022 2V395A023 4V395A699 4V395A461 4V395A462 4V395A466 4V395A471 2V395A069 4V395A162 4V395A167 4V395A468 4V395A302 4V395A436 4V395A439 4V395A440 4V395A449 4V395A502 4V395A517 2V395A103 2V395A104 2V395A150 2V395A158 4V395A540 4V395A541 4V395A544 1V395A113 2V395A294 2V395A295 2V395A297 2V395A310 2V395A318 4V395A085 4V395A087 2V395A227 2V395A232 2V395A233 2V395A206 1V395A086 4V395A043 4V395A066 4V395A744 4V395A233 4V395A255 4V395A303 4V395A379 4V395A409 4V395A756 4V395A786 4V395A430 4V395A448 2V395A319 2V395A321 2V395A322 2V395A273 4V395A154 4V395A567 4V395A576 4V395A184 4V395A185 4V395A074 4V395A193 4V395A608 4V395A681 4V395A683 4V395A680 4V395A728 4V395A729 4V395A731 4V395A734 4V395A213 4V395A333 2V395A306 4V395A542 4V395A543 4V395A559 4V395A496 1V395A098 4V395A272 4V395A251 4V395A245 4V395A077 4V395A702 2V395A047 2V395A025 2V395A274 4V395A730 4V395A054 4V395A078 4V395A480 4V395A217 4V395A266 2V395A229 2V395A271 2V395A243 2V395A254 4V395A463 4V395A467 4V395A410 4V395A411 4V395A412 4V395A413 4V395A414 4V395A418 4V395A421 4V395A426 4V395A427 4V395A428 4V395A429 4V395A450 4V395A477 4V395A772 4V395A038 4V395A044 4V395A049 4V395A057 4V395A060 4V395A067 4V395A068 4V395A069 4V395A079 4V395A320 4V395A214 4V395A219 2V395A108 2V395A205 2V395A210 2V395A255 4V395A452 4V395A443 4V395A444 4V395A445 4V395A570 2V395A002 2V395A003 2V395A004 2V395A250 2V395A259 2V395A260 2V395A262 2V395A275 2V395A282 2V395A284 2V395A286 2V395A287 2V395A288 2V395A289 2V395A290 2V395A291 2V395A292 4V395A750 2V395A151 4V395A606 4V395A700 4V395A701 2V395A068 2V395A230 2V395A231 2V395A234 4V395A553 1V395A100 1V395A102 1V395A107 2V395A074 2V395A214 4V395A189 4V395A215 4V395A555 4V395A735 4V395A746 2V395A279 2V395A050 4V395A306 4V395A566 4V395A574 2V395A049 2V395A147 2V395A017 2V395A159 4V395A153 4V395A601 2V395A071 2V395A076 4V395A308 2V395A152 2V395A153 4V395A550 4V395A175 4V395A176 4V395A721 2V395A212 4V395A632 4V395A575 1V395A112 4V395A300 4V395A301 4V395A686 4V395A687 4V395A073 4V395A075 4V395A552 4V395A627 1V395A109 1V395A115 2V395A021 4V395A338 2V395A155 2V395A300 2V395A302 4V395A088 4V395A254 4V395A275 4V395A605 4V395A609 4V395A224 4V395A331 4V395A337 4V395A248 2V395A261 2V395A277 4V395A106 4V395A113 2V395A242 2V395A251 2V395A252 2V395A218 2V395A219 4V395A138 4V395A249 4V395A257 4V395A313 4V395A314 4V395A315 2V395A042 4V395A307 4V395A312 4V395A497 2V395A317 2V395A320 2V395A323 2V395A326 2V395A327 2V395A016 1V395A103 2V395A006 4V395A434 4V395A216 4V395A363 4V395A246 4V395A364 2V395A268 2V395A272 4V395A173 4V395A188 2V395A237 4V395A523 4V395A569 4V395A235 4V395A613 4V395A510 4V395A564 4V395A573 4V395A579 4V395A227 2V395A253 2V395A278 2V395A280 2V395A012 2V395A015 2V395A020 2V395A024 4V395A247 4V395A265 4V395A086 4V395A304 EPX-4400HD - Catalog Number 5900094 1V491A537 1V491A125 1V491A132 1V491A150 1V491A525 1V491A476 1V491A481 1V491A220 1V491A244 1V491A106 1V491A166 1V491A167 1V491A168 1V491A175 1V491A451 1V491A454 1V491A353 1V491A356 1V491A134 1V491A162 1V491A163 1V491A165 1V491A184 1V491A192 1V491A194 1V491A239 1V491A456 1V491A457 1V491A464 1V491A429 1V491A433 1V491A210 1V491A552 1V491A553 1V491A474 1V491A121 1V491A127 1V491A128 1V491A190 1V491A200 1V491A259 1V491A506 1V491A140 1V491A208 1V491A003 1V491A103 1V491A559 1V491A206 1V491A313 1V491A445 1V491A402 1V491A403 1V491A405 1V491A193 1V491A145 1V491A195 1V491A102 1V491A108 1V491A458 1V491A073 1V491A432 1V491A216 1V491A219 1V491A241 1V491A246 1V491A225 1V491A104 1V491A107 1V491A114 1V491A131 1V491A484 1V491A499 1V491A044 1V491A088 1V491A304 1V491A308 1V491A321 1V491A551 1V491A053 1V491A070 1V491A236 1V491A147 1V491A087 1V491A110 1V491A120 1V491A123 1V491A097 1V491A016 1V491A153 1V491A157 1V491A143 1V491A183 1V491A187 1V491A199 1V491A188 1V491A203 1V491A209 1V491A250 1V491A547 1V491A548 1V491A545 1V491A309 1V491A115 1V491A116 1V491A139 1V491A038 1V491A039 1V491A042 1V491A043 1V491A045 1V491A048 1V491A049 1V491A059 1V491A077 1V491A401 1V491A404 1V491A408 1V491A430 1V491A196 1V491A142 1V491A182 1V491A198 1V491A305 1V491A325 1V491A440 1V491A516 1V491A519 1V491A081 1V491A460 1V491A467 1V491A501 1V491A502 1V491A507 1V491A473 1V491A480 1V491A307 1V491A312 1V491A177 1V491A322 1V491A421 1V491A520 1V491A521 1V491A141 1V491A174 1V491A202 1V491A179 1V491A186 1V491A122 1V491A126 1V491A083 1V491A085 1V491A113 1V491A571 1V491A570 1V491A574 1V491A573 1V491A572 1V491A558 1V491A531 1V491A489 1V491A510 1V491A082 1V491A089 1V491A093 1V491A095 1V491A518 1V491A137 1V491A453 1V491A019 1V491A054 1V491A072 1V491A297 1V491A311 1V491A204 1V491A217 1V491A260 1V491A262 1V491A263 1V491A205 1V491A207 1V491A212 1V491A214 1V491A261 1V491A533 1V491A535 1V491A238 1V491A240 1V491A257 1V491A444 1V491A428 1V491A431 1V491A436 1V491A426 1V491A427 1V491A033 1V491A058 1V491A201 1V491A529 1V491A532 1V491A094 1V491A001 1V491A354 1V491A361 1V491A365 1V491A366 1V491A367 1V491A368 1V491A369 1V491A378 1V491A379 1V491A380 1V491A381 1V491A382 1V491A446 1V491A463 1V491A438 1V491A505 1V491A526 1V491A555 1V491A471 1V491A197 1V491A004 1V491A009 1V491A014 1V491A030 1V491A032 1V491A034 1V491A528 1V491A556 1V491A557 1V491A483 1V491A133 1V491A159 1V491A160 1V491A161 1V491A169 1V491A176 1V491A155 1V491A067 1V491A079 1V491A084 1V491A086 1V491A091 1V491A092 1V491A180 1V491A228 1V491A101 1V491A513 1V491A514 1V491A536 1V491A538 1V491A539 1V491A503 1V491A504 1V491A508 1V491A509 1V491A226 1V491A227 1V491A242 1V491A248 1V491A249 1V491A222 1V491A223 1V491A235 1V491A243 1V491A247 1V491A074 1V491A075 1V491A231 1V491A265 1V491A135 1V491A515 1V491A523 1V491A310 1V491A472 1V491A298 1V491A144 1V491A151 1V491A154 1V491A211 1V491A470 1V491A475 1V491A478 1V491A479 1V491A482 1V491A306 1V491A119 1V491A522 1V491A407 1V491A534 1V491A156 1V491A118 1V491A389 1V491A096 1V491A111 1V491A112 1V491A256 1V491A025 1V491A015 1V491A554 1V491A455 1V491A012 1V491A090 1V491A224 1V491A158 1V491A229 1V491A435 1V491A437 1V491A439 1V491A441 1V491A443 1V491A465 1V491A466 1V491A357 1V491A027 1V491A026 1V491A434 1V491A512 1V491A477 1V491A323 1V491A530 1V491A080 1V491A170 1V491A171 1V491A173 1V491A181 1V491A024 1V491A005 1V491A013 1V491A355 1V491A524 1V491A315 1V491A423 1V491A213 1V491A020 1V491A022 1V491A028 1V491A462 1V491A129 1V491A146 1V491A136 1V491A391 1V491A392 1V491A394 1V491A406 1V491A409 1V491A410 1V491A191 1V491A230 1V491A237 1V491A233 1V491A234 1V491A442 1V491A010 1V491A078 1V491A117 1V491A452 1V491A549 1V491A138 1V491A152 1V491A164 1V491A178 1V491A185 1V491A373 K944620 Device Listing #D059810
RECALLING FIRM/MANUFACTURER
Fujinon Inc., Wayne, NJ, by letter dated January 7, 2011. Firm initiated recall is ongoing.
REASON
The  FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under premarket notification/510K process.
VOLUME OF PRODUCT IN COMMERCE
783 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care. Recall # Z-1093-2011
CODE
Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter dated November 29, 2010. Firm initiated recall is complete.   
REASON
Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
VOLUME OF PRODUCT IN COMMERCE
265 boxes (95 vials)
DISTRIBUTION
Nationwide, Internationally

___________________________________
PRODUCT
1) Centurion Medical Products Central line procedure tray, CVI3070, Sterile. Recall # Z-1070-2011;
2) Centurion Medical Products Central venous catheter pack, CV13225, Sterile. Recall # Z-1071-2011;
3) Centurion Medical Products Port access tray, DT12050, Sterile. Recall # Z-1072-2011;
4) Centurion Medical Products Port access tray DT6040, Sterile. Recall # Z-1073-2011;
5) Centurion Medical Products Port cath tray DT6765, Sterile. Recall # Z-1074-2011;
6) Centurion Medical Products Implanted access port tray DT7105, Sterile. Recall # Z-1075-2011;
7) Centurion Medical Products Port access tray DT7780, Sterile. Recall # Z-1076-2011;
8) Centurion Medical Products VAD access kit HT2415, Sterile. Recall # Z-1077-2011;
9) Centurion Medical Products VAD Tray HT1995A, Sterile. Recall # Z-1078-2011;
10) NeoMedical Incorporated, V- Cath Insertion Tray, REF301-00, Sterile. Recall # Z-1079-2011;
11) Centurion Medical Products Insertion/PPE Kit CV12590, Sterile. Recall # Z-1080-2011;
12) Centurion Medical Products PICC Line Kit CV12880, Sterile. Recall # Z-1081-2011;
13) Centurion Medical Products Venous access kit, CV1515, Sterile. Recall # Z-1082-2011;
14) Centurion Medical Products Custom PICC insertion tray DT11460, Sterile. Recall # Z-1083-2011;
15) Centurion Medical Products Central line procedure kit DT12210, Sterile. Recall # Z-1084-2011;
16) Centurion Medical Products Port access tray DT12965, Sterile. Recall # Z-1085-2011;
17) Centurion Medical Products PICC line tray DT3185, Sterile. Recall # Z-1086-2011;
18) Centurion Medical Products Port access tray DT7030, Sterile. Recall # Z-1087-2011;
19 Centurion Medical Products Port access tray DT7150, Sterile. Recall # Z-1088-2011;
20) Centurion Medical Products VAD access tray DT7810, Sterile. Recall # Z-1089-2011;
21) Centurion Medical Products Port access tray with sorbaview 2000 and chloraprep DT9155, Sterile. Recall # Z-1090-2011;
22) Centurion Medical Products Port access tray DT9195, Sterile. Recall # Z-1091-2011;
23) Centurion Medical Products VAD access tray HT2440A, Sterile. Recall # Z-1092-2011
CODE
1) Units: 2009092450 and 2009100150;
2) Units: 2009102350 and 2009100750;
3) Unit: 2009100450;
4) Unit: 2009100850;
5) Unit: 2009100550;
6) Unit: 2009100550;
7) Unit: 2009102250;
8) Units: 2009101950 and 2009092350;
9) Unit: 2009102950;
10) Unit: 2009092850;
11) Unit: 2009102850;
12) Unit: 2009092550;
13) Unit: 2009103050;
14) Unit: 2009101550;
15) Unit: 2009100150;
16) Units: 2009101350 and 2009092850;
17) Units: 2009093050 and 2009101550;
18) Unit: 2009100750;
19) Unit: 2009101950;
20) Units: 2009101550 and 2009092450;
21) Unit: 2009100550;
22) Unit: 2009092450;
23) Units: 2009102250 and 2009100950
RECALLING FIRM/MANUFACTURER
Recalling Firm: Centurion Medical Products, Howell, MI, by letters on June 3, 2010 and June 21, 2010.
Manufacturer: Centurion Medical Products, Salisbury, NC. Firm initiated recall is complete.
REASON
The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.
VOLUME OF PRODUCT IN COMMERCE
4,160 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. Recall # Z-1094-2011
CODE
Serial numbers ending in 0063,0110,0196,0197, 0230,0281,0285,0293, 0319,0329,0332,0358, 0361,0362,0396,0435, 0440,0468,0474,0606, 0642, 0664, 0687, and 0719 through 1331
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Santa Clara, CA, by letter dated October 15, 2010.
Manufacturer: C2 Diagnostics, Montpellier Cedex 5, France. Firm initiated recall is ongoing.
REASON
There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.
VOLUME OF PRODUCT IN COMMERCE
611 ‘instruments, 82 FRU’s
DISTRIBUTION
Nationwide, Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago
___________________________________
PRODUCT
Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00. One single unit to a package. Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement. Recall # Z-1095-2011
CODE
Lot #SMTFJ
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated January 6, 2011.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
The labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pulmonary Valve & Conduit SG Used in heart surgery. Recall # Z-1219-2011
CODE
Serial Number: 9748180
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated January 7, 2011. Firm initiated recall is ongoing.
REASON
A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Hill-Rom TotalCare Bed, P1900. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED). Recall # Z-1220-2011;

2) Hill-Rom TotalCare Bariatric Bed, P1840. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED). Recall # Z-1221-2011
CODE
1) Units: J080AM6716, J086AM6798, J095AM7032, J095AM7033, J101AM7149, J101AM7150, J101AM7156, J101AM7157, J101AM7159, J101AM7160, J108AM7280, J108AM7282, J109AM7288, J109AM7290, J112AM7320, J112AM7325, J112AM7327, J113AM7330, J114AM7338, J122AM7472, J122AM7475, J122AM7476, J122AM7479, J122AM7482, J122AM7483, J123AM7489, J123AM7494, J123AM7496, J123AM7500, J123AM7501, J123AM7505, J126AM7512, J126AM7516, J126AM7520, J126AM7524, J126AM7525, J127AM7529, J127AM7541, J127AM7547, J127AM7548, J128AM7558, J136AM7695, J136AM7698, J137AM7727, J137AM7728, J137AM7730, J140AM7735, J140AM7748, J140AM7750, J149AM7885, J154AM7933, J154AM7935, J154AM7938, J154AM7942, J154AM7943, J162AM8072, J162AM8089, J079AM6675, J079AM6685, J141AM7769, J141AM7770, J141AM7771, J142AM7785, J150AM7891, J150AM7895, J151AM7909, J151AM7915, J151AM7919, J151AM7930, J154AM7949, J154AM7954, J155AM7965, J156AM7994, J157AM8001, J155AM7958, J155AM7971, J079AM6658, J084AM6725, J084AM6734, J084AM6741, J085AM6766, J085AM6769, J085AM6771, J085AM6782, J085AM6784, J086AM6793, J086AM6794, J086AM6795, J086AM6807, J086AM6817, J086AM6818, J086AM6823, J087AM6824, J087AM6826, J087AM6827, J087AM6835, J087AM6837, J087AM6843, J087AM6844, J087AM6849, J087AM6853, J088AM6863, J088AM6864, J088AM6867, J091AM6902, J092AM6938, J092AM6949, J094AM6981, J094AM6983, J094AM6984, J094AM6985, J094AM6987, J094AM6988, J094AM6994, J094AM6998, J094AM6999, J094AM7002, J095AM7009, J095AM7013, J098AM7047, J098AM7049, J098AM7050, J098AM7053, J098AM7055, J098AM7057, J098AM7059, J098AM7061, J098AM7069, J098AM7075, J099AM7081, J099AM7083, J099AM7086, J099AM7088, J099AM7091, J099AM7093, J099AM7094, J099AM7096, J099AM7098, J099AM7099, J099AM7100, J099AM7102, J099AM7104, J100AM7108, J100AM7109, J100AM7114, J100AM7116, J100AM7117, J100AM7120, J100AM7124, J100AM7125, J100AM7129, J101AM7153, J101AM7154, J101AM7161, J101AM7164, J101AM7168, J101AM7170, J102AM7175, J102AM7176, J102AM7182, J102AM7185, J102AM7189, J105AM7193, J106AM7229, J106AM7230, J107AM7247, J136AM7696, J136AM7699, J136AM7700, J136AM7706, J137AM7710, J137AM7717, J137AM7718, J137AM7721, J137AM7723, J137AM7733, J141AM7759, J141AM7760, J141AM7761, J141AM7765, J141AM7766, J141AM7772, J141AM7777, J142AM7778, J142AM7787, J142AM7788, J142AM7790, J142AM7793, J142AM7795, J142AM7796, J142AM7797, J142AM7798, J143AM7799, J143AM7801, J143AM7802, J143AM7803, J151AM7906, J155AM7978, J156AM7980, J156AM7989, J156AM7998, J157AM8009, J157AM8017, J157AM8019, J158AM8024, J158AM8034, J158AM8040, J158AM8041, J158AM8046, J161AM8049, J161AM8051, J161AM8052, J161AM8055, J161AM8057, J161AM8062, J161AM8064, J161AM8065, J162AM8068, J162AM8069, J162AM8077, J162AM8083, J162AM8086, J162AM8087, J084AM6722, J084AM6729, J084AM6742, J085AM6758, J085AM6759, J086AM6791, J086AM6813, J087AM6850, J088AM6875, J091AM6904, J091AM6908, J091AM6911, J091AM6915, J091AM6916, J095AM7016, J098AM7040, J114AM7345, J114AM7347, J114AM7352, J115AM7358, J115AM7373, J115AM7375, J116AM7393, J116AM7395, J119AM7405, J119AM7420, J119AM7421, J120AM7424, J120AM7427, J120AM7433, J121AM7444, J121AM7448, J129AM7582, J129AM7588, J137AM7722, J140AM7740, J140AM7755, J141AM7775, J157AM8016, J158AM8027, J100AM7131, J100AM7134, J100AM7135, J100AM7137, J101AM7147, J143AM7804, J143AM7806, J143AM7809, J143AM7810, J143AM7819, J148AM7847, J148AM7852, J148AM7856, J149AM7865, J149AM7875, J098AM7065, J098AM7067, J098AM7070, J084AM6736, J085AM6762, J085AM6768, J085AM6780, J085AM6781, J092AM6937, J092AM6950, J092AM6951, J093AM6958, J093AM6960, J093AM6966, J093AM6970, J094AM6977, J094AM6979, J101AM7162, J101AM7163, J102AM7171, J102AM7178, J102AM7180, J102AM7181, J102AM7183, J102AM7184, J102AM7186, J102AM7188, J102AM7191, J102AM7192, J105AM7194, J105AM7195, J105AM7198, J105AM7201, J105AM7202, J105AM7205, J105AM7207, J105AM7208, J105AM7212, J105AM7213, J105AM7216, J105AM7219, J105AM7220, J106AM7228, J106AM7231, J107AM7246, J107AM7255, J107AM7259, J107AM7262, J108AM7267, J108AM7278, J114AM7346, J114AM7354, J114AM7356, J115AM7359, J129AM7584, J129AM7586, J129AM7590, J129AM7593, J129AM7595, J130AM7602, J130AM7604, J130AM7607, J130AM7609, J130AM7611, J130AM7614, J130AM7616, J133AM7623, J133AM7626, J133AM7630, J133AM7633, J133AM7636, J133AM7639, J134AM7642, J134AM7644, J134AM7646, J134AM7649, J134AM7653, J134AM7659, J134AM7660, J134AM7661, J134AM7662, J135AM7664, J135AM7666, J135AM7668, J135AM7669, J135AM7670, J135AM7680, J135AM7681, J136AM7685, J136AM7686, J136AM7687, J136AM7689, J140AM7743, J141AM7767, J142AM7780, J142AM7781, J143AM7805, J143AM7807, J143AM7808, J143AM7811, J143AM7812, J143AM7815, J143AM7818, J144AM7820, J144AM7823, J144AM7824, J144AM7825, J144AM7826, J144AM7828, J144AM7829, J144AM7831, J144AM7832, J144AM7833, J144AM7835, J144AM7836, J144AM7837, J144AM7839, J144AM7840, J148AM7843, J148AM7845, J148AM7846, J148AM7849, J148AM7850, J148AM7851, J148AM7853, J148AM7854, J148AM7855, J148AM7857, J148AM7858, J148AM7859, J148AM7862, J149AM7863, J149AM7868, J150AM7898, J151AM7902, J155AM7959, J155AM7967, J155AM7970, J155AM7973, J156AM7983, J156AM7984, J156AM7987, J156AM7991, J156AM7995, J157AM8005, J157AM8018, J157AM8020, J158AM8030, J158AM8035, J158AM8044, J161AM8047, J161AM8050, J161AM8053, J161AM8054, J161AM8056, J161AM8058, J161AM8060, J161AM8061, J161AM8063, J161AM8067, J162AM8070, J162AM8074, J162AM8076, J162AM8080, J162AM8081, J162AM8085, J163AM8091, J163AM8094, J163AM8095, J163AM8101, J163AM8103, J163AM8105, J085AM6775, J085AM6776, J085AM6786, J086AM6801, J086AM6809, J086AM6810, J086AM6814, J086AM6820, J087AM6828, J087AM6831, J087AM6832, J087AM6840, J087AM6852, J088AM6868, J095AM7023, J102AM7173, J084AM6749, J085AM6777, J095AM7024, J095AM7029, J098AM7043, J098AM7044, J098AM7046, J098AM7051, J098AM7056, J098AM7060, J098AM7062, J098AM7066, J098AM7068, J098AM7071, J098AM7072, J098AM7073, J098AM7074, J098AM7076, J099AM7077, J099AM7079, J099AM7082, J099AM7084, J099AM7087, J099AM7089, J099AM7097, J099AM7101, J099AM7103, J099AM7105, J099AM7106, J100AM7118, J100AM7122, J100AM7123, J100AM7127, J100AM7128, J100AM7133, J101AM7141, J101AM7142, J101AM7146, J088AM6883, J091AM6907, J094AM6986, J079AM6660, J079AM6663, J079AM6667, J079AM6670, J079AM6672, J079AM6676, J079AM6677, J079AM6679, J079AM6680, J079AM6681, J079AM6687, J079AM6688, J080AM6700, J080AM6705, J080AM6714, J150AM7888, J150AM7889, J085AM6763, J107AM7257, J107AM7261, J108AM7264, J108AM7266, J108AM7268, J108AM7269, J108AM7271, J108AM7273, J108AM7274, J108AM7276, J109AM7291, J109AM7292, J109AM7293, J109AM7294, J109AM7295, J109AM7296, J114AM7353, J114AM7355, J115AM7360, J100AM7110, J101AM7144, J084AM6752, J088AM6869, J095AM7010, J095AM7020, J095AM7022, J095AM7025, J098AM7058, J098AM7064, J114AM7357, J088AM6876, J091AM6924, J091AM6926, J092AM6930, J092AM6932, J115AM7363, J116AM7379, J105AM7196, J105AM7217, J106AM7223, J106AM7226, J106AM7239, J129AM7583, J129AM7594, J102AM7190, J130AM7599, J112AM7310, J112AM7311, J112AM7312, J112AM7313, J112AM7314, J112AM7315, J112AM7316, J112AM7317, J112AM7321, J112AM7323, J113AM7328, J113AM7331, J113AM7332, J113AM7333, J113AM7334, J121AM7462, J121AM7464, J122AM7465, J122AM7466, J122AM7467, J122AM7468, J122AM7469, J100AM7112, J100AM7113, J107AM7254, J086AM6802, J107AM7260, J092AM6933, J107AM7256, J084AM6733, J085AM6774, J085AM6785, J086AM6799, J088AM6865, J092AM6946, J092AM6948, J092AM6955, J095AM7017, J093AM6957, J093AM6961, J092AM6934, J092AM6952, J106AM7233, J157AM8012, J157AM8015, J088AM6879, J084AM6726, J085AM6764, J085AM6779, J086AM6822, J087AM6825, J087AM6845, J095AM7030, J106AM7235, J106AM7238, J106AM7241, J107AM7244, J107AM7245, J107AM7250, J107AM7251, J107AM7252, J127AM7530, J127AM7534, J127AM7538, J127AM7543, J127AM7545, J127AM7549, J128AM7553, J128AM7554, J128AM7555, J128AM7559, J128AM7562, J128AM7563, J128AM7564, J128AM7566, J128AM7568, J128AM7569, J128AM7570, J128AM7572, J128AM7573, J128AM7574, J129AM7575, J129AM7576, J129AM7578, J129AM7579, J129AM7580, J130AM7612, J130AM7618, J133AM7622, J134AM7655, J134AM7658, J135AM7665, J135AM7667, J137AM7724, J137AM7732, J140AM7734, J140AM7737, J140AM7747, J141AM7776, J142AM7779, J142AM7782, J142AM7783, J142AM7792, J157AM8011, J157AM8013, J157AM8021, J158AM8025, J158AM8028, J088AM6874, J088AM6877, J088AM6881, J088AM6892, J088AM6894, J091AM6900, J091AM6910, J091AM6913, J091AM6928, J092AM6939, J093AM6963, J093AM6965, J094AM6978, J094AM6990, J095AM7012, J084AM6745, J086AM6805, J087AM6834, J087AM6842, J115AM7371, J115AM7374, J129AM7592, J079AM6657, J079AM6659, J079AM6661, J079AM6662, J079AM6664, J079AM6665, J079AM6666, J079AM6668, J079AM6669, J079AM6671, J079AM6673, J079AM6674, J079AM6678, J079AM6682, J079AM6683, J079AM6684, J080AM6697, J080AM6698, J080AM6699, J080AM6701, J080AM6704, J084AM6751, J116AM7387, J119AM7403, J119AM7406, J119AM7407, J119AM7411, J119AM7415, J119AM7419, J120AM7429, J120AM7431, J136AM7690, J136AM7690, J080AM6706, J080AM6707, J080AM6708, J080AM6711, J080AM6712, J080AM6713, J080AM6719, J084AM6720, J084AM6721, J084AM6724, J088AM6880, J088AM6884, J088AM6886, J088AM6887, J091AM6898, J091AM6899, J091AM6905, J093AM6968, J150AM7892, J150AM7897, J150AM7899, J151AM7903, J151AM7904, J151AM7905, J151AM7911, J151AM7912, J151AM7914, J151AM7917, J151AM7921, J151AM7922, J151AM7925, J151AM7926, J151AM7927, J151AM7929, J154AM7936, J154AM7940, J154AM7946, J154AM7947, J154AM7948, J154AM7953, J155AM7955, J155AM7964, J155AM7974, J080AM6689, J080AM6690, J080AM6691, J080AM6692, J080AM6693, J080AM6694, J080AM6695, J080AM6696, J108AM4762, J108AM7272, J108AM7277, J108AM7279, J108AM7281, J108AM7283, J108AM7285, J109AM7287, J109AM7298, J109AM7300, J109AM7302, J109AM7304, J109AM7306, J112AM4736, J112AM7308, J112AM7318, J112AM7319, J112AM7322, J112AM7324, J112AN7319, J113AM7329, J114AM7337, J114AM7339, J114AM7340, J095AM7011, J095AM7018, J095AM7021, J095AM7026, J095AM7027, J095AM7028, J095AM7031, J095AM7034, J098AM7037, J098AM7039, J099AM7078, J099AM7080, J099AM7085, J098AM7045, J098AM7048, J101AM7151, J108AM7275, J114AM7348, J122AM7481, J122AM7484, J123AM7491, J115AM7372, J120AM7442, J120AM7443, J121AM7446, J121AM7447, J121AM7450, J121AM7452, J121AM7456, J121AM7458, J121AM7459, J121AM7460, J121AM7461, J122AM7486, J149AM7874, J149AM7878, J149AM7883, J157AM8004, J126AM7514, J126AM7518, J126AM7526, J114AM7344, J114AM7350, J115AM7370, J115AM7377, J116AM7380, J116AM7383, J116AM7385, J116AM7389, J116AM7396, J116AM7397, J116AM7398, J119AM7402, J119AM7409, J119AM7413, J119AM7417, J120AM7422, J120AM7423, J120AM7425, J120AM7426, J120AM7428, J120AM7435, J120AM7437, J120AM7438, J120AM7439, J120AM7441, J154AM7950, J155AM7961, J155AM7962, J155AM7976, J156AM7981, J156AM7986, J156AM7997, J130AM7608, J133AM7637, J133AM7638, J134AM7647, J150AM7887, J150AM7893, J133AM7625, J133AM7632, J135AM7682, J135AM7683, J137AM7715, J163AM8098, J157AM8008, J158AM8038, J162AM8079, J162AM8088, J163AM8093, J163AM8097, J163AM8099, J163AM8102, J163AM8104, J163AM8106 and J098AM7042;

2) Units: J106AM7237, J107AM7243, J107AM7249, J115AM7361, J115AM7365, J115AM7368, J084AM6731, J084AM6737, J085AM6756, J085AM6760, J084AM6723, J095AM7019, J098AM7041, J084AM6747, J086AM6812, J114AM7341, J156AM7992, J085AM6757, J086AM6792, J086AM6796, J086AM6806, J086AM6806, J091AM6906, J091AM6919, J095AM7014, J101AM7145, J114AM7342, J116AM7391, J119AM7400, J130AM7605, J148AM7842, J148AM7844, J148AM7848, J162AM8078, J163AM8107, J113AM7335, J113AM7336, J127AM7535, J127AM7542 and J133AM7621
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated January 19, 2011. Firm initiated recall is ongoing.
REASON
The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.
VOLUME OF PRODUCT IN COMMERCE
945 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Maquet Heartstring Aortic Cutter 4.3 mm, AC-3043. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel. Recall # Z-1222-2011
CODE
Lot numbers: 9081071 and 9082071
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Cardiovascular, San Jose, CA, by letters on June 10, 2020.    
Manufacturer: Maquet Puerto Rico Inc., Dorado, PR. Firm initiated recall is ongoing.
REASON
Pouch integrity may be compromised, resulting in loss of sterility.
VOLUME OF PRODUCT IN COMMERCE
35 nationwide, 360 internationally
DISTRIBUTION
IA, KY, IL, WI, TX, NC, Japan, Germany and Hong Kong

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS III
___________________________________
PRODUCT
Pump in Style Advanced (PNSA) Breast Pump; a daily use, double pump, electric powered breast pump; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk. Recall # Z-1224-2011
CODE
Manufacture dates 02/10/10 through 03/03/10
RECALLING FIRM/MANUFACTURER
Medela Inc., McHenry, IL, by letter dated January 11, 2011. FDA initiated recall is ongoing. 
REASON
The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
VOLUME OF PRODUCT IN COMMERCE
11,154 units
DISTRIBUTION
Nationwide, including Puerto Rico

RECALLS AND FIELD CORRECTIONS:  VETERINARY – CLASS I
___________________________________
PRODUCT
The Iams Proactive Health Indoor Weight & Hairball Care. Sold in blue 6.8-pound bags, UPC 19014 03921. Recall # V-097-2011
CODE
Code date of 02304173 (B1-B6). Best if Used By Date: Dec 18 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH, by telephone on August 29, 2010.  
Manufacturer: Proctor & Gamble, The Iams Co – Aurora, Aurora, NB. Firm initiated recall is ongoing.
REASON
A confirmatory result indicating the presence of salmonella was received from P & G's outside laboratory on August 27th.
VOLUME OF PRODUCT IN COMMERCE
2,516/6.8 lb bags
DISTRIBUTION
CA, CO, IA, KS, MN, OR & TX

END OF ENFORCEMENT REPORT FOR FEBRUARY 16, 2011

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