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U.S. Department of Health and Human Services

Enforcement Report - Week of December 17, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. Lot 6003827, Exp. Date 04/2015 Class II Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC
Drugs ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02 Lot 6003930, exp. date 04/2014 Class II Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC
Drugs CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01. Lot 6003853, exp. date 04/2014 Class II Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Fresenius Kabi USA, LLC
Drugs Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. Lot #: NC082768, Exp 12/23/2014 Class II Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers. Baxter Healthcare Corp.
Food Sweet 2 Eat Yellow Peaches; California Tree Fruit; Product of USA; Packed in the following configurations: 2.5 lb. box, 4-4.5 lb. box 4-4.5 lb box for Trader Joe's 8/2 Clamshell - net weight 2 lbs. Costco Consumer Box, 5 lbs Sam's Club consumer box - 4 lbs (Summer Flame) BJ's 4 lb clamshell 2 lb bag. Sticker information - Sweet 2 Eat: 94044 Org TR YF Peach 4044 TR Peach; 4038 CA Peach Varieties include: August Flame, August Lady, , Autumn Flame, Bright Princess, Brittney Lane, Candy Flame, Crimson Lady, Crimson Princess, Earli Rich, Elegant Lady, Grand Finale, Henry 2,3 & 4, July Flame, June Flame, June Flavor, June Time, Kaweah, King Midas 17, Last Tango., May Princess, O'Henry, , Princess Time, Rich Lady,, Sierra Rich, Spring Flame 18, 20, 20.5, 21, 22, SU Peach 13, 15, 17, Sugartime, Summer Flame 26, 29. 24, , Summer Zee, Sweet Dream, Sweet Henry, Tra Zee, Vista, Zee Lady, Zee Pride. Wawona Packing Cutler, CA. Item 94044 - 3098795; 00895009002236; Item 4044 - 3099510; 00895009002212; Item 4038 - 3099544; 00895009002229; 2 lb. bag UPC: 0 33383 32200 1; Organic 2.5 lb box UPC 8 491300036 3; 4-4.5 lb box UPC 033383 32370 1: BJ's 4-4.5 clamshell UPC 0 33383 32211 7; Sam's club 4 lb carton UPC 8 49315 00028 8; Organic 8/2  ...
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Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Sweet 2 Eat White Peaches; California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: 4-4.5 lb. box BJ's 4 lb Clamshell Costco 5 lb box. Sam's Club consumer box - 4 lbs (Summer Flame) Sticker information - Sweet 2 Eat: 94041 Org TR WF Peach 4401 - White Peach Varieties include: Autumn Snow, ice Princess, Ivory Dutchess, Ivory Queen, Late White Delight, September Snow, Sierra Snow, Snow Angel, Snow Blaze, Snow Gem, Snow Giant, Snow King, Snow Lady, Snow Princess, Summer Sweet, White Delight. Wawona Packing Cutler, CA. Item 4401 - 3099608; 00895009002250; Item 94401 -3098841; 00895009002243; 4-4.5 lb box UPC 033383 32372 5: BJ's 4-4.5 clamshell UPC 0 33383 32216 2; Sam's club 4 lb carton UPC 8 49315 00028 8; Costco Consumer Box 5 lbs UPC 8 4931589407 8; Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Sweet 2 Eat Yellow Nectarines California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's Club 4 lb Nectarine Pouch (summer Flare); Sam's Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; Costco Consumer Box - 5 lbs. Organic 8/2 Clamshell - 2 lbs. Organic 2 1/2 lb. consumer box; Trader Joe's 4 lb consumer - 4-4.5 lbs. Labels: 94378 - Org TR YF NEC; 4378 TR NEC; 4036 CA Nectarine Varieties Include:August Bright, August Fire, August Red, Diamond Bright. Diamond Ray, Fire Sweet, Grand Bright, Honey Fire, honey May, Honey Royale, Kay Glo, Late Red Jim, Mango, Prince Jim, Red Bright, Red Glenn, Red Jim, Red Roy, ,Rose Bright, Royal Glo, September Bright NS 21 Super Star, Spring Bright, Spring Fire, Spring Flare 20, Spring Flare 22, Spring Flare 23, Summer Bright, Summer Fire , Summer Flare 27, Summer Flare 28, summer flare 30, Summer Flare 31, Summer Flare 35, Zee Fire Wawona Packing Cutler, CA. Item 94378 - 3098808; 00895009002137; Item 4378 -3099499; 00  ...
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Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Sweet 2 Eat White Nectarines, California Tree Fruit; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; 4-4.5 lb box; Costco Consumer Box - 5 lbs.; . Labels: 3035 White Nectarine 93035 Organic TR WF NEC; Varieties include Arctic Pride, Arctic Snow, August Pearl, Candy Pearl Diamond Pearl,Fire Pearl, Giant Pearl,Grand Pearl, Kay Pearl, Majestic Pearl, Summer Pearl, Polar Light, Regal Pearl, Ruby Pearl Snow Flare 21, Snow Pearl, Spring Pearl. Wawona Packing Cutler, CA. Item 94378 - 3098808; 00895009002137; Item 4378 -3099499; 00895009002113 4-4.5 lb box UPC 033383 32373 2; Sam's Club Consumer Box 4 lb UPC 0 33383 32361 9; BJ's Clamshell 4-4.5 lb. UPC 0 33383 32315 2 Costco Consumer Box 5 lbs UPC 8 49315 47932 9. Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Sweet 2 Eat Plums; Product of USA: Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configurations: Sam's 3 1/2 lb Clamshell (Black Diamond)Consumer Box - 4 lbs. BJ's 4 lb. Clamshell; 2 lb. bag. Labels: 4040 CA Black Plum; 4042 CA Red Plum; 4440 Tree Ripe Plum; 94040 Org Black Plum; 94042 Org Red Plum. Varieties include: Black Plum: Angeleno, Black Amber, black Diamond 11, Black Kat, Slack Splendor, Catalina, Earli Queen, Flavor Rich, Friar, Howard Sun, Owen T,, SP-25 Black Giant, Su Plum 11/37, SU Plum 34/36, SU Plum 41/42. SU Plum, 43. Red Plum: Betty Ann, Fall Fiesta, Fortune, Fruit Punch, Hiromi Red,Joanna Red, John W., Red Yummy, Royal Diamond, September Yummy, Simka, Yummy Beauty Green Plum: October Sun Wawona Packing Cutler, CA. Item 4040 - 3099501; 00895009002311; Item 4042 - 3099536; 00895009002218; Item 4440 - 3189881; 00895009002366; Item 94040 - 3098816; 00895009002335 Item 94042 - 3098824; 00895009002342; Sam's Club Consumer Box 4 lb UPC 0 33383 32016 8; BJ's Clamshell 4-4.5 lb. UPC 0 33383 45468 9; 2 lb Bag Plum UPC 033383 32010 6. Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Pluot: Product of USA: Brand names: Sweet 2 Eat, Sweet 2 Eat Organic Orchard Perfect, Trader Joes, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Packed in the following configuration: BJ's 4 lb. Clamshell; Labels: 3278 Plumcot; 3609 Red Plumcot 3610 Green Plumcot 3611 Black Plumcot. Varieties include Dapple Dandy, Dapple Supreme. Flavor Fall, Flavor Grenade, Flavor Heart, Flavorosa, Sugar Jewell, Sweet Treat, Crimson Glo. Wawona Packing Cutler, CA. Item 3278 - 3099552; 00895009002519; Item 3609 - 3099561; 00895009002526; Item 3610 - 3099579; 00895009002533; Item 3611 - 3099587; 00895009002540. Item 94040 - 3098816; 00895009002335 Item 94042 - 3098824; 00895009002342; BJ's Clamshell 4-4.5 lb. UPC 0 46142 001290 1. Class I Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes. Wawona Packing Company
Food Whole Foods Market Dip Peach Salsa, UPC/PLU 029648300000 Whole Foods Market Scale-Salsa Peach, UPC/PLU 96483 Whole Foods Market Peach Salsa MIN, UPC/PLU 96483 Whole Foods Market Peach Salsa XS, UPC/PLU 90614 Whole Foods Market Peach Salsa, UPC/PLU 25023900000 Whole Foods Market Dip Salsa Peach-LG, UPC/PLU 29648300000 Whole Foods Market Salsa Peach, UPC/PLU 29648300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market FM Grill Tray Peach, UPC/PLU 025994200000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Peaches with Burrata & Balsamic, UPC/PLU 22206300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market HSH Kale Barley Peach Salad, UPC/PLU 22442300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Peaches, UPC/PLU 22703900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market HSH Peach Chutney, UPC/PLU 22935500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Scale-Yogurt Cup Peaches and Cream, UPC/PLU 96595 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Mango Peach Salsa MIN, UPC/PLU 50195 Whole Foods Market Mango Peach Salsa XS, UPC/PLU 58122 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cake Slice Chantilly Seasonal, UPC/PLU 21615600000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 24420800000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 28825800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cake Large Chantilly Peach, UPC/PLU 21617800000; Whole Foods Market Cake Small Chantilly Peach, UPC/PLU 21617900000; Whole Foods Market Cake Slice Chantilly Peach, UPC/PLU 21623200000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tart Large Fresh Fruit, UPC/PLU 21633000000; Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 21633100000, Whole Foods Market Tart Small Fresh Fruit, UPC/PLU 24985200000; Whole Foods Market Tart Fresh Fruit Large, UPC/PLU 14450 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cake Large Layer 1/4 Sheet Chantilly, UPC/PLU 21677200000; Whole Foods Market Cake Individual Chantilly, UPC/PLU 21677400000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Sweet Petites 2 For $3, UPC/PLU 21687700000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tart Peach 6", UPC/PLU 21704100000; Whole Foods Market WF Bakery Tart-Peach 4", UPC/PLU 20791000000; Whole Foods Market WF Bakery Tart-Peach 9", UPC/PLU 20791100000; Whole Foods Market WF Bakery Tart-Peach Mini, UPC/PLU 20791200000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Pie Large Peach, UPC/PLU 21759600000; Whole Foods Market Pie Small 6" Peach, UPC/PLU 24032900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tart Large Galette Seasonal Fruit, UPC/PLU 24987600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tart Large Square Fruit, UPC/PLU 28893200000; Whole Foods Market Tart Fruit Large, UPC/PLU 20189700000; Whole Foods Market Tart Fruit Large Square, UPC/PLU 20611000000; Whole Foods Market Tart Fruit Medium, UPC/PLU 26255; Whole Foods Market Tart Fruit Medium, UPC/PLU 20189800000; Whole Foods Market Tart Fruit Small, UPC/PLU 20189600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Summer Splash, UPC/PLU 25102000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Nectarine Lemonade, UPC/PLU 25104900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Heirloom Tomato & Peach Salad, UPC/PLU 28353400000/83534; UPC/PLU 20264900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Seasonal Fruit Tart 4", UPC/PLU 20900400000; Whole Foods Market Seasonal Fruit Tart 6", UPC/PLU 20900600000 Whole Foods Market Seasonal Fruit Tart 9", UPC/PLU 20900700000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peaches n Cream Cake 6", UPC/PLU 20733500000; Whole Foods Market Peaches n Cream Cake 8", UPC/PLU 20733600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cake-Peaches Cream 9", UPC/PLU 20179200000; Whole Foods Market Cake-Peaches Cream 6", UPC/PLU 20931300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Pie-Peaches and Cream 8in, UPC/PLU 20139000000;Whole Foods Market Pie-Peaches and Cream 4in, UPC/PLU 20628800000; Whole Foods Market WFM Pie-Peaches and Cream Mini, UPC/PLU 20656900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market WFM Dess Bar Cobbler-Peach, UPC/PLU 20643100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market WFM Dess Bar-Peach Crumble, UPC/PLU 20666800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market WF Bakery Parfait-Peach, UPC/PLU 20683800000; Whole Foods Market Peach Parfait, UPC/PLU 20690500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market WF Bakery Parfait-Seasonal Fruit, UPC/PLU 20690500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Ramekin Peach, UPC/PLU 20129300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cobbler Peach, UPC/PLU 20136000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Upside Down Cake-Peach Blueberry, UPC/PLU 25715800000, Whole Foods Market Cake Small Upside Down Peach Blue, UPC/PLU 24632500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market HSH Parfait-Blueberry, UPC/PLU 20659600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Smoothie-Immunity Boost 16 oz., UPC/PLU 50172; Whole Foods Market Smoothie-Immunity Boost 24 oz., UPC/PLU 50173; Whole Foods Market Smoothie-Immunity Boost 32 oz., UPC/PLU 50174 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Smoothie-Apple Pie 16 oz (HSH), UPC/PLU 25113; Whole Foods Market Smoothie-Apple Pie 24 oz (HSH), UPC/PLU 2007 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Smoothie-Peach Pizazz 24 oz., UPC/PLU 50279; Whole Foods Market Smoothie-Peach Pizazz 16 oz., UPC/PLU 50278; Whole Foods Market Smoothie-Peach Pizazz 32 oz., UPC/PLU 50280 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Balsamic Chicken Breast & Peaches, UPC/PLU 20254100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market BBQ Peach Tempeh, UPC/PLU 20254000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Bleu Peach Pizza, UPC/PLU 20547600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Crispy BBQ Peach Tempeh, UPC/PLU 20253800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Cumin Lime Grilled Peach and Mozzarella Towers, UPC/PLU 20211600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Peaches and Cream, UPC/PLU 20253700000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Salmon with Peach Ginger Jam, UPC/PLU 20217400000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Salmon with Peach Rosemary Jam, UPC/PLU 20255600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Shrimp and Nectarine Salad, UPC/PLU 20254100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Grilled Spiced Peach and Kale Salad, UPC/PLU 20213300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Heirloom Tomato and Nectarine Salad, UPC/PLU 20253800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Heirloom Tomato Peach and Mozzarella Salad, UPC/PLU 20253800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Fruit Crisp, UPC/PLU 21222100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Glazed Pork Loin, UPC/PLU 20249000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Stuffed Pork Loin, UPC/PLU 20216400000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peaches, UPC/PLU 21085000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peaches with Toasted Almonds and Basil (HSH), UPC/PLU 20250100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peaches, Feta with toasted almonds and Basil, UPC/PLU 20253800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Caramelized Peach, UPC/PLU 20256200000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Caramelized Peach with Ricotta, UPC/PLU 20256300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market CC HSH Pear Crisp Slaw, UPC/PLU 25730500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market FM Sangria Mix LG, UPC/PLU 29690300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Salmon Fillet with Peach Salsa, UPC/PLU 29913800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Basil Glazed Smoked Salmon, UPC/PLU 29074000000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Basil Stuffed Blackened Salmon, UPC/PLU 29512800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Basil Stuffed Salmon, UPC/PLU 25179600000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Chipotle Peach Turkey, UPC/PLU 29966100000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market MRH Peach Butter, UPC/PLU 20034900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tea Hive-Orchard Peach Freeze, UPC/PLU 30868 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tea Hive-Peach Julep Sparkler, UPC/PLU 30865 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peach Goat Medallion, UPC/PLU 29535400000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Tart Galette Peach, UPC/PLU 24070900000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Parfait, UPC/PLU 20642800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peachy Keen Cold Pressed 16 oz, UPC/PLU 29682700000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Fruit Kabobs for Grilling, UPC/PLU 29656500000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Lime Infused Peaches and Raspberries, UPC/PLU 29178200000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Salsa Peach and Cucumber, UPC/PLU 29648300000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Peachy Palmer, UPC/PLU 15766 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market 4" fresh fruit tart decorated with plums, UPC/PLU 0201189005002; Whole Foods Market 6" fresh fruit tart decorated with plums, UPC/PLU 0201898022000; Whole Foods Market 9" fresh fruit tart decorated with plums, UPC/PLU 0201897029000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Whole Foods Market Fresh Peachy Keen Juice 16 oz., UPC/PLU 29683800000 Sold between June 1 and July 21, 2014 at Whole Foods Stores Class II The product has the potential to be contaminated with Listeria monocytogenes. Whole Foods Market
Food Margaret Holmes Mixed Greens 14.5 oz, Distributed by McCall Farms, Effingham, SC Can Code: F13EX Class III Swollen Cans; Firm received complaints of illnesses due to consumption of recalled products. Mccall Farms Inc
Food Margaret Holmes, Turnip Greens, 14.5 oz, Distributed by McCall Farms, Effingham, SC Can Code: F13EX Class III Swollen Cans; Firm received complaints of illnesses due to consumption of recalled products. Mccall Farms Inc
Devices BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Brightview XCT Class II It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully. Philips Medical Systems, Inc.
Devices Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482, 35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502,  ...
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Class I Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099. The serial number range is as follows for the finished device: 14GF053772-14HF032124 (Sequential serial numbers) Class II It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration. Invacare Corporation
Devices A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus. 1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name:  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names. 1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names. 1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names. 1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number:  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names. Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name. 1) Instrumed Product Name: Bunnell Drill, 5 3/4", w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4"; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311. Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names. 1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names. Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names. 1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name. 1) Instrumed Product Name: Hudson Cerebellar Extension; Instrumed Product Number: 600-00499; Trade Name: Boss Industries; Boss Industries Product Name: Hudson Cerebellar Extension; Boss Industries Item Number: 74-0132; Lot Number: 110411. Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names. 1) Instrumed Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Instrumed Product Number: 600-00509;  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names. 1) Instrumed Product Name: Cushing Burr, 3/8", 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names. 1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names. 1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names. 1) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: D'errico Perforator Drill, 16 mm; Symmetry Surgical Item Number: 57-6076; Lot Number: 110211. 2) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Teleflex  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. 1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names. 1) Instrumed Product Name: Hudson Cranial Drill Set  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name. 1) Instrumed Product Name: Galt Trephine, 5/8"; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8"; CareFusion Item Number: VM85-1273; Lot Number: 120411. Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names. Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names. 1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number:  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names 1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names. 1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313. 2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name:  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names. 1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name. 1) Instrumed Product Name: Gardner-Wells Titanium Wrench  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names. Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. 1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864;  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names. 1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Devices Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name. 1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed  ...
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Class II The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Instrumed International, Inc.
Biologics Cornea 133214; Class II Human Cornea, recovered from an ineligible donor, was distributed. Eye Bank For Sight Restoration
Devices Soft Contact Lens Lots # 8246525202 & 8255525096 Class II Portions of the lots may contain units with an incorrect lens axis condition. Cooper Vision Caribbean Corp.
Biologics Red Blood Cells Leukocytes Reduced W088414100739; Class II Blood product, collected from a donor whose travel history was not complete, was distributed. Blood Bank Of Hawaii
Biologics Red Blood Cells Leukocytes Reduced W137514207061; Class II Blood product, collected from an unsuitable donor, was distributed. Lane Memorial Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W050911078648; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Red Blood Cells (Apheresis) W050911078648; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced W050911078718; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911077526; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Cryoprecipitated AHF W050911077526; Class II Blood products, collected from ineligible donors, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W040714537077; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced 2538410; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W038114036456; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W038113215637; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W038113215637; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Devices Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and symptomatic sequelae after radial head resection. Cat #s: ALN-RST-0700, ALN-RST-0702, ALN-RST-0704, ALN-RST-0706, ALN-RST-0708, ALN-RST-0800, ALN-RST-0802, ALN-RST-0802, ALN-RST-0804, ALN-RST-0806, ALN-RST-0808, ALN-RST-0900, ALN-RST-0902, ALN-RST-0904, ALN-RST-0906, ALN-RST-0908, ALN-RST-1000, ALN-RST-1002, ALN-RST-1004, ALN-RST-1006, ALN-RST-1008, ALN-RST-1100, ALN-RST-1102, ALN-RST-1104, ALN-RST-1106, ALN-RST-1108; Lot #s: AN0610023, AN0212065, AN0913033, AN0913034, AN0610024, AN0913035, AN0913036, AN0610025, AN0913037, AN0913038, AN0610026, AN0913039, AN0913040, AN0610027, AN0913041, AN0913042, AN0610028, AN0212066, AN0913043, AN0913044,  ...
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Class II Report received where the Align Radial Stem fractured. Skeletal Dynamics
Food Oceans Catch All Natural Jonah Crab Combo Meat, Packaged in round plastic containers (tub with snap-on lid), sold refrigerated: 6 ounce, 8 ounce, and 16 ounce 6 ounce: lot number 0104791, with a sell by date before 10/13/14; lot number 0104666, with  ...
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Class I Product may be be contaminated with Listeria monocytogenes. Rome Packing Co., Inc.
Food Oceans Catch All Natural Fresh Jonah Crab Leg Meat, Packaged in round plastic containers (tub with snap-on lid), sold as refrigerated: 5 ounce, 8 ounce, and 16 ounce 5 ounce: lot number 0104804, with a sell by date before 10/15/14; 8 ounce: lot number 0104665, with a sell  ...
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Class I Product may be be contaminated with Listeria monocytogenes. Rome Packing Co., Inc.
Devices BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples. Distributed in USA REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min  ...
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Class II BD Insyte Autoguard may have potential damage along the body of the catheter. Becton Dickinson & Company
Drugs Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25 All Lots Class III Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate. CareFusion 213, LLC
Biologics Platelets Pheresis Leukocytes Reduced W116514207796Q; Class II Blood product, with platelet concentration below the specified minimum requirement, was distributed. Central Shared Services, LLC.
Biologics Cartilage 144097101 to 144097211 Class III Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. AlloSource, Inc.
Devices Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures. Lot: L75066 Class II Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes. Zimmer, Inc.
Devices INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates. Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169. Class II An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board. INO Therapeutics (dba Ikaria)
Devices Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B, Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint Model 01-6551TI, Lot #s: 535370A, 535370B, 535370C, 535370D. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint Model 01-6550TI, Lot #s: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, 544220A. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint Model 24-6650TI, Lot #s: 531960A, 531960B. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B, Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint Model 24-6551TI, Lot #s: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, 544180A. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint Model 24-6555TI, Lot #s: 525210B, 525200A, 525200B, 525210A. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint Model 24-6546TI, Lot #s: 526040B, 526050A, 526040A, 526050B. Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint Model 24-6545TI, Lot #s: 520220B, 520220A, 520210A, 520210B Class II Laser etching on the parts is wider and deeper than the conditions previously validated. Biomet Microfixation, LLC
Devices Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years. GMDN code; 31119 Class II The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge. Snug Seat Inc
Devices Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage Lot No. 1401-040 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions. Lot No. 1307-024, 1302-031, 1210-015 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen. Lot No. 1307-065, 1301-009 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. Lot No. 1302-014 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter. Lot No. 1301-038 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. Lot No. 1211-002, 1210-016 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage. Lot No. 1212-001, 1212-034 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity. Lot No. 1212-005 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. Lot No. 1210-028 Class II PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. Pfm Medical Inc
Devices Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Model Number ASHA4730-01 (HipVac) lot numbers: 1021255, 1021620, 1022188, 1022482, 1022636, 1023089, 1024067, 1025482, 1025480, 102481, 1025764, 1025765, 1026875, 1027163, 1027702, 1028327, 1029265, 1030025, 1031353, 1031759, 1031760, 1032765, 1032766, 1033773, 1033974, 1034227, 1034451, 1035036, 1035295, 1038550, 1039318, 1039903, 1042371, 1042370, 1043421, 1044678, 1045361, 1046599, 1047067, 1050441, 1053407, 1053408, 1052669, 1054471,  ...
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Class II Potential breach of sterile barrier due to defective product tray. ArthroCare Medical Corporation
Devices Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. model number: 10140000 Class II It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator. Siemens Medical Solutions USA, Inc
Biologics Platelets Irradiated W140914189614; Class II Platelet product, collected from a donor who disclosed a history of drug use, was distributed. South Texas Blood & Tissue Center
Biologics Platelets Pheresis Leukocytes Reduced W043214013968; Class II Platelet product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, was distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced W038614846786; Class II Platelet product that did not meet specifications, was distributed. Suncoast Communities Blood Bank, Inc.
Devices Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012) Healon EndoCoat Device identification: For Healon EndoCoat, each lot is assigned a unique lot  ...
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Class II AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye. Abbott Medical Optics Inc (AMO)
Food "Everything Bagels" product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels. This product has the UPC number 7 17887 23121 1. The product is labeled in parts: "***Everything Bagels***Net Wt. 16 oz (1 lb) 454 g***Produced By Schwartz Brothers Bakery Seattle, Renton WA***7 17887 23121 1***Schwartzbros.com***. Best By dates of 10/14/14 to 11/10/14 Class II Mislabeling. Product inside a plastic bag actually contains milk but mis-labeled as "Everything Bagels" and this label does not declare milk. Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
Biologics Source Plasma 4570434871; 4570433054; 4570431561; 4570429605; 4570416637; Class III Blood products, collected from a donor who should have been deferred due to history, were distributed. Octapharma Plasma, Inc.
Food ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021 Packaging: For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sale: 6-packs of 1 liter bottles and as individual bottles. For the 50.7 fl oz. (1.5 liter) plastic bottles: Wholesale: packed in 12 bottles per case. Retail sale: Individual bottles. For the 20 fl oz plastic bottles: Wholesale: 24 bottle case; 24 bottle tray; 4 - 6 pack trays. Retail sale: Individual bottles and 6-packs (retail). JUL 22 2014 time NW1 Best by Jul 21 2016; Jul 23 2014 time NW1 Best by Jul 22 2016; Jul 24 2014 time NW1 Best by Jul 23 2016; and Jul 25 2014 time NW1 Best by Jul 24 2016 Class II Product may contain mold. Nature's Way Purewater Systems, Inc.
Devices Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body. This field correction involves all models of Silhouette and Sure-T insulin infusion sets. Class II Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA). Medtronic Mimed
Biologics Red Blood Cells W038113272890; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W038113272890; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W038113985801 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Drugs Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15 Class II Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. Pfizer Inc.
Devices 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. Model 1488-210-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12D020574 12D020584 12D020594 12D020614 12D020624 12D020634 12D020704 12D020714 12D020734 12E036114 12E036124 12E036134 12E036144 12E036154 12E036164 12E036174 12E036184 12E036204 12E036214 12E036244 12E036254 12E036264 12E036274 12E036284 12E036294 12E036314 12E036324 12E036334 12E036354 12E036374 12E036384 12E036394 12E036404 12E036414 12E036434 12E036444 12E036454 12E038334 12E038344 12E038354  ...
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Class II In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Stryker Endoscopy
Devices 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. Model 1488-710-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12F016274 12F016294 12F055824 12F055844 12F055874 12F055884 12F055894 12F055904 12F055914 12F055924 12F055934 12F055954 12F055964 12F055974 12F055994 12F056004 12F056024 12F056034 12F056054 12F056064 12F056094 12F056104 12F056124 12F056154 12F056164 12F056174 12F056184 12F056194 12F056204 12F056664 12F056674 12F056684 12F056694 12F056704 12F056714 12F056744 12F058884 12F058894 12F058904 12F058924 12F058934 12F058944 12F058964 12G054154 12G054174 12G054194 12G054214 12G054224 12G054234 12G054244 12G054264 12H011414 12H011434 12H011444 12H011454 12H011474 12H011494 12H050834 12H050844 12H050854 12I039444 12I039454 12I039464 12I039474 12I039494 12I039504 12I039524 12I039534 12I040844 12I040854 12I040864 12I040874 12I040894 12I040924 12I040934 12I047324. 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454 12I016464 12I016474 12I016484 12I016494 12I016504 12I016514 12I016524 12I016534 12I016544 12I016554 12I016564 12I018674 12I018684 12I018694 12I018704 12I018714 12I018724 12I018734 12I018744 12I018754 12I018764 12I018774 12I018784 12I018794 12I018804 12I018814 12I018824 12I018834 12I018844 12I018854 12I018864 12I018874 12I018884 12I018894 12I018904 12I018914 12I018924 12I018934 12I018944 12I019254 12I019264 12I019274 12I019284 12I019294 12I019304 12I019314 12I019324 12I019334 12I019344 12I033824 12I033874 12I033894 12I033904 12I033914 12I033924 12I033934 12I033944 12I033954 12I033964 12I033974 12I033984 12I033994 12I034004 12I034214 12I034224 12I034234 12I034244 12I034254 12I034264 12I034274 12I034284 12I034304 12I034814 12I034824 12I034834 12I034844 12I034854 12I034864 12I034874 12I034884 12I034894 12I034924 12I034934 12I034944 12I034954 12I034964 12I034974 12I034984 12I034994 12I035214 12I035224 12I035244 12I035254 12I035284 12I035294 12I035304 12J002614 12J002634 12J002664 12J002674 12J002694 12J002714 12J002724 12J002744 12J002804 12J002824 12J002854 12J002864 12J020084 12J020144 12J020154 12J020164 12J020594 12J020614 12J020634 12J020644 12J020654 12J020664 12J063964 12J063994 12J064004 12J064024 12J064034 12J064044 12J064064 12J064074 12J064084 12J064094 12J064104 12J064114 12J064124 12J064144 12J064154 12J064164 12J064174 12J064184 12J064194 12J064204 12J064214 12J064224 12J072934 12J072964 12J072994 12J073014 12J073034 12J073044 12J073054 12J073064 12J073074 12J073084 12K002644 12K002654. Class II In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Stryker Endoscopy
Devices 1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. Model 1488-610-122: 1488 HD 3-Chip Camera Head with Integrated Coupler. Serial numbers: 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454 12I016464 12I016474 12I016484 12I016494 12I016504 12I016514 12I016524 12I016534 12I016544 12I016554 12I016564 12I018674 12I018684 12I018694 12I018704 12I018714 12I018724 12I018734 12I018744 12I018754 12I018764 12I018774 12I018784 12I018794 12I018804 12I018814 12I018824 12I018834 12I018844 12I018854 12I018864 12I018874 12I018884 12I018894 12I018904 12I018914 12I018924 12I018934 12I018944 12I019254 12I019264 12I019274 12I019284 12I019294 12I019304 12I019314 12I019324 12I019334 12I019344 12I033824 12I033874 12I033894 12I033904 12I033914 12I033924 12I033934 12I033944 12I033954 12I033964 12I033974 12I033984 12I033994 12I034004 12I034214 12I034224 12I034234 12I034244 12I034254 12I034264 12I034274 12I034284 12I034304 12I034814 12I034824 12I034834 12I034844 12I034854 12I034864 12I034874 12I034884 12I034894 12I034924 12I034934 12I034944 12I034954 12I034964 12I034974 12I034984 12I034994 12I035214 12I035224 12I035244 12I035254 12I035284 12I035294 12I035304 12J002614 12J002634 12J002664 12J002674 12J002694 12J002714 12J002724 12J002744 12J002804 12J002824 12J002854 12J002864 12J020084 12J020144 12J020154 12J020164 12J020594 12J020614 12J020634 12J020644 12J020654 12J020664 12J063964 12J063994 12J064004 12J064024 12J064034 12J064044 12J064064 12J064074 12J064084 12J064094 12J064104 12J064114 12J064124 12J064144 12J064154 12J064164 12J064174 12J064184 12J064194 12J064204 12J064214 12J064224 12J072934 12J072964 12J072994 12J073014 12J073034 12J073044 12J073054 12J073064 12J073074 12J073084 12K002644 12K002654. Class II In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period Stryker Endoscopy
Biologics Platelets Pheresis Leukocytes Reduced W03941423783600; Class II Platelet product, which failed leukoreduction testing, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813169207; Class II Blood product, labeled as antigen negative but subsequently tested as antigen positive, was distributed. OneBlood, Inc.
Devices Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689 Class II Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported. Arrow International Inc
Devices Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery. Lot numbers 061814-95 and 080614-91 Class II The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers. Alcon Research, Ltd.
Food Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars. Product Code: L334 12233. UPC: 0 72058 60864 4. Lot Number: B4036P. Best By: AUG 2015. Class II Orrington Farms Chicken Flavored Broth Base & Seasoning, Low Sodium labels were placed on jars of Orrington Farms Beef Flavored Broth Base & Seasoning, Low Sodium. Kent Precision Foods Group, Inc.
Devices The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging. Lot number 12981001 with the following Serial Numbers: 8110138055 8110141155 8110141281 8110141459 8110138056 8110141162 8110141304 8110141469 8110138061 8110141167 8110141305 8110141471 8110138096 8110141168 8110141315 8110141497 8110139306 8110141182 8110141320 8110141518 8110139330 8110141184 8110141331 8110141527 8110139856 8110141188 8110141335 8110141533 8110140819 8110141193 8110141342 8110141587 8110140824 8110141215 8110141368 8110141604 8110140985 8110141219 8110141380 8110141605 8110141045 8110141222 8110141391 8110141613 8110141082 8110141230 8110141403 8110141616 8110141083 8110141238 8110141415 8110141621 8110141114 8110141240 8110141416 8110141705 8110141119 8110141244 8110141418 8110141731 8110141127 8110141247 8110141421 8110141739 8110141128 8110141253 8110141423 8110141750 8110141138 8110141258 8110141431 8110141782 8110141142 8110141260 8110141445 8110141788 8110141153 8110141279 8110141452 8110141798 Class II Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. Medtronic Perfusion Systems
Food HeartLight Seafood brand Frozen Yellowfin Tuna Ground Meat (Thunnus albacares), IQF packed in a master carton of 10 x 1 lbs HDPE bags Lot numbers: 155080514161, 156080514161, and 157608051461; Raw material lot numbers: 1415505, 141560, and 14157605 Class II Product may have high histamine levels and may be unfit for human consumption. Heartlight Seafood LLC
Devices LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. Lot Number 14FM05730 Class II The stem taper on this device is undersized; the gauge point is not deep enough. Smith & Nephew, Inc.
Devices LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. Lot Numbers: 14EM16708, 14EM21988, 14DM22269 Class II The stem taper on this device is undersized; the gauge point is not deep enough. Smith & Nephew, Inc.
Devices LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic. Lot Number 14EM23391 Class II The stem taper on this device is undersized; the gauge point is not deep enough. Smith & Nephew, Inc.
Devices Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014 Class II Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US. Concentric Medical Inc
Devices Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella. Lot number: 1374439, Exp: 31 Aug 2015 Class II Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting. Remel Inc
Devices MEVION S250, used for proton radiation therapy. Serial Number: S250-0001 Class II Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%. Mevion Medical Systems, Inc.
Food Houdini, 3 oz Honey Mustard Pretzel Nuggets, item # COM 562 Lot 30014 Class I The wrong seasoning was used on the pretzels, which contains whey, that is not declared on the label. Baptista's Bakery, Inc
Food Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. Dallas, TX 75218, www.CheesecakeRoyale.com MFG#10204 Class II Recalled product contains undeclared FD&C Yellow #5 and wheat. Cheesecake Royale, Inc.
Food CARROT CAKE, Weight: 8 lbs. (112 oz.) - 3.6 kg, UPC#85538300025 MFG#025 Class II Recalled product contains undeclared walnuts. Walnut is not listed on the ingredients statement, however pecans are listed as an ingredient. Cheesecake Royale, Inc.
Food Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041 MFG#041 Class II Recalled product contains undeclared wheat. Cheesecake Royale, Inc.
Food Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042 MFG#242 Class II Recalled product contains undeclared wheat. Cheesecake Royale, Inc.
Devices Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015 Class II Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications. Concentric Medical Inc
Cosmetics ReadyBath Shampoo Caps, Scented are fabric-lined caps are pre-moistened rinse-free shampoo caps used to cleanse hair and are individually packaged in a film packet. There are 30 packets per carton. Product Code: MSC095230. Lot Number: 14IE0027. Expiration Date: September 2016. Class III The shampoo caps may contain broken needles. Medline Industries, Inc.
Devices Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. model numbers: 10592457, 10863171, 10863172, 10863173, 7502029 , 10496279, with multiple serial numbers: 1187, 3182, 3183, 3212, 3206, 3207, 1361, 10870, 12068, 10733, 3052, 2323, 1496, 3246, 2254, 1089, 1213, 14898, 2626, 1624, 2365, 3087, 13504, 11795, 13921, 2971, 12271, 13090, 9594, 2890, 1372, 12789, 3062, 1856, 2500, 13591, 14005,  ...
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Class II Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy. Siemens Medical Solutions USA, Inc
Drugs GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20 Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015 Class II Defective Container: Vials may be missing stoppers. Fresenius Kabi USA, LLC
Biologics Source Plasma 41908070385; 41908016530; 41908016530; 41908014236; 41908014236; 41908017269; 41908011676; 41908017461; 41908011975; 41908011094; 41908107862; 41907955190; 41907955190; 41908109420; 41908109420; 41908109577; 41908107440; 41908102156; 41908132822; 41908134529; 41908167638; 41908083370; 41908112928; 41908111386; 41908118481; 41908110834; Class III Plasma products, collected from donors whose suitability to donate was not adequately determined, were distributed. CSL Plasma
Devices IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, and 17308586. Expiry Dates from June 25, 2015 to September 24, 2015. Class II Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field. Boston Scientific Corp
Food Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ Batch No. 2013/12/14, Best before: Jun 8, 2015 Class II Dried Plum Candy contains non-permitted cyclamates, undeclared benzoic acid and undeclared Yellow #5. Tristar Food Wholesale Co Inc
Devices TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) SN 110441 110403 110485 110055 110394 110126 110266 110511 110332 110333 110499 110468 110508 110470 110505 110507 110522 110385 110388 110228 110334 110494 110480 110109 110462 110471 110501 110469 110356 110478 110260 110275 110457 110430 110315 110447 110314 110506 110170 110465 110510 110496 110472 110077 110347 110124 110259 110117 110294 110146 110419 110189 110446 110422 110467 110353 110364 110384 110410 110363 110300 110162 110267 110428 110405 110299 110246 110429 110071 110232 110200 110305 110330 110407 110361 110136 110413 110458 110231 110371 110211 110304 110479 110409 110466 110437 110164 110205 110392 110487 110489 110184 110397 110036 110451 110427 110426 110327 110475 110454 110093 110476 110400 110377 110484 110455 110453 110486 110393 110498 110085 110229 110412 110425 110434 110459 110088 110386 110301 110448 110481 110328 110504 110068 110078 110474 110482 110491 110464 110387 110137 110290 110308 110285 110445 110497 110503 110206 110463 110038 110502 110060 110500 110106 110180 110013 110081 110033 110490 110420 110368 110492 110402 110115 110040 110210 110509 110438 110415 110050 110396 110424 110097 110202 110349 110203 110408 110090 110244 110456 110084 110027 110029 110473 110209 110091 110281 110286 110094 110155 110381 110100 110271 110390 110493 110174 110483 110452 110268 110360 110176 110516 110269 110367 110227 110369 110323 110461 110254 110395 110383 110348 110515 110477 110488 110021 110196 110298 110158 110495 Class II Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption. TomoTherapy Incorporated
Biologics Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined M12115 Class II Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, was distributed. NOVARTIS VACCINES AND DIAGNOSTICS S.r.l
Devices Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability. Serial Number: 0340552 Class II Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting ConforMIS, Inc.
Food Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699. Best Buy dates of 10/27-11/30. Class I Pies labeled in-store did not have the allergen "walnuts" declared in a contains statement or in the ingredient list. Whole Food Market
Drugs Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 Lot ET5122, Exp. 10/17 Class III Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. Sandoz Incorporated
Drugs Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61 Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61 Class II Lack of Assurance of Sterility; improperly crimped fliptop vials Hospira Inc.
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