Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples.
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY  10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL  61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VT, VA, WI and WV.
Frozen Jamba, Fruit & Veggie Smoothies, Green Fusion, Green Apple, Mango, Pineapple, Kiwi, Banana, Broccoli and Spinach, Makes 2-8oz Smoothies, Net Wt. 8oz (227.2g), packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85102-1, Item no. 85102, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Listeria contamination due to various GMP violations. possible.
Frozen Jamba, Fruit & Veggie Smoothies, Red Fusion , Red raspberry, Strawberry, Dark Sweet cherry, Purple Carrot & Sweet Potato, Makes 2-8oz Smoothies, Net Wt. 8oz (227.2g), packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85167-0, Item no. 85167, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Mango-a-go-go, Mango and Pineapple with Non-Fat Yogurt, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85099-4, Item no. 85099, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Orange Dream Machine, Peaches, Orange and Vanilla Flavored Non-Fat Yogurt, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-851678-7, Item no. 85168, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Razzmatazz, Strawberry, Raspberry and Blueberry with Non-Fat Yogurt, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85100-7, Item no. 85100, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Strawberries Wild, Strawberry and Banana with Non-Fat Yogurt, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85098-7, Item no. 85098, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Caribbean Passion, Mango, Strawberry and Peach with Non-Fat Yogurt, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
UPC: 8-84038-85168-7, Item no. 85169, Best by Dates from 18 Mar 2016 through 17 Oct 2016, Code Dates from 72644AH01 through 71075AH01.
Frozen Jamba, All Natural Smoothies, Blue Fusion, Blueberry, Banana, Apple, Blackberry, Carrot, Broccoli and Spinach, Makes 2-8oz, Net Wt. 8oz (227.2g), Smoothies, packed in plastic pouches, Distributed by: Rader Farms, Inc.
Fresh Frozen Grade A Speckled Butter Beans, Net Wt. 32 oz. (2 lb.) 907 g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20000-1; Fresh Frozen Grade A Specked Butter Beans, Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549,UPC 0-86069-50000-2; Fresh Frozen Speckled Butter Beans, Net Wt. 16 oz. (1 lb.) 454 g, UPC 0-86069-20001-8
Fresh Frozen Grade A Baby Lima Beans, Net Wt. 32 oz. (2 lb.) 907 g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20010-0; Fresh Frozen Grade A Baby Lima Beans,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50010-1; Fresh Frozen Baby Lima Beans, Net Wt. 16 oz. (1 lb.) 454 g, UPC 0-86069-20012-4, Fresh Frozen Fordhook Lima Beans, Net Wt. 24 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20016-2
Fresh Frozen Grade A Cut Green Beans, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20020-9; Fresh Frozen Grade A Cut Green Beans,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50020-0; Fresh Frozen Cut Green Beans, Net. Wt. 16 Oz. (1 lb.) 454 g, UPC 0-86069-20021-6, Steamables Cut Green Beans, Net. Wt. 12 Oz., Distributed By Fresh Frozen Foods, Jefferson, GA 30549, UPC 0-86069-11200-7
Fresh Frozen Grade A Italian Green Beans, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20340-8; Fresh Frozen Grade A Italian Green Beans,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50340-9; Fresh Frozen Italian Green Beans, Net. Wt. 16 Oz. (1 lb.) 454g, UPC 0-86069-20341-5
Fresh Frozen Grade A Crowder Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20030-8; Fresh Frozen Grade A Crowder Peas,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50030-9
Fresh Frozen Grade A Blackeye Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20040-7; Fresh Frozen Grade A Blackeye Peas,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50040-8, Fresh Frozen Blackeye Peas, Net Wt. 16 Oz. (1 lb) 454 g, UPC 0-86069-20043-8
Fresh Frozen Grade A Purple Hull Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20041-4; Fresh Frozen Grade A Purple Hull Peas,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50041-5
Fresh Frozen Grade A Field Peas with Snaps, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20050-6; Fresh Frozen Grade A Field Peas with Snaps,  Net Wt. 80 Oz. (5 lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50050-7, Fresh Frozen Field Peas with Snaps, Net Wt. 16 Oz (1 lb) 454g, UPC 0-86069-20051-3
Fresh Frozen Grade A Butter Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20060-5; Fresh Frozen Butterpeas, Net Wt. 16 Oz (1 lb) 454g, UPC 0-86069-20063-6
Fresh Frozen Grade A Butter Beans, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20005-6; Fresh Frozen Butter Beans, Net Wt. 16 Oz (1 lb) 454g, UPC 0-86069-20006-3
Fresh Frozen Grade A Green Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20061-2; Fresh Frozen Grade A Green Peas, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-086069-50060-6, Steamables Green Peas Beans, Net Wt. 12 Oz , UPC 0-86069-11210-6
Fresh Frozen Grade A Peas and Carrots, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20290-6; Fresh Frozen Grade A Peas and Carrots, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-086069-50290-7
Fresh Frozen Grade A Zipper Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20042-1
Fresh Frozen Grade A White Acre Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20032-2
Fresh Frozen Grade A Whole Okra, Net Wt. 32 Oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20350-7, Fresh Frozen Grade A Whole Okra, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, Fresh Frozen Whole Okra, Net Wt. 16 Oz. (1 Lb.) 454g, UPC 0-86069-20351-4
UPC 0-86069-20350-7 FF Item Number 312, No UPC FF Item Number 315, UPC 0-86069-20351-4 FF Item Number 31299
Fresh Frozen Grade A Cut Okra, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20070-4, Fresh Frozen Grade A Cut Okra, Net Wt. 80 Oz. (5 Lb) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50240-2, Fresh Frozen Cut Okra, Net. Wt. 16 Oz. (1 Lb) 454g, UPC 86069-20071-1, The Inn Grade A Fancy Cut Okra, Net Wt. 48 Oz. (3 Lb) (1361g), Packed for Inn Foods Inc., 310 Walker St., Watsonville, CA 950076, UPC 0-86289-20139-0
Fresh Frozen Grade A Breaded Okra, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20075-9, Fresh Frozen Grade A Breaded Okra, Net Wt. 80 Oz. (5 Lb) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50075-0, Fresh Frozen Breaded Okra, Net. Wt. 16 Oz. (1 Lb) 454g, UPC 86069-20076-6
Fresh Frozen Grade A Cut Yellow Corn, Net Wt. 32 Oz. (2 Lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20100-8, Fresh Frozen Grade A Cut Corn, Net Wt. 80 Oz. (5 Lb.) 2268g , Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50100-9, Fresh Frozen Cut Yellow Corn, Net Wt. 16 Oz. (1 Lb.) 454 g, UPC 0-86069-20101-5,  Steamable Cut Yellow Corn, Net Wt. 12 Oz., Dist. By Fresh Frozen Foods, Jefferson, GA 30354 UPC 0-86069-11230-4
3'' Corn on Cob 96 Ct., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, Fresh Frozen Grade A Corn-on-Cob,  Net Wt. 32 Oz, (2 Lb.) 907g, UPC 0-86069-20200-5, Fresh Frozen Grade A Corn-on-Cobb, Net Wt. 80 Oz. (5 Lb.), Dist. By  Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50250-1, Corn on Cobb 8 Count, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549 UPC 0-86069070100-3
Fresh Frozen Grade A Cut White Corn, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20102-2, Fresh Frozen Grade A Cut White Corn, Net Wt. 80 Oz. (5 Lb.) Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50102-3
Fresh Frozen Grade A Sliced Squash, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20300-2, Fresh Frozen Sliced Squash, Net. Wt. 80 Oz., (5 Lb.), Dist. By Fresh Frozen Foods, Jefferson, GA 30549, UPC 0-86069-50300-3, Fresh Frozen Sliced Yellow Squash, Net Wt. 16 Oz. (1 Lb.) Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20301-9
Fresh Frozen Grade A Breaded Squash, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20270-8
Fresh Frozen Grade A Sliced Zucchini, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20310-1
Fresh Frozen Chopped Vidalia Onions & Squash, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20510-5
Fresh Frozen Grade A Diced Vidalia Onions, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20500-6, Fresh Frozen Chopped Vidalia Onions, Net Wt. 12 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10530-6, Fresh Frozen Diced Onions, 2 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549 (no UPC)
UPC 0-86069-20500-5 FF Item Number 542, UPC 0-86069-10530-6, FF Item Number 54, FF Item Number 792.
Fresh Frozen Grade A Sliced Carrots, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20295-1, Fresh Frozen Sliced Carrots, Net Wt. 20 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, Fresh Frozen Sliced Carrots, Net. Wt. 16 Oz. (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20296-8
Fresh Frozen Grade A Brussels Sprouts, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20355-2, Fresh Frozen Brussels Sprouts, Net Wt. 16 Oz. (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20356-9
Fresh Frozen Chopped Mustard Greens, Net Wt. 16 Oz, (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25070-9, Fresh Frozen Mustard Greens, Net. Wt. 32 Oz.. (2 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 39549, UPC 0-86069-25071-6
Fresh Frozen Grade A Broccoli Cuts, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20140-4, Fresh Frozen Grade A Broccoli Cuts, Net. Wt. 60 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50140-5, Fresh Frozen Broccoli Cuts, Net Wt.16 Oz. (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20142-8
Fresh Frozen Chopped Spinach, Net. Wt. 12 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25091-4, Fresh  Frozen Grade A Chopped Spinach, Net Wt. 32 Oz. (2 Lb.), Dist. Grade A Broccoli Cuts, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25090-7
Steamables Mixed Vegetables, Net. Wt. 12 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11270-0, Fresh Frozen Mixed Vegetables, Net Wt. 16 Oz. (1 Lb.) 454g, Dist. by Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20081-0, Fresh Frozen Grade A Mixed Vegetables, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 86069-50080-4, Fresh Frozen Grade A Mixed Vegetables, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 86069-20080-3
Steamables California Blend, Net Wt. 10 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11275-5,  Fresh Frozen California Blend, Net Wt. 16 Oz. (1 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 86069-20013-1, Fresh Frozen Grade A California Blend, Net. Wt. 32 Oz. (2 Lb.), Dist. By Fresh Frozen Foods, Jefferson, GA 30549, UPC 0-86069-20011-7, Fresh Frozen Grade A California Blend, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Jefferson, GA 30549, UPC 86069-50011-8, Fresh Frozen Grade A Premium California Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 86069-20014-8, The Inn Grade A Fancy California Blend, Net Wt. 32 Oz. (2 LB) (907g), Packed For Inn Foods Inc., 310 Walker St., Watsonville, CA 95076, UPC 86289-20420-9
Fresh Frozen Grade A Summer Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20330-9, Steamables Summer Blend, Net Wt. 12 Oz. (340.8g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11280-9
Fresh Frozen Grade A Vegetable Gumbo, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20150-3, Fresh Frozen Vegetable Gumbo, Net Wt. 16 Oz. (1 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20151-0
Fresh Frozen Grade A Vegetable Soup Blend with Tomatoes, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20160-2
Fresh Frozen Grade A Stew Mix, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-21270-7, Fresh Frozen Stew Mix, Net Wt. 16 Oz. (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-21271-4
Fresh Frozen Grade A Stir Fry Vegetables, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20280-7
Fresh Frozen Grade A Italian Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20285-2, Steamables Italian Blend, Net Wt. 10 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11290-8
Fresh Frozen Grade A Fajita Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20425-2
Fresh Frozen Grade A Tejano Style Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods,  Inc., Jefferson, GA 30549, UPC 0-86069-20400-9
Fresh Frozen Grade A Jalisco Style Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20405-4
Fresh Frozen Grade A Seasoning Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20430-4, Fresh Frozen Grade A Seasoning Blend, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069020432-0, Fresh Frozen Seasoning Blend, Net Wt. 16 Oz. (1 Lb.) 454g, Dist. By Fresh Frozen Foods,  Inc., Jefferson, GA 30549, UPC 0-86069-20431-3
Fresh Frozen Grade A Country Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20170-1
Fresh Frozen Grade A Strawberries, Net Wt. 16 Oz. (2 Lb.) (454g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10180-3
Fresh Frozen Grade A Blackberries, Net Wt. 16 Oz. (2 Lb.) (454g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10260-2
Fresh Frozen Grade A Sliced Peaches, Net Wt. 16 Oz. (2 Lb.) (454g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10190-2
Fresh Frozen Grade A Blueberries, Net Wt. 12 Oz. (340g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10500-9
Fresh Frozen Grade A Triple Berry Blend, Net Wt. 12 Oz. (340g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10230-5
Fresh Frozen Grade A Boil Blend, Net Wt. 80 Oz. (5 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50265-5
Fresh Frozen Biscuits Southern Style, Contains 12 Biscuits, Net Wt. 25 Oz. (708g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-95015-9
Fresh Frozen Southern Style Cheese Biscuits, Contains: 12 Biscuits, Net Wt. 25 Oz. (706g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-95020-3
Fresh Frozen Butter Biscuits, Contains: 12 Biscuits, Net Wt. 25 Oz. (708g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-95040-1
Fresh Frozen Chopped Turnip Greens with Diced Turnips, Net Wt. 16 Oz. (454g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25061-7, Fresh Frozen Grade A Chopped Turnip Greens and Diced Turnips, Net Wt. 32 Oz. (2 Lb.) 908.8g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-250060-0, IQF Turnip Greens, Net Wt. 2 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25050-1, Fresh Frozen Turnip Greens, Net Wt. 1 Lb., Dist. By Fresh Frozen Foods, Inc, Jefferson, GA 30549, UPC 0-86069-25051-8
Fresh Frozen Diced Celery, Net Wt. 2 lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, (no UPC)
Fresh Frozen IQF Collards, Net Wt. 2 lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25040-2
Fresh Frozen Diced Red Pepper, Net Wt. 2 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, (no UPC), Fresh Frozen Diced Green Pepper, Net Wt. 2 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549 (no UPC)
Fresh Frozen Yam Patties, Net Wt. 2 Lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20120-6, Fresh Frozen Sweet Potato Cuts, Net Wt. 28 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20112-1
Worldwide Distribution - US (nationwide) and the countries of:  The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.   Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
The double swivel connector may crack or separate on the endobronchial tube.
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.   Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile.    Used to aspirate liquids or semisolids from a patient's upper airway.
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile.   Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA  92833, UPC 7 11746 00075 8.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)
Model Number: 5291 Serial Number: 529A004357
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Model Number: 6531, Serial Number: 653A119083
Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Model Number: 6551, Serial Number: 655A108177
Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Model Number: 6700, Serial Numbers: 670A101355 and  670A101355
Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
Model Number: 6980, Serial Numbers: 698101503
Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion.   This part is used in the Alaris Medley LVP 8100 infusion pump.
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion.   This part is used in the Alaris Medley LVP 8100 infusion pump.
HEB Bake Shop 8 Hamburger, Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 04122041461; HEB Bake Shop 6 Texas Sized Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220742264; Kurz Texas Size Plain Buns (no label)
HEB Bake Shop 8 Seeded Hamburger Buns Enriched Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220101276; HEB Bake Shop 6 Texas Sized Seeded Hamburger Buns Enriched Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220217618
Good Bread 16 Wheat Buns, Net Wt. 29.4 oz (832g); HEB Bake Shop 8 Wheat Hamburger Buns, Net Wt. 18 OZ (1 LB 2 OZ), UPC: 041220191642
HEB Bake Shop 100% Whole Wheat 8 Hamburger Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220830565
Hill Country Fare 16 Hot Dog Buns Enriched Buns, Net Wt. 24 OZ (1 LB 8 OZ) (680g). UPC: 04122041611; Hill Country Fare 8 Hot Dog Buns Enriched Buns, Net Wt. 12 OZ (340g), UPC: 041220602018; HEB Bake Shop 8 White Hot Dog Buns Enriched Buns, Net Wt. 12 OZ, UPC: 041220839100
Good Bread 10'' Coney, Net Wt. 18.2 OZ (516g), UPC: 041220181506; Good Bread 16 Hot Dog Enriched Buns Net Wt. 24 oz (680g) UPC: 04122018147
HEB Bake Shop 8 Wheat Hot Dog Buns, Net Wt. 12 OZ, UPC: 041220191659
Product was distributed Nationwide.  No foreign, military, or government distribution was made.
Crystal Farms Simply Potatoes Shredded Hash Browns packaged as individual plastic bags Net Wt. 20 oz (1 lb 4 oz) 567 g; UPC 0 20169 22233 4.  The 20 oz containers are packed 12 per case (15 lbs total weight); UPC 2 00 20169 22233 8.  Distributed by Crystal Farms, Minnetonka, MN.
Product may contain small slivers of shredded golf ball.
Blood product, with a low platelet count, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Distributed in FL, IL, MA, MI, MO, PA and TN.
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile.  Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
Becton Dickinson is recalling these BD Vacutainer SST Plus Blood Collection Tubes because some of the tubes were manufactured with stoppers that had not been validated to meet current manufacturing specifications.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Worldwide Distribution-US (nationwide) and the countries of  Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.
Alaris Syringe Pump, Model No. 8110.  Delivers fluids.
Channel  Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module.  After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08,  Kit Lot Number 0094B Exp Date 2015-12-12
Janssen Diagnostics, LLC received complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models.   Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.  Intended for replacement of the proximal end of the radius.
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only.  Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Catalog number 5530-G-209    Lot Code LEF064
Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.
American Science & Engineering Inc,Gemini Cabinet X-ray system.
During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult,  pediatric and neonatal patients.
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Worldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.
all lots of part numbers: 900.50, 900.51
The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.
Distributed US (nationwide) and in Canada.
RadPRO 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
The manufacturer has advised that electrostatic energy may be stored in Systems that can cause a short-circuit which, in turn, can generate an Electromagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or patient.
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : United Arab Emirates, Barbados, Bahamas, Chile, Costa Rica, Italy, Lebanon, and Singapore.
Medline Electrical Clipper with Charging base    The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.
Product item number: DYND70800  with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.
Charging base of surgical clippers overheats and smokes.
Nationwide Distribution-including  AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
Magic3TM Hydrophilic-coated Female Intermittent Catheters (6''), 10 Fr, (30/box), Product Code 51610.   Intermittent catheter.
Potential breach of the sterile barrier packaging.
Magic3TM Hydrophilic-coated Female Intermittent Catheters (6''), 12 Fr, (30/box), Product Code 51612.   Intermittent catheter.
Magic3TM Hydrophilic-coated Female Intermittent Catheters (6''), 14 Fr, (30/box), Product Code 51614.   Intermittent catheter.
Magic3TM Hydrophilic-coated Female Intermittent Catheters (6''), 16 Fr, (30/box), Product Code 51616.   Intermittent catheter.
Magic3TM Hydrophilic-coated Female Intermittent Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S.   Intermittent catheter.
AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
Bronchial Double Lumen Tube Set (Left), Sterile
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Bronchial Double Lumen Tube Set (Right), Sterile
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
White Bronchial Double Lumen Tube Set (Right) Sterile
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
Product Code 116164-000390  Batch Number 14BT21
ME, NH, VT, MA RI, CT, NY, NJ, PA, DE, MD, DC, VA
Friendly's  Vienna Mocha Chunk Ice Cream Tub,  48 U.S. FL. OZ.  UPC: 0-29839 00557-4
No U.S. distribution. Foreign distribution to the following; Mexico and El Salvador
Maruchan Instant Lunch Sabor A Pollo, Contenido Neto 64 g, UPC code: 0 41789 00191 8,  Maruchan Inc. Irvine, CA 92618.    Product is packaged in a styrofoam cup with cardboard label wrapped around.
Maruchan Instant Lunch Con Camaron, Limon y Habanero, Contenido Neto 64 g, UPC code: 0 41789 00186 4,  Maruchan Inc. Irvine, CA 92618.    Product is packaged in a styrofoam cup with cardboard label wrapped around.
Maruchan Instant Lunch Con Camaron, Contenido Neto 64 g, UPC code: 0 41789 00195 6,  Maruchan Inc. Irvine, CA 92618.    Product is packaged in a styrofoam cup with cardboard label wrapped around.
Worldwide Distribution - US Distribution and to the countries of : Canada, Spain, France, Great Britain, Philippines, Netherlands, Japan, China, Australia, Denmark, South Africa, Germany, Qatar, Turkey, Hong Kong, Costa Rica, Austria, Finland, Indonesia, Norway, Malaysia, Belgium, Czech Republic, Hungry, United Arab Emirates, Poland, Colombia, Belgium and Malta.
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873.     The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module.  The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.
Radiometer America, Inc. is recalling Fixation Kit N20, used with TCM CombiM and Philips TcG10, due to recently becoming aware that when the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.
Red Blood Cells Leukocytes Reduced Irradiated
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B0043, NDC 0338-0553-18.
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B1301, NDC 0338-0049-11.
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
in case a system error occurs and the system enters  the ''Bypass Fluoro'' mode while the X-ray locking  function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in ''Bypass Fluoro'' or to restart the system.
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Software versions up to and including 1.5.1.
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
US Nationwide Distribution in the states of:  NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE      Product Usage:  The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
The cutting efficiency of the Countersinks was out of specification.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Dry Bream-lesh (Fish), Net Wt. varies - weighed upon sale, product is vacuum packed, Distributed by: Royal Sweet Bakery 119 49 Street Brooklyn, NY 11232, PRODUCT OF RUSSIA
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets
Worldwide distribution.  US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50;    Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
Part number: CT/NGSWAB-50: Lot numbers: 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, Flock swab expires end of July 2015. Kit expires October 2015.  Lot numbers 26N121H, and 28N134D.- Cleaning swabs expire end of June 2016. Kits expires November 2016.
Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50;    Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
Part number: GXCT/NGURINE-50; Lot numbers: 23E104B, 23E104C, 26N128C, 26N1281, 29N142A, 29N142B, 29N142C, 29N142D, 29N142E, 29N142F, and 29N142G  All with transfer pipette expiring end of May, June or July 2016. Collection kits expires in August, September, October of November 2016.
Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
The firm has identified fuses with the improper amperage rating were installed in the Symbia S systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
The firm has identified fuses with the improper amperage rating were installed in the Symbia T systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
Nationwide and internationally, including Canada
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
Potential for micropores to form, allowing fluid to enter the hollow handle. No injuries reported.
distributed in Pierce and King County of Washington only.
Classic Caramel Gourmet Popcorn, sold under brand Freedom Snacks, packaged in a flexible plastic bag, net wt. 10 oz..  There is NO UPC.   The product is labeled in parts: ''***FREEDOM SNACKS***CLASSIC CARAMEL Gourmet Popcorn***Ingredients: popcorn, brown sugar, sugar, corn syrup, butter (cream, salt), soybean oil, soy lecithin, salt, natural flavor***Contains: DAIRY, SOY***''.
11242015 (This code represents best by date of Nov. 24, 2015)
Undeclared milk. The ingredients statement declared butter and the Contains statement declared dairy.
Sea Salt Caramel Gourmet Popcorn, sold under brand Freedom Snacks, packaged in a flexible plastic bag, net wt. 10 oz..  There is NO UPC.   The product is labeled in parts: ''***FREEDOM SNACKS***SEA SALT CARAMEL Gourmet Popcorn***Ingredients: popcorn, sugar, brown sugar, corn syrup, butter (cream, salt), soybean oil, soy lecithin, sea salt, natural flavoring***Contains: SOY, DAIRY***''.
Milk is not declared on label.  The ingredients statement declared butter and the Contains statement declared dairy.
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only.  Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637.  NDC: 24208-439-01.
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
US: FL, GA, IL, MI, NY, NC, PA, WV.   OUS: Germany, Hong Kong, Italy.
Medtronic EOPA Arterial Cannula,  Model # 77620.  Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
Medtronic is initiating an Urgent Medical Device Recall for 221 units of EOPA Arterial Cannula that were shipped without the guidewire. Product affected by this issue is limited to a single lot (2015060544) of model 77620. No other devices are affected by this recall.
Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
IBC Suction Wand Catalog Number 1990S   Product  Usage:  The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40    Product Usage:  The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118   Product Usage:  The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ  07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ  07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
buPROPion Hydrochloride Extended-release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only. Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
Labeling: Incorrect And/Or Missing Package Insert: Product is labeled with unapproved labeling.
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
Failed Dissolution Testing: Failed 24 month dissolution testing.