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U.S. Department of Health and Human Services

Enforcement Report - Week of August 26, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices 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. Model Number: D135601 Lots #'s 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, and 15968813LA, with Exp Date 8/31/2014 Lots #'s 15976735L, 15976820L, 15976823L, 15978174L, 15978179L, 159784180L, and 15978181L with Exp Date 9/30/2014 Class II 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. Cordis Corporation
Drugs 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. Lot #: 7801312, Exp 06/15 Class I Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples. Mylan Institutional LLC
Drugs 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. Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15 Class I Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples. Mylan Institutional LLC
Drugs 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. Lot #: 7801221, 7801222, Exp 03/16 Class I Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples. Mylan Institutional LLC
Drugs 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. Lot #: 7801273, 7801284, Exp 05/16 Class I Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples. Mylan Institutional LLC
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20000-1 FF Item Number 102, UPC 0-86069-50000-2 FF Item Number 105, UPC 0-8069-20001-8 FF Item Number 10299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20010-0 FF Item Number 112, UPC 0-86069-50010-1 FF Item Number 115, UPC 0-8069-20012-4 FF Item Number 11299, UPC 0-86069-20016-2 FF Item Number 144 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20020-9 FF Item Number 124, UPC 0-86069-50020-0 FF Item Number 125, UPC 0-8069-20021-6 FF Item Number 12499, UPC 0-86069-11200-7 FF Item Number S124 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20340-8 FF Item Number 132, UPC 0-86069-50340-9 FF Item Number 135, UPC 0-8069-20341-5 FF Item Number 13299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20030-8 FF Item Number 203, UPC 0-86069-50030-9 FF Item Number 205 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20040-7 FF Item Number 212, UPC 0-86069-50040-8 FF Item Number 215, UPC 0-86069-20043-8 FF Item Number 21299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20041-4 FF Item Number 222, UPC 0-86069-50041-5 FF Item Number 225 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20050-6 FF Item Number 242, UPC 0-86069-50050-7 FF Item Number 245 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20060-5 FF Item Number 252, UPC 0-86069-20063-6 FF Item Number 25299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20005-6 FF Item Number 256, UPC 0-86069-20006-3 FF Item Number 25699 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20061-2 FF Item Number 262, UPC 0-86069-50060-6 FF Item Number 265, UPC 0-86069-11210-6 FF Item Number S262 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20290-6 FF Item Number 272, UPC 0-86069-50290-7 FF Item Number 275 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20042-1 FF Item Number 283 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20032-2 FF Item Number 295 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20070-4 FF Item Number 303, UPC 0-86069-50240-2 FF Item Number 305, UPC 0-86069-20071-1 FF Item Number 30399, UPC 0-86289-20139-0 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20075-9 FF Item Number 323, UPC 0-86069-50075-0 FF Item Number 325, UPC 0-86069-20101-5 FF Item Number 40299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20100-8 FF Item Number 402, UPC 0-86069-50100-9 FF Item Number 405, UPC 0-86069-20101-5 FF Item Number 40299, UPC 0-86069-11230-4, FF Item Number S402 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 No UPC FF Item Number 421, UPC 0-86069-20200-5 FF Item Number 422, UPC 0-86069-50250-1 FF Item Number 425, UPC 0-86069-70100-3 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20102-2 FF Item Number 432, UPC 0-86069-50102-3 FF Item Number 435 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20300-2 FF Item Number 502, UPC 0-86069-50300-3 FF Item Number 505, UPC 0-86069-20301-9, FF Item Number 50299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20270-8 FF Item Number 510 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20310-1 FF Item Number 522 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20510-5 FF Item Number 531 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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. Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20595-1 FF Item Number 603, FF Item Number 604, UPC 0-86069-20296-8, FF Item Number 60399 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20355-2 FF Item Number 659, FF Item Number 604, UPC 0-86069-20356-9 FF Item Number 65999 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-25070-9 FF Item Number 77499, UPC 0-86069-25071-6 FF Item Number 774 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20140-4 FF Item Number 703, UPC 0-86069-50140-5, FF Item Number 705, UPC 0-86069-20142-8 FF Item Number 70399 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-25091-4 FF Item Number 7791, UPC 0-86069-25090-7 FF Item Number 779 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-11270-0 FF Item Number S806, UPC 0-86069-20081-0 FF Item Number 80699, UPC 0-86069-50080-4 FF Item Number 805, UPC 0-86069-20080-3 FF Item Number 806 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-11275-5 FF Item Number S814, UPC 0-86069-20013-1 FF Item Number 81499, UPC 0-86069-20011-7 FF Item Number 814, UPC 0-86069-50011-8 FF Item Number 815, UPC 0-86069-20014-8 FF Item Number 813, UPC 86289-20420-9 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20330-9 FF Item Number 826, UPC 0-86069-11280-9 FF Item Number S826 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20150-3 FF Item Number 833, UPC 0-86069-20151-0 FF Item Number 83399 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20160-2 FF Item Number 836 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20270-7 FF Item Number 842, UPC 0-86069-21271-4 FF Item Number 84299 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20280-7 FF Item Number 852 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20285-2 FF Item Number 862, UPC 0-86069-11290-8, FF Item Number S862 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20425-2 FF Item Number 866 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20400-9 FF Item Number 877 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20405-4 FF Item Number 882 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20430-6 FF Item Number 898, UPC 0-86069-20432-0, FF Item Number 897, UPC 0-86069- 20431-3, FF Item Number 89899 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20170-1 FF Item Number 856 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-10180-3 FF Item Number 90199 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-10260-2 FF Item Number 91199 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-10190-2 FF Item Number 92199 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food Fresh Frozen Grade A Blueberries, Net Wt. 12 Oz. (340g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10500-9 UPC 0-86069-10500-9 FF Item Number 952 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-10230-5 FF Item Number 971 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-50265-5 FF Item Number 1582 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-95015-9 FF Item Number 4022 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-95020-3 FF Item Number 4031 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-95040-1 FF Item Number 4061 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-95061-7 FF Item Number 77899, UPC 0-86069-25060-0, FF Item Number 778, UPC 0-86069-25050-1 FF Item Number 777, UPC 0-86069-25051-8 FF Item Number 77780 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food Fresh Frozen Diced Celery, Net Wt. 2 lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, (no UPC) FF Item Number 762 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food Fresh Frozen IQF Collards, Net Wt. 2 lb., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25040-2 UPC 0-86069-25040-2 FF Item Number 776 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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) FF Item Number 795, FF Item Number 798 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Food 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 UPC 0-86069-20120-6 FF Item Number 1002, UPC 0-86069-20112-1, FF Item Number 1570 Class I Listeria contamination due to various GMP violations. possible. Inventure Foods
Devices 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. Product Code: 5-16028, Lot numbers: 01L1300279, 01A1400574, 73D1400255, 73F1400448, 73J1400537, 73A1500341 and 73C1500431; Product Code: 5-16035, Lot numbers: 01J1300471, 01J1300472, 01K1300050, 01K1300073, 01K1300578, 01L1300382, 01L1300383, 01L1300557, 01M1300073, 01M1300312, 01A1400226, 01A1400432, 01B1400083, 01B1400356, 01B1400357, 01C1400260, 73D1400097, 73E1400504, 73F1400449, 73G1400387, 73G1400597, 73H1400033, 73H1400332, 73J1400259, 73J1400260, 73J1400261, 73K1400130, 73K1400131, 73K1400132, 73K1400225, 73K1400226, 73K1400227,  ...
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Class I The double swivel connector may crack or separate on the endobronchial tube. Teleflex Medical
Devices 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. Product Code: 5-16128, Lot numbers: 73L1400012, 73K1400582, 73L1400233  ...
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Class I The double swivel connector may crack or separate on the endobronchial tube. Teleflex Medical
Devices HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway. Product Code: 5-16142, Lot numbers: 01J1300535, 01M1300215, 01A1400321, 73D1400579 and 73E1400113. Class I The double swivel connector may crack or separate on the endobronchial tube. Teleflex Medical
Devices 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. Product Code: 5-15401, Lot numbers: 01K1300254, 01L1300393, 01M1300212, 01A1400436, 01C1400086, 73D1400096, 73D1400496, 73E1400269, 73F1400153, 73F1400352, 73G1400052, 73G1400288, 73H1400331, 73J1400401, 73L1400106, 73M1400208, 73A1500345, 73B1500272 and 73C1500255. Class I The double swivel connector may crack or separate on the endobronchial tube. Teleflex Medical
Biologics Red Blood Cells W050911066037 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911066037 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. HCSC-Blood Center
Drugs PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8. All lots Class I 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. GC Natural Nutrition, Inc.
Devices Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities) Model Number: 5291 Serial Number: 529A004357 Class II 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 Mfg., LLC
Devices Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6531, Serial Number: 653A119083 Class II 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 Mfg., LLC
Devices Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6540 Class II 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 Mfg., LLC
Devices Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6541, Serial Numbers: 654A105210, 654A105204, 654A105208 and 654A105209. Class II 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 Mfg., LLC
Devices Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6550, Serial Numbers: 655A108119, 655A108120, 655A108121, 655A108122, 655A108123, 655A108124, 655A108125, 655A108126, 655A108127, 655A108128, 655A108129, 655A108130, 655A108131, 655A108132, 655A108133, 655A108134, 655A108135, 655A108136, 655A108137, 655A108138, 655A108139, 655A108140, 655A108141, 655A108142, 655A108143, 655A108144, 655A108145, 655A108146, 655A108147, and 655A108148 Class II 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 Mfg., LLC
Devices Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6551, Serial Number: 655A108177 Class II 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 Mfg., LLC
Devices Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6570, Serial Numbers: 657A102238, 658A102236 and 657A102237 Class II 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 Mfg., LLC
Devices Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6700, Serial Numbers: 670A101355 and 670A101355 Class II 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 Mfg., LLC
Devices Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6740 Class II 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 Mfg., LLC
Devices Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6940, Serial Numbers: 694A106059, 694A106060, 694A106112, 654A105206, 654A105207, 694A106090, 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041, 694A106042, 694A106043, 694A106044, 694A106045, 694A106087, 694A106088, 694A106089, 694A106058 and 694A106099 Class II 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 Mfg., LLC
Devices Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Model Number: 6950, Serial Numbers: 695104466, 695104467, 695104445, 695104273, 695104460, 695104461, 695104462, 695104463, 695104464, 695104465, 695104450, 695104451, 695104452, 695104431, 695104438, 695104442, 695104444, 695104437, 695104438, 695104439, 695104440, 695104441, 695104442, 695104443, 695104444, 695104439 and 695104437 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041,  ...
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Class II 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 Mfg., LLC
Devices 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) Model Number: 6240, Serial Numbers: 624100510, 624100511, 624100512, 624100513, 624100514, 624100515, 624100516, 624100519, 624100520, 624100521, 624100522, 624100523, 624100524, 624100525, 624100526, 624100527, 624100528, 624100529, 624100530, 624100531, 624100532, 624100533, 624100534, 624100535, 624100536, 624100537, 624100538, 624100539 and 624100540 Class II 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 Mfg., LLC
Devices 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 Class II 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 Mfg., LLC
Devices 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. P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000. Class I Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. Elite Biomedical Solutions LLC
Devices 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. P/N 49000204 Lot #'s 031815100, 032415100, 04061545 and 043015215 Class I Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. Elite Biomedical Solutions LLC
Food 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) Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food 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 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food 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 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food HEB Bake Shop 100% Whole Wheat 8 Hamburger Buns, Net Wt. 17.75 OZ (1 LB 1.75 OZ), UPC: 041220830565 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food 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 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food 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 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food HEB Bake Shop 8 Wheat Hot Dog Buns, Net Wt. 12 OZ, UPC: 041220191659 Best By Dates: 7/3/2015, 7/4/2015 Class II Products may contain cotton fibers. H E B Grocery Company, LP
Food 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. Lot 5153 Use By: Aug 23 2015 Class II Product may contain small slivers of shredded golf ball. Michael Foods, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W3985150515826 Class II Blood product, with a low platelet count, was distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W137515202891 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Lane Memorial Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W069114144378- part 1; W069114144378- part 2 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W204914009929 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross SW Region
Devices 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. REF #367986, Lot #'s 5133957 and 5133959 Class III 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. Becton Dickinson & Company
Biologics Red Blood Cells 1404200 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing 1404200 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices Alaris Syringe Pump, Model No. 8110. Delivers fluids. 14024904 14024905 14024906 14024907 14024908 14024924 14024925 14024951 14024952 14024953 14024954 14024955 14025002 14025003 14025004 14025005 14025006 14025022 14025023 14025025 14025026 14025028 14025032 14025033 14025034 14025035 14025036 14025045 14025046 14025047 14025086 14025087 14025088 14025089 14025090 14025104 14025105 14025106 14025107 14025108 14025110 14025111 14025114 14025115 14025116 14025117 14025118 14025119 14025120 14025121 14025124 14025125 14025136 14025137 14025138 14025139 14025160 14025161 14025194 14025195 14025196 14025197 14025283 14025284 14025331 14025332 14025352 14025353 14025354 14025355 14025356 14025357 14025391 14025392 14025405 14025406 14025407 14025408 14025409 14025410 14025411 14025412 14025434 14025439 14025440 14025441 14025545 14025546 14025583 14025584 14025585 14025599 14025600 14025607 14025608 14025621 14025623 14025625 14025626 14025642 14025643 14025685 14025686 14025786 14025787 14025788 14025789 14025799 14025800 14025837 14025838 14025839 14025840 14025842 14025845 14025848 14025849 14025871 14025872 14025893 14025894 14025905 14025913 14025914 14025920 14025968 14025980 14025982 14026009 14026010 14026013 14026014 14026230 14026231 14026232 14026281 14026282 14026283 14026284 14026285 14026286 14026358 14026359 14026360 14026363 14026364 14026365 14026367 14026484 14026485 14026486 14026487 14026488 14026503 14026505 14026506 14026547 14026549 14026551 14026553 14026567 14026568 14026572 14026657 14026658 14026659 14026782 14026783 14026818 14026901 14026902 14026903 14026904 14026910 14026911 14026982 14026983 14026984 14026985 14026987 14026989 14027121 14027122 14027130 14027131 14027132 14027133 14026508 14028388 14027403 14027407 14027414 14027415 14027416 14027434 14027435 14027460 14027461 14027476 14027477 14027496 14027498 14027501 14027520 14027522 14027597 14027598 14027602 14027603 14027604 14027647 14027648 14027694 14027699 14027700 14027709 14027710 14027792 14027794 14027810 14027814 14027816 14027844 14027846 14027870 14027871 14027873 14027874 14027875 14027876 14027904 14027905 14027939 14027945 14027946 14027947 14027948 14027949 14027950 14027951 14027985 14027986 14027987 14027988 14027995 14027996 14027997 14027998 14028076 14028077 14028078 14028079 14028117 14028118 14028119 14028121 14028122 14028123 14028124 14028125 14028126 14028176 14028177 14028178 14028179 14028202 14028203 14028204 14028205 14028211 14028212 14028302 14028303 14028308 14028311 14028321 14028323 14028325 14028366 14028367 14028368 14028369 14028370 14028386 14028387 14028389 14028411 14028412 14028413 14028414 14028415 14028416 14028417 14028418 14028419 14028420 14028421 14028422 14028120 14028365 14029287 14028999 14029072 14029083 14029339 14029358 14029483 14028436 14028438 14028440 14028442 14028480 14028481 14028514 14028515 14028517 14028518 14028519 14028521 14028529 14028531 14028565 14028566 14028567 14028589 14028591 14028677 14028678 14028679 14028680 14028681 14028682 14028692 14028698 14028699 14028725 14028728 14028729 14028733 14028734 14028805 14028806 14028807 14028808 14028816 14028830 14028919 14028920 14028921 14028922 14028923 14028924 14028969 14028996 14028998 14029009 14029010 14029038 14029039 14029074 14029076 14029077 14029165 14029168 14029169 14029170 14029172 14029200 14029201 14029202 14029203 14029204 14029235 14029236 14029286 14029288 14029312 14029340 14029356 14029376 14029481 14028568 14028997 14029231 14029341 14029357 14029359 14029575 14028726 14029171 14029522 14028964 14029166 14029167 14029173 14029233 14029270 14029337 14029338 14029374 Class I 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. CareFusion 303, Inc.
Devices 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 Class II 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. Veridex, LLC
Devices 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 Class I 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. Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Devices rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius. Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial  ...
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Class II 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. Stryker Howmedica Osteonics Corp.
Devices uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty. Part Number: UHA-S1 (Ulnar Stem Implant #1 Sterile Packed) - Lot #'s 17584, 17585, 22217301, 22217302, 23470801, 19066-S2, 19417-S2, 19418-S2, 1973-S2, 19732-S2, 19785-S2, 19815-S2  ...
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Class II 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. Stryker Howmedica Osteonics Corp.
Devices 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. Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901,  ...
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Class II 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. Stryker Howmedica Osteonics Corp.
Devices Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius. Part Number: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566, 18567, 18568, 18697, 18837, 22297901, 22297902, 22848901, 19099-S2, 19101-S2, 19684-S2, 19685-S2, 19716-S2, 19769-S2, 19803-S2, 19846-S2, 19918-S2, 19919-S2 and 19982-S2; Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295, 18753, 18839, 22098402,  ...
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Class II 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. Stryker Howmedica Osteonics Corp.
Devices 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. Part Number: 390-0305 (Sigmoid Notch Radial Stem, Small) - Lot #'s 18362, 22834401 and 23852901; Part Number: 390-0307 (Sigmoid Notch Radial Stem, Large) - Lot #'s 18728, 18815, 18816, 18817, 23834501 and 23853001 Class II 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. Stryker Howmedica Osteonics Corp.
Devices 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 Class II 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). Stryker Howmedica Osteonics Corp.
Devices American Science & Engineering Inc,Gemini Cabinet X-ray system. Gemini systems Class II 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. American Science & Engineering, Inc.
Devices PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. Catalog Number(s): 8416400, 8417400 Class I The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. Draeger Medical, Inc.
Devices 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. Catalog Number 07989138, Siemens Material Number (SMN) 10327381, Lot Numbers: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558; with expiration dates June 30, 2015 through April 30, 2016. Class II A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA® Chemistry Systems Acetaminophen assay for certain lots. Siemens Healthcare Diagnostics, Inc.
Devices 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 Class II 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. Synthes (USA) Products LLC
Devices 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. Serial numbers: G29393 , G29395 , G29404 , G29416 , G29426 , G29864 , G29873 , G29878 , G30025 , G30155 , G30156 , G30160 , G30165 , G30173 , G30236 , G30240 , G30250 , G30254 , G30258 , G30567 , G30570 , G30684 , G30689 , G30761 , G30762 , G30771 , G30808 , G30902 , G30952 , G30960 , G31065 , G31077 , G31252 , G31256 , G31259 , G31271 , G31285 , G31403 , G31412 , G31526 , G31761 , G32487 , G32498 , G32514 , G32577 , G32581 , G32584 , G32587 , G32657 , G32671 , G32753 , G32936 , G33004 , G33102 , G33103 , G33111 , G33112 , G33126 , G33127 , G33144 , G33212 , G33238 , G33309 , G33324 , G33333 , G33344 , G33581 , G33585 , G33634 , G33708 , G33711 , G33721 , G33723 , G35389 , G35422 , G35429 , G35430 , G35442 , G35450 , G35462 , G35480 , G35504 , G35524 , G35611 , G35620 , G35630 , G35641 , G35665 , G35718 , G36042 , G36137 , G36148 , G36206 , G36211 , G36217 , G36222 , G36227 , G36244 , G36272 , G36281 , G36287 , G36468 , G36492 , G36526 , G36537 , G36542 , G36566 , G36573 , G36581 , G36601 , G36626 , G36643 , G36681 , G36689 , G36732 , G36751 , G36761 , G37108 , G37119 , G37129 , G37158 , G37168 , G37188 , G37196 , G37209 , G37234 , G37239 , G37280 , G37293 , G37357 , G37359 , G37413 , G37422 , G37430 , G37442 , G37456 , G37466 , G37475 , G37490 , G37494 , G37501 , G37508 , G37528 , G37536 , G37587 , G37588 , G37641 , G37646 , G37678 , G38058 , G38060 , G38069 , G38076 , G38082 , G38173 , G38178 , G38190 , G38198 , G38272 , G38279 , G38292 , G38293 , G38385 , G38391 , G38613 , G38629 , G38635 , G38643 , G38652 , G38657 , G38666 , G38711 , G38712 , G39465 , G39467 , G39518 , G39533 , G39551 , G39588 , G39589 , G39639 , G39650 , G39657 , G39782 , G39791 , G39800 , G39801 , G39808 , G39809 , G39818 , G39822 , G40016 , G40024 , G40025 , G40116 , G40120 , G40124 , G40126 , G40185 , G40186 , G40190 , G40196 , G40199 , G40203 , G40211 , G40216 , G40227 , G40590 , G40989 , G41058 , G41066 , G41083 , G41098 , G41100 , G41104 , G41108 , G41109 , G41114 , G41119 , G41143 , G41163 , G41192 , G41203 , G41213 , G41218 , G41222 , G41234 , G41244 , G41245 , G41256 , G41267 , G60058 , G60061 , G60062 , G60063 , G60064 , G60065 , G60066 , G60067 , G60069 , G60070 , G60166 , G60169 , G60400 , G60406 , G60415 , G60418 , G60429 , G60430 , G60431 , G60432 , G60435 , G60461 , G60518 , G60520 , G60576 , G60577 , G60582 , G60597 , G60606 , G60631 , G60635 , G60652 , G61307 , G61311 , G61333 , G61337 , G61339 , G61356 , G61367 , G61368 , G61393 , G61394 , G61698 , G61702 , G61706 , G61707 , G61711 , G61715 , G61716 , G61720 , G61725 , G61726 , G61786 , G61795 , G61804 , G61812 , G61814 , G61818 , G61867 , G61872 , G61873 , G61880 , G62011 , G62012 , G62015 , G62020 , G62029 , G62030 , G62037 , G62053 , G62059 , G62062 , G62066 , G62500 , G62502 , G62511 , G62558 , G62564 , G62565 , G62566 , G62626 , G62660 , G62662 , G62682 , G62684 , G62687 , G62747 , G62750 , G62762 , G62804 , G62814 , G62821 , G62828 , G62860 , G62863 , G62867 , G62883 , G62891 , G62892 , G62900 , G62938 , G62943 , G63212 , G63318 , G63328 , G63333 , G63495 , G64500 , G64510 , G64512 , G64789 , G64807 , G64813 , G64854 , G64855 , G64883 , G64891 , G64941 , G65043 , G65172 , G65266 , G65269 , G65275 , G65281 , G65281 , G65289 , G65290 , G65393 , G65395 , G65588 , G65691 , G65692 , G66862 , G66872 , G67257 Class II 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. Sedecal S.A.
Devices 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. Class II Charging base of surgical clippers overheats and smokes. Medline Industries Inc
Devices Magic3TM Hydrophilic-coated Female Intermittent Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter. Lot Number 73600023 Class II Potential breach of the sterile barrier packaging. C.R. Bard, Inc.
Devices Magic3TM Hydrophilic-coated Female Intermittent Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter. Lot Number 73600014, 73600079, 73600110, 73600128, 73600219 Class II Potential breach of the sterile barrier packaging. C.R. Bard, Inc.
Devices Magic3TM Hydrophilic-coated Female Intermittent Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter. Lot Number 73600003, 73600006, 7360007, 73600011, 73600012, 73600013, 73600016, 73600017, 73600020, 73600021, 73600024, 73600080, 73600081, 73600082, 73600095, 73600096, 73600097, 73600123, 73600124, 73600125, 73600126, 73600144, 73600145, 73600163, 73600164, 73600167, 73600181, 73600196, 73600217, 73600218 Class II Potential breach of the sterile barrier packaging. C.R. Bard, Inc.
Devices Magic3TM Hydrophilic-coated Female Intermittent Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter. Lot Number 73600015, 73600068, 73600129 Class II Potential breach of the sterile barrier packaging. C.R. Bard, Inc.
Devices Magic3TM Hydrophilic-coated Female Intermittent Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter. Lot Number 53620387, 53621274, 53621279 Class II Potential breach of the sterile barrier packaging. C.R. Bard, Inc.
Devices Bronchial Double Lumen Tube Set (Left), Sterile Product Code 116100260  Batch Number 13GT24, 13HT07, 13IT16, 13KT23, 14AT08, 14DT19, 14ET10, 14ET11, 14FT04, 14FT10, 14GT03; Product Code 116100280   ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Bronchial Double Lumen Tube Set (Right), Sterile Product Code 162000260 Batch Number 14CT11; Product Code 116200280 Batch Number 13JT05, 13KT18, 14CT11, 14FT05, 14FT10; Product Code 116200350 Batch Number 13FT12R, 13GT11, 13HT07, 13KT23, 14AT08; Product Code 116200370 Batch Number 13KT23, 13LT14, 14DT25, 14ET23; Product Code 116200390 Batch Number 13HT12, 13JT08, 13KT18, 14ET10; Product Code 116200410 Batch Number 14ET05,  ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Bronchial One Lumen Tube - Left Product Code 115900-000065 Batch Number 13FT06, 13GT24, 13JT08, 13KT12, 13LT08, 14AT20, 14DT19, 14ET04, 14GT10, 14GT15, 14IT11, 14JT09, 14JT24; Product Code 115900-000080 Batch Number 13FT17, 13IT11, 13KT05, 13KT12, 14AT04, 14BT04, 14BT15, 14DT19, 14ET04, 14ET22, 14GT15, 14GT18, 14IT14, 14JT09, 14JT18 Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Bronchial One Lumen Tube - Right Product Code 115901-000065 Batch Number 13FT06, 13IT05, 13JT08, 13KT12, 14CT11, 14DT03, 14DT24, 14ET04, 14FT04, 14FT20, 14GT10; Product Code 115901-000080 - Batch Number 13GT16, 13KT18, 13LT08, 14CT11, 14DT03, 14DT24, 14GT15, 14HT12, 14HT20, 14JT04, 14JT12, 14JT21 Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Carlens Bronchial Double Lumen Tube Set (Left) Sterile Product Code 116101370  Batch Number 13KT12, 13LT04; Product Code 116101390  Batch Number 13KT18; Product Code 116101410  Batch Number 13FT12R, 13GT05, 13JT11, 13JT15; Product Code 116101-000350  Batch Numbers 14JT14; Product Code 116101-000370  Batch Numbers 13FT06, 13FT12, 13FT18, 13GT05, 13GT29, 13HT07, 13HT12, 13HT17, 13IT16, 13IT20R, 13JT08, 13JT21,  ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Tracheopart Set (Left), Sterile Produce Code 116400-000750  Batch Number 13FT06, 13GE28J, 13GE31J, 13GT11, 13GT29, 13IT05, 13IT16, 13JT11, 13JT21R, 13JT25R, 13KT05R, 13LT11, 14BT09,  ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Tracheopart Set (Right), Sterile Product Code 116401-000750  Batch Number 13FT06, 13GT24, 13JT21, 13IT21R, 13KT23, 13KT23R, 14CT21, 14ET11, 14ET22, 14ET28, 14FT16, 14GT15, 14GT23, 14IT17, 14JT18; Product Code 116401-000850  Batch Number 13IT05, 13IT21R, 13KT05, 13LT08, 14CT16, 14DT19, 14ET10, 14ET22, 14FT16, 14GT05, 14GT18, 14HT03, 14HT09; Product Code 116401-000950  Batch Number 13JT21R, 14CT06, 14CT16, 14DT20,  ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices White Bronchial Double Lumen Tube Set (Right) Sterile Product Code 116201-000350 Batch Number 13FT17, 13GT05, 13GT24, 13HT07,  ...
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Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Devices Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Product Code 116164-000390  Batch Number 14BT21 Class II Customer complaints reporting that the cobb connector detached from the main connector prior to use. Teleflex, Inc.
Food Friendly's Vienna Mocha Chunk Ice Cream Tub, 48 U.S. FL. OZ. UPC: 0-29839 00557-4 WC 10 06/18/16 xxxx xxxxxx Use By: 6/18/2016 Class II Foreign object Friendly Ice Cream Corp.
Food 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. lot #: LD452 Class II Potential metal fragments in products. Maruchan, Inc.
Food 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. lot #: LE471 Class II Potential metal fragments in products. Maruchan, Inc.
Food 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. lot #: LF463 Class II Potential metal fragments in products. Maruchan, Inc.
Devices 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. Model #: 905-873 Lots: 407221, 407231, 407241, 407251, 408041, 408191, 408201, 408211, 408231, 408232, 408261, 408271, 409021, 409101, 409231, 409291, 410021, 410141, 410281, 411171, 411201, 411261, 412021, 412111, 412161, 412201, 501081, 501131, 501191, 501311, 502031, 502101, 502131, 502171, 502231, 502261, 503091, 503231, 503311, 504031, 504081, 504111, 504271, 505041, 505061, 505141, 505181 Class II 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. Radiometer America Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036815267231 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. OneBlood, Inc.
Drugs 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. Lot#: P327635, Exp 12/15 Class I Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. Baxter Healthcare Corp.
Drugs 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. Lot#: P319921, Exp 12/15 Class I Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. Baxter Healthcare Corp.
Devices 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. Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 146669 153131 153229 146877 157435 146663 147100 147049 147233 136077 147189 147190 153695 157660 153727 157458 146335 146659 153779 146993 153280 153648 153674 160395 160484 135757 136513 136562 147273 157698 147030 147239 146988 160348 157532 160502  ...
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Class II 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. Siemens Medical Solutions USA, Inc
Devices 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. Class III Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. Getinge Sourcing LLC
Devices 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. Lot numbers 1362-01 and 1364-01 Class II The cutting efficiency of the Countersinks was out of specification. Trilliant Surgical Ltd.
Biologics Red Blood Cells Leukocytes Reduced W137515205918 Class III Blood product, collected from a donor whose arm inspection was not documented, was distributed. Lane Memorial Blood Bank
Biologics Source Plasma LR0704884, LR0705385, LR0707049 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. BPL Plasma, Inc
Food 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 Best before 11-08-2015 Class I The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets Natar Foods, Inc.
Devices 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. Class III 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. Cepheid
Devices 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. Class III 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. Cepheid
Devices 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. Model number 8717741. Class II 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 Medical Solutions USA, Inc.
Devices 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. Model numbers: 8717733, 10275007, 10275008, 10275009 and 10275010. Class II 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 Medical Solutions USA, Inc.
Devices 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. Model numbers: 10764801, 10764802, 10764803 and 10764804. Class II 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 Medical Solutions USA, Inc.
Devices 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. Part Numbers 03.100.013 03.100.014 with lot numbers: 5001180 5001181 5043720 5043721 5043722 5043723 5056224 5056410 5056411 5101097 5106064 5109323 5162016 5207917 5252353 5252354 5303914 5303916 5626912 904732 / A7OA43 908057 / A7PA10 909551 / A7PA20 910819 / A7PA30 T100870 T104992 T108114 T114599 T938508 T939338 T939640 T942069 T945414 T946497 T949375 T954443 T958062 T963371 T968151 T968381 T972086 T974174 T974550 T977901 T980418 T980555 T983069 T984285 T987813 T993091 T996572 T999967 5001182 5001183 5042920 5042921 5042922 5042923 5056851 5087081 5087082 5109324 5109325 5109326 5109327 5162012 5207918 5252394 5256421 5256479 5256480 5305758 5305759 5305760 5877095 6040220 6040225 6040226 6056133 6056134 903786 / A7OA37 904731 / A7OA43 908058 / A7PA10 909552 / A7PA20 910911 / A7PA31 T100871 T104993 T108115 T114598 T932954 T935264 T939339 T945413 T946498 T947785 T954444 T958061 T963372 T968152 T974175 T977904 T980511 T983070 T984228 T987809 T989000 T993092 T996565 T999969 Class II Potential for micropores to form, allowing fluid to enter the hollow handle. No injuries reported. Synthes (USA) Products LLC
Food 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) Class II Undeclared milk. The ingredients statement declared butter and the Contains statement declared dairy. Freedom Snacks
Food 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***". 11242015 (This code represents best by date of Nov. 24, 2015) Class II Milk is not declared on label. The ingredients statement declared butter and the Contains statement declared dairy. Freedom Snacks
Drugs Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01. Lot #221211, Expiry: 09/30/2015 Class II Lack of Assurance of Sterility: Failed preservative effectiveness testing. Bausch & Lomb, Inc.
Devices 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. Lot number 2015060544; Class II 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. Medtronic Perfusion Systems
Devices 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. 033115-3445 Class II It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. International Biophysics Corp.
Devices 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. 042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488 Class II It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. International Biophysics Corp.
Devices 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. 031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541 Class II It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. International Biophysics Corp.
Drugs 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. Lot #: DM12700, Exp 09/15 Class II CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Wockhardt Usa Inc.
Drugs 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. Lot #: DM13219, Exp 10/15; DM13428, Exp 11/15 Class II CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Wockhardt Usa Inc.
Drugs 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 Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015 Class III 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. Sun Pharma Global Fze
Drugs 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 Lot #: 52217, Expiry: 04/18 Class III Labeling: Incorrect And/Or Missing Package Insert: Product is labeled with unapproved labeling. Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Drugs univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01. Lot #: 98016P1, Expiry: April, 2016 Class II Failed Dissolution Testing: Failed 24 month dissolution testing. Ucb, Inc
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