ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
Discoloration; due to prolonged heat exposure.
Humei Foods DRIED LILY, Net Wt. 340 g 12 oz +- 5 g -- PRODUCT OF CHINA --- Firms on label: Shanghai Dingmei International Trade Co., LTD, Add: Room 516B, No. 1218, Walma Road, Shanghai, China 200011 Tel: 86 21 33761911 Fax: 86 21 33761933 -- Shanghai Huipu Food Co., LTD,  Add: No. 4545, Daye Highway, Fengxian, Shanghai, China 201404 Tel: 86 21 57488229 Fax: 86 21 57489557 -- Distributed By: Humei Trading INC (New York), Add: 1811 Neck Road, Brooklyn, NY 11229 Tel: 1 646 708 6758 --- Nutrition Facts: Serving Size 50 g, Serving About 3
The product contained undeclared sulfites (409.1 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Ah! Laska Organic Cocoa Non Dairy  Chocolate Mix; Low Fat, Vegan, USDA Organic;  Net Wt. 12 oz. (340 g);  UPC 7-60519-10028-7;    Ingredient: Organic cane sugar, organic cocoa powder (non-alkaline) organic, rice syrup solids, xanthan gum (a natural thickener) carrageenan (a natural seaweed extract emulsifier), maltodextrin, organic vanilla powder.    Made in a facility that processes peanuts, sesame, dairy, eggs, fish, and soy. This product is wheat free and gluten free.    Distributed by Ah!Laska  313 Iron Horse Way  Providence RI    Product of USA  Visit us at www.ahlaska.com
Internal testing confirmed the presence of milk allergen in finished product that is labeled ''Non-Dairy''.
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents)  2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Worldwide Distribution -  US: Nationwide in the state of AK, AL, 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal,  Saudi Arabia,  Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
Through customer complaints, Hospira has become aware that in GemStar (Phase 3) infusion pumps, list numbers 13000, 13100, and 13150, the connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the ''self-test'' while powering up which will result in a Beeper Error (''code 10/001/000''). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090   Product Usage:  The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
14085, 14086, 14092, 14095, 14101, 14106   *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System  Platform (APS)
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System  Platform (APS)
HAQUE brand GOLDEN RAISINS, WT 7 OZ. --- SURMA DISTRIBUTORS LLC Brooklyn, NY 11237  --- Nutrition Facts: Serving Size 1/4 tsp (0.5 g), Servings 204
The product was found to contain undeclared sulfites (1329.2 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas  77478, NDC 75901-7210-53.
Presence of Particulate Matter:  The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Barricini Milk Chocolate Peanut Butter Pretzels in Net Wt 6.5 oz. plastic tub, UPC 075655235181   Back Panel:  Milk Chocolate Peanut Butter Cups  Barricini  Manufactured by Bazzini Holdings, LLC  Allentown, PA 18106
Undeclared wheat. The back panel applied to some containers of milk chocolate peanut butter pretzels was for milk chocolate peanut butter cups, which does not declare wheat.
Hexasol (tm) Injection, 300 mg oxytetracycline and 20 mg flunixin meglumine per mL, 500 mL, Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian, Norbrook Laboratories Limited, NDC 55529-016-05. Hexasol (tm) (oxytetracycline and flunixin) Injection is a sterile preconstituted solution of the broad-spectrum antibiotic oxytetracycline and the NSAID flunixin meglumine.
Crystallization; Crystals observed suspended in the injectable solution.
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS , Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).
The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
3M Attest  Auto-reader. Model numbers 390, 390G,and  490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
The purpose of this communication is to inform you of a correction needed to the labeling of 3M Attest  Auto-readers 390, 390G, & 490.  Labeling on units shipped prior to May 16th, 2014 did not contain the statement ''This product contains dry natural rubber'' as required by the United States Food and Drug Administration (FDA) for medical devices.  The non-slip pads at the bottom of the unit contain dry natural rubber.   One incident of an allergic reaction in a sensitized individual has been reported.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.
Pall Corporation is recalling several lots of its Pall Breathing Circuit Filters due to a possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Distributed in the states of Indiana and Kentucky
Chocolate Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Batch Numbers: 1aCHOC030314, 3aCHOC030314, 2cCHOC030814.
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.
Cinnamon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Codes on the products distributed to Comfy Cow retail locations are not tracked.
Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Peanut Butter Cow Tracks Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Batch Numbers: 3aCTRX110913, 5aCTRX112413, and 2bCTRX022714.
Erica's PB&J Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Say ''Cheeeeeesecake'' Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Batch Numbers: Say Cheeeeeesecake 1aCHZ031914.
Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Black Raspberry Chip Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Batch Numbers: 1bBRC120313, 2aBRC121513, and 1aBRC010714.
Blue Cheese Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Caramel Mocha Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Coconut Almond Bliss Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
The Doctor's Cure Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Egg Noggin' Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Freshly Roasted Coffee Ice Cream and Policeman's Special Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Georgia Butter Pecan Ice Cream and Simply Southern Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Ginger 2 Snaps Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Key To My Heart Lime Pie Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Lemon Cream Raspberry Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Old 502 Sangria Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Raspberry Sorbet. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Sorghum & Grits Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Strawberry Fields Forever Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Arnold Palmer Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Aww Shucks Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Banana Nana Fofana Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Banana Walnut Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Blackberry Cobbler Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Blueberry French Toast with Bacon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Bonjour Toast Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Brown Butter Peanut Brittle Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Candy Cane Lane Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Caramel Apple Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Chatty Cathy Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Cherry Amaretto Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Chocolate Bourbon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Chocolate Coconut Almond Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Chocolate Peanut Butter Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Coconut Almond White Chocolate Dream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
CooCoo for Coconut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Fudgesicle Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Green Apple Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Hazelnut Crunch Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Jack and Cola Float Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Java Chip Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Peaches and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Pistachio Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Pretzel Logic Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Raspberry Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Raspberry Lemonade Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Rocky Road Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Shorty's Strawberry Shortcake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
S'mores Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Watermelon Mint Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Policeman's Special Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
17 - 3gal units; 1 - 1.5gal unit; 1 - 5.2qt unit
Tiramisu Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Vermont Maple Walnut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Bourbon Ball Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Batch Numbers: 3bBOUR032314; 1aBOUR030414; 1aBOUR020614
Shirley's Red Velvet Cake with Cheesecake Swirl Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Cookie Monster Dough Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Cookies and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Shirley's Red Velvet Cake with White Chocolate Icing Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Green Tea Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Sunnyside Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Vanilla Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
20 - 3gal units; 1 - 1.5gal unit; 8 - 5.2qt units
Chocolate ''Chip Off the Old Block'' Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Chocolate Squared Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Hey Jude Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Minty Chocolate Chippy Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Sister Bean's White Chocolate Mocha Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Ze German Chocolate Cake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.
7,758,650 ea. (total for all types listed)
The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Adaptor, 040 Hum, International, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Product Code: 4000040, Lot number: AG14.
Humidifier Adaptor 040, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Product Code: 000-40, Lot numbers: AA19, AB12, AC20, AE03, AE18, AE21, AF09, AF16, AG10, AG12 & AH11.
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, Research Triangle Park, NC 27708, USA.
Product Code: 000-40F, Lot numbers: AA05 & AC01.
Coca Cola Vanilla, 12 pack/12 fl oz cans, UPC: 49000 03124, Canned under authority of the Coca Cola Company, Atlanta, GA 30313 By a member of the Coca Cola Bottlers Association, Atlanta, GA.
The product contains undeclared aspartame.
Product was distributed to five Washington state retail accounts.
Hot smoked Coho salmon; Gold foiled, vacuum packaged units, approximately  pounds each. Adhesive label affixed to front or back of package. Label reads in part, ''**Smoked Coho INGREDIENTS, SALMON CURED WITH WATER, DEXTROSE, FLAVORING, SODIUM NITRITE. PROCESSED BY SUNRISE MEATS***PORT ANGELES WASHINGTON***REFRIGERATE BELOW 38 DEGREE***''
Sunrise Meats is voluntarily recalling one batch of refrigerated, vacuum-packaged hot smoked salmon due to inadequate water phase salt content to control the hazard of Clostridium botulinum growth and toxin formation.
Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200   The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Report of the product penetrating the sterile barrier; this could render the product unsterile.
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660   The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665   The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660   The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Egg White Salad with Chives, 6 oz., packaged in round plastic containers with film seals and snap lids under the Trader Joe's brand. This is a ready-to-eat refrigerated deli salad sold at retail locations.
The lot code is SELL BY JUN 10 2014 The UPC code is 00666695
This voluntary recall has been initiated because the Trader Joe's Egg White Salad with Chives tested positive for Listeria monocytogenes.
Product was distributed in the United States to: AL, AR ,AZ, CA, CO, CT ,DE, FL, ID, IL, IN, KY, MI, MN, MO, MS, NC, NE, NV, NY, OH, OR, PA, SC, RI, TN, TX, UT, VA, and WV.   No foreign distribution.
Mountain House Freeze-Dried Precooked Scrambled Eggs with Ham and Red & Green Peppers, 19.4 oz 1 LB 3.4 oz), packed in #10 metal can. Product is labeled in part ''***INGREDIENTS: Precooked Scrambled Eggs* (whole eggs, egg yolk, nonfat dry milk, modified corn starch, corn oil, salt, yeast extract, sunflower oil, smoke flavoring, xanthan gum). Ham* (ham, salt, dextrose, sodium tripolyphosphate, sodium erythorbate, smoke flavor, sodium nitrite), Red and Green Peppers*. *Freeze Dried  CONTAINS: Milk, Egg.***OREGON FREEZE DRY, INC***ALBANY, OR***''
Two codes are being recalled:   BEST USED BY MAR 2039 14082  BEST USED BY FEB 2039  14042    Codes are stamped on bottom of can.    The affected cans were sold in cases labeled as Granola with Milk and Blueberries, which can be identified by Lot Number 1141144 and Lot 1140585 -on the side of the case.    Product Code 30-449.
248 cans (Mixture of correctly and incorrectly labeled cans)
Oregon Freeze Dry, Inc. is voluntarily recalling Mountain House Scrambled Eggs with Ham and Red & Green Peppers due to undeclared wheat, soy and coconut. Canned product has the potential to be mislabeled and actually contain Mountain House Granola with Milk and Blueberries.
Oaxaca brand of Anelina in 1/2 oz plastic bags with paper label reading in part: ''Oaxaca Mexican Products 100 8th Street Passaic New Jersey 07055 UPC 807310007466 ***''
approximately 8 cases (24 plastic bags per case)
Anelina contains undeclared and unapproved colors.
USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
Worldwide Distribution - USA (nationwide) and the countries of  India, Japan, China, Australia and Canada.
Zimmer  EDI  PERIARTICULAR PLATING SYSTEM  CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Zimmer recently received a complaint regarding a screw that did not correspond to the part number and lot number information on the package label.  Zimmer determined that two lots of screws were commingled.  Specifically, screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432.  The affected product was distributed between 3/6/14 and 4/21/14.
The Cookies Cottage (Brand) Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits), 180g.   Packaged in 24packets per carton.
U-Can Food Trading, Inc. initiated a voluntary recall of The Cookies Cottage brand, Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits) due to undeclared FD&C Blue #1, Yellow #5, and Carmoisine, a dye not permitted for use.
US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
Henora REF: 70-4026-09V1  300psi I.V. Catheter Extension Set     Product Usage:  Catheter extension set for high pressure procedures.
Problem with low adhesion of the tubing to luer connection  which may lead to a separation of the extension set while in use.
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems   Intuitive Surgical Inc.,  'Sunnyvale, CA  94086
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
Worldwide Distribution - US (nationwide):  CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured  and marketed prior to FDA approval.
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system.   Intuitive Surgical Inc.  Sunnyvale, CA 94086
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Distributed in the states of IL, NY, GA, and RI.
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile,  non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue.  Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
Distributed in the states of FL, NM, WA, WI, and TX.
CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter.  The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber.
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA,  NDC 0409-7793-62
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Distributed in the states of CA, CO, IL, OK, OR and WI.
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly.
Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada.
Essential NEO, Audio/Visual Integration Unit   An audio/visual integration unit.
KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.
US Nationwide in the states of FL, LA, PA, WA, WY and the country of  Hong Kong
The Hospira MedNet Medication Management Suite (MMS).   Product Usage:  The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.
1) Software Version 5.5, List Number: 16037-04-13;  2) Software Version 5.8.1, List Number: 16037-04-31;   3) Software Version 5.8.2, List Number: 16037-04-33
Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of ''nanog/kg/min'' and ''milliUnits/min'' are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of ''nanog/kg/min'' or ''milliUnits/min'' on an unmatched medication will produce an incorrect program on the Plum A+/Plum A+3 infuser. The incorrect rate that will appear on the infuser will be a higher or lower value than what was intended from the original Auto Program. The incorrect program displayed on the Plum A+ device cannot start on its own; father a clinician must verify the program before starting the infusion. This issue can only occur with Plum A+/Plum A+3 devices using the Auto Programming feature.
Hula Brand Products; Hana Ebi Red; artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages.  Servins size 2 pinches (1 g)    Manufactured by Modern Macaroni Co., Honolulu, HI  Serving size is ''2'' pinches
FDA sample 466576 found 208.46 ppm of Sulfites in Hana Ebi dried shrimp product.
Hula Brand Products; Hana Ebi Green,  artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages.  Serving size 2 pinches (1 g)    Manufactured by Modern Macaroni Co., Honolulu, HI  Serving size is ''2'' pinches
Worldwide Distribution - US (nationwide in the states of  AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam,  China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.
The STERIS 4085 General Surgical Table   Product Usage:  is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level.   If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.
US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.
Reliance 1227 Cart and Utensil Washer/Disinfector   Product Usage:  Usage:  The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force.  Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.