Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from donors who traveled to a malarial endemic area, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The package reads in part ''***Northern Chef***GLUTEN FREE, OVEN READY LIGHTLY COATED COD***KEEP FROZEN/DO NOT REFREEZE***NET WT 10 OZ.(284g)   UPC 8 7797100274 2  Product number 707300461  12/10oz bags placed in a  Master Case weighing 7.5lbs    Master Case UPC - GTN 14-10877971002749
Each bag has a trace code and best buy date in the lower left corner. Will be one of the following codes:   10140216127 - May 7th, 2014  10140216128  May 8th, 2014  10140216129  May 9th, 2014  10140216130  May 10th, 2014  10140216131  May 11th, 2014  10140216132  May 12th, 2014  10133016127  May 7th, 2014  10133016128  May 8th, 2014  10133016129  May 9th, 2014  10133016130  May 10th, 2014  10133016131  May 11th, 2014  10133016132  May 12th, 2014    Numeric number represents a 6 digit PO, followed by  2 digits that represent the year and 3 digits which represent the day of the year.     Master carton has the same lot code as that on the individual bags.
861 master cartons (12/10oz bags per carton)
Tai Foong USA, Inc. is recalling Northern Chef Lightly Coated Cod Fingers because the contains statement fails to identify eggs.  Eggs are declared in the ingredient statement.
CA, MA, NY, MN, PA, MO, WA, TN, TX, MI, AZ, MD, OR, KS, IL, GA, NJ, IA, LA. and Canada.  Other foreign distribution has not yet been provided.
Granny Smith Apples, ''Granny's Best'' or ''Big B'';   sold in 40-45 lb. cases with cardboard trays or  in 3 lb. poly bags (~12 apples). 5 lb. poly bags (~ 18 apples) and loose fill TriWall containers ~ 700 lbs.    Bidart Bros., Bakersfield, CA 93312
All Granny Smith apples produced or sold in 2014 for use in manufacturing of caramel apples..
Recall of Granny Smith Apples from 2014 harvest used in caramel apple production due to their association with Listeriosis outbreak. Expansion of recall on January 6, 2015 to include all Granny Smith and Gala apples in the 2014 Production.
Gala Apples ''Big B'';   sold in 40-45 lb. cases with cardboard trays or  in 3 lb. poly bags (~12 apples). 5 lb. poly bags (~ 18 apples) and loose fill TriWall containers ~ 700 lbs.    Bidart Bros., Bakersfield, CA 93312
All Gala produced or sold in 2014 for use in manufacturing of caramel apples..
Recall of Granny Smith Apples from 2014 harvest used in caramel apple production due to their association with Listeriosis outbreak.. Expanded to include all Granny Smith and Gala apples from 2014 production
Cumin Powder (comino molido) Various brands: 1)  Key Food Quality Natural Spices , NET WT. 12 oz., UPC 073296001440; 2.)La Mina'' Quality Natural Spices  NET WT. 12 oz., UPC 818685010517; 3) Salma Natural Cumin NET WT. 12 oz., UPC 023913159085; 4.) Spice Class All Natural Cumin Powder NET WT. 7 oz,  UPC 815978004239 and 12 oz., UPC 815978008220; 5) CASABLANCA NET WT. 7 oz., UPC 639235101178 and NET WT. 5 LB,  in a plastic, clear container; 6) Natural spices H NET WT. 7 oz., UPC 63923510835; 7) Leader Meret Cumin Ground (toz kimyon NET WT. 7 oz., UPC 639235132356; 8) All Island Spice NET WT. 2.5 ozs., UPC 609539084729
267 cases/12 bottles/12 oz; 468 cases/12 bottles/ 7  oz; 5 cases/12 bottles/2.5 oz; 110 units 5 lb bags
Cumin may contain undeclared peanut protein.
Product was distributed to Alabama, Florida and Louisiana
Single serving pie, 7 oz., is packed in a black paper cup with clear plastic lid, with white Sour Cream Lemon sleeve label.  Product is labeled in part, ''***Winn Dixie bakery PIE Sour Cream Lemon Pie***NET WT. 7 oz. (198 g.)***Distributed by Winn-Dixie Stores Jacksonville, FL 32254***''   UPC: 0 21140 00083 5
Julian Date on bottom of cup ''4300''.   Best Used by Date  08/23/15.
Fresh Foods Corporation of America dba Cyrus O'Leary's Pies is recalling singe serve Sour Cream Lemon pies due to undeclared coconut and sulfites.
nationwide via internet sales and retail stores
My Spice Sage CUMIN GROUND under the following labels and packaging: 1) NET WT 1 oz (28g) UPC 00105001, packed in a plastic resealable bag 2) NET WT 4 oz (113g) UPC 00105004 packed in a plastic resealable bag, 3) NET WT 4.9 oz (139g) UPC 00105000 packed in a plastic bottle, 4) NET WT 16 oz (454g) UPC 00105016 packed in a plastic resealable bag and 5) NET WT 50 lb packed in a plastic bag.  Zenobia Company LLC 92 Main Street Suite 319 Yonkers, NY 10701 Tel. 877-890-5244 www.MySpiceSage.com
lot numbers: 6909. 6764, 6820 (internal coding system) Catalog#: 105
US: Nationwide (AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, MA, MD, MI, MN, ND, NE, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, WI, WV) + District of Columbia
Honey & Oat Mixers ready-to-eat dry cereal sold under the market pantry brand and packaged in card stock cartons with a new weight of 18 oz. (1 lb. 2 oz.) 510 g.
Dark Chili Powder packaged in the following configurations: (1) a 5 by 7 in clear square bag with a zipper seal and a label weight of 2.24 oz (63.5 g), Distributed by The Fresh Market, Greensboro, NC, and (2) 4 oz clear square glass bottle with a silver metal cap and a label weight of 1.85 oz (52.4 g), Distributed by The Fresh Market, Greensboro, NC;
The products contain cumin that may be contaminated with undeclared peanut allergens.
Archer Farms Cumin, ground, packaged in 6 oz clear square glass bottle with a silver metal cap and a label weight of 2.8oz (79 g), Distributed by Target Corp. Minneapolis, MN;
HT Traders Blue Cheese Jalapeno Spicy & Unique Seasoning Blend packaged in a 6 oz clear square glass bottle with a black metal cap and a label weight of 3.7 oz (104.9 g), Proudly Distributed by Harris Teeter, LLC., Matthews, NC;
Notified by immediate supplier of recall of ground cumin from Turkey due to the presence of peanut protein.
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
2284 cartons (100 individual unit doses per carton)
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Adkins Barbecue Spice Net Wt. 25 lbs. UPC: 0-77139-21382-3
American Spice received recalled cumin from Adams Extract & Spice, LLC and used for their BBQ Spice Blend.  Product was distributed in bulk packaging for further use.
Nationwide in US: CA, TN, WA, ID,    and worldwide:  Hong Kong, Vietnam, China, Singapore
Health One Pharmaceuticals is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
Best Women's Formula for Menopause, 90 capsules
Glucosamine Chondroitn MSM, 120 Vegetarian Capsules
Magnolia Sinus, 100 Vegetarian Capsules, 500mg
Four things Combination, 100 Vegetarian Capsules, 500mg
Gentiana Combination, 100 Vegetarian Capsules, 500mg
Griffonia Seed Extract 5-HTP Capsule, 60 capsules, 100mg
Nikente Astaxanthin Bilberry, 60 Capsules, 30g.
Complex Tablet San Ye Qing, 120 tablets, 500mg
LBL reads in part:***  AL'S PICADERA*** MANTENGASE REFRIGERADO  ENTREMESES & POSTRES*** 3 LECHES***''
Product manufactured during 1/13/2015 and 1/20/2015.
Tres Leches Cake label does not declare soy as part of the ingredients.
French Broad Chocolates, Bubbie's Almond Bar, 60g (2.1 oz) bar, with aluminum foil with polyester ribbon & paper outer wrapper
Batch No. 130607 (Best by Date June 2014) and 130827 (Best By Date August 2014)
Cacao moth in the almonds of the chocolate bar.
Frozen Shredded Pork Enchilada Meal; Heat sealed frozen dinners,16 oz and 29.6 oz   UPC for 16 ounce small is 12859007998, and UPC for 29.6 ounce large is 12858013990
Market of Choice Frozen Chicken Tamale Pie Meal, Market of Choice Frozen Pulled pork Meals with Love Rub, and Market of Choice Pulled Pork Enchilada Meals are being recalled due to the potential of undeclared peanut.
Frozen Smoked Pulled Pork with Sweet Chili BBQ Sauce, Heat sealed frozen dinners, 16 oz and 29.6 oz   UPC for 16 oz.: 12855005998  UPC for 29.6 oz: 1285400999
Frozen Chicken and Green Chili Tamale Pie, Heat sealed frozen dinners, 16 oz and 29.6 oz   UPC for 16 oz.: 12851007996  UPC for 29.6 oz: 12850013998
Product was distributed in the State of CT.
Cumin Ground, 2.75 oz., UPC: 811267012008.  Product is packaged in a plastic bottle with a black flip-top lid.
Product may contain undeclared peanut protein.
Cajun Seasoning, 4 oz., UPC: 811267011735.  Product is packaged in a plastic bottle with a black flip-top lid.
Austin Grand Prize Green Salsa; 1st Runner-up Texas Hot Sauce Challenge 1992; Mfg. Exclusively for: Skins N More Inc. 805 E. Court St., Suite #160 Seguin, Texas 78155 (210) 889-2109
Austin Grand Prize Hot Sauce; Best of Show Austin-San Antonio Hot Sauce Challenge 1991; Mfg. Exclusively for: Skins N More Inc. 805 E. Court St., Suite #160 Seguin, Texas 78155 (210) 889-2109
Tastefully Simple Corn, Black Bean Salsa NET WT 16 OZ (454g); Distributed by Tastefully Simple, Inc. Alexandria, MN 56308
Trigger's Black Bean & Corn Salsa NET Wt 16 Oz. - MEDIUM HEAT; Manufactured in San Antonio, TX for Trigger Beeler's Gourmet Foods
Florentina's Gourmet SALSA RANCHERA HOT Net Wt. 16 oz. (454g)
TEXAS WILD VERDE (GREEN) HOT SALSA NET WT. 16 oz. (454g) Manufactured for: Meier Ranch Foods
TEXAS WILD 4x HOT & CHUNKY VERY HOT SALSA NET WT. 16 oz. (454g) Manufactured for: Meier Ranch Foods
TEXAS WILD BLACK BEAN & CORN MILD SALSA NET WT. 16 oz. (454g) Manufactured for: Meier Ranch Foods
TEXAS STING HOT BUFFALO WINGS SAUCE Manufactured for RB FOODS COMPANY NET 12 FL OZ (355ML)
TEXAS STING MEDIUM BUFFALO WINGS SAUCE Manufactured for RB FOODS COMPANY NET 12 FL OZ (355ML)
Van Roehling TEQUILA GREEN SALSA Net Wt. 12 oz. (340g) Manufactured by: VR FOOD'S LLC dba Van Roehling
Clint's Texas Salsa Black Bean & Corn NET WT. 16 oz. (454g) DISTRIBUTED BY:  Clint's Picante Inc.
Fredericksburg Farms ALL NATURAL AND GLUTEN FREE! Fredericksburg Peach Salsa 12 oz. (340g) Medium Distributed By: Fredericksburg Farms, Inc.
Fredericksburg Farms ALL NATURAL AND GLUTEN FREE! Rio Grande Black Bean & Corn Salsa 12 oz. (340g) Mild Distributed By: Fredericksburg Farms, Inc.
Florentina's Gourmet SALSA RANCHERA Medium Net Wt. 16 oz. (454g)
FRONTIER PICANTE SAUCE NET WT. 138 oz. (8.62 lbs.) 3.91 kg Manufactured for FRONTIER ENTERPRISES 8520 Crownhill Blvd. San Antonio, TX 78209
Central Market HATCH GREEN CHILE SALSA VERDE MEDIUM NET WT. 16 OZ (1 LB) 454 g DISTRIBUTED BY H--E-B CENTRAL MARKET AUSTIN, TEXAS 78735
Central Market HATCH GREEN CHILE SALSA ROJA MEDIUM NET WT. 16 OZ (1 LB) 454 g DISTRIBUTED BY H--E-B CENTRAL MARKET AUSTIN, TEXAS 78735
Bald Eagle Foods Cub Mild Salsa Net Wt. 16 oz. (454 g) DISTRIBUTED BY: Bald Eagle Foods P.O. Box 2674 Waterloo, IA 50704
Bald Eagle Foods Black Bear Medium Salsa Net Wt. 16 oz. (454 g) DISTRIBUTED BY: Bald Eagle Foods P.O. Box 2674 Waterloo, IA 50704
MARK'S LONE STAR CERTIFIED GOOD STUFF RESTAURANT SALSA MEDIUM NET WT. 16 OZ (1 LB)
Natalie's HATCH CHILE & KALE GREEN SALSA NET WT. 16OZ (453g)
Class Delites AZTEC SALSA Roasted Corn & Black Beans Net Wt. 12 oz. (340g)  Dist. By: CLASSY DELITES, INC. P.O. BOX 340189 AUSTIN, TEXAS 78734
Class Delites SPINACH AVOCADO DIP Net Wt. 12 oz. (340g)  Dist. By: CLASSY DELITES, INC. P.O. BOX 340189 AUSTIN, TEXAS 78734
AUSTIN CHILE CO GUACAMOLE PABLANO SALSA MEDIUM NET ET. 16 OZ (453g)
SILVER STAR TEX-MEX SALSA CILANTRO & LIME MEDIUM NET WT 16OZ (453g) Brought to You By: SilverStar Salsas Box 50583 Austin, TX 78763
SILVER STAR TEX-MEX SALSA CHUNKY PICANTE MEDIUM NET WT 16OZ (453g) Brought to You By: SilverStar Salsas Box 50583 Austin, TX 78763
Maria's Picante Sauce NEt WT. 12 OZ. (342g) Distributed by Maria's Mexican Restaurante Bogalusa, LA 70427
Big Cock Ranch Hot Shit Salsa Net Weight 16 oz. (453g) Big Cock Ranch Lexington, TX 78947
SOUTHERN HEAT medium salsa NET WT. 16 OZ. (454g) Distributed By: Lone Star Heat Products, Inc. P.O. Box 171572 Arlington, Texas 76003 U.S.A.
STAGECOACH SALSA CLASSIC SAN ANTONIO SALSAS MEDIUM Net Wt. 16 oz. (454g) Manufactured Exclusively for: Stagecoach Salsa Company 25011 Saddle Trail San Antonio, texas 78255
STAGECOACH SALSA CLASSIC SAN ANTONIO SALSAS MILD TENDERFOOT Net Wt. 16 oz. (454g) Manufactured Exclusively for: Stagecoach Salsa Company 25011 Saddle Trail San Antonio, Texas 78255
STAGECOACH SALSA CLASSIC SAN ANTONIO SALSAS BUBBA'S CHIPOTLE BLACK BEAN &CORN Net Wt. 16 oz. (454g) Manufactured Exclusively for: Stagecoach Salsa Company 25011 Saddle Trail San Antonio, Texas 78255
Julio's Home Style hot Salsa NET WT. 11.5 oz. (326 g) MANUFACTURED FOR JULIO'S 3900 HWY 90 E. DEL RIO, TX 78840
Julio's Home Style mild Salsa NET WT. 11.5 oz. (326 g) MANUFACTURED FOR JULIO'S 3900 HWY 90 E. DEL RIO, TX 78840
Santitos Salsa Medium Hot Net Wt. 16 oz. (454g) Manufactured for: Santitos Salsa San Antonio, TX 78224 PO Box 240083
Santitos Salsa Mild Net Wt. 16 oz. (454g) Manufactured for: Santitos Salsa San Antonio, TX 78224 PO Box 240083
Native Texan Hatch Chile Salsa Verde Medium NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan TEX-MEX Mild NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan Picante Mild NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan Hatch Chile Salsa Roja Medium NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan Chili Fixin's Four Cup Recipe NET WT. 17oz 480g. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan Tex-Mex Medium  NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Native Texan Peach Medium  NET WT. 16oz 453g 1LB. Brought to You by: Native Texan Food Co. box 50583, austin, TX 78763
Texas Texas Medium Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
Texas Texas Mild Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
Texas Texas Roasted Addiction Medium Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
Texas Texas Gournet Peach Medium Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
Texas Texas Homestyle Hot Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
Texas Texas Black Bean & Corn Medium Salsa Net Wt. 16 OZ. (1LB) 454g Distributed by Sanderson Specialty Foods, Inc. Austin, Texas
SOUTHERN HEAT chipotle salsa NET WT. 16 OZ. (454g) Distributed By: Lone Star Heat Products, Inc. P.O. Box 171572 Arlington, Texas 76003 U.S.A.
STAGECOACH SALSA CLASSIC SAN ANTONIO SALSAS MISS MICHELE'S PEACH SALSA Net Wt. 16 oz. (454g) Manufactured Exclusively for: Stagecoach Salsa Company 25011 Saddle Trail San Antonio, Texas 78255
Salsa was distributed within Washington.
Mild Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***MILD***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 54632 4
San Juan Salsa Co. is recalling six varieties of salsa due to potential peanut contamination.
Medium Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***MEDIUM***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 54633 1.
Hot Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***HOT***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 54634 8
Traditional Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***TRADITIONAL***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 54636 2
Afterburner Salsa, 14 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***AFTERBURNER***Keep Refrigerated***NET WT. 14 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 54635 5
Pineapple Mango Salsa, 13 oz; product is packaged in clear plastic tub with plastic lid, labeled in part, ''***SAN JUAN SALSA CO.***Pineapple Mango Salsa***Keep Refrigerated***NET WT. 13 oz (397 g)***SAN JUAN SALSA CO. 5919 195TH ST. NE #5, ARLINGTON, WA 98223***'' UPC code: 7 18738 63010
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Catalog Numbers: Part # BPC.45, BPC.60, BPC.80, and BPC.105
Devices are misbranded - currently registered as Class I, but are actually Class II.
Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105
Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
Blood product, possibly contaminated with air, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, collected from a donor for whom there was no documentation of an arm inspection, was distributed.
Blood products, collected from a donor who subsequently reported a tattoo/piercing, were distributed.
The label reads in part ''Christ Kitchen *** Blameless Blondies*** Net Weight: 15 oz (425gm).   Product is a dry bakery mix and is packaged in a flexible plastic bag within a corrugated cardboard sleeve.
Conflicting information provided by WSDA vs recalling firm.  Firm states that 299 units have been distributed while WSDA states 375 units distribtued
Christ Kitchen is recalling Blameless Blondies, a dry bakery mix, because milk, soy and wheat allergens are not declared in product labeling.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III;   AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.
Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.
See's Stores nationwide and through internet sales.
See's Candies Classic Red Heart with Assorted Chocolates (8 oz. 227 g),  42 hearts per carton; UPC 737666091201  Ingredients: Sugar, Cream, Chocolate , Cocoa Butter, Corn Syrup, milk, brown sugar, butter, honey, egg whites, molasses, salt, gelatin, vanilla, baking soda, hydroxylated soy lecithin, (an emulsifier), cornstarch, confectionery glaze, soy lecithin (an emulsifier), vanillin (an artifical flavor) May contain traces of Tree nuts and peanuts.    Manufactured by Sees Candies Inc./Sees Candy Shops Inc., San San Francisco CA 94080/Los Angeles, CA 90016
One packaging run of 8 oz. Classic Red Hearts with Assorted Chocolates was packaged in the wrong box and does not include tree nuts in the ingredient statement.
Pacific Coast Selections Stuffed Mushrooms; Net Wt. 7 oz. (198g)  Best if sold by: 02/13/15  GHCA036 A16;  UPC 0.98487-10131.0    Cooking Instructions: Place mushrooms on baking sheet and bake for 10-12 minutes until heated through and beginning to brown.    GH Foods CA,  Sacramento, CA  95828
Lot Code: GHCA 036 A16 Code Date:  Best if Used By: 2/13/15
Sub ingredient of Worcestershire sauce (anchovy) was not listed on finished product label.
Blood products, which did not meet acceptable product specifications, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which were not quarantined subsequent to receiving information regarding medical history, were distributed.
Hellas Golden Double Smoked Herring Vacuum Karagounis Bros SA -Hellas -35 A.3 - C.E.  2nd Industrial Zone -37500 VOLOS   TEL.: +30 24250 22018 - FAX : +30 24250 23747  Imported in USA by: Moscahlades Bros. Inc. 27 East 33rd St Paterson, NJ 07514  USA PH.: 973 881 1960 FAX: 973 881 1962    packaged in a carton  approximately 12 packages per case
Smoked herring may be potentially contaminated with C. botulinum.
Whole Foods Market Divine Treasures 100000 Smooches, Vegan Chocolate packaged in a clear round 8 oz  plastic container, various weights
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, possibly contaminated with air, were distributed.
Natural Shaped Fried Egg (patties), 1.75 oz. frozen egg patties, packaged 144-count per case, Net WT. 15.75 lb. (7.14 KG), under two brand names:    (1) Pappetti's Table Ready, UPC Code 46025 85879. The responsible firm name on the label is Michael Foods Inc., Minnetonka, MN 55305; and  (2) Glen view Farms IQF, UPC Code 58108 37237. The responsible firm name on the label is U.S. Foodservice, Inc., Rosemont, IL 60018.
Expiration dates:  2/11/2015 thru 1/26/2016
MR. HYDE INTENSE ENERGY PRE WORKOUT, Green Apple Natural and Artificial Flavor Dietary Supplement Net Weight 8.0 OZ (228 grams)
The product contains more yohimbine hcl than declared on the label
Chef's Delight Spices & Herbs - Ground Cumin, Net Wt. 5.0 lb Jugs, Packed for Hermolia, Packed by CO, Brooklyn, NY
Prima Spice Inc. is recalling Chef Delight's Ground Cumin due to possible peanut protein contamination.  This recall is a result of the Schiff Foods Product recall.
YC-1800 OPHTHALMIC YAG LASER SYSTEM;   The YC-1800 allows the safe and bloodless treatment of intraocular  diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.
Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images.
Nationwide including government commissaries.  No foreign consignees.
Organic Horizon Sandwich Crackers Cheddar, 7.5 oz packages, 12 boxes per case.
Best Before date: 17 MAY 2015 on top of individual box. UPC: 42365 00464 on bottom of box.  Wholesale customers should look for cases with UPC: 42365 00465 for Peanut Butter sandwich crackers, same Best Before date.
WhiteWave Foods is voluntarily recalling 7.5 oz packages of Horizon Cheddar Sandwich Crackers because they may contain undeclared peanuts due to an inadvertent packaging error. The outer package is labeled as a cheddar sandwich cracker and the inner package contains the peanut butter sandwich crackers.
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System.  The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Syngo.plaza.  A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.  It supports the physician in diagnosis and treatment planning.
Possibly incomplete archived studies during pre-fetch.  In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
Healthy Mama Boost it Up  Mango with Ginger Caffeine Free Protein with Energy Drink 12 fl oz Distributed by: Maternal Science, Inc.  50 Tice Boulevard, Suite 340  Woodcliff Lake, NJ 07677      UPC 810758020058
Healthy Mama Brand dietary supplements contain undeclared milk.
Healthy Mama Boost it Up Pom Cherry Caffeine Free Protein with Energy Drink 12 fl oz Distributed by: Maternal Science, Inc.  50 Tice Boulevard, Suite 340  Woodcliff Lake, NJ 07677      UPC 810758020126
Healthy Mama Boost It Up Mighty Mango Caffeine Free Protein with Energy Drink 12 fl oz Distributed by: Maternal Science, Inc.  50 Tice Boulevard, Suite 340  Woodcliff Lake, NJ 07677      UPC 810758020058
Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of:  Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland,  Austria, Hungary, Netherlands and Portugal.
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits.
Boston Scientific is initiating this Medical Device Recall of the Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kit. To date, Boston Scientific has received 11 complaints for device fragmentation after the catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
Orthovita, Inc., dBA Stryker Orthobiologics.
Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI  CA MO LA VA IA OH and NC.
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
US Nationwide in the states of IL, IN, KY, MI, PA, and TN
Double Swivel Connector with Suction Port Connector, Airway (Extension)  King Systems part 7169    Product Usage:  An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.
Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.
Product was shipped to the following states: AL, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI & WV.
JOHN FRIEDA Beach Blonde Sun Streaks Lightening Spray 3.5 FL. OZ (103mL) peel back for directions, ingredients and warnings. Bottle UPC 7 17226 20857 7 Case UPC 1 07172 62085 7 4
The product is being recalled due to defective peel out labels which inhibits the consumer from viewing the warnings, directions, and ingredient statement for the product.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Crown Naturals Trail Mix, Net Wt. 9 oz. (7.80 LB), Sale by: 10/9/2015, Product of USA, Packed by Crown Food, North Bergen, NJ 07047
Crown Naturals Trail Mix was sampled and found to contain undeclared FD&C Yellow #6.
US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM.  Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28.   Product Usage:  The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI).  Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.
Horchata Post Mix Fountain Syrup, 3 gallons (11.4 Liters), UPC 0 09319 00006 0.
Fiesta Pacific is recalling all Brown Label Horchata due a formulation error and no process on file to prevent the growth of potentially harmful bacteria, including Clostridium botulinum.
Worldwide Distribution - US Distribution to the states of : CA, LA, FL, WI, NY, IL, MD and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.
Boston Scientific:  Expel'' Drainage Catheter with Twist-Loc'' Hub APDL Drainage Catheter and APDL Drainage Catheter Kit,  Expel'' Drainage Catheter APD Drainage Catheter,   Expel'' Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
Boston Scientific is initiating this Medical Device Field Correction of the Expel'' APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation  after an Expel'' APD catheter was implanted in the biliary system. The most serious foreseeable patient  risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in the reported case, this was performed to retrieve the device fragments.
Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.
LIS27T -  Lacrimal Intubation Set RX Only Sterile    Used in various ophthalmology procedures.
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Product was shipped to all fifty (50) states plus DC.
Cheryl's Buttercream Frosted Cut-Out BUNNY HEAD COOKIES, Net Wt 1.5oz (43g), Cheryl's Westerville, Ohio 43082 www.Cheryls.com ALLERGEN STATEMENT: Contains Wheat, Soy, Milk and Eggs. Produced in a plant that also handles peanuts and tree nuts.
The cookie was packed in the incorrect film.  The film that it was packed in lacks the ingredient cocoa.
US Distribution in states of: AL, AR, CA, FL, GA, IL, MO, NC, TN, and TX.
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010   The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
The syringe carrier is missing components: a damper and spring.
Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Potential breach of the sterile barrier packaging.
Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc   Product Usage:  The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.
The firm is recalling ToggleLoc's and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Ziploop Button   Product Usage:  The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
Zimmer, Inc is voluntarily recalling 22 lots of Persona Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines.  Model numbers 1009-9012-000.   Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.
Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976    In vitro Diagnostics Use.
The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
American National Red Cross Southeastern Michigan Region
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Worldwide Distribution - Nationwide Distribution to the states of : AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV and WY., and to the countries of : Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Cambodia, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jumeirah, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Training, Tunisia, Turkey, United Arab Emirates,United Kingdom, Uzbekistan and Viet Nam.
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
Worldwide Distribution: US (nationwide) distibution in states of: CA; and countries of: Ireland & Israel.
RECLAIM Assembled Implant Inserter Adaptor
CATALOG NO. : 2975-00-920:  Barcode (GTIN): 10603295156192  Lot No.  Distribution  SO2018074 (Distributed)  SO2018072 (Not Distributed)  SO2018073 (Not Distributed)  SO2018075 (Not Distributed)  SO2018080 (Not Distributed)
On February 23, 2015, DePuy Orthopaedics, Inc. initiated a voluntarily recall for one lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument. The instrument is being recalled because it may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Lack of Assurance of Sterility; increased complaints received for leaks
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Domestic: AL, CA, FL, NY, NJ, MI, TX, OK, MD, IL, NV, HI    Non Domestic: Guam    No VA/DOD
Mrs. Fields White Chunk Macadamia Cookies; 12 individually wrapped cookies in a tray/box; there are 6 trays/boxes to a case. Therefore there are 72 cookies in a case; 2.1 oz single size serving.
Item No. 960330; UPC Wrapped Cookie: 8-86002-55053-4; UPC Carton: 8-86002-57053-2; UPC Case: 0-08-86002-57033-4;    Lot #s:   330510035C Production Date: 3-Oct-1 Best By:Oct 03 15  330510035B Production Date: 3-Oct-14 Best By: Oct 03 15  330510045A Production Date: 4-Oct-14 Best By:Oct 04 15  330511125B Production Date: 12-Nov-14 Best By:Nov 12 15  330512035C Production Date: 3-Dec-14 Best By:Dec 03 15  330512235B Production Date: 23-Dec-14 Best By:Dec 23 15  330601315A Production Date: 31-Jan-15 Best By:Jan 31 16  330602245C Production Date: 24-Feb-15 Best By:Feb 24 16
The potentially affected inventory totals 16,877 cases of cookie; 1,215,144 individually wrapped cookies
The Company is recalling the Mrs. Fields White Chunk Macadamia cookies because the package is not compliant with the requirements of FALCPA to recognize the presence of the macadamia allergen in the ingredient listing or the allergen ''Contains'' declaration.
Skintact ECG Electrode FS-50, Catalog no.  58028 , &  Stable Base ECG Electrode SBT-60, Catalog no.  50547.    To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
The electrodes may fail to transmit signals.
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX   The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX   The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX   The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX   The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
LAPAROSCOPIC TUBING SET, 3/16''  X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -  STERILE, REF 24311 QTY 10/CS, STERILE EO   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8'' x 16' (2.22 cm  x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
VACUUM TUBING 7/8'' X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
VACUUM TUBING 7/8'' X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
TUBING SET 7/8'' X 6' WITH 1/4'' x 24'' TUBING, REF 24136, QTY 3/CS, NON STERILE,  NO LATEX   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
(S) TUBE SET 1/4'' X 10' (0.64 cm X 304.8 cm) with 7/8'' (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
LASER RESISTANT WAND   - STERILE, 7/8'' X 8'' (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO   Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MM, MS, MO, MT, NE NV,N, NM, NY, NC, ND, OH,OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR, VI and the countries of:Australia, Austria, Bahamas, Belgium, Bolivia ,Botswana, Brazil ,Brunei,  Darussalam, Bulgaria, Burkina Faso, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark,, Dominican Republic, Egypt, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Luxembourg, Macedonia, Malaysia, Mauritius, Morocco, Mozambique, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua,  New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre and Miquelon,Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, and Yemen. .
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392.     Product Usage:  The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: - Complete heart block - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Support following cardiac surgery - Acute myocardial infarction complicated by heart block - Atrial tachyarrhythmias that require high-rate burst pacing for treatment
serial numbers equal or lower than DJH009999P
Medtronic Model 5392 External Pulse Generators (EPGs) could experience a performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy.
There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
ACCU-CHEK Connect Diabetes Management App; Instruction Manual   Designed to transfer data for diabetes management.
The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user.  A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carbohydrate Entry screens.
US Distribution in states of: MO, GA, AZ, NE, TX, and VA.
CD123 (9F5) PE   Catalog number 649453    Analyte Specific Reagent
One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody  and may result in an unexpected staining pattern.
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC,  Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V.   Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.
Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.
Worldwide Distribution: US (nationwide) including all states in continental USA, except DE and including DC and PR; and countries: AUSTRIA, AUSTRALIA, NEW ZEALAND, BELGIUM, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, IRELAND, ITALY, NETHERLANDS, POLAND, PORTUGAL, ROMANIA, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SLAVADOR, PANAMA, and CANADA.
Covidien Trellis'' 6 and Trellis'' 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030.   Product Usage:  The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Medtronic is conducting a voluntary recall of all former Covidien Trellis'' 6 and Trellis'' 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.