Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX;  and, the country of Canada.
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748.     Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.
Product is distributed by Euro USA Food Distributor
Picnic Gourmet Spreads ( Moroccan Cilantro Cheese Spread) 8 oz containers .12 Containers per case
Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854
Picnic Gourmet Spreads ( Red Pepper Feta Cheese Spread) 8 oz containers .12 Containers per case
Picnic Gourmet Spreads ( Parmesan Cheese Spread) 8 oz containers .12 Containers per case
Picnic Gourmet Spreads ( Tandoori Garlic Cheese Spread) 8 oz containers .12 Containers per case
Picnic Gourmet Spreads ( Herbed Goat Cheese Spread) 8 oz containers .12 Containers per case
RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
Philips Electronics North  America Corporation
US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.
Welcome Home Jerky Duck, Item No. 15104, 15106, Sku No. 328408, 328409, Bag Wt. 12oz, 25.5oz
Centinela Feed & Pet Supplies is recalling Home Duck Jerky & Duck Treats because they may contain trace amounts of antibiotics.
Welcome Home Duck Jerky, Item No. 10204, 10206, Sku No. 318384, 318385, Bag Wt. 14oz, 30 oz
Welcome Home Duck Sticks, Item No. 102012, 10214, Sku No. 318388, 318389, Bag Wt. 14oz, 42oz
Worldwide Distribution - US (nationwide) and to the countries of : Guam,  United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic,  France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom
2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US
The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices.  The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Cyclosporin 1% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Tacrolimus 0.03% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Cyclosporin 0.2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Methocarbamol 100mg/mL Injection, packaged in 50 mL sterile glass vials, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Cyclosporin 2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution, packaged in 2.5 mL and 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Tacrolimus 0.02% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Whole Foods Market Midwest Distribution Center  480 West 45th Street Munster, IN 46321
Tofu Curry Cous Cous Salad packaged in a clear plastic 16 oz box with a white and green label with black lettering.
Undeclared Allergens. The Tofu Curry Cous Cous Box salad label does not declare peanuts, soy, and eggs.
Specialty Commodities, Inc. is recalling a specific lot of Flax Meal that may be contaminated with Salmonella typhimurium.
AZ, CA, CO, DE, GA, ID, IL, IN, MA, MI, MN, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT AND WA  Canada
Halo Spot's Stew Wholesome Turkey Recipe Sensitive Formula for Cats (Dry Cat Kibble)
3 lbs. All Lots with Best by Date of 09/04/2016  6 lbs. All Lots with Best by Date of 09/04/2016
Product was shipped to the following states: AK, CA, FL, GA, IL, IN, KS, MD, MI, MN, MS, NC, NH, OH, PA & TX.
ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4
The firm was notified by their supplier that the Flax Meal delivered to them test positive for Salmonella Typhimurium.
USA: CA  CO  FL  GA  IL  IN  KY  MA  MD  MI  MN  NC  NE  NJ  NV  NY  OH  PA  RI  SC  TX  WA    Canada
Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820
Best If Used By: April 24, 2016 and July 24, 2016.
The shrimp powder is manufactured in Thailand and imported to the United States by Eastland. Eastland then distributes the shrimp powder nationwide to retail stores.
The New York Department of Agriculture and Markets notified Eastland Food Corp. that they analyzed a sample of the shrimp powder and determined that the product contained FD&C Yellow #6, but the label failed to declare its presence. Yellow #6 can cause an allergic reaction for a small population of individuals.
IL, TX, CA, WA, NJ, FL, IN, NY, KY, OH, PA, SC, OK
Fritz Aquatics Mardel Coppersafe Provides Relief From Unwelcome Parasites Net 1 Gallon (3.8L)  Treats 3024 Gallons; Fritz Aquatics Mardel Coppersafe Provides Relief From Unwelcome Parasites Net 16 FL OZ (473mL) Treats 378 Gallons; NDC: 53745-013-38; OTC
Incorrect dosage instructions were printed on the labels. Upon use, the incorrect instructions would result in a 217% increase in active ingredient concentration.
Lot Number: 2824FID101 Expiration: 10/9/2016 and 3244FID101 Expiration: 11/20/2016
The recall product was distributed in Colorado and Texas
East-West Classic Sweet & Sour Sauce, 12 fl. Oz., Glass bottle, 6/case, Refrigerate after opening, Distributed by East-West Specialty Sauces, Inc. Denver, CO 80204
East-West Specialty Sauces is recalling Classic Sweet & Sour Sauce due to mislabeling.  The  Zesty Orange sauce had been mislabeled with Sweet & Sour labels East-West Specialty Sauces is recalling Classic Sweet & Sour Sauce due to mislabeling.  The  Zesty Orange sauce had been mislabeled with Sweet & Sour labels which presents a potential wheat and soy allergen issue.
Whole Foods Market Raspberry Brownie;   sold as a single item (2. oz.) or a 4 pack (15 oz.);    Ingredients: Unbleached wheat flour, sugar, butter (pasteurized cream, salt), eggs, cocoa, vanilla, raspberry preserves (raspberries, sugar, fruit pectin, citric acid), baking soda and seal salt, non-stick spray (soy, soy lecithin) Contains: wheat, milk, soy, eggs.    Whole Foods, Emeryville, CA.    UPC - single:  0022241800000  UPC 4-pack:  0024374200000, 0024374800000
Metal shavings were found around the perimeter of brownies purchased by customer.
Whole Foods Market Peanut Butter & Yah Brownie;  Sold as Single- 3. oz and 4 pack  15 oz;.     Ingredients: Ingredients: Cane sugar, cage free eggs, expeller pressed canola oil, unbleached wheat flour (wheat flour, malted barley, flour, niacin, iron, folic acid) cocoa powder (processed with Alkali) semi-sweet chocolate (unsweetened chocolate, sugar, anhydrous dextrose, soy lecithin, vanilla), butter (milk, salt) pure vanilla, peanut butter (peanuts, salt). Contains wheat, eggs, milk, soy, peanuts.    Whole Foods, Emeryville, CA.    UPC - single: 0023426200000;  UPC - 4-pack: 0024374000000;
Whole Foods Market Tart Key Lime Square  Net wt 16 oz.     Whole Foods, Emeryville, CA.    UPC - 0022263800000
Whole Foods Market Brownie Choc Full O' Nuts;   Sold as single (2 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour,  sugar, butter (pasteurized cream, salt), cream, eggs, cocoa, vanilla, non GMO corn syrup, walnuts, baking soda and seal salt. Non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs, treenuts.     Whole Foods, Emeryville, CA.    UPC -  single: 0024373100000; 0024373200000;  UPC - 4-pack: 0024365400000; 0024374300000.
Whole Foods Market Crazy for Cream cheese Brownie;   Sold as single (4 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour, cocoa, vanilla, sugar, butter (pasteurized cream, salt), eggs, cream cheese (pasteurized milk and cream cheese culture, salt, xanthan and or carob bean stabilizer) sugar, butter (cream, salt) baking soda and sea salt, non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs.     Whole Foods, Emeryville, CA.    UPC -  single: 0024044800000, 0024369200000,   UPC - 4-pack: 00243693000000; 0024369400000.
Whole Foods Market Salted Caramel Swirl Brownie;   Sold in 4-pack (15 oz.)    Ingredients: cane sugar, cage free eggs, expeller pressed canola oil, unbleached wheat flour (wheat flour, malted barley, flour, niacin, iron, folic acid) cocoa powder (processed with alkali), semisweet chocolate (unsweetened c chocolate, sugar, anhydrous dextrose, soy lecithin, vanilla) butter (milk, salt),  pure vanilla, salt, caramel (non GMO corn syrup, S,C, whole milk (milk, skim milk, sugar) evaporated milk (milk, dipotassium phosphate carrageenan, Vitamin D3) sugar, water, palm oil, cream monodiglycerides, salt, soy lecithin, disodium phosphate,  natural flavors, salt. Contains  eggs, milk, soy, wheat.     Whole Foods, Emeryville, CA.    UPC - 4-pack: 0024375100000; 0024829300000.
Whole Foods Market Brownie Double Trouble;   Sold as single (2 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour,  sugar, butter (pasteurized cream, salt), cream, eggs, cocoa, vanilla, baking soda and seal salt. Non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs.     Whole Foods, Emeryville, CA.    UPC -  single: 0024370300000; 0024829300000  UPC - 4-pack: 0024370000000;
Stryker Medical Division of Stryker Corporation
Worldwide Distribution - US Nationwide and the countries of   Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.
Potential for power cord to melt; hazards include electric shock and fire.
model number: 2920-000-000  units serialized
3 Consignees in NY, PA, MN.  No foreign, VA/govt.
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension,  Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL,  805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD.    Product Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
Software Version 3.2 and below; Serial Numbers J56000024  - 56002339
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Software Version 3.2 and below; Serial Numbers J46000001 - 46000678
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD.    Product Usage:  The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Software Version 9.4 and below; Serial Numbers J27000001 - 27004539
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
BD Intelliport Medication Management System Sensor    The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.
The sterility of the product cannot be assured. This may result in increased risk of infection.
Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor.     The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording.    Affected Product Names and Part Numbers:    -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10)  -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10)  -MAC   S3: 0574-0132 (single blade) or 0270-0771 (box of 10)  -MAC   S4: 0574-0133 (single blade) or 0270-0772 (box of 10)    The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
7733 units (6377 units in the US and 1356 units International)
appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Nationwide Distribution including    AL  AR  AZ  CA  CO  CT  DE  FL  GA  IA  ID  IL  IN  KY  LA  MA  MD  MI  MN  MO  MS  MT  NC  ND  NE  NH  NJ  NM  NV  NY  OH  OK  OR  PA  RI  SC  TN  TX  UT  VA  VT  WA  WI  WV
Super Arrow-Flex Percutaneous Sheath Introducer Sets    REF CL-07035 or CL-07635 or CL-07735 or CL-07835  Super Arrow-Flex  Percutaneous Sheath Introducer Set  with Integral Hemostasis Valve/Side Port  and Radiopaque Tip Marker Band  Contents:  1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque  with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator  1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr.  Rx only.    The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela
Iris International noted loose or missing analyte pads  found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.
Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation    The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
Components of the DVR ePAKs can oxidize during shipment and storage prior to use.  A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product.   If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body r
All Lots.    Part number:                    Description:   811810050 	DVR EPAK EX NRW LOCK PLT RIGHT  811811040 	DVR EPAK NRW MINI LOCK PLT R  811811050 	DVR EPAK NRW LOCK PLT R  811812040 	DVR EPAK MINI LOCK PLT R  811812050 	DVR EPAK DIST VLR PT STD R  811812060 	DVR EPAK DISTAL VLR PLT MED RT  811812090 	DVR EPAK DISTAL PLT LONG RT  811812125 	DVR EPAK EXT LONG LOCK PLT R  811812175 	DVR EPAK EX-EXT LONG LK PLT R  811813050 	DVR EPAK WIDE LOCK PLT R  811814050 	DVR EPAK VOLAR RIM PLATE RIGHT  811815050 	DVR EPAK VOLAR RIM NRW PLT RT  811817050 	DVR EPAK DORSAL PLATE STD RT  811817150 	DVR EPAK DORSAL PLATE WIDE RT  811818060 	DVR EPAK RADIAL PLT STD RIGHT  811818160 	DVR EPAK RADIAL PLATE WIDE RT  811820050 	DVR EPAK EX NRW LOCK PLT LEFT  811821040 	DVR EPAK NRW MINI LOCK PLT L  811821050 	DVR EPAK NRW LOCK PLT L  811822040 	DVR EPAK MINI LOCK PLT L  811822050 	DVR EPAK LOCK PLT L  811822060 	DVR EPAK MEDIUM LOCK PLT L  811822090 	DVR EPAK LONG LOCK PLT L  811822125 	DVR EPAK EXT LONG LOCK PLT L  811822175 	DVR EPAK EX-EXT LONG LK PLT L  811823050 	DVR EPAK WIDE LOCK PLT L  811824050 	DVR EPAK VOLAR RIM PLATE LEFT  811825050 	DVR EPAK VOLAR RIM NRW PLT LT  811827050 	DVR EPAK DORSAL PLATE STD LEFT  811827150 	DVR EPAK DORSAL PLATE WIDE LT  811828060 	DVR EPAK RADIAL PLATE STD LEFT  811828160 	DVR EPAK RADIAL PLATE WIDE LT  811839050 	DVR EPAK ULNA PLATE BILATERAL  811899001 	DVR EPAK RIGHT DNI  811899002 	DVR EPAK LEFT DNI  811899003 	EPAK DVR C/LCK VOLR RIM RT DNI  811899004 	EPAK DVR C/LCK VOLR RIM LT DNI  811899005 	EPAK DVR DORSAL PLATE RT DNI  811899006 	EPAK DVR DORSAL PLATE LT DNI  811899007 	EPAK DVR RDL COLUMN PLT RT DNI  811899008 	EPAK DVR RDL COLUMN PLT LT DNI  811899009 	EPAK DVR ULNA PLT BILAT DNI  811911050 	DVR EPAK NRW LOCK PEG RT  811912050 	DVR EPAK LOCK PEG RT  811913050 	DVR EPAK WIDE LOCK PEG RT  811921050 	DVR EPAK NRW LOCK PEG LT  811922050 	DVR EPAK LOCK PEG LT  811923050 	DVR EPAK WIDE LOCK PEG LT  811999001 	DVR EPAK PEG RIGHT DNI  811999002 	DVR EPAK PEG LEFT DNI
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.
Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.
All products were distributed to SCA North America in both the US and Canada
ULTRA Washcloths - 48 count wipes per pack; ULTRA Washcloths Scent Free - 48 count wipes per pack; Ultra Flush Washcloths - 48 count wipes per pack; ULTRA Adult Wipe - 48 count wipes per pack. All packaged in flexible plastic.
Odor reported in a complaint is characteristic of product spoilage.
Date range being recalled is June 1, 2015 (1525 R) to December 31, 2015 (3655 R)
Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag.    Catalog #: GIS-28  Lot #: 61442434  Expiration Date: 2018/04
Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77
Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77
Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood and Blood Products for Reprocessing
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Worldwide Distribution - US including CA, NY, VA, IL, IN, SC, NC, AR, MO, ND, AL, PA, MI, WA, OR, LA, FL, GA, OH, KS, KY, TX, MA, AZ, NJ, UT, IO, NM, WV, MS, NE, and MD   OUS: Australia, Chile, Columbia, Costa Rica, Argentina, Korea, Japan, Panama, Malaysia, Puerto Rico, Canada, and The Netherlands.
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor)  Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied by Kirkstall Precision was made according to the W1.4034 (420 stainless) which does not conform to 420 S29 indicated on the print.  All units manufactured to date were manufactured using 420 stainless. Therefore, all lots of PN: 402852 are considered in scope.
Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202,  Trilogy EC, Garbin, Garbin Plus    Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
11 digit S/N begginning with GV or TV; also TGY1D01463
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Bean Snacks (NA-PIA-JO), Net Wt. 10.60 oz (300G), 50 bgs/case
TF Foods is recalling Bean Snacks because it contains undeclared peanut allergen.
Refrigerated, fresh, Panko breaded cod fillet packed in blue foam tray with plastic overwrap. Label reading:  Giant Eagle Japanese Breaded Cod Fillet various weights.  Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238  Sold from August 2015 to present with various expiration dates.
All lot codes up to and including February 8, 2016 of Giant Eagle brand Japanese Breaded Cod Fillets, prepared and sold from the Seafood department inside Giant Eagle and Market District supermarkets through February 4, 2016 have been voluntarily recalled by Giant Eagle due to an undeclared soy allergen.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System  contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921.    The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.
Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.
Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags
Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .
LightSpeed 16 (MDAS only  , , 2339985  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging s
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
LightSpeed Ultra (8-slice MDAS), 5120327-3    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic im
Discovery LS, 2286327    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slic
Discovery ST, , 2339985  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slic
LightSpeed Plus (4-slice MDAS  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Mfg Lot or Serial #	System ID  00000002493PT5	0850450029
LightSpeed QX/I (4-slice MDAS)    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system
One distribution center in Tennessee. Product was further distributed to other distribution centers in Tennessee, Kentucky, and Louisiana.
Land O Lakes, Fresh Buttery Taste Spread, 48% Vegetable Oil Spread, A product of Land O'Lakes Inc. Arden Hills, MN. Packaged in 5 gram plastic cups.
Cases of 5 gram portion cups of margarine for the food service market were distributed without label information. The cups therefore failed to disclose the margarine contained the allergens milk and soy.
Production date J28115 Lot number 150528116
US Distribution only: AZ, WA, MN, CA, CT, FL, NV, UT, MA, PA, CO. MS, GA, NY, TX, IL, OH, OR, KS, MO, NC, ID, VA
Living Tree Community Foods Organic Macadamia Butter, 8 oz. glass jar.  Certified Organic.  UPC 64143200987
Recall of macadamia nuts and macadamia butter after notification by immediate supplier that the product is under recall due to potential contamination Salmonella
Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch.  Certified Organic
Worldwide Distribution US (nationwide) and Internationally to:  Canada  AR                    AU                    BD                    BR                    CA                    CH                    CL                    CN                    CO                    DO                    EC                    GT                    HK                    ID                    IE                    IL                    IN                    JP                    KR                    LK                    MM                    MX                    MY                    NI                    NP                    NZ                    PE                    PH                    PY                    SA                    SG                    TH                    TW                    UY                    VN                    ZA
ADVIA Centaur Systems Calibrator E Lot  42  and 43 Bias with the Testosterone Assay
Scrub-Stat 4 (chlorhexidine gluconate) Foam  Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
Arrow International, Inc., Division of Teleflex Medical Inc.
Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
King Soopers City Market GOURMET BREAD PUDDING; Various Sizes, INGREDIENTS: HALF & HALF***APPLES, LIQUID EGG***SPICES, SALT***RAISINS, CINNAMON. CONTAINS EGG, MILK, SOY, WHEAT; UPC 2 47460 0XXXX
Product is being recalled due to undeclared walnuts.
distributed in AK, AZ, CA, CO, ID, IL, MA, MT, NE, NV, NY, OR, and WA.
613 cases of 1.3oz, 3,231 cases of 4oz, 247 cases of 8oz.
Best By dates starting 2.01.16 through 8.01.16.
Throughout the US in the following states: MA, OH, WI, IN, MS, AR, OK, MO, AZ, AL, NM, TX, FL, IA, ME, IL, VA, NY, PA, GA
Bertolli Extra Virgin Olive Oil, 8.5 oz. and Carapelli Extra Virgin Olive Oil, 25.5 oz., packaged in glass bottles.
The product is being recalled due to the detection of trace amounts of two pesticides, Trifloxystrobin and Tebuconazole, that do not have a tolerance in the US for olive oil.
U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL  No foreign distribution.
Urban Oven   Artisan-Baked Short Bread Cookies  Lemon Pistachio  All Natural  NET WT. 5 oz    UPC Code: 7 18122 06374 1  SKU #: C4000
Urban Oven, LLC is recalling Urban Oven Butter Cookies, Cocoa Cookies, Pecan Cookies, and Lemon Pistachio Cookies because it does not declare milk on the label from the ingredient butter.
Urban Oven   Artisan-Baked Short Bread Cookies  Classic Butter  All Natural  NET WT. 5 oz.    UPC Code: 7 18122 06344 4  SKU #: C1000
Urban Oven   Artisan-Baked Short Bread Cookies  Pecan   All Natural  NET. WT. 5 oz.    UPC Code: 7 18122 06364 2  SKU #: C3000
Urban Oven   Artisan-Baked Short Bread Cookies  Cocoa  All Natural  NET Wt. 5 oz.    UPC Code: 7 18122 06354 3  SKU #: C2000
The product was shipped to 2 U.S.  firm ins: Cereal Ingredients Inc. 4720 S. 13th St, Leavenworth Kansas, 606048 and Rohtstein Corp, Walnut Hill Station, 70 Olympia Ave, Woburn, Mashachusetts. The product was also distributed to foreign firms, please see attached documents.
Cornstach packaged in a 50lb. bag with white and green label containing black lettering.
1, 402, 243 lbs. of product. product was shipped in 50 lb. bags.
Food grade Cornstarch may contain metal fragments >1 mm in width and up to 50 mm in length.
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541    Intended to fill a endontontically obturated root canal treatment
Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3.  The products outer package is identified as SM3 which matches the product inside.
MD, MI, MN, NJ, and TX.  Outside the US to include:  Canada
Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG)
Clasen Quality Coatings received notification of a positive Listeria monocytogenes micro test in NH Atlas 1M Creamy Peanut Drop.
8pk Strawberry Waffy Wafers, Global Brands item UPC 876274000806  BB 8/14/16 20142nj, BB 10/27/16 20145nj
Dollar Only Wholesale is recalling Strawberry Wafers because it may contain undeclared FD&C Red#3 and Yellow#6.
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Medtronic 0-arm 02 Imaging System  Catalog Number: Bl-700-02000  The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.    The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
Hartley Medical Center Pharmacy, Incorporated
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/  Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml,   vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml,  vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long Beach, CA
Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only,  Hartley Med Ctr Pharmacy, Long Beach, CA
Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml,   vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
CARROLL SHELBY'S(R) ORIGINAL TEXAS BRAND White CHICKEN CHILI KIT, NET WT 3 OZ (85g), DIST. BY REILY FOODS COMPANY, NEW ORLEANS, LA 70130, UPC 7239610019
Cartons of Carroll Shelby White Chicken Chili (3oz retail carton) produced before 03/03/2015 state that the sodium per serving was 0 mg, the correct amount is 590 mg per serving.
US Distribution to the states of : OR and NY
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
The products have been identified to contain an incorrect size Diaphragm.
Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only.  Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
Worldwide Distribution-US (nationwide) including DC and  PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.
Denali Filter-Jugular/Subclavian Delivery System  Product Code: DL900J/DL950J;  Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
Product #     Lot #  DL900J	GFZJ0450  DL900J	GFZJ0452  DL900J	GFZJ0455  DL900J	GFZK0303  DL900J	GFZJ0454  DL900J	GFZK0304  DL900J	GFZK0306  DL950J	GFZJ1176  DL950J	GFZJ1177  DL900J	GFZK0309  DL900J	GFZK0305  DL900J	GFZK0308  DL900J	GFZJ0456  DL900J	GFZK0307  DL900J	GFZJ0460  DL900J	GFZJ0459  DL900J	GFZK0310  DL900J	GFZK0311  DL900J	GFZK0314  DL900J	GFZK0313  DL900J	GFZK0312  DL900J	GFZK0315  DL900J	GFZK0316  DL900J	GFZK0317  DL900J	GFZK0358  DL900J	GFZK0318  DL900J	GFZK0319  DL900J	GFZK0360  DL900J	GFZK0361  DL950J	GFZK0350  DL900J	GFZK0359  DL900J	GFZK0362  DL900J	GFZK0363  DL900J	GFZK0365  DL900J	GFZK0344  DL900J	GFZK0345  DL900J	GFZK0346  DL950J	GFZK2376  DL900J	GFZK3551  DL900J	GFZK3553  DL900J	GFZK3555  DL900J	GFZK3552  DL900J	GFZK3554  DL900J	GFZK3557  DL900J	GFZK0340  DL900J	GFZK0341  DL900J	GFZK0342  DL900J	GFZK0343  DL900J	GFZK0348  DL900J	GFZK0349  DL900J	GFZK3556  DL900J	GFZK0347  DL900J	GFZK3558  DL900J	GFZK3559  DL900J	GFZK3560  DL900J	GFZK3561
Denali Filter-Femoral Delivery System  Product Code: DL900F/DL950F;  Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Product #      Lot #  DL900F	GFZJ0276  DL900F	GFZJ0278  DL900F	GFZJ0277  DL900F	GFZJ0279  DL900F	GFZJ0421  DL900F	GFZJ0425  DL900F	GFZJ0430  DL900F	GFZJ0432  DL900F	GFZJ0429  DL950F	GFZJ0223  DL900F	GFZJ0433  DL900F	GFZJ0434  DL950F	GFZJ1174  DL900F	GFZJ0436  DL900F	GFZJ0435  DL900F	GFZJ0442  DL900F	GFZJ0443  DL900F	GFZK0287  DL900F	GFZJ0446  DL900F	GFZK0291  DL900F	GFZK0288  DL900F	GFZJ0444  DL900F	GFZK0290  DL900F	GFZK0289  DL900F	GFZK0292  DL900F	GFZK0294  DL900F	GFZK0296  DL900F	GFZK0293  DL900F	GFZK0294  DL900F	GFZK0297  DL900F	GFZK0295  DL900F	GFZK0299  DL900F	GFZK0298  DL900F	GFZK0300  DL900F	GFZK0301  DL900F	GFZK0302  DL900F	GFZK0351  DL900F	GFZK0352  DL900F	GFZK0356  DL900F	GFZK0355  DL900F	GFZK0357  DL900F	GFZK0337  DL900F	GFZK0354  DL900F	GFZK0338  DL900F	GFZK0364  DL900F	GFZK0339  DL950F	GFZK2368  DL900F	GFZK3526  DL900F	GFZK0367  DL900F	GFZK3527  DL900F	GFZK3524  DL900F	GFZK3525  DL900F	GFZK0328  DL900F	GFZK0330  DL900F	GFZK0331  DL900F	GFZK0332  DL900F	GFZK0333  DL900F	GFZK0334  DL900F	GFZK3523  DL900F	GFZK0336  DL900F	GFZK0335  DL900F	GFZK3528  DL900F	GFZK3529  DL900F	GFZK3530  DL900F	GFZK3538  DL900F	GFZK3543  DL950F	GFZK2369
Armed Forces Americas except Canada; California
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Apheresis product, for which the attached label was missing required information was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed
Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.
distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
total 1075 units (614 units in the US and 461 outside the US)
The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.
Mississippi Valley Regional Blood Center
Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed.
Apheresis Plasma Frozen withing 24 hours After Phlebotomy
Plasma Frozen within 24 Hours After Phlebotomy (FP24)
Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis Plasma Frozen withing 24 Hours After Phlebotomy
Plasma Frozen Within 24 Hours After Phlebotomy (FP24)
Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI.
Mobile wDR motorized portable diagnostic X-ray systems.  Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.