Recalling Firm
Philips Electronics North America Corporation
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Stryker Medical Division of Stryker Corporation
Arrow International, Inc., Division of Teleflex Medical Inc.
Hartley Medical Center Pharmacy, Incorporated
Mississippi Valley Regional Blood Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
Product is distributed by Euro USA Food Distributor
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.
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
Whole Foods Market Midwest Distribution Center 480 West 45th Street Munster, IN 46321
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
Product was shipped to the following states: AK, CA, FL, GA, IL, IN, KS, MD, MI, MN, MS, NC, NH, OH, PA & TX.
USA: CA CO FL GA IL IN KY MA MD MI MN NC NE NJ NV NY OH PA RI SC TX WA Canada
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.
IL, TX, CA, WA, NJ, FL, IN, NY, KY, OH, PA, SC, OK
The recall product was distributed in Colorado and Texas
Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.
3 Consignees in NY, PA, MN. No foreign, VA/govt.
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
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.
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
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
Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.
All products were distributed to SCA North America in both the US and Canada
Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
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.
Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
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.
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 .
One distribution center in Tennessee. Product was further distributed to other distribution centers in Tennessee, Kentucky, and Louisiana.
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
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
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).
distributed in AK, AZ, CA, CO, ID, IL, MA, MT, NE, NV, NY, OR, and WA.
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
U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL No foreign distribution.
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.
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
MD, MI, MN, NJ, and TX. Outside the US to include: Canada
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
US Distribution to the states of : OR and NY
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.
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.
Armed Forces Americas except Canada; California
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.
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.

Product Description
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.
Picnic Gourmet Spreads ( Moroccan Cilantro Cheese Spread) 8 oz containers .12 Containers per case
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
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
Welcome Home Jerky Duck, Item No. 15104, 15106, Sku No. 328408, 328409, Bag Wt. 12oz, 25.5oz
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
Cyclosporin 1% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614
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
Tofu Curry Cous Cous Salad packaged in a clear plastic 16 oz box with a white and green label with black lettering.
Halo Spot's Stew Wholesome Turkey Recipe Sensitive Formula for Cats (Dry Cat Kibble)
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
Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820
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
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
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
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;
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.
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.
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.)
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.
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.
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.
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.
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.
Apheresis Platelets, Leukocytes Reduced, Irradiated
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.
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
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 and Blood Products for Reprocessing
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.
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.
Bean Snacks (NA-PIA-JO), Net Wt. 10.60 oz (300G), 50 bgs/case
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.
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.
Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags
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
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.
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
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.
Living Tree Community Foods Organic Macadamia Butter, 8 oz. glass jar. Certified Organic. UPC 64143200987
Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch. Certified Organic
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
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
Carys Dark Chocolate Almond Toffee with Hawaiian Salt. Product is packaged in printed cardboard packages in 1.3 oz , 4 oz, and 8 oz sizes. There are 12 packages per case. UPC 8 31617 00515, net wt. 1.3 oz. UPC 8 31617 00504, net wt. 4 oz. UPC 8 31617 00580, net wt. 8 oz.
Bertolli Extra Virgin Olive Oil, 8.5 oz. and Carapelli Extra Virgin Olive Oil, 25.5 oz., packaged in glass bottles.
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 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
Cornstach packaged in a 50lb. bag with white and green label containing black lettering.
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG)
8pk Strawberry Waffy Wafers, Global Brands item UPC 876274000806 BB 8/14/16 20142nj, BB 10/27/16 20145nj
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.
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
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
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.
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.
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.
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.
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)
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.

Product Quantity
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
7733 units (6377 units in the US and 1356 units International)
613 cases of 1.3oz, 3,231 cases of 4oz, 247 cases of 8oz.
1, 402, 243 lbs. of product. product was shipped in 50 lb. bags.
total 1075 units (614 units in the US and 461 outside the US)

Reason for Recall
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.
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
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Centinela Feed & Pet Supplies is recalling Home Duck Jerky & Duck Treats because they may contain trace amounts of antibiotics.
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).
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.
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.
The firm was notified by their supplier that the Flax Meal delivered to them test positive for Salmonella Typhimurium.
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.
Incorrect dosage instructions were printed on the labels. Upon use, the incorrect instructions would result in a 217% increase in active ingredient concentration.
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.
Metal shavings were found around the perimeter of brownies purchased by customer.
Potential for power cord to melt; hazards include electric shock and fire.
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).
The sterility of the product cannot be assured. This may result in increased risk of infection.
appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
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.
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.
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
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.
Odor reported in a complaint is characteristic of product spoilage.
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.
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
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.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
TF Foods is recalling Bean Snacks because it contains undeclared peanut allergen.
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.
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.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
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.
Recall of macadamia nuts and macadamia butter after notification by immediate supplier that the product is under recall due to potential contamination Salmonella
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Product is being recalled due to undeclared walnuts.
Carys Dark Chocolate Almond Toffee with Hawaiian Salt is recalled because lecithin is declared in the ingredients statement but the Contains statement does not declare soy.
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.
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.
Food grade Cornstarch may contain metal fragments >1 mm in width and up to 50 mm in length.
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.
Clasen Quality Coatings received notification of a positive Listeria monocytogenes micro test in NH Atlas 1M Creamy Peanut Drop.
Dollar Only Wholesale is recalling Strawberry Wafers because it may contain undeclared FD&C Red#3 and Yellow#6.
Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
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.
The products have been identified to contain an incorrect size Diaphragm.
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.
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.
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.
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.
Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed.
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.

Code Info
3 lbs. All Lots with Best by Date of 09/04/2016 6 lbs. All Lots with Best by Date of 09/04/2016
Best If Used By: April 24, 2016 and July 24, 2016.
Lot Number: 2824FID101 Expiration: 10/9/2016 and 3244FID101 Expiration: 11/20/2016
model number: 2920-000-000 units serialized
Software Version 3.2 and below; Serial Numbers J56000024 - 56002339
Software Version 3.2 and below; Serial Numbers J46000001 - 46000678
Software Version 9.4 and below; Serial Numbers J27000001 - 27004539
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
Date range being recalled is June 1, 2015 (1525 R) to December 31, 2015 (3655 R)
11 digit S/N begginning with GV or TV; also TGY1D01463
Mfg Lot or Serial # System ID 00000002493PT5 0850450029
Production date J28115 Lot number 150528116
Best By dates starting 2.01.16 through 8.01.16.
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
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