Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Micro Therapeutics Inc, Dba Ev3 Neurovascular

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

Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada
Domestic: Nationwide in USA; Internationally: Canada
Coverage is predominately the Midwest, specifically Nebraska, Iowa, Kansas, Colorado and South Dakota. Smaller concentration of stores in ND, WY, UT, OK, TX, MN and WI.
Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland
Distributed to direct accounts in the state Missouri.
VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA and District of Columbia
Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
NC, MA, NJ, WI, IA, one customer in England
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
Nationwide. No VA/govt/military, Canadian, or other foreign consignees.
U.S. distribution to the following; AZ, MN and MO.
Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.
Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
Worldwide distribution. U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.

Product Description
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952
Beirut Lift Turnip Pickles Imported & Distributed By: Baroody Import Inc. 1500 B Main Ave. -Clifton, NJ 07011 Tel: 973.3404832 700 g - UPC 642036014141 2 kg - UPC 642036014219 10 kg - UPC
Refrigerated, Ready to Eat Pickles Half Sour packaged in 18 Lb. bulk white plastic bucket labeled in part ***204062**PICKLES HALF SOUR BY LB***
Refrigerated, ready-to-eat sour pickles packaged in a 18 Lb. bulk white plastic bucket labeled in part ***204112**SOUR PICKLES BY LB***
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 10.9 oz. (310g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil Forelka Style**Net Wt. 10.0 oz. (310g)** UPC # 825512 004915
Refrigerated, Ready to Eat Herring Ivasi packaged in Lb. bulk white plastic bucket labeled in part ***204183**HERRING IVASI BY PC***
Refrigerated, Ready to Eat Holland Herring in Oil under firms brand name FRESH SEAFOOD packaged in a 24 oz. (680g) plastic retail container labeled in part ***FRESH**SEAFOOD**Holland Herring in Oil**Net Wt. 24 oz. (680g)*** UPC # 825512008128
Refrigerated, Ready to Eat Mushrooms Maslyata Korolevskie packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204394**MUSHROOMS MASLYATA KOROLEVSKIE POD RUMOCHKU BY LB ***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204883**HERRING DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Cherry Tomatoes packaged in 15 Lb. bulk white plastic bucket labeled in part ***204017**CHERRY TOMATOES BY LB***
Refrigerated, ready-to-eat red tomatoes packaged in a 15 Lb. bulk white plastic bucket labeled in part ***204061**RED TOMATOES BY LB***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204709**HERRING FILLET SUPER DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container labeled in part ***FRESH**SEAFOOD**Pacific Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004946
Refrigerated, ready-to-eat SOUR CABBAGE BY LB packaged in a 25 Lb. bulk white plastic bucket labeled in part ***204023**MARINATED CABBAGE BY LB***
Refrigerated, Ready to Cabbage Boyarskaya packaged in 25 Lb. bulk white plastic bucket labeled in part ***204259**CABBAGE BOYARSKAYA BY LB***
Refrigerated, Ready to Eat Herring Super Dunayskaya packaged in clear vacuum package labeled in part ***204450**HERRING SUPER DUNAYSKAYA IN VACUUM BY PC***
Refrigerated, ready-to-eat Korean Carrot Salad packaged in bulk 25 Lb. white plastic bucket labeled in part ***204034**SALAD KOREAN CARROT BY LB***
Refrigerated, Ready to Eat Salad Izolda packaged in 25 Lb. bulk white plastic bucket labeled in part ***204129**SALAD IZOLDA BY LB***
Refrigerated, Ready to Eat Marinated Shitake Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204138**HERRING IVASI BY PC***
Refrigerated, Ready to Eat Herring in Spicy Brine under firms brand name FRESH SEAFOOD packaged in a 46 oz. (1275g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring in Spicy Brine**Net Wt. 46 oz. (1275g)***UPC # 825512008166
Refrigerated, Ready to Eat Marinated Opyata Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204136**MARINATED OPYATA MUSHROOMS BY LB ***
Refrigerated, Ready to Eat Herring Fillets In Oil under firms brand name FRESH SEAFOOD packaged in a 28.2oz. (800g) plastic retail container labeled in part ***FRESH**SEAFOOD**SUPER DUNAYSKAYA**Herring Fillets in Oil**Net Wt. 28.2 oz. (800g)
Refrigerated, Ready to Eat Salad Pikantniy packaged in 25 Lb. bulk white plastic bucket labeled in part ***204143**SALAD PIKANTNIY BY LB***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204311**HERRING SUPER DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204857**HERRING NORWAY SUPER JUMBO BY PC***
Refrigerated, Ready to Eat Herring Fillets Matjes under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillet Matjes**Net Wt. 16.2 oz. (460g)*** UPC # 825512004960
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004984
Refrigerated, Ready to Eat Red Cabbage packaged in 18 Lb. bulk white plastic bucket labeled in part ***204070**RED CABBAGE BY LB***
Refrigerated, ready-to-eat marinated oyster mushrooms packaged in a 4.5 Lb. small clear plastic bucket labeled in part ***204139**MARINATED OYSTERS BY LB***
Refrigerated, ready-to-eat marinated apples packaged in 15 Lb. bulk white plastic bucket labeled in part ***204022**MARINATED APPLES BY LB***
Refrigerated, Ready to Eat Herring Fillets in Oil Lightly Salted under firms brand name FRESH SEAFOOD packaged in a 16 oz. (454g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillets in Oil Lightly Salted**Net Wt. 16 oz. (454g)***UPC # 825512014044
Trader Joe's Chocolate Orange Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847162
Trader Joe's Chocolate Raspberry Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847122
Misty Fjord Lox, vacuum packed in 4 oz serving size packs.
Misty Fjord Maple Smoked Salmon, vacuum sealed 6 oz plastic packs.
Misty Fjord Lemon Pepper Smoked Salmon, vacuum sealed 6 oz plastic packs.
Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case)
SOFiT Protein Plus Sunflower Seeds Sea Salt; Seeds covered by a crunchy protein shell: NET WT. 1 OZ.
SOFiT Protein Plus Pumpkin Seeds Sesame Garlic, Seeds covered by a crunchy protein shell: NET WT. 1 OZ.
SOFiT Protein Plus Almonds Jalapeno Garlic, whole almonds covered by a crunchy protein shell: NET WT. 1 OZ.
Muscle Milk Pro Series 40 14 oz., 40 g protein; Going Bananas UPC (case): 8-76063-00294-3; UPC (unit): 8-76063-00284-4
Muscle Milk Pro Series 40 14 oz;, 40 g protein Crushin' Cookies. UPC (case): 8-76063-00293-6; UPC (unit): 8-76063-00283-7
Muscle Milk 14 oz Chocolate, 25 g protein. UPC (case): 8-76063-00221-9; UPC (unit): 8-76063-00201-1
Muscle Milk 14 oz. 25 g protein Caramel Kick UPC (case): 8-76063-00214-1; UPC (unit): 8-76063-00219-6
Muscle Milk 10 oz. 18 g protein. Sold in 4 packs Vanilla Creme UPC (case): 8-76063-00272-1; UPC (unit): 8-76063-00262-2
Muscle Milk 10 oz. 18 grams protein. Sold in 4 packs Chocolate; UPC (case): 8-76063-00271-4; UPC (unit): 8-76063-00261-5
Muscle Milk Pro Series 40 14 oz.; 40 g protein Intense Vanilla UPC Case: 8-76063-00291-2; UPC Unit: 8-76063-00281-3
FitPro Go! 14oz Chocolate; 35 g protein UPC Case: 8-5418200328-7; UPC Unit: 8-5418200324-9
Muscle Milk 14 oz., 25 g protein Strawberry; UPC (case): 8-76063-00229-5; UPC (unit): 8-76063-00209-7
Muscle Milk Pro Series 40, 14 oz.. 40 g protein; Knock Out Chocolate UPC (case): 8-76063-00290-5; UPC (unit): 8-76063-00280-6
Muscle Milk 100 Calorie 14 oz Chocolate UPC (case): 8-76063-00575-3; UPC (unit): 8-76063-00565-4
Muscle Milk 14 oz, 25 g protein. Vanilla Creme UPC (case): 8-76063-00222-6; UPC (unit): 8-76063-00202-8
FitPro Go! 14oz, 35 g protein Chocolate Chip Cookies UPC(Case): 8-5418200338-6; UPC Unit: 8-5418200325-6
FitPro Go! 14oz Strawberry; 35g protein UPC (Case): 8-5418200329-4; UPC (Individual): 8-5418200326-3
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
White Wine & Garlic Wine Drizzle, packaged in 5 oz and 8 oz glass bottles, www.winedrizzle.com, Higginsville, MO 64037
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network
Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz
Market Basket Plain Sub (Grinder) rolls-
Market Basket Bulkie Rolls- Plain, Wheat packaged 15.6 oz
, packaged 16 oz. 18, oz, 20 oz, 25 oz, 29 oz
Koffee Kup Hoogie Rolls- Wheat, Sourdough, Potatoe packaged 15 oz and 15.6 and 17 oz
Big Y Plain Grinders- Enriched wheat and Enriched White packaged 15 oz
Koffee Kup Kaiser Rolls: Egg, Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz
Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
Koffee Kup Bar-B-Que Sweet Buns- Plain, Corn, Sesame Seed and Wheat w/Oat Topping, packaged 8 oz.
Koffee Kup Potatoe Hamburger Buns, Plain and Seeded, 8 pk
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows.
On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal.
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature.
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements.
Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Professional Botanicals MealPlex (756 grams) and Veo Natural Pearl 3.0 (378 grams) Ultimate Meal Drinks in Plastic Tub Containers. Dietary Supplement.
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
Bindi Fantasia nel dessert, 7982 Coconut Gran Sorbetto, 1.24 Gal (4.8L), UPC 8 15073 01326 6, Distributed by: Bindi North America, Kearny, NJ 07032
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Fruit 66 Strawberry Melon, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients. UPC 98341-00116.
Fruit 66 Tropical Punch, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients. UPC 98341-00108.
Fruit 66 Passion Fruit Mango, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients. UPC 98341-00109.
Fruit 66 Mixed Berry, 8 FL OZ (240 mL) 100% Juice Non-Carbonated. Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients. UPC 98341-00117.
SOMATOM Definition Flash system, x-ray, tomography, computed
SOMATOM Definition AS system, x-ray, tomography, computed
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
Brownwood Farms Michigan Cherry Preserves 12oz glass bottles and 1 gallon. Private labels: Art's Tavern (Cherry Preserves 12oz).
Brownwood Farms Cherry Raspberry Preserves 12oz glass bottles and 1 gallon.
Brownwood Farms America's Original Cherry Butter 12oz and 22oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Cherry Butter 12oz). Bowers Harbor Vineyards (Cherry Butter 12oz). Crossroads (10oz). Central Market (16oz).
Brownwood Farms Jalapeno Cherry Butter 12oz and 20oz glass bottles and 1 gallon. Private labels: Kimmel Orchard & Vineyard (Jalapeno Cherry Butter 12oz). Benjamin Twiggs (Cherry Pepper Jam 10oz). Central Market (16oz).
Brownwood Farms Pear & Cinnamon Preserves 10oz glass bottles and 1 gallon.
Brownwood Farms Strawberry Preserves 12oz glass bottles and 1 gallon. Private labels: Art's Tavern (Strawberry Preserves 12oz).
Krispy Kreme Doughnuts Original Glazed Doughnuts, 6 count and 12 count boxes.
Fit & Active 100 Calorie Whole Almonds 7 0.63oz bags per retail carton Flexible film bags in paperboard carton
Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.)
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Product Quantity
700 g - 5,580 containers; 2 kg - 1200 containers; 10 kg- 50 pails
3617 12-8oz. bottle cases, 27218 12-16oz. bottle cases, 22241 12-32oz. bottle cases, and 9082 4-gallon cases
35734 cases shipped, 12 x 14 oz. per case
7216 cases - 24 units per case - six-4 packs
21561 cases shipped; 12 x 14 oz. units per case
14024 cases shipped, 12 x 14 oz. containers
42,740 cartons (24 count carton from 7 total lots)
4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.
46,472 unit dose blister cards (10 cards of 10 tablets each)
1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)
132 worldwide distribution (98) of those units in US
27 cases (Lot #6211) and 6 cases (Lot #6265)

Reason for Recall
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
Sampling analysis revealed the product contains undeclared colors (FD&C Red #3 and Red #40).
Beirut Lift Turnip Pickles contain undeclared beet root red color.
Products were recalled due to the potential presence of plastic foreign material.
Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes.
Trader Joe's Co. is recalling all codes of Trader Joe's Chocolate Orange Sticks and Trader Joe's Chocolate Raspberry Sticks because the products may contain more than the stated traces of milk on the label.
Misty Fjord Seafoods LLC is recalling Lemon Pepper smoked salmon, Maple smoked salmon and Lox salmon due to the potential to be contaminated with Listeria Monocytogenes.
The firm issued a press release on May 6, 2016, which encouraged consumers with affected bottles to return the product to the store for a refund. The recall will extend through the wholesale and retail distribution chain via scripted phone notification. The firm has informed distributors/retails to remove the product from shelves and track by using the best by date and sku. Products should be destroyed. The information has been posted on the firm website.
The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1. Products have the potential to be contaminated with Listeria monocytogenes.
Products recalled due to premature spoilage (swelled containers & foul odor).
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
There is a potential for a component failure of the device which could necessitate medical intervention.
Drizzle product contains undeclared milk, a subingredient of a listed ingredient: Parmesan cheese
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Baked bread products may contain foreign material-plastic pieces
ring which may cause the cylinder to leak.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Dietary supplement contains excess amount of fluoride.
Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen.
The EP Catheters may be mislabeled for French size during reprocessing.
Trumpf has identified six incidents of pinched cables.
Potential presence of particulate matter on the blood side of the dialyzer
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Product recalled due to undeclared milk allergen (sodium caseinate).
The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.
1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.
Products contain milk not declared on the label.
Possible piece of plastic in the product.
Walnuts undeclared on outer retail unit carton.
Pieces of plastic and metal discovered within product.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code Info
no lot codes dates of distribution: 3/11/2015-8/12/2015
Lot code in black ink on label: 3/8 & 3/15
Lot code in black ink on label: 3/10 & 3/17
Lot code in black ink on label: 3/9, 3/11, & 3/16
Lot code in black ink on label: 3/9 & 3/16
Gallons with Best By dates between 6/16/16 and 10/11/16 are recalled.
HP Hood Lot numbers:E15336, A16023, F16107.
HP Hood Lot numbers: A16018, B16019, A16112.
Whitacre Spinal Needle, TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015
NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773
Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.
Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656
Lot code of the replacement cylinders, 2016-02-01
All lot codes in the following: Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK
All lot codes in the following kits: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31131141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,MINI-PLUS KIT 31145397 7497-8 S
All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31141586 K-1660-S STD. MINI-KIT STER. 31141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,M
04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20
Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
Lot BMZCE039, Expiration Date 2018-12-31
Lot #6211 with best before date 07/29/18 and Lot #6265 with best before date 09/21/18
There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes are assigned to this part number. The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device
All product on market, any best by date prior to 9/28/2018.
N/A - Product produced on October 20, 2016
Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.