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

Distribution Pattern
Direct US customers: IN and OH. NO foreign.
Bertagni product was distributed directly in CA, IL, MI, MN, NY, OH, and OR between 5/11/15 and 11/12/15. Meijer product was distributed in IL, IN, KY, MI, OH, and WI between 6/12/15 to 10/26/15.
Distributed nationwide throughout the U.S.A. Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.
Nationwide Distribution to FL, MO, and WV.
Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.
U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia
Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.
Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom
US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.
Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Nationwide U.S. distribution through online sales. No foreign distribution.
Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada
AL, AZ, CA, CO, CT, FL, HI, IL, IN, LA, MD, MA, MO, NY, NC, OH, TN, TX, VT, WA
Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.

Product Description
causing misuse and feed contamination. No labeling, all products in tanker trucks.
bulk custom ordered animal feed for swine
Alfalfa Hay, Square-baled, Bound with reddish-orange twine, weighing approximately 70 lbs.
Meijer frozen Butternut Squash Ravioli, product is packaged in a paper box, net weight 12 oz., UPC 760236398479
Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139.
Raw Meal Organic Vanilla Spiced Chai Powder; Organic Shake and Meal Replacement; 909 g, 455 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each). Packaged in plastic bottle with colored label.
Raw Meal Organic Chocolate Powder; Organic Shake and Meal Replacement; 986 g, 493 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
Raw Meal Organic Original Powder; Organic Shake and Meal Replacement; 908 g, 454 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz. The responsible name on the label is Nuwati Herbals Inc., House Springs, MO.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
Dimension Assays: Direct HDL Cholesterol (AHDL)
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Dimension Vista Assays: Enzymatic Creatine (ECRE)
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Dimension Vista Assays: Triglycerides (TRIG)
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Advia Chemistry Assay: LDL Cholesterol, Direct
Dimension Vista Assays: Uric Acid (URCA)
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments
Imperial Choice Mandarin Oranges Broken Segments in Light Syrup; Net WT. 11 oz.; Imported by Acme Food Sales, Seattle, WA 98108; Product of China; 4200/01029; PRO: DEC 21, 2013; Best By: Dec 21, 2016
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Granna's 808 French Toast, Diced Potatoes, Mandarin Oranges in three compartment black, plastic tray, stored frozen
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Axial Torque Limiting Driver Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Product Quantity
LaCrosse, IN up to 13,644 ton; Reynolds, IN up to 8,383 ton; Flora, IN up to 8,553 ton
Total (including all flavors) of 422,923 bottles/units
9,817 batteries (8,170 with monitors and 1,647 as spare parts)

Reason for Recall
causing misuse and contamination in animal feed.
Co-Alliance is voluntarily recalling the feed manufactured at the LaCrosse facility between July 1, 2014-September 19, 2014 due to an ongoing Class I recall of the grease that was used in manufacturing the animal feed. The grease is an industrial waste by-product from the manufacturing process for Lasalocid, which is not approved for swine feed.
Product was found to be contaminated with blister beetles which can be deadly to horses.
Meijer frozen Butternut Squash Ravioli is recalled because product may contain undeclared cashew and almond.
Bertagni fresh Sweet Butternut Squash Ravioli is recalled because the products may contain undeclared cashew and almond.
Products possibly contaminated with Salmonella
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
Failed Dissolution Specifications; three month stability time point.
20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
Greater Pittsburgh Community Food Bank is announcing a voluntary recall of one lot of Imperial Choice Mandarin Oranges Broken Segments in Light Syrup because some of the cans from this lot may leak, bulge or burst open. The product may be contaminated by spoilage organisms or pathogens, which could lead to serious or life threatening illness if consumed. This recall only affects cans marked wi
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
Product has whey listed on the label, not milk.
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Classic Pesto Sauce (with a twist) is recalled because Parmesan cheese is declared but milk is not declared on label.
Lemon Pesto Sauce recalled because parmesan cheese is declared but milk is not declared on label.
Discoloration: presence of atypical yellow discoloration of the solution .
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Failed Impurities/Degradation Specifications; 12 month stability time point
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
in the system setting - scanner options.
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.
Incorrect component used to manufacture distal femoral replacement.
Bradshaw is recalling 1st Generation Axial Torque Limiting Driver because the firm became aware of a component failure that had the potential to cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Potential of an allergic reaction in a patient with nickel sensitivity.
Undeclared whey protein containing the allergens of milk and soy lecithin.
Instructions for use booklet may puncture the outer Tyvek lid.
Galileo Echo automated blood bank analyzer, with potentially incorrect Color Level settings, were identified and corrected.
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

Code Info
bulk custom feed produced and distrbuted between July 1, 2014-September 19, 2014
Product distributed on or after August 11, 2015
Expiration date: 11/5/2016 Lot code: 519 E
Expiration dates from 8/3/16 to 1/29/17. Lot codes: 506B, 508C, 511D, 512C, 513B, 516B, 520A, 522B, 522F, 523B, 523C, 529C, 530F, 531F, 535C, and 536A. The lot code is interpreted as below: Example 506B: 5=2015; 06= week 6 of the year; B= second day of the week (Tuesday)
Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
Cholesterol_2 (CHOL2): 74719 Cholesterol_concentrated (CHOL_c): 74718
Device Listing: Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated (UA_c) - D033081, Catalog # 74715
Device Listing: D 044702 - Direct HDL Cholesterol (AHDL), Catalog # DF48B
Device Listing: D011436 Uric Acid (URCA), Catalog # DF77
Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A
Device Listing: D089144 Enzymatic Creatinine (ECRE), Catalog # K1270A
Device Listing: Direct HDL Cholesterol: D126055; Catalog # 74073
Device Listing: D089144(Enzymatic Creatine (ECRE) Catalog # DF270B
Device Listing: D011436 - Triglycerides (TGL), Catalog # DF69A
Device Listing: D126071, Triglyceride_2, Catalog # 74082 Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084
Device Listing: LDL Cholesterol, Direct: D126056; Catalog # 74028
Device Listing: D011436 - Uric Acid (URCA), Catalog # K1077
Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330
Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721
Device Listing: D011286 Triglycerides (TGL), Catalog # DF69A
Product # 016400; All SNs, irrespective of production date. Product # 010520; All SNs with production date starting 14.14
Product Code: 808; Best By Dates 04/05/2016 through 04/05/2017
Device Identifier: PIN 19960, Lot: 19960