The Recall Desk

Archive

August 2014 recalls

458 recalls were announced in August 2014.

What the numbers show

Critical
18
Severe
90
High
160
Moderate
169
Low
21

Of the 458 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

Which agencies issued them

201–300 of 458

  • ModerateFDA (Devices)·Z-2189-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professiona
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-2322-2014·2014-08-20

    Miceli Dairy Recalls Ricotta Cheese for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento and Dutch Farms Fat Free Ricotta Cheese due to beta lactam residues found in the whey protein concentrate used.

    Product
    Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2316-2014·2014-08-20

    Nutrition Express Recalls Vitamins Due to Excess Folic Acid Content

    Nutrition Express is recalling specific vitamin products because the folic acid content was found to be higher than the label claim.

    Product
    Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186946609).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2326-2014·2014-08-20

    Cool Tropics Rips Slush Recalled Due to Spoilage Bacteria and Yeasts

    Manufacturing Solutions International is recalling specific lots of Cool Tropics Rips Slush, Sour Apple Flavored, because laboratory results revealed spoilage-type bacteria and yeasts.

    Product
    Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE" UPC Code 9 76017 0
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2236-2014·2014-08-20

    Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles

    Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.

    Product
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to ge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2237-2014·2014-08-20

    Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error

    Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.

    Product
    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterpr
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2185-2014·2014-08-20

    Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2215-2014·2014-08-20

    Zimmer Recalls Moore Hip Prosthesis Stems Due to Packaging Failures

    Zimmer, Inc. is voluntarily recalling 68 units of Moore Hip Prosthesis Long Fenestrated Stems because packaging design verification tests failed, allowing stems to breach package trays.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2170-2014·2014-08-20

    Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges

    Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.

    Product
    Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2186-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions

    Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydroceph
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2180-2014·2014-08-20

    Siemens Syngo RT Software Recalled for Sporadic System Crashes

    Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.

    Product
    Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic tre
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2315-2014·2014-08-20

    Nutrition Express Recalls Lindberg B-Complex Vitamins for Folic Acid Labeling Error

    Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the folic acid content was found to be higher than the label claim.

    Product
    Lindberg B-Complex, 50mg, 60 capsules (UPC 092865236601), 120 capsules (UPC 092865236120), 240 capsules (UPC 092865236243).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2188-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • LowFDA (Devices)·Z-2233-2014·2014-08-20

    BD Multi Check CD4 Low Control Recalled for Incorrect Date Labeling

    BD Biosciences is recalling 85 units of BD Multi Check CD4 Low Control due to an incorrect distribution date on the outer box label.

    Product
    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Drugs)·D-1537-2014·2014-08-20

    Pfizer Recalls Depo-Medrol Vials Due to pH Specification Failure

    Pfizer is recalling 93,800 vials of Depo-Medrol (methylprednisolone acetate) because a stability test showed a pH level below the registered specification.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2120-2014·2014-08-20

    Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.

    Product
    GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2304-2014·2014-08-20

    Allegro Original Marinade Recalled for Elevated Yeast Levels

    Allegro Fine Foods Inc is recalling Allegro Original Marinade due to elevated yeast levels that may cause premature spoilage.

    Product
    Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-2176-2014·2014-08-20

    Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power

    AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.

    Product
    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2178-2014·2014-08-20

    Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets

    Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.

    Product
    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2135-2014·2014-08-20

    Enhancement Medical Recalls Injectable Gel Due to Production Process Change

    Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.

    Product
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V508000·2014-08-19

    NABI Recalls 2014 BRT and LFW Buses Due to Fuel Filter Defect

    NABI is recalling 35 model year 2014 BRT and LFW transit buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    NABI — NABI BRT, LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V511000·2014-08-19

    Blue Bird Recalls Non-School Buses with Cracking Wheelchair Lifts

    Blue Bird is recalling 90 non-school buses from 2007-2015 because wheelchair lift platform side plates may crack, posing an injury risk to operators.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, MICRO BIRD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14257·2014-08-19

    Brita Recalls Children's Water Bottles Due to Laceration Hazard

    Brita is recalling about 242,500 children's water filter bottles because the lids can break into sharp pieces, posing a laceration hazard. No injuries have been reported.

    Product
    Brita hard-sided water filter bottle for kids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14258·2014-08-19

    Bexco Recalls Franklin & Ben Mason Cribs Due to Fall and Entrapment Hazards

    Bexco is recalling Franklin & Ben Mason 4-in-1 Convertible Cribs because the front panel can separate from the side panels, creating a gap that poses fall and entrapment risks to children.

    Product
    Franklin & Ben Mason 4-in-1 Convertible Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V510000·2014-08-19

    Blue Bird School Bus Wheelchair Lift Platform Recall

    Blue Bird is recalling certain 2007-2015 school buses because wheelchair lift platform side plates may crack, posing an injury risk to operators.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, MICRO BIRD, CONVENTIONAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V509000·2014-08-19

    Starcraft RV Recalls 2015 Launch Travel Trailers Due to Tire Label Error

    Starcraft RV is recalling 12 model year 2015 16RB Launch travel trailers because the Federal ID label lists incorrect tire pressure, which could lead to a tire blowout.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT LAUNCH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V504000·2014-08-18

    Dakota Air Ride Trailers Recalled for Suspension Pivot Bolt Failure Risk

    Dakota Trailer Manufacturing is recalling 2014 Air Ride Grain and Side Dump trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    DAKOTA GRAIN — DAKOTA GRAIN, DAKOTA SIDE DUMP AIR RIDE GRAIN, AIR RIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V507000·2014-08-18

    Jerr-Dan Recalls Ford Super Duty Trucks Due to Fire Risk

    Jerr-Dan is recalling 2009-2014 Ford F-350, F-450, and F-550 Super Duty trucks modified with specific PTO assemblies. Oil leaks from the PTO pressure switch may soak the exhaust thermal blanket, increasing fire risk.

    Product
    FORD — FORD F-550 SUPER DUTY, F-450 SUPER DUTY, F-350 SUPER DUTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V506000·2014-08-18

    Winnebago Vista and Itasca Sunstar Motorhomes Recalled for Fire Risk

    Winnebago is recalling 2015 Vista and Itasca Sunstar motorhomes because a missing damper plate could allow air to blow out the range flame, potentially causing a propane fire.

    Product
    WINNEBAGO — WINNEBAGO VISTA, ITASCA SUNSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V505000·2014-08-18

    Spartan Emergency Vehicles Recalled for Fuel Filter Defect

    Spartan is recalling 2013-2015 emergency vehicles and chassis because fuel filters may separate, causing the engine to stall without warning.

    Product
    SPARTAN — SPARTAN SB, GLADIATOR, METROSTAR, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E054000·2014-08-18

    Buyers Products Recalls Warning Triangles Due to Wind Instability

    Buyers Products is recalling warning triangles that may blow over in wind gusts, potentially failing to warn other drivers of a stopped vehicle.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V503000·2014-08-15

    Altec Recalls Aerial Devices and Digger Derricks Due to Fire Risk

    Altec is recalling 2000-2013 Aerial Devices and Digger Derricks because a battery equalizer component may conduct electricity and cause a fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·053-2014·2014-08-15

    Whole Foods Recalls Ground Beef Due To Possible E. Coli O157:H7 Contamination

    Whole Foods Market is recalling 368 pounds of ground beef products in Massachusetts due to possible E. coli O157:H7 contamination linked to three confirmed illnesses.

    Product
    Massachusetts Firm Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V502000·2014-08-14

    Jayco Recalls 2014-2015 Precept Motorhomes Due to Fire Risk

    Jayco is recalling 2014-2015 Precept motorhomes because damaged seat wiring may short and cause a fire. Owners should contact dealers for free repairs.

    Product
    JAYCO — JAYCO PRECEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14743·2014-08-14

    Arctic Cat Snowmobiles Recalled for Fuel Leak and Fire Hazard

    Arctic Cat is recalling about 3,260 model year 2014 and 2015 XF 7000 and ZR 7000 snowmobiles because the fuel line assembly can leak, posing a fire hazard.

    Product
    Arctic Cat snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2300-2014·2014-08-13

    Hot Mama's Foods Recalls Edamame Hummus for Listeria Concerns

    Hot Mama's Foods is recalling Trader Joe's Edamame Hummus due to possible Listeria monocytogenes contamination.

    Product
    Edamame Hummus sold under the Trader Joe's brand and packaged in a transparent plastic tub with a white lid and with a net weight of 8 oz (227 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2298-2014·2014-08-13

    Hot Mama's Foods Recalls Chipotle Hummus Due to Listeria Concerns

    Hot Mama's Foods is recalling Chipotle Hummus sold under the Giant Eagle Market District brand due to concerns about possible Listeria monocytogenes.

    Product
    Chipotle Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2301-2014·2014-08-13

    Hot Mama's Foods Recalls Hummus and Dip Products for Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.

    Product
    5 Layer Fiesta Dip sold under the Trader Joe's brand and packaged in a transparent plastic tub with a net weight of 11.5 oz (326 g) or 24 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2297-2014·2014-08-13

    Hot Mama's Foods Recalls Hummus Due to Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.

    Product
    Roasted Red Pepper Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2292-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Potential Peanut Presence

    KIND, LLC is recalling several varieties of KIND and Strong & KIND bars due to the potential presence of peanut protein.

    Product
    STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2291-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Potential Peanut Presence

    KIND, LLC is recalling several protein bar varieties due to the potential presence of peanut protein. The recall covers 12,190 cases distributed nationwide and in Mexico.

    Product
    STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2302-2014·2014-08-13

    Hot Mama's Foods Recalls Hummus Due to Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.

    Product
    Spicy Yellow Lentil Hummus sold under the Eat Well Embrace Life brand and packaged in a transparent plastic tub with a net weight of 10 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2295-2014·2014-08-13

    Hot Mama's Foods Recalls Archer Farms Hummus Due to Listeria Concerns

    Hot Mama's Foods is recalling Archer Farms Traditional Hummus due to concerns about possible Listeria monocytogenes contamination.

    Product
    Traditional Hummus sold under the Archer Farms brand and packaged in either a transparent plastic tub or a white plastic tub with a net weight respectively of 10 oz (283 g) or 2 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2299-2014·2014-08-13

    Hot Mama's Foods Recalls Garlic Hummus Due to Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.

    Product
    Garlic Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials

    Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because the manufacturer is not registered with the FDA.

    Product
    Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1532-2014·2014-08-13

    L-Carnitine Injection Recalled for Lack of FDA Approval and Registration

    Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.

    Product
    L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2290-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Potential Peanut Presence

    KIND, LLC is recalling several Strong & Kind and Kind protein bars nationwide and in Mexico due to the potential presence of peanut protein.

    Product
    STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1526-2014·2014-08-13

    Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1521-2014·2014-08-13

    BCAA 4% Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1528-2014·2014-08-13

    B Complex Injection Recalled for Lack of FDA Approval

    Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

    Product
    B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2293-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Peanut Allergen

    KIND, LLC is recalling several KIND and Strong & KIND bar varieties due to the potential presence of peanut protein.

    Product
    STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2014·2014-08-13

    Alexion Recalls Soliris Vials Due to Visible Particulate Matter

    Alexion Pharmaceuticals is recalling 96,506 vials of Soliris (eculizumab) because the product failed appearance tests for visible particles under labeled storage conditions.

    Product
    SOLIRIS — SOLIRIS (ECULIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V500000·2014-08-13

    GM Recalls 2011-2014 Chevrolet Express and GMC Savana CNG Vehicles

    General Motors is recalling 2011-2014 Chevrolet Express and GMC Savana CNG vehicles due to a potential natural gas leak that could cause a fire or explosion.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2296-2014·2014-08-13

    Hot Mama's Foods Recalls Hummus and Dip for Listeria Concerns

    Hot Mama's Foods is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes contamination.

    Product
    Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2294-2014·2014-08-13

    KIND Recalls Multiple Protein Bars Due to Potential Peanut Presence

    KIND, LLC is recalling several protein bar varieties nationwide and in Mexico due to the potential presence of peanut protein.

    Product
    STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1531-2014·2014-08-13

    FDA Recalls G.A.C. 375 Injection Due to Unregistered Manufacturer

    The FDA is recalling G.A.C. 375 Injection USP because the manufacturing firm is not registered with the FDA as a drug manufacturer.

    Product
    G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2014·2014-08-13

    FDA Recalls Unapproved Lipo 8 Injection Vials Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Lipo 8 Injection USP 200 mg/ml vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1514-2014·2014-08-13

    Janssen Recalls Risperdal CONSTA Due to Sterility Failure

    Janssen Pharmaceuticals is recalling one lot of Risperdal CONSTA (risperidone) 25 mg dose packs due to a sterility failure detected in a stability sample.

    Product
    RISPERDAL CONSTA — RISPERDAL CONSTA (RISPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treat
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2137-2014·2014-08-13

    Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure

    Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.

    Product
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2165-2014·2014-08-13

    ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid press
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V498000·2014-08-13

    Ford F-Series Super Duty Trucks Recalled for Fire Risk

    PJ's Truck Bodies is recalling 2009-2013 Ford F-350, F-450, and F-550 trucks modified with specific PTO assemblies due to an oil leak that poses a fire risk.

    Product
    FORD — FORD F-550, F-450, F-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2289-2014·2014-08-13

    KIND Bars Recalled Due to Potential Peanut Protein Presence

    KIND, LLC is recalling specific lots of KIND Healthy Grains Maple Pumpkin Seed Bars and other bars due to the potential presence of undeclared peanut protein.

    Product
    KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2014·2014-08-13

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.

    Product
    Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and mont
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2164-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fl
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2151-2014·2014-08-13

    Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex

    Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.

    Product
    Latex Dental Dams labeled as Non-Latex Dental Dams
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2140-2014·2014-08-13

    Ortho VITROS 4600 Chemistry System Recalled for Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- 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, r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2014·2014-08-13

    Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect

    Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.

    Product
    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montori
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2303-2014·2014-08-13

    MuscleTech Amino Build Recalled for Potential Egg Cross-Contamination

    Milk Specialties Co is recalling two lots of MuscleTech Amino Build Fruit Punch due to potential cross-contamination with egg protein.

    Product
    MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2158-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 units of Trifurcated Transpac IT Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2153-2014·2014-08-13

    PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

    PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

    Product
    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak

    ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2166-2014·2014-08-13

    PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk

    PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.

    Product
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-1515-2014·2014-08-13

    Sandoz Alprazolam Tablets Recalled for Stainless Steel Metal Particulates

    Mckesson Packaging Services is recalling Sandoz Alprazolam Tablets 0.25 mg due to the presence of stainless steel metal particulates.

    Product
    Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2136-2014·2014-08-13

    X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery

    X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.

    Product
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1520-1014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.

    Product
    Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1519-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer

    Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2139-2014·2014-08-13

    Ortho VITROS 3600 Immunodiagnostic System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2014·2014-08-13

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 5600 Integrated System --- 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 Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2305-2014·2014-08-13

    Beirut Lift Turnip Pickles Recalled for Undeclared Dyes

    Baroody Imports Inc. is recalling Beirut Lift Turnip Pickles because the product contains undeclared FD & C Red #40 and unallowable dye Rhodamine B.

    Product
    Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2147-2014·2014-08-13

    Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors

    Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.

    Product
    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1527-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin injections because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.

    Product
    Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1533-2014·2014-08-13

    FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad

    Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.

    Product
    Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.