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Showing 23481–23500 of 29086 results

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RENASYS EZ/ RENASYS EZ Plus (Smith & Nephew, Inc.) – renasys ez canisters exhibiting visib... (2014)

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Prismaflex HF 1000. Product number 107140. Each set is pa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide

• Gambro Renal Products, Incorporated

RENASYS EZ/ RENASYS EZ Plus (Smith & Nephew, Inc.) – renasys ez canisters exhibiting visib... (2014)

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

RENASYS EZ Canister (Smith & Nephew) – Inlet Port Deformation (2014)

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Class IIModerate

FDAJul 18, 2014Nationwide• Smith & Nephew, Inc.

Prismaflex HF 1400 (Gambro) – Connector Breakage (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Pedi-Pak Pedi-Syringe Filter (Genesis BPS, LLC.) – genesis bps is recalling numerous dev... (2014)

Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

Class IIModerate

FDAJul 17, 2014Nationwide• Genesis BPS, LLC.

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Pa... (Zimmer, Inc.) – zimmer dental is recalling the tapere... (2014)

Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

Class IIModerate

FDAJul 17, 2014Nationwide• Zimmer, Inc.

Tetrahydrozoline HCL (SST) – CGMP deviation (2014)

CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Class IIModerate

FDAJul 17, 2014CA• SST Corporation

Vital Sync RMS 1.0 when loaded with v2.4 software, packag... (Nellcor Puritan Bennett Inc. (dba Covidien LP)) – covidien is conducting a field correc... (2014)

Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.

Class IIModerate

FDAJul 17, 2014CA, CO, GA +5 more• Nellcor Puritan Bennett Inc. (dba Covidien LP)

Pedi-Pak Pedi-Syringe Filter (Genesis BPS, LLC.) – genesis bps is recalling numerous dev... (2014)

Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

Class IIModerate

FDAJul 17, 2014Nationwide• Genesis BPS, LLC.

Pedi-Pak Pedi-Syringe Filter (Genesis BPS, LLC.) – genesis bps is recalling numerous dev... (2014)

Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

Class IIModerate

FDAJul 17, 2014Nationwide• Genesis BPS, LLC.

Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on... (Nellcor Puritan Bennett Inc. (dba Covidien LP)) – covidien is conducting a field correc... (2014)

Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.

Class IIModerate

FDAJul 17, 2014CA, CO, GA +5 more• Nellcor Puritan Bennett Inc. (dba Covidien LP)

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Ga... (Pentax Medical Company) – the instructions for use for the pent... (2014)

The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

Class IIModerate

FDAJul 17, 2014CA, CO, ID +2 more• Pentax Medical Company

TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part... (TomoTherapy Incorporated) – accuray is voluntarily recalling tomo... (2014)

Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.

Class IIModerate

FDAJul 17, 2014Nationwide• TomoTherapy Incorporated

Siemens Dimension EXL Integrated Chemistry System in vitr... (Siemens Healthcare Diagnostics, Inc.) – the reagent lid hinge may lose its ef... (2014)

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

Class IIModerate

FDAJul 16, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and... (ORTHO-CLINICAL DIAGNOSTICS) – customers may receive positively bias... (2014)

Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.

Class IIModerate

FDAJul 16, 2014Nationwide• ORTHO-CLINICAL DIAGNOSTICS

TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part... (TomoTherapy Incorporated) – accuray is voluntarily recalling tomo... (2014)

Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.

Class IIModerate

FDAJul 16, 2014Nationwide• TomoTherapy Incorporated

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cur... (Novocol, Inc.) – septodont is recalling self-etch bond... (2014)

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

Class IIModerate

FDAJul 16, 2014IN, NY, OR +2 more• Novocol, Inc.

Instructions for Use for the blue endo MOREsolution Elect... (Market-Tiers Inc) – some pages of the instructions for us... (2014)

Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

Class IIModerate

FDAJul 16, 2014Nationwide• Market-Tiers Inc

Darby Dental Supply Compolite Bond SE Self-Etch/Light-Cur... (Novocol, Inc.) – septodont is recalling self-etch bond... (2014)

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

Class IIModerate

FDAJul 16, 2014IN, NY, OR +2 more• Novocol, Inc.

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