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Showing 61941–61960 of 68218 results

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Biomet, Inc.: Compress Short Instruments Anchor Plug Holder, 12mm, stai...

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Spacelabs Healthcare, Incorporated: Ultraview Digital Telemetry Transmitter, Model 90478 The ...

Telemetry Modules are failing to alarm for low heart rate and asystole.

FDAJul 18, 2008Nationwide• Spacelabs Healthcare, Incorporated

Biomet, Inc.: Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedi...

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Biomet, Inc.: Compress/Finn Instrument Set Compress Anchor Plug Assembl...

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Biomet, Inc.: Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthop...

The blades will oxidize after the first cleaning.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Biomet, Inc.: Compress Instrument 13mm Anchor Plug Holder, stainless st...

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 base, 110/120V; Model ...

Local pump controls including start/stop button, select button and manual button may not function.

FDAJul 18, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Facet Technologies: Premier Value Lancing Device. UPC Code: 840986016707, The...

The Alternate Site Cap was not included in the package as indicated on the labeling.

FDAJul 18, 2008Nationwide• Facet Technologies

DiaDexus, Inc: PLAC Test ELISA kit, catalog number 90106, enzyme immunoa...

Product may give Lp-PLA2 values at up to 22% lower than accurate values.

FDAJul 18, 2008Nationwide• DiaDexus, Inc

DiaDexus, Inc: PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, T...

Product may give Lp-PLA2 values at up to 22% lower than accurate values.

FDAJul 18, 2008Nationwide• DiaDexus, Inc

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 base; Model 801764. N...

The units may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.

FDAJul 18, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Synaptic Corp: Synaptic 3600 and 3800 with Cranial Electrical Stimulatio...

Device was distributed without marketing approval.

FDAJul 18, 2008Nationwide• Synaptic Corp

Biomet, Inc.: Compress Instrument Anchor Plug Holder, stainless steel, ...

The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

FDAJul 18, 2008Nationwide• Biomet, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 Base, 100/120V; Model ...

The pumps may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.

FDAJul 18, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 (4 inch diameter Rolle...

Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.

FDAJul 18, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Apogee Medical, Inc: Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. ...

Laceration Risk

Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

FDAJul 17, 2008Nationwide• Apogee Medical, Inc

American Medical Systems: AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Ste...

The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump.

FDAJul 17, 2008LA• American Medical Systems

Spacelabs Healthcare, Incorporated: Ultraview Digital Telemetry Transmitter, Model 91341-09 T...

During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

FDAJul 17, 2008Nationwide• Spacelabs Healthcare, Incorporated

Apogee Medical, Inc: Apogee Intermittent Catheter with Coude tip, 12 Fr 16", C...

Laceration Risk

Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

FDAJul 17, 2008Nationwide• Apogee Medical, Inc

Apogee Medical, Inc: Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1...

Laceration Risk

Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

FDAJul 17, 2008Nationwide• Apogee Medical, Inc

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