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Showing 20701–20720 of 22584 results

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Lemaitre Vascular, Inc.: LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Vo...

Product sterility maybe compromised due to defective packaging

FDAFeb 7, 2005AL, CA, FL +5 more• Lemaitre Vascular, Inc.

Unknown Manufacturer: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1

The tip may separate from the device and render it unusable

FDAFeb 7, 2005AZ, CA, CO +18 more

Dade Behring: MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; ...

There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

FDAFeb 7, 2005IN, PR• Dade Behring

Cygnus LLC: Centrifuge Model CF-6 with lid lock. (Block Model number...

The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.

FDAFeb 4, 2005NY• Cygnus LLC

Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030: Varian brand Clinac 600C (CD, EX) and Portal Vison with D...

Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

FDAFeb 4, 2005IN• Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030

Bausch & Lomb Inc: SofLens 66 Toric Visibility Tinted Contact Lenses for Dai...

Portion of lot contains lenses with incorrect refractive power.

FDAFeb 4, 2005Nationwide• Bausch & Lomb Inc

Ups Supply Chain Solutions: RAPID SYPHILIS TEST KIT, per insert, contents of the kit ...

The kits are not approved for use in the United States.

FDAFeb 4, 2005Nationwide• Ups Supply Chain Solutions

Medtronic Emergency Response Systems, Inc.: LIFEPAK 500 AED.

Potential to not detect patients at the low end of the patient impedance range.

FDAFeb 3, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Sunrise Medical, Inc.: Sunrise Hoyer Advance Patient lifts

The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.

FDAFeb 3, 2005FL, GA, OK +4 more• Sunrise Medical, Inc.

Becton Dickinson Infusion Therapy: BD Nexiva Closed IV Catheter System, 18 gauge

The Y-luer connection may crack during normal product use.

FDAFeb 3, 2005FL, IL, OR +3 more• Becton Dickinson Infusion Therapy

Radiometer America Inc: TC Monitor - Transcutaneous Monitor for p02 and pC02, Mod...

Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped.

FDAFeb 2, 2005Nationwide• Radiometer America Inc

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.

FDAFeb 1, 2005Nationwide• Terumo Cardiovascular Systems Corp

Motion Control, Inc.: Spectre brand AC wall adapter to be used with ProControl ...

Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.

FDAFeb 1, 2005CA, FL, NJ +8 more• Motion Control, Inc.

Radiometer America Inc: D 744 Chloride membrane, CI, REF Model #942-061, accesso...

The CI membrane units generate too low values for status and sensitivity during calibration.

FDAFeb 1, 2005Nationwide• Radiometer America Inc

Greer Laboratories Inc: Sterile Empty Vials for Allergenic Extracts, 100ml size

Product may not be sterile.

FDAJan 28, 2005AZ, CA, FL +14 more• Greer Laboratories Inc

Medtronic Surgical Navigation Technologies, Inc: Stealth Station Cranial Application v.4.5

The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

FDAJan 28, 2005AL, AZ, AR +20 more• Medtronic Surgical Navigation Technologies, Inc

The Spineology Group: Fill Tube,straight, Catalog # 300-1001, is used for the ...

Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials.

FDAJan 28, 2005AZ, AR, CA +8 more• The Spineology Group

The Spineology Group: Fill Tube,diverted, Catalog # 300-1002, is used for the ...

Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials.

FDAJan 28, 2005AZ, AR, CA +8 more• The Spineology Group

The Spineology Group: Platen, Catalog # 301-124, is a mechanism used to lock or...

Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials.

FDAJan 28, 2005AZ, AR, CA +8 more• The Spineology Group

Guidant Corporation Advanced CardiovascularSystem: Voyager RX Coronary Dilatation Catheter

Leak at guide wire exit notch could introduce air into the artery.

FDAJan 27, 2005IN• Guidant Corporation Advanced CardiovascularSystem

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