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Showing 65721–65740 of 68218 results

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VIASYS Med Systems: Stackhouse Lens/Hood, Mark III Universal; a sterile dispo...

The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

FDASep 13, 2005Nationwide• VIASYS Med Systems

Accumetrics Inc: Accumetrics part number 29001 VerifyNow Instrument, print...

In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

FDASep 13, 2005CA, FL, IL +6 more• Accumetrics Inc

Integra LifeSciences Corp.: Selector Ultrasonic Integra Ultrasonic Aspirator System, ...

Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.

FDASep 13, 2005Nationwide• Integra LifeSciences Corp.

VIASYS Med Systems: Stackhouse FreedomAire Lens/Hood; a sterile disposable pr...

The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

FDASep 13, 2005Nationwide• VIASYS Med Systems

D.T. Davis Enterprises Ltd.: HoverMatt Patient Transfer Solution/Air Transfer Mattress

Instructions for use are not adhering to the product

FDASep 13, 2005Nationwide• D.T. Davis Enterprises Ltd.

Terumo Cardiovascular Systems Corp: Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 ...

There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

FDASep 12, 2005Nationwide• Terumo Cardiovascular Systems Corp

Baxter Healthcare Renal Div: Spanish Patient At-Home Guide for the HomeChoice/HomeChoi...

The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.

FDASep 12, 2005Nationwide• Baxter Healthcare Renal Div

Vascular Solutions, Inc.: D-Stat Hemostat Band, model number 3500. Sterile, latex ...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Vascular Solutions, Inc.: D-Stat Dry Hemostatic Bandage, model number 3000. Steril...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Avid Medical Inc: Custom Procedure Trays, containing various configurations...

Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.

FDASep 9, 2005Nationwide• Avid Medical Inc

Lifescan Inc: Lifescan OneTouch SureStep Meter Blood Glucose monitoring...

The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.

FDASep 9, 2005Nationwide• Lifescan Inc

Vascular Solutions, Inc.: D-Stat 2 Dry Hemostatic Bandage, model number 3010. Ster...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Integra Neuro Sciences: NeuroSensor Cerebral Blood Flow and Intracranial Pressure...

Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring.

FDASep 8, 2005Nationwide• Integra Neuro Sciences

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

When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.

FDASep 8, 2005NY• Cygnus LLC

Datascope Corp: Spectrum Patient Monitor, Physiological, Patient with arr...

Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

FDASep 7, 2005CA, IL, NY +1 more• Datascope Corp

Datascope Corp: Passport 2 with View 12 ECG Analysis Module. It is a tra...

Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

FDASep 7, 2005CA, IL, NY +1 more• Datascope Corp

HemoSense Inc: HemoSense brand INRatio Prothombin Time Monitoring System...

A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

FDASep 7, 2005IN, OR• HemoSense Inc

Beckman Coulter Inc: Synchron LX Systems Version 4.5 Operating Software

Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.

FDASep 6, 2005Nationwide• Beckman Coulter Inc

AGA Medical Corporation: AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Siz...

The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.

FDASep 6, 2005Nationwide• AGA Medical Corporation

Medtronic Emergency Response Systems, Inc.: standard (hard) paddles used with the LIFEPAK 12 defibril...

Potential for voltage pins in connector of therapy cable to break.

FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

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