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Showing 66561–66580 of 68218 results

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Cincinnati Sub-Zero Products: Warm Air Model 135 Warming Units.

Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.

FDANov 5, 2004Nationwide• Cincinnati Sub-Zero Products

Baxter Healthcare Renal Div: Baxter CAPD Solution Transfer Set for use with UV-Flash G...

Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.

FDANov 5, 2004Nationwide• Baxter Healthcare Renal Div

Baxter Healthcare Corp. Rt.: Colleague 3 CX Triple Channel Volumetric Infusion Pumps, ...

A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

FDANov 4, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Colleague Single Channel Volumetric Infusion Pumps, produ...

A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

FDANov 4, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Colleague 3 Triple Channel Volumetric Infusion Pumps, pro...

A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

FDANov 4, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Colleague CX Single Channel Volumetric Infusion Pumps, pr...

A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

FDANov 4, 2004Nationwide• Baxter Healthcare Corp. Rt.

Medrad Inc: Stellant Dual Syringe Kits. CT Injector and Accessories....

Sterility can be compromised by a tear in the outer packaging.

FDANov 3, 2004Nationwide• Medrad Inc

Bard Access Systems, Inc: Site-Rite Sterile Ultrasound Probe Cover with Gel

Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Bard Access Systems, Inc: Site Rite II, Site Rite 3, and Site Rite IV Systems with ...

Conductivity gel pouches, labeled as sterile, may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Bard Access Systems, Inc: Ultra/Phonic Conductivity Gel, 20 ml. Each unit is a foi...

Conductivity gel pouches, labeled as sterile, may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Access CardioSystems: AccessAED PAD (without ECG trace) -Public Access Defibril...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Power Surgical Solutions: Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge ...

Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

FDANov 3, 2004Nationwide• Power Surgical Solutions

Access CardioSystems: AccessAED (without audio record) Model Number: 9100-0100-0

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessALS (Advanced Life Support) Model Number: 9100-0100-2

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessALS Package Model Number: 9100-0150-2

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Harvard Clinical Technology: Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001

Potential pump motor/encoder assembly failure may cause over infusing medication in patients

FDANov 3, 2004AK, CA, CT +18 more• Harvard Clinical Technology

Access CardioSystems: AccessAED Package (without audio record) Model Number: 9...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Access CardioSystems: AccessAED (with audio record) Model Number: 9100-0100-1

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

Bard Access Systems, Inc: Intraoperative Ultrasound Cover Kit

Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile.

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Access CardioSystems: AccessAED Package (with audio record) Model Number: 9100...

Device may fail to deliver shock due to a faulty circuit board

FDANov 3, 2004Nationwide• Access CardioSystems

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