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Showing 20941–20960 of 22584 results

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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

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: 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

Bard Access Systems, Inc: Site-Rite Sterile Needle Guide Kit - 18 gauge

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

FDANov 3, 2004Nationwide• Bard Access Systems, Inc

Harvard Clinical Technology: Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

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 PAD Package (without ECG trace) Model Number: ...

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

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: AccessALS Package Model Number: 9100-0150-2

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

FDANov 3, 2004Nationwide• Access CardioSystems

Hospira Inc.: Angiographic Syringe, 10 cc Thumb Ring with Rotator Reser...

Syringes could possibly allow air to enter the patient's vascular system.

FDANov 2, 2004Nationwide• Hospira Inc.

Hospira Inc.: Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.

Syringes could possibly allow air to enter the patient's vascular system.

FDANov 2, 2004Nationwide• Hospira Inc.

Omron Healthcare, Inc.: Medication Bottle (U22-3), a component of the MicroAir Vi...

A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.

FDANov 2, 2004Nationwide• Omron Healthcare, Inc.

Hospira Inc.: Catheterization Kits containing Angiographic Syringes wit...

Syringes could possibly allow air to enter the patient's vascular system.

FDANov 2, 2004Nationwide• Hospira Inc.

Hospira Inc.: Angiographic Syringe, 12 cc Thumb Ring with Rotator Reser...

Syringes could possibly allow air to enter the patient's vascular system.

FDANov 2, 2004Nationwide• Hospira Inc.

Beckman Coulter Inc: CXP software for Cytomics FC500 Cytometer

Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.

FDANov 2, 2004Nationwide• Beckman Coulter Inc

Baxter Healthcare Renal Div: HomeChoice and Yume Automated Peritoneal Dialysis Systems...

The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.

FDANov 1, 2004Nationwide• Baxter Healthcare Renal Div

Diasorin Inc.: DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.

FDANov 1, 2004FL, TX, UT• Diasorin Inc.

Baxter Healthcare Renal Div: HomeChoice PRO and Yume Plus Automated Peritoneal Dialysi...

The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.

FDANov 1, 2004Nationwide• Baxter Healthcare Renal Div

Diasorin Inc.: DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800...

DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).

FDANov 1, 2004GA, KS, MT +1 more• Diasorin Inc.

Boston Scientific Scimed: RunWay 6F Cardiovascular Guide Catheter.

The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon

FDAOct 29, 2004Nationwide• Boston Scientific Scimed

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