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Showing 66581–66600 of 68218 results

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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

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

Harvard Clinical Technology: Harvard 2 Syringe Pump manufactured for Rita Medical (OEM...

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

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

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

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.: 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 Thumb Ring with Rotator Reser...

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

FDANov 2, 2004Nationwide• Hospira 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.

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 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.

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

DPC Cirrus: Immulite 2500 Automated Immunoassay Analyzer, Human chori...

Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.

FDAOct 29, 2004Nationwide• DPC Cirrus

Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vesse...

Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.

FDAOct 29, 2004FL, HI, IL +10 more• Beckman Coulter Inc

Becton Dickinson & Co.: BD Phoenix ID/AST panels, catalog numbers 448007, 448008,...

The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.

FDAOct 29, 2004Nationwide• Becton Dickinson & Co.

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

Medtronic Xomed, Inc.: Brand name: NIM EMG Endotracheal Tube ...

The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.

FDAOct 29, 2004Nationwide• Medtronic Xomed, Inc.

SCC Soft Computer: Product is SoftPath ASCII Software Releases 2.3.0 and 4.3...

Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.

FDAOct 27, 2004Nationwide• SCC Soft Computer

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