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Showing 21841–21860 of 22584 results

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Roche Diagnostics Corp.: Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD04...

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

FDADec 29, 2003Nationwide• Roche Diagnostics Corp.

Hill-Rom, Inc.: Hill-Rom brand Century+ bed; model P1400.

If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input.

FDADec 26, 2003Nationwide• Hill-Rom, Inc.

Laerdal Medical Corporation: LAERDAL Silicone Resuscitator (LSR), Adult size, containi...

Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.

FDADec 23, 2003Nationwide• Laerdal Medical Corporation

Laerdal Medical Corporation: Intake/Reservoir Valve (Part No. 875400), used in all siz...

Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.

FDADec 23, 2003Nationwide• Laerdal Medical Corporation

Esaote Biomedica S.P.A. c/o The Anson Group: Esaote brand ArchiWin Colour ECG System; part 9704325000.

If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

FDADec 23, 2003CA, FL, IN +1 more• Esaote Biomedica S.P.A. c/o The Anson Group

Esaote Biomedica S.P.A. c/o The Anson Group: Esaote brand Formul@ ECG System; part 9704220000.

If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

FDADec 23, 2003CA, FL, IN +1 more• Esaote Biomedica S.P.A. c/o The Anson Group

Esaote Biomedica S.P.A. c/o The Anson Group: Esaote brand Archimed 4220 ECG System; part 9704220000.

If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

FDADec 23, 2003CA, FL, IN +1 more• Esaote Biomedica S.P.A. c/o The Anson Group

Esaote Biomedica S.P.A. c/o The Anson Group: Esaote brand Formula for Archimed ECG System; part 970422...

If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.

FDADec 23, 2003CA, FL, IN +1 more• Esaote Biomedica S.P.A. c/o The Anson Group

C.R. Bard, Inc., Urological Division: Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, ...

Product packaging may contain holes compromising sterility.

FDADec 22, 2003Nationwide• C.R. Bard, Inc., Urological Division

C.R. Bard, Inc., Urological Division: Bard Platinum Class II Flat Wire Stone Basket, Ureteral S...

Product packaging may contain holes compromising sterility.

FDADec 22, 2003Nationwide• C.R. Bard, Inc., Urological Division

Beckman Coulter Inc: ICON 25 hCG test kit.

Test can exhibit false negative results.

FDADec 22, 2003Nationwide• Beckman Coulter Inc

Depuy Orthopaedics, Inc.: P.F.C. Knee System 7 Fluted Femoral Stem 18mmX12...

The collar was incorrectly etched for the R (right) and L (Left) orientation

FDADec 22, 2003NY• Depuy Orthopaedics, Inc.

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET c8000 Magnesium, List n...

Complaints that instructions for use were not clear.

FDADec 22, 2003Nationwide• Abbott Laboratories Diagnostic Div

Wilson-Cook Medical Inc: Oasis-One Action Stent Introduction System with ST-2 Soeh...

Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm

FDADec 22, 2003IN• Wilson-Cook Medical Inc

Hill-Rom, Inc.: Hill-Rom Newborn bassinet; model P247.

The caster/wheel may come off of the bassinet, causing the bassinet to tip.

FDADec 19, 2003Nationwide• Hill-Rom, Inc.

Access CardioSystems: Access AED and Access ALS Automated External Defibrillato...

Difibrillator may fail to operate due to a faulty component on the circuit board

FDADec 19, 2003AL, CA, FL +4 more• Access CardioSystems

Shelhigh Inc: EnDura No-React Dural Substitute. Product comes in diffe...

The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.

FDADec 19, 2003Nationwide• Shelhigh Inc

Siemens Medical Solutions USA, Inc: Magnetom Allegra System. Nuclear Magnetic Resonance Imagi...

tissue roll can become magnetic

FDADec 18, 2003CA, CT, FL +16 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Magnetom Trio System. Nuclear Magnetic Resonance Imaging ...

tissue roll can become magnetic

FDADec 18, 2003CA, CT, FL +16 more• Siemens Medical Solutions USA, Inc

Becton Dickinson & Company: VACUTAINER Brand Push Button Blood Collection Sets.

A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.

FDADec 17, 2003CA, VA• Becton Dickinson & Company

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