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Showing 67481–67500 of 68218 results

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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

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

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

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.

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

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

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

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

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 Trio System. Nuclear Magnetic Resonance Imaging ...

tissue roll can become magnetic

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

Baxter Healthcare Corp. Rt: Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9...

Premature motor failure.

FDADec 17, 2003Nationwide• Baxter Healthcare Corp. Rt

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

Abbott Laboratories HPD/ADD/GPRD: 18 Gauge thin wall needle as part of a Central Venous Cat...

18 gauge needles in Central Venous Catheter kits may be partially occluded.

FDADec 17, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Advanced Sterilization Products: Cidex Plus Test Strips

May not accurately detect minimum effective concentration (MEC)

FDADec 17, 2003Nationwide• Advanced Sterilization Products

Beckman Coulter Inc: Array Systems Calibrator 5 Part No. 465250

The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

FDADec 17, 2003Nationwide• Beckman Coulter Inc

Wilson-Cook Medical Inc: Howell D.A.S.H. II Access System, Wire Guided Sphincterotome

Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.

FDADec 17, 2003AZ, CA, IN +4 more• Wilson-Cook Medical Inc

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