PlainRecalls
FDA Devices Moderate Class II Terminated

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications

Reported: May 22, 2013 Initiated: May 3, 2013 #Z-1317-2013

Product Description

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications

Reason for Recall

ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

Details

Recalling Firm
ConMed Corporation
Units Affected
Domestic: 49,010; Foreign: 600
Distribution
Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
Location
Utica, NY

Frequently Asked Questions

What product was recalled? ▼
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications. Recalled by ConMed Corporation. Units affected: Domestic: 49,010; Foreign: 600.
Why was this product recalled? ▼
ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2013. Severity: Moderate. Recall number: Z-1317-2013.

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