FDAFDA · Food and drugs·Recall number Z-1317-2013
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
Published May 22, 2013 · Recall initiated: May 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConMed Corporation
- Distributor
- Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
- Lot
- Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013; Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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