PlainRecalls
FDA Devices Moderate Class II Terminated

Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

Reported: May 8, 2013 Initiated: April 8, 2013 #Z-1185-2013

Product Description

Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

Reason for Recall

Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient

Details

Recalling Firm
Covidien LLC
Units Affected
7485 (sets of 2)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.. Recalled by Covidien LLC. Units affected: 7485 (sets of 2).
Why was this product recalled?
Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Which agency issued this recall?
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1185-2013.