Recall Z-1184-2013— Covidien LLC

Name: FDA recall Z-1184-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-08

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2013-04-08, terminated 2015-11-19. It names one FDA 510(k) clearance: K012218. Product: Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.. Reason: 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.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2013-04-08
Terminated: 2015-11-19
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LP·cleared 2001-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.