Recall Z-0043-2015— Covidien LLC

Name: FDA recall Z-0043-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-18

Class I · Terminated

Class I FDA medical device recall by Covidien LLC, initiated 2014-09-18, terminated 2017-05-24. It names one FDA 510(k) clearance: K012218. Product: Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R. Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators.

Recalling firm: Covidien LLC
Classification: Class I
Status: Terminated
Initiated: 2014-09-18
Terminated: 2017-05-24
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

Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R

Reason for recall

Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators

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