Recall Z-0047-2015— Covidien LLC

Name: FDA recall Z-0047-2015
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: K955882. Product: MediChoice¿ Multifunction Electrode Part Number: MC171 OH. Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs.

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

K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSGraphic Controls Corp.·cleared 1996-10-24

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

MediChoice¿ Multifunction Electrode Part Number: MC171 OH

Reason for recall

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

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