RegWardenFDA facility compliance records
Recall

Class I — Covidien LLC

Recalling firmCovidien llc
Registered facilityView this company's 22 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusTerminated
ReasonCovidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
ProductCoviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
Quantity9,850 pairs
DistributionWorldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
Initiated2014-09-18
Classified2014-10-16
Terminated2017-05-24
Recall numberZ-0044-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Covidien LLC (Z-0044-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69257/

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