FDA Device Recall Z-0043-2015: Covidien LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0043-2015.

Recall Res Number

Z-0043-2015

Recalling Firm / Manufacturer

Covidien LLC

FEI Number

1282497

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-18

Date Posted

2014-10-15

Date Terminated

2017-05-24

Product Code

DRO

Event Number

69257

Product Quantity

317,550 pairs

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

Action Details Covidien notified customers by letter via Federal Express on 9/18/14. The letter requests that they immediately verify that they are not stocking Covidien electrodes for use with Philips FR3 or FRx AED units. A customer reply acknowledgement form is provided to allow Covidien to track the effectiveness of the notification. Covidien is adding a label to all levels of packaging that alerts the user that the product is not compatible with the FR3 and FRx AED units. Distribution partners notified to address product in the distribution chain that is available to be relabeled. For questions customers should call (800) 962-9888, option 8, then extension 2500. For questions regarding this recall call 508-261-8000.

Distribution Pattern Worldwide 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.

Code Information / Serial Numbers All lots

Related Establishments / Registrations

Cardinal Health Registration: 1219103 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
Covidien LLC Registration: 1282497 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Cardinal Health Registration: 1921846 View Registration
KATECHO LLC Registration: 1930027 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
CD LEYCOM Registration: 3003493679 View Registration
CADEX ELECTRONICS, INC. Registration: 3003800159 View Registration
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. Registration: 3003832357 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
QUIPMENT Registration: 3008717264 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
TRIBALCO Registration: 3010317211 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
RRC POWER SOLUTIONS LTD. Registration: 3013826848 View Registration
PHYSIO-CONTROL, INC. Registration: 3015876 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
EMI (DONGGUAN) ASIA LIMITED Registration: 3017422354 View Registration
SCHILLER AG Registration: 8030978 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0043-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer