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Health product recall

Kendall 1010P and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes (2014-09-17)

Starting date:
September 17, 2014
Posting date:
September 26, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41547

Recalled products

  1. Kendall 1010P Multi-Function Defibrillation Electrodes
  2. Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

Reason

Incompatibility between the Philips Automated External Defibrillators (AED) models FR3 and FRX defibrillators and Covidien Medi-Trace cadence and Kendall Defibrillation Electrodes. These electrodes will not connect with Philips FR3 and FRX AED units, and in the case of the use of Covidien Defibrillation Electrodes with the Philips FR3 AED units, could result in a delay of therapy. The FRX AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use.

Affected products

A. Kendall 1010P Multi-Function Defibrillation Electrodes

Lot or serial number

Not applicable

Model or catalog number
  • 22660PC
  • 22660R
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES


B. Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

Lot or serial number

Not applicable

Model or catalog number
  • 40000006
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES