MEDI-TRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODE (2015-08-19)

Starting date:

August 19, 2015

Posting date:

September 1, 2015

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-54890

• Reason
• Affected products

Affected Products

1. MEDI-TRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODE

Reason

This voluntary recall is being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of our manufacturing process. The use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician burns. No patients have been reported related to this damaged wire insulation issues.

Affected products