PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM (2016-02-03)

Starting date:

February 3, 2016

Posting date:

February 26, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57284

• Reason
• Affected products

Affected Products

A. PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM

Reason

Physio-Control's supplier of QUIK-COMBO adult, pacing/defibrillation/ECG Electrodes with EDGE System technology and REDI-PAK preconnect system is voluntarily recalling specific production lots. The defibrillation electrodes are used in conjunction with certain Physio-Control LIFEPAK products. This voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of the affected lots. 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.

Affected products