Health Canada — Medical Devices · Canada · 2016-02-26 · Type II
As described by Health Canada — Medical Devices: PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM (2016-02-03)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.