FDAnews Device Daily Bulletin

Physio-Control Announces Recall of AED Electrodes

March 21, 2016

Physio-Control has announced a recall of specific lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to possible damage to the wire insulation during the manufacturing process.

The company asks that customers quarantine and return any unused products, according to a safety notice.

No complaints related to the issue have been received, the safety notice adds. However, using the product in the damaged condition may result in an increased risk for reduced or no patient therapy, arcing of current, sparking or patient or clinician burns. — Anisa Jibrell