🇨🇦 IceMan CLASSIC3™

Hazard/Reason: Complaints received reporting a consistent failure mode described as a broken connector on IceMan CLASSIC™ cube unit.  If the connector is broken, the unit may not function as intended, which could result in a temporary interruption of prescribed cold therapy until a replacement unit is provided.  Leakage could saturate the barrier (dressings) and contact the surgical site with non-sterile water, which could in potential cold-related tissue injury or surgical site infection.

This page links to official sources. Verify model/lot/batch details in the official notice.