Hazard description
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.
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