Recall Monitor
Health Products

IceMan CLASSIC3™

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Physical medicine
Product: IceMan CLASSIC3™
Issue: Medical devices - Performance
What to do: Customers are notified and provided instructions on follow up. Quarantine and return affected products.
Audience: Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
IceMan CLASSIC3™10132511-0494
IceMan CLASSIC3™11052511-0494

Issue

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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