CanadaIceMan CLASSIC3™ units (model/catalogue 11-0494) with lot or serial numbers 101325 and 110525 are affected; identify them by that model and those lot/serial numbers. They were recalled because complaints reported a broken connector that can cause the unit to stop functioning and leakage that could saturate dressings and contact the surgical site with non-sterile water, potentially causing cold-related tissue injury or surgical site infection; customers are being notified, instructed to quarantine and return affected products.
What's being recalled
Companies: DJO, LLC, 5919 Sea Otter Place, Carlsbad, California, United States, 92010.
How to identify it
Affected products: IceMan CLASSIC3™; Lot or serial number: 101325; Model or catalogue number: 11-0494
Affected products: IceMan CLASSIC3™; Lot or serial number: 110525; Model or catalogue number: 11-0494
The hazard
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.
What to do
Customers are notified and provided instructions on follow up. Quarantine and return affected products.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States