IceMan CLASSIC3™
Brand(s)
Summary
Customers are notified and provided instructions on follow up. Quarantine and return affected products.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
IceMan CLASSIC3™ |
101325 |
11-0494 |
IceMan CLASSIC3™ |
110525 |
11-0494 |
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.
Additional information
Details
DJO, LLC
5919 Sea Otter Place, Carlsbad, California, United States, 92010
Get notified
Receive emails about new and updated recall and safety alerts.