IceMan CLASSIC3™
Brand(s)
Last updated
Summary
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
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Physical medicine
Companies
DJO, LLC
5919 Sea Otter Place, Carlsbad, California, United States, 92010
Published by
Health Canada
Audience
Industry
Recall class
Type II
Recall date
Identification number
RA-82155
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