Z-2326-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2012
- Initiation Date
- August 11, 2010
- Termination Date
- September 6, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 502 units
Product Description
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
Reason for Recall
This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Code Information
Lot # D101564