Device product
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.
Z-2326-2012
Product summary
- Event
- Event 58247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 502 units
- Official record key
device-enforcement:Z-2326-2012
Official wording
Reason: 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.
Code information: Lot # D101564
Distribution pattern: Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Derived failure modes
-
Labeling or packaging
mislabeled