Z-2326-2012 Class II Terminated
FDA device recall Z-2326-2012 was initiated by Breg Inc, An Orthofix Company on August 11, 2010 and is designated Class II. 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… The recall status is terminated (terminated September 6, 2012). Affected quantity: 502 units.
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