Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provid...
FDA Recall #Z-2326-2012 — Class II — August 11, 2010
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.
Recalling Firm
Breg Inc, An Orthofix Company — Carlsbad, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
502 units
Distribution
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Code Information
Lot # D101564
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated