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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Detail

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.
Recall Number Z-2326-2012
Classification Class II
Code Info Lot # D101564
Product Distributed Qty 502 units
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.

Event Detail

Event Id 58247
Product Type Devices
Status Terminated
Recalling Firm Breg Inc, An Orthofix Company
City Vista
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-08-11
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Nova Scotia.