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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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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
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Nova Scotia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot # D101564 Class II 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. 502 units Z-2326-2012