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 | Telephone |
| 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 |
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