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Terminated

ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only

FDA Recall Z-0556-03 · Posted 2003-02-13

Recalling FirmThermage
Recall StatusTerminated
Product CodeGEI
Date Initiated2002-12-09
Date Terminated2003-04-30
Product Quantity1,326 units

Reason for Recall

Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.

Firm Action

The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.

Root Cause

Other

Distribution Pattern

The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. Government or Canadian distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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