BEUDAMED
    FDA Recall Terminated

    CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.

    Recall: Z-1275-2012 · Initiated February 27, 2012

    Recall

    Recall Number
    Z-1275-2012
    Event Number
    57924
    Firm
    Healthtronics, Inc.
    FEI Number
    3008262715
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 27, 2012
    Posted
    March 21, 2012
    Terminated
    March 19, 2013
    Address
    9825 Spectrum Dr, Bldg 2 # 275, Austin, TX, 78717-4929

    Description

    CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.

    Reason

    HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.

    Action

    Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification Section on page two, and 3) Return this letter with the affected product to the address provided. For questions about this recall contact Endocare, Inc at 877-367-4873.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.

    Quantity

    9274 units