BEUDAMED
    FDA Recall Terminated

    HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.

    Recall: Z-0825-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0825-2013
    Event Number
    63933
    Firm
    Healthtronics, Inc.
    FEI Number
    3008262715
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    December 20, 2012
    Posted
    February 15, 2013
    Terminated
    April 22, 2013
    Address
    9825 Spectrum Dr, Bldg 2 # 275, Austin, TX, 78717-4929

    Description

    HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.

    Reason

    The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

    Action

    Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355.

    Distribution

    Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI

    Quantity

    50 units