BEUDAMED
    FDA Recall Terminated

    Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220

    Recall: Z-1046-2007 · Initiated June 6, 2007

    Recall

    Recall Number
    Z-1046-2007
    Event Number
    38072
    Firm
    Wallach Surgical Devices, Inc.
    FEI Number
    1216677
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2007
    Posted
    July 11, 2007
    Terminated
    July 15, 2015
    Address
    235 Edison Road, Orange, CT, 06477-3603

    Description

    Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220

    Reason

    The tip may separate from the probe.

    Action

    Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product.

    Distribution

    Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania

    Quantity

    14 units