BEUDAMED
    FDA Recall Terminated

    Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

    Recall: Z-2291-2018 · Initiated April 17, 2018

    Recall

    Recall Number
    Z-2291-2018
    Event Number
    80300
    Firm
    Exsurco Medical
    FEI Number
    3011981870
    Product Code
    GFD
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    April 17, 2018
    Terminated
    June 15, 2020
    Address
    10804 Green Rd, Wakeman, OH, 44889-9676

    Description

    Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

    Reason

    Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.

    Action

    On April 17, 2018 Exsurco Medical hand delivered notices to customers. Customers were advised to take the following actions: -Review, complete and return the Customer Response Card. -Upon verifying the information, provide the information to all Burn Account Managers. -An Exsurco Field Service Technician will perform the correction. Starting July 1, 2018, Exsurco Medical will issue URGENT Medical Device Recall notices and response cards to Burn Account Managers via certified mail or by hand delivery. Exsurso Medical will also provide replacement hoses simultaneously. Burn Account Managers are advised to take the following actions: -Review, complete and return the Customer Response Card. -Replace all impacted X101004 Pneumatic Hoses with replacement hoses. -Discard impacted X101004 Pneumatic Hoses as outlined in the recall notification. Should you have any questions regarding this matter please contact (440) 204-3239/ email: [email protected].

    Distribution

    CA, GA, MO, OH & TX

    Quantity

    70 coaxial hoses