BEUDAMED
    FDA Recall Terminated

    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

    Recall: Z-1454-2017 · Initiated February 27, 2017

    Recall

    Recall Number
    Z-1454-2017
    Event Number
    76587
    Firm
    CORENTEC CO., LTD Seobuk-gu 12 Yeongsanhong 1-gil Seobuk-gu, Cheonan-si Korea (the Republic of)
    FEI Number
    3009106092
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2017
    Posted
    March 13, 2017
    Terminated
    May 11, 2017

    Description

    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

    Reason

    Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

    Action

    Corentec sent an Medical Device Recall letter dated February 23, 2017. The recalling firm notified the consignee via written notification by email and by phone. The recalled products will be returned to the recalling firm. For further questions please call (512) 327-9997

    Distribution

    US Distribution to the state of : PA

    Quantity

    5 ea