BEUDAMED
    FDA Recall Terminated

    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

    Recall: Z-1266-2016 · Initiated January 13, 2016

    Recall

    Recall Number
    Z-1266-2016
    Event Number
    73157
    Firm
    PMBS, LLC
    FEI Number
    3012085539
    Product Code
    KCT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 13, 2016
    Terminated
    September 27, 2017
    Address
    40 Milltown Rd, Stockton, NJ, 08559-1303

    Description

    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

    Reason

    Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

    Action

    On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum including instructions for running the equiptment with extended cycles. For more information please contact Ms. Michele Mauzerall, CEO at 908-300-7093.

    Distribution

    FL, GA, MN, NY, OH, OR SC, and TN

    Quantity

    58 units