BEUDAMED
    FDA Enforcement Class II Terminated

    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.

    Recall: Z-1627-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1627-2013
    Event ID
    65205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Surgical Instrument Service And Savings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    May 3, 2013
    Classification Date
    July 1, 2013
    Termination Date
    July 11, 2013
    Address
    2747 Sw 6th St, N/A, Redmond, OR, 97756-7109, United States

    Description

    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.

    Reason

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

    Code Info

    123263, 122279, 123190.

    Distribution

    Nationwide Distribution.

    Quantity

    6 units