BEUDAMED
    FDA Enforcement Class II Terminated

    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

    Recall: Z-1994-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1994-2012
    Event ID
    61958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PSC Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    June 1, 2012
    Classification Date
    July 11, 2012
    Termination Date
    September 15, 2015
    Address
    3230 Commerce Center Pl, Louisville, KY, 40211-1900, United States

    Description

    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

    Reason

    Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.

    Code Info

    Model/part Number: 90-7004, Lot Numbers: 017897

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

    Quantity

    7 units