BEUDAMED
    FDA Enforcement Class II Terminated

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

    Recall: Z-1998-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1998-2012
    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.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

    Reason

    Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.

    Code Info

    Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017.

    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

    40 Units