BEUDAMED
    FDA Enforcement Class II Terminated

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    Recall: Z-0644-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0644-2013
    Event ID
    63842
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 16, 2013
    Initiation Date
    November 5, 2012
    Classification Date
    January 7, 2013
    Termination Date
    January 16, 2013
    Address
    22872 Avenida Empresa # 3, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    Reason

    Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.

    Code Info

    Lot Number: 1179107

    Distribution

    Worldwide Distribution - USA (nationwide) and France.

    Quantity

    72 units