BEUDAMED
    FDA Enforcement Class II Terminated

    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    Recall: Z-1331-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1331-2016
    Event ID
    73456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    December 22, 2015
    Classification Date
    April 5, 2016
    Termination Date
    October 3, 2016
    Address
    22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    Reason

    Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.

    Code Info

    Lot #: 1239287

    Distribution

    U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain

    Quantity

    N/A