BEUDAMED
    FDA Recall 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 · Initiated December 22, 2015

    Recall

    Recall Number
    Z-1331-2016
    Event Number
    73456
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    MCH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 22, 2015
    Posted
    April 5, 2016
    Terminated
    October 3, 2016
    Address
    Margarita, CA, 92688-2650

    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.

    Action

    Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe. The customer notification letter requested that the following actions be taken: - Check inventory for recalled product. - Complete the attached Recall Notification Confirmation Form to acknowledge the recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested. - Return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 713-8936. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at [email protected].

    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