BEUDAMED
    FDA Recall Terminated

    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

    Recall: Z-2533-2017 · Initiated May 4, 2017

    Recall

    Recall Number
    Z-2533-2017
    Event Number
    77277
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 4, 2017
    Posted
    June 14, 2017
    Terminated
    March 6, 2018
    Address
    Margarita, CA, 92688-2650

    Description

    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

    Reason

    Due to possibility of insufficient sterilization.

    Action

    An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to 949-713-8847. The recall letter instructs the customers that for product return questions to contact Karen Mitchell, Associate Manager Sales Operations, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at [email protected]. On 8/21/17 an Urgent Medical Device recall letter was sent to their customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of the Kii trocar model, CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. During shipment, the trocar packaging has the potential to become punctured with small holes, which would compromise the sterile barrier.

    Distribution

    US and worldwide: Australia, Finland, France, United Kingdom

    Quantity

    7,939 units total (870 units in US)