BEUDAMED
    FDA Recall Terminated

    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

    Recall: Z-2590-2014 · Initiated August 6, 2014

    Recall

    Recall Number
    Z-2590-2014
    Event Number
    69021
    Firm
    Ellex iScience, Inc.
    FEI Number
    3005641545
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 6, 2014
    Posted
    September 4, 2014
    Terminated
    October 28, 2014
    Address
    4055 Campbell Ave, Menlo Park, CA, 94025-1006

    Description

    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

    Reason

    One lot may not have been properly sealed, resulting in a non-sterile device.

    Action

    Urgent Medical Device Recall letters were sent to all customers on August 6, 2014 by trackable mail. Letters advised on the potential lack of sterility of iTRACK250A, Canaloplasty Microcatheter Kit, lot 1404-03 due to improperly sealed pouches. Lack of sterility may pose the risk of infection to the patient. Customers are identify and segregate any affected product in their inventory. The affected product should be returned following the instructions provided. Replacement product will be provided at no charge. Questions should be directed to Customer Care at 1-888-846-4724, M-F 8 am to 4:30 Pm Eastern Time.

    Distribution

    Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.

    Quantity

    148 devices