BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2590-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2590-2014
    Event ID
    69021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ellex iScience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 6, 2014
    Classification Date
    September 4, 2014
    Termination Date
    October 28, 2014
    Address
    4055 Campbell Ave, Menlo Park, CA, 94025-1006, United States

    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.

    Code Info

    Lot number 1404-03; Expiration: March 31, 2016

    Distribution

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

    Quantity

    148 devices