BEUDAMED
    FDA Enforcement Class II Terminated

    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

    Recall: Z-0011-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0011-2019
    Event ID
    80569
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ellex iScience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 10, 2018
    Initiation Date
    January 11, 2018
    Classification Date
    October 1, 2018
    Termination Date
    October 2, 2018
    Address
    41316 Christy St, Fremont, CA, 94538-3115, United States

    Description

    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

    Reason

    Sterility failure found in one of the units in the lot.

    Code Info

    Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108

    Distribution

    Distribution US nationwide and Switzerland.

    Quantity

    90 units