BEUDAMED
    FDA Recall 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 · Initiated January 11, 2018

    Recall

    Recall Number
    Z-0011-2019
    Event Number
    80569
    Firm
    Ellex iScience, Inc.
    FEI Number
    3005641545
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 11, 2018
    Terminated
    October 2, 2018
    Address
    41316 Christy St, Fremont, CA, 94538-3115

    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.

    Action

    The recalling firm called their consignees on 1/11/2018 instructing them to quarantine unused devices and monitor the patients operated with the devices in this lot. The firm issued a letter dated 1/16/2018 via FedEx Express on 1/17/2018 informing them a potential issue had been identified and to segregate the product immediately.

    Distribution

    Distribution US nationwide and Switzerland.

    Quantity

    90 units