BEUDAMED
    FDA Enforcement Class II Ongoing

    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

    Recall: Z-1556-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1556-2022
    Event ID
    90622
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro Therapeutics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2022
    Initiation Date
    June 30, 2022
    Classification Date
    August 18, 2022
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811, United States

    Description

    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

    Reason

    Outer carton packaging of microcatheters were exposed to wet substance during transport.

    Code Info

    Lot # B177543 UDI: (00) 847536006270

    Distribution

    US Nationwide Distribution: None OUS: Brazil

    Quantity

    8 units