BEUDAMED
    FDA Enforcement Class II Terminated

    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

    Recall: Z-1270-2022 · Reported June 22, 2022

    Enforcement

    Recall Number
    Z-1270-2022
    Event ID
    90292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2022
    Initiation Date
    May 16, 2022
    Classification Date
    June 16, 2022
    Termination Date
    December 23, 2024
    Address
    3721 Valley Centre Dr Ste 500, San Diego, CA, 92130-3328, United States

    Description

    Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

    Reason

    Due to a potential failed sterilization process.

    Code Info

    Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719

    Distribution

    U.S.: WA and WI O.U.S.: Canada

    Quantity

    11 devices