BEUDAMED
    FDA Enforcement Class II Ongoing

    BF-MP60: OES Bronchofiberscope

    Recall: Z-1046-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1046-2022
    Event ID
    89942
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    March 8, 2022
    Classification Date
    May 6, 2022
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    BF-MP60: OES Bronchofiberscope

    Reason

    Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

    Code Info

    All serial numbers. UDI: 04953170339394

    Distribution

    US Nationwide distribution.

    Quantity

    60 units