BEUDAMED
    FDA Enforcement Class II Ongoing

    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

    Recall: Z-1055-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1055-2022
    Event ID
    89881
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 18, 2022
    Initiation Date
    April 1, 2022
    Classification Date
    May 10, 2022
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

    Reason

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

    Code Info

    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

    Distribution

    U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

    Quantity

    All Serial Numbers manufactured/distributed since January 2018