BEUDAMED
    FDA Enforcement Class II Terminated

    GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03

    Recall: Z-1471-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1471-2020
    Event ID
    84329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Verathon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    March 31, 2019
    Classification Date
    March 11, 2020
    Termination Date
    December 14, 2021
    Address
    20001 N Creek Pkwy, Bothell, WA, 98011-8218, United States

    Description

    GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03

    Reason

    A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.

    Code Info

    GlideScope Video Laryngoscope Operation and Maintenance Manual Catalog #: 0900-4940 Product can be further identified as In-Service USB 0901-0197 Affected Revision Rev. 00 distributed January 1, 2019 February 28, 2019 GlideScope Video Laryngoscope Product Serial Numbers are included in Appendix A: Domestic and Foreign Consignee List (in Associated Documents)

    Distribution

    US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada

    Quantity

    239 manuals