BEUDAMED
    FDA Enforcement Class I Terminated

    ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers

    Recall: Z-0497-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0497-2021
    Event ID
    86484
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Flexicare Medical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    December 2, 2020
    Initiation Date
    September 22, 2020
    Classification Date
    November 26, 2020
    Termination Date
    July 29, 2024
    Address
    Cynon Valley Business Park, Mountain Ash, N/A, Rhondda Cynon Taff, N/A, N/A, United Kingdom

    Description

    ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers

    Reason

    When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

    Code Info

    Part/ Lot: 038-990-080U/ 191102901, 200300486, 200300539, 200500068, 200500069, 200803210, 191201567, 200904316, 200904319; 038-990-075U/ 191102900, 200100157, 200300535, 200300536, 200300537, 200402330, 200402331, 200402333, 200402334, 200402335, 200402336, 200402337, 200403976, 200404287, 200500991, 200500992, 200501790; 038-990-070U/ 201000813, 201100558; 038-990-065U/ 201000808, 202002462 *Note: product and lot number list updated per 12/23/2020 letter to customers

    Distribution

    US nationwide distribution.

    Quantity

    2087