BEUDAMED
    FDA Enforcement Class II Terminated

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    Recall: Z-0148-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0148-2023
    Event ID
    90938
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SenTec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 9, 2022
    Initiation Date
    August 22, 2022
    Classification Date
    October 28, 2022
    Termination Date
    May 26, 2026
    Address
    Ringstrasse 39, N/A, Therwil, N/A, N/A, Switzerland

    Description

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    Reason

    Weak skin adhesion.

    Code Info

    batch #220139

    Distribution

    US Nationwide distribution.

    Quantity

    17208 units