BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated August 22, 2022

    Recall

    Recall Number
    Z-0148-2023
    Event Number
    90938
    Firm
    SenTec AG Ringstrasse 39 Therwil Switzerland
    FEI Number
    3004149774
    Product Code
    LKD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 22, 2022
    Posted
    October 28, 2022

    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.

    Action

    The firm issued a letter to its consignees on 08/22/2022 regarding below standard adhesion properties of the MARe-SF (Multisite Attachment Rings - for Sensitive, Fragile skin) product containing replacement product in the form of the premium product - the Patient Application Kit (PAK-SF) and the recommendation to discard the affected product.

    Distribution

    US Nationwide distribution.

    Quantity

    17208 units