BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

    Recall: Z-2528-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2528-2025
    Event ID
    97407
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B.Braun Medical S.A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2025
    Initiation Date
    July 21, 2025
    Classification Date
    September 5, 2025
    Address
    Celsa Lg Medical, 30 avenue des Temps Modernes; Cs 10031, Chasseneuil du Poitou CEDEX, N/A, N/A, France

    Description

    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

    Reason

    The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.

    Code Info

    Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;

    Distribution

    US Nationwide distribution in the state of PA.

    Quantity

    58 units