BEUDAMED
    FDA Enforcement Class I Ongoing

    Halyard CATH LAB kit. Model Number: SACL75AM.

    Recall: Z-1973-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1973-2026
    Event ID
    98686
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AVID Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    March 13, 2026
    Classification Date
    May 1, 2026
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351, United States

    Description

    Halyard CATH LAB kit. Model Number: SACL75AM.

    Reason

    Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

    Code Info

    Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393).

    Distribution

    US distribution to FL, IL, MO, MS, NC, NE, TX.

    Quantity

    228 kits