BEUDAMED
    FDA Enforcement Class I Ongoing

    Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

    Recall: Z-1975-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1975-2026
    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 HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

    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: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).

    Distribution

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

    Quantity

    2,932 kits