BEUDAMED
    FDA Enforcement Class I Ongoing

    Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

    Recall: Z-1976-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1976-2026
    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 NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

    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: UINR44-01. UDI (Kit Lot Number): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076).

    Distribution

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

    Quantity

    204 kits