BEUDAMED
    FDA Enforcement Class I Ongoing

    Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

    Recall: Z-1970-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1970-2026
    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 CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

    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

    1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).

    Distribution

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

    Quantity

    222 kits