BEUDAMED
    FDA Enforcement Class I Ongoing

    Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

    Recall: Z-1981-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1981-2026
    Event ID
    98720
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    May 6, 2026
    Address
    85 Shaffer Park Dr, Tiffin, OH, 44883-9290, United States

    Description

    Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

    Reason

    Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

    Code Info

    ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911

    Distribution

    US distribution to MN. No OUS distribution.

    Quantity

    7,311 kits