BEUDAMED
    FDA Enforcement Class II Ongoing

    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

    Recall: Z-0796-2025 · Reported January 8, 2025

    Enforcement

    Recall Number
    Z-0796-2025
    Event ID
    95889
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Med Michigan Holding Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 8, 2025
    Initiation Date
    November 19, 2024
    Classification Date
    December 31, 2024
    Address
    2680 Walker Ave Nw Ste C, Walker, MI, 49544-1385, United States

    Description

    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

    Reason

    Incomplete or partial pouch seals, which may result in a breach in the sterility.

    Code Info

    UDI-DI 00817278010514 Lot 08294-080724

    Distribution

    Product distributed to a distributor located in IL.

    Quantity

    109 boxes (2,180 eaches)