BEUDAMED
    FDA Enforcement Class II Ongoing

    Portex Spinal Tray, Item No. A3729-24 A3595

    Recall: Z-1101-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1101-2026
    Event ID
    98168
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2026
    Initiation Date
    December 19, 2025
    Classification Date
    January 15, 2026
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    Portex Spinal Tray, Item No. A3729-24 A3595

    Reason

    Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

    Code Info

    1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

    Quantity

    64290 total