BEUDAMED
    FDA Enforcement Class II Ongoing

    OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

    Recall: Z-1359-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1359-2025
    Event ID
    96343
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 26, 2025
    Initiation Date
    February 6, 2025
    Classification Date
    March 14, 2025
    Address
    85 Shaffer Park Dr, N/A, Tiffin, OH, 44883-9290, United States

    Description

    OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

    Reason

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

    Code Info

    UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    54 kits