BEUDAMED
    FDA Enforcement Class II Ongoing

    EAR PACK , Model No SFEA12A

    Recall: Z-1351-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1351-2025
    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

    EAR PACK , Model No SFEA12A

    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 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    51 kits