BEUDAMED
    FDA Enforcement Class II Ongoing

    LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

    Recall: Z-1344-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1344-2025
    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

    LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-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 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-052911

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    1836 kits