BEUDAMED
    FDA Enforcement Class II Ongoing

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    Recall: Z-2469-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2469-2025
    Event ID
    97358
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2025
    Initiation Date
    July 14, 2025
    Classification Date
    August 28, 2025
    Address
    85 Shaffer Park Dr, Tiffin, OH, 44883-9290, United States

    Description

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    Reason

    During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

    Code Info

    1) Model/Item Number LLBN11C: UDI/DI 00191072233530, Kit Lot Numbers: 70-051710, 70-052354; 2) Model/Item Number LLLD19I: UDI/DI 00191072233493, Kit Lot Numbers: 70-051324, 70-051967, 70-053006, 70-053303, 70-053710.

    Distribution

    US distribution to states of: IL and LA

    Quantity

    781 units