BEUDAMED
    FDA Recall Open, Classified

    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

    Recall: Z-1342-2025 · Initiated February 6, 2025

    Recall

    Recall Number
    Z-1342-2025
    Event Number
    96343
    Firm
    American Contract Systems Inc
    FEI Number
    3008492337
    Product Code
    OHM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 6, 2025
    Posted
    March 14, 2025
    Address
    85 Shaffer Park Dr, Tiffin, OH, 44883-9290

    Description

    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

    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.

    Action

    The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    1106 kits