BEUDAMED
    FDA Enforcement Class II Ongoing

    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

    Recall: Z-1352-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1352-2025
    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

    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

    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 00191072167491 00191072218698 Lots 971241 947241 926241 894241 70-051029 70-051995 70-052417 70-052771

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    237 kits