BEUDAMED
    FDA Enforcement Class II Ongoing

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

    Recall: Z-2466-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2466-2025
    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) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

    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 ASCY24A: UDI/DI 00191072201621, Kit Lot Numbers: 12-7370111, 12-7388611, 12-7388611, 12-7139611, 12-7191911, 12-7231611, 12-7263911; 2) Model/Item Number BUCY78E: UDI/DI 00191072235350, Kit Lot Numbers: 42-7962811; 3) Model/Item Number LMCP22T: UDI/DI 00191072235510, Kit Lot Numbers: 42-8027411, 42-8106111, 42-7885511, 42-7823511; 4) Model/Item Number LMTU31T: UDI/DI 00191072235527, Kit Lot Numbers: 42-7987311, 42-8059311, 42-8112211, 42-7832311, 42-7845011, 42-7914911; 5) Model/Item Number SACY80S: UDI/DI 00191072233370, Kit Lot Numbers: 70-052954, 70-052248, 70-51139, 70-053309, 70-053805; 6) Model/Item Number SPUR64F: UDI/DI 00191072238764, Kit Lot Numbers: 12-7394711, 12-7328411, 12-7096811, 12-7168211.

    Distribution

    US distribution to states of: IL and LA

    Quantity

    1127 units