BEUDAMED
    FDA Enforcement Class II Ongoing

    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT

    Recall: Z-0177-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0177-2026
    Event ID
    97659
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 4, 2025
    Classification Date
    October 16, 2025
    Address
    1601 Se Gateway Dr Ste 120, Grimes, IA, 50111-5223, United States

    Description

    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT

    Reason

    Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

    Code Info

    UICL44P UDI-DI 191072194268 Lot 8003911 Bag serial number N/A; UICL44R UDI-DI 191072234018 Lot 8317711 Bag serial number 68244081 * If bag serial number is listed as "n/a", then entire lot is affected

    Distribution

    US Nationwide distribution in the states of SD, IA, MN, WA, IL.

    Quantity

    32,433 total