BEUDAMED
    FDA Enforcement Class II Ongoing

    V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001

    Recall: Z-0737-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0737-2024
    Event ID
    93610
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2024
    Initiation Date
    November 16, 2023
    Classification Date
    January 17, 2024
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001

    Reason

    Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.

    Code Info

    UDI-DI: 10885403065866 Lot Numbers: L22XRD, C23XRD, E23XRD, and F23XRD.

    Distribution

    US Nationwide distribution.

    Quantity

    4,214 units