BEUDAMED
    FDA Enforcement Class II Terminated

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    Recall: Z-1668-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1668-2022
    Event ID
    90749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 7, 2022
    Initiation Date
    August 12, 2022
    Classification Date
    August 31, 2022
    Termination Date
    September 20, 2024
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    Reason

    Procedure packs contained a recalled product.

    Code Info

    NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627

    Distribution

    US Nationwide distribution in the states of OH and TN.

    Quantity

    1306 kits