BEUDAMED
    FDA Enforcement Class III Terminated

    Regard Custom Procedure Kits containing BD Luer Lok Access Devices

    Recall: Z-0837-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0837-2022
    Event ID
    89710
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 6, 2022
    Initiation Date
    February 24, 2022
    Classification Date
    March 30, 2022
    Termination Date
    April 25, 2022
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard Custom Procedure Kits containing BD Luer Lok Access Devices

    Reason

    Recalled devices were packaged in convenience kits.

    Code Info

    IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)

    Distribution

    US Nationwide distribution in the state of Missouri.

    Quantity

    1750 kits