BEUDAMED
    FDA Enforcement Class II Ongoing

    Regard, Item Number 830067009, custom cardiovascular procedure kit

    Recall: Z-1376-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1376-2021
    Event ID
    87472
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 14, 2021
    Initiation Date
    March 4, 2021
    Classification Date
    April 8, 2021
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard, Item Number 830067009, custom cardiovascular procedure kit

    Reason

    ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.

    Code Info

    Lot number: 75818I; Expiration Date: 05/18/2021

    Distribution

    US Nationwide distribution in the state of Missouri.

    Quantity

    16 kits