BEUDAMED
    FDA Enforcement Class II Terminated

    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

    Recall: Z-2265-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2265-2020
    Event ID
    85591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    April 20, 2020
    Classification Date
    June 5, 2020
    Termination Date
    August 21, 2020
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

    Reason

    Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

    Code Info

    Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.

    Distribution

    US nationwide distribution in the states of MO, AR and OK.

    Quantity

    40 Kits.