BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2265-2020 · Initiated April 20, 2020

    Recall

    Recall Number
    Z-2265-2020
    Event Number
    85591
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    FTN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2020
    Terminated
    August 21, 2020
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    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.

    Action

    ROi CPS, LLC notified customer on 04/23/2020 via "Urgent Medical Device Recall Notice" The recall letter identified the affected product requested the users to review their inventory and quarantine the affected lots. The consignees were asked to complete and return the recall form.

    Distribution

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

    Quantity

    40 Kits.