BEUDAMED
    FDA Recall Terminated

    Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

    Recall: Z-0950-2022 · Initiated February 28, 2022

    Recall

    Recall Number
    Z-0950-2022
    Event Number
    89793
    Firm
    Resource Optimization & Innovation LLC
    FEI Number
    3004513970
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 28, 2022
    Terminated
    May 24, 2022
    Address
    645 Maryville Centre Dr, Ste 200, Saint Louis, MO, 63141-5846

    Description

    Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

    Reason

    A kit component, the PDI Prevantics Swab, was recalled.

    Action

    ROI issued correction notices on 02/28/2022 and 03/07/2022 to the initial consignees who had been shipped the affected Regard brand IV Start Kits containing the affected PDI Prevantics products. There will be no product recovered due to the notice received from Owens & Minor instructing that the affected kits be labeled with an label instructing the user not to use the Prevantics products.

    Distribution

    US distribution to two consignees located in Missouri

    Quantity

    3,570 kits