BEUDAMED
    FDA Recall Terminated

    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

    Recall: Z-0509-2021 · Initiated March 23, 2020

    Recall

    Recall Number
    Z-0509-2021
    Event Number
    86680
    Firm
    Janus Trade Group
    FEI Number
    3016611533
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 23, 2020
    Posted
    November 30, 2020
    Terminated
    May 20, 2021
    Address
    556 Industrial Way W, Eatontown, NJ, 07724-4236

    Description

    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

    Reason

    Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

    Action

    Between March 13-25, 2020, Janus Trade Group made phone contact with customers requesting to check if customers had product on hand. If customers had product on hand, they were asked to send it back to JTG for a full refund.

    Distribution

    US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

    Quantity

    1365 cases (200 units/case)