BEUDAMED
    FDA Recall Terminated

    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

    Recall: Z-0092-2022 · Initiated March 10, 2020

    Recall

    Recall Number
    Z-0092-2022
    Event Number
    88667
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    DRO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 10, 2020
    Terminated
    September 22, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

    Reason

    Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

    Action

    The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products.

    Distribution

    Austria, France, Germany, Great Britain, and Saudi Arabia

    Quantity

    17980 units