BEUDAMED
    FDA Recall Terminated

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    Recall: Z-0152-2022 · Initiated December 8, 2020

    Recall

    Recall Number
    Z-0152-2022
    Event Number
    88741
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 8, 2020
    Terminated
    August 4, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    Reason

    The labeling was missing information on sterilization and prohibition of reuse.

    Action

    The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product.

    Distribution

    Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

    Quantity

    3420 devices