BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.

    Recall: Z-1502-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1502-2021
    Event ID
    87551
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medela AG Medical Technology
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 5, 2021
    Initiation Date
    December 2, 2020
    Classification Date
    April 27, 2021
    Termination Date
    June 17, 2024
    Address
    Lattichstrasse 4b, N/A, Baai, N/A, N/A, Switzerland

    Description

    Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.

    Reason

    Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

    Code Info

    Catalog Number: 077.0193 UDI Code: 07612367052719 Lot Number: W-024423

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA,FL,GA, IL, MA, MI, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, and WV. The country of Netherlands.

    Quantity

    6,244 units