BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A

    Recall: Z-1527-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1527-2025
    Event ID
    96528
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 23, 2025
    Initiation Date
    March 19, 2025
    Classification Date
    April 16, 2025
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-4667, United States

    Description

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A

    Reason

    Lack of sterility assurance for closed suction catheter systems

    Code Info

    Lot Code: Lot/ Serial Number(s): 1555468 Each: 00609038989655 DSP: 10609038989652 Case: 20609038989659

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.

    Quantity

    1040 units