BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

    Recall: Z-1524-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1524-2025
    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: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A

    Reason

    Lack of sterility assurance for closed suction catheter systems

    Code Info

    Lot Code: Lot/ Serial Number(s): 1555453, 1564227 Each: 00609038944920 DSP: 10609038944927 Case: 20609038944924

    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

    9020 units