BEUDAMED
    FDA Enforcement Class II Terminated

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    Recall: Z-1754-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1754-2025
    Event ID
    96734
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Numed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 21, 2025
    Initiation Date
    April 21, 2025
    Classification Date
    May 13, 2025
    Termination Date
    December 17, 2025
    Address
    2880 Main Street /Rt 11b, Hopkinton, NY, 12965, United States

    Description

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    Reason

    Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

    Code Info

    Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.

    Distribution

    US distribution to Pennsylvania.

    Quantity

    4 units