BEUDAMED
    FDA Enforcement Class II Terminated

    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

    Recall: Z-1276-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1276-2021
    Event ID
    87333
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epimed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    February 1, 2021
    Classification Date
    March 18, 2021
    Termination Date
    October 17, 2022
    Address
    141 Sal Landrio Dr, N/A, Johnstown, NY, 12095-3835, United States

    Description

    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

    Reason

    Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

    Code Info

    Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049

    Distribution

    US Nationwide distribution

    Quantity

    5835 units