BEUDAMED
    FDA Enforcement Class II Completed

    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

    Recall: Z-2313-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2313-2021
    Event ID
    88317
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Epimed International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 25, 2021
    Initiation Date
    December 28, 2017
    Classification Date
    August 18, 2021
    Address
    13958 Diplomat Dr, N/A, Farmers Branch, TX, 75234-8805, United States

    Description

    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

    Reason

    Potential for stylet to protrude from the distal end of the catheter

    Code Info

    Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)

    Distribution

    Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

    Quantity

    140 units