BEUDAMED
    FDA Enforcement Class I Terminated

    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

    Recall: Z-2244-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2244-2021
    Event ID
    88266
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    June 16, 2021
    Classification Date
    August 16, 2021
    Termination Date
    January 4, 2023
    Address
    15 Hampshire St Bldg 5, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

    Reason

    The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.

    Code Info

    All lot codes

    Distribution

    US Nationwide distribution.

    Quantity

    7197 units