BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

    Recall: Z-0351-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0351-2023
    Event ID
    91090
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    October 27, 2022
    Classification Date
    December 9, 2022
    Termination Date
    October 7, 2024
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

    Reason

    There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

    Code Info

    UDI/DI 10801902159448, Lot Number 13F22C0349

    Distribution

    US Distributor in states of: FL, GA, KY, OH, PA and WV.

    Quantity

    80 units