BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow Three-Lumen CVC

    Recall: Z-1290-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1290-2022
    Event ID
    90147
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    May 5, 2022
    Classification Date
    June 27, 2022
    Termination Date
    September 4, 2024
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Arrow Three-Lumen CVC

    Reason

    Gravity flow rates on the affected product lidstock are incorrect.

    Code Info

    Catalog Number: CV-12123-F; Lot Numbers: 71F20A0430 [UDI: (01)20801902122838(17)211214(10)71F20A0430], 71F20A2583 [UDI: (01)20801902122838(17)250103(10)71F20A2583], 71F20B0793 [UDI: (01)20801902122838(17)250115(10)71F20B0793], 71F20B2188 [UDI: (01)20801902122838(17)250204(10)71F20B2188], 71F20C1356 [UDI: (01)10801902136944(17)220630(10)71F20C1356], 71F20D1047 [UDI: (01)20801902122838(17)250402(10)71F20D1047], 71F20E2225 [UDI: (01)20801902122838(17)250531(10)71F20E2225], 71F20G2376 [UDI: (01)20801902122838(17)250701(10)71F20G2376], 71F20K0771 [UDI: (01)20801902122838(17)241130(10)71F20K0771], 71F20K2265 [UDI: (01)20801902122838(17)250228(10)71F20K2265], 71F20L0567 [UDI: (01)20801902122838(17)250228(10)71F20L0567], 71F20M1262 [UDI: (01)20801902122838(17)250331(10)71F20M1262], 71F21B0849 [UDI: (01)10801902179514(17)250430(10)71F21B0849], 71F21B0850 [UDI: (01)20801902122838(17)250430(10)71F21B0850], 71F21B2430 [UDI: (01)20801902122838(17)250430(10)71F21B2430], 71F21C0637 [UDI: (01)20801902122838(17)250331(10)71F21C0637], 71F21C0964 [UDI: (01)10801902170856(17)260214(10)71F21C0964], 71F21D0025 [UDI: (01)20801902122838(17)250430(10)71F21D0025], 71F21E0586 [UDI: (01)20801902122838(17)250430(10)71F21E0586], 71F21E1030 [UDI: (01)20801902122838(17)250430(10)71F21E1030], 71F21E2583 [UDI: (01)20801902122838(17)250430(10)71F21E2583], 71F21F1156 [UDI: (01)20801902122838(17)250430(10)71F21F1156], 71F21J0698 [UDI: (01)20801902122838(17)250430(10)71F21J0698]

    Distribution

    US Nationwide distribution in the states of Florida.

    Quantity

    10,301 units