BEUDAMED
    FDA Enforcement Class II Terminated

    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

    Recall: Z-0649-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0649-2018
    Event ID
    79197
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    October 17, 2017
    Classification Date
    February 20, 2018
    Termination Date
    April 14, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

    Reason

    These finished good kits may contain the incorrect Springwire Guide (SWG).

    Code Info

    Lot numbers: Product Code ASK-45703-PNHS: 23F16M0498 Product Code ASK-45703-PGMCL: 23F17A0505 Product Code ASK-45703-PNW: 23F17B0116

    Distribution

    Distribution US Nationwide

    Quantity

    5,926 total