BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

    Recall: Z-2556-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2556-2019
    Event ID
    83593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2019
    Initiation Date
    August 6, 2019
    Classification Date
    September 23, 2019
    Termination Date
    September 29, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

    Reason

    Products may contain the incorrect banner card within the kit

    Code Info

    Lot Number: 13F18H0499

    Distribution

    US Nationwide distribution.

    Quantity

    231 units