BEUDAMED
    FDA Enforcement Class II Terminated

    AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump

    Recall: Z-0952-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0952-2019
    Event ID
    81375
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    October 2, 2018
    Classification Date
    February 25, 2019
    Termination Date
    November 12, 2021
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump

    Reason

    Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

    Code Info

    74A1600493 74E1701689 74A1701278 74F1601947 74B1700147 74G1601342 74B1700922 74H1601292 74C1601403 74H1602005 74C1601458 74J1601528 74C1601839 74K1601040 74C1602928 74K1601957 74C1702397 74L1601996 74D1600766 74L1602670 74E1600739 74M1501120 74E1601599 74M1600311 74E1700481 74M1600671

    Distribution

    Nationwide distribution.

    Quantity

    26