BEUDAMED
    FDA Enforcement Class II Terminated

    AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

    Recall: Z-0949-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0949-2019
    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 550 x 5ML/HR CPNB, Product code MC0050XL 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

    74C1601434 74E1602096 74C1602395 74F1602444 74C1703028 74F1700186 74D1700428 74G1702048 74D1701032

    Distribution

    Nationwide distribution.

    Quantity

    9