BEUDAMED
    FDA Enforcement Class II Terminated

    AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump

    Recall: Z-0940-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0940-2019
    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 1-14ML/HR CPNB, Product code MVBXL- 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

    74A1801376 74G1702799 74A1801900 74H1700167 74A1802544 74H1701111 74B1700925 74H1701796 74C1701765 74H1702406 74D1700392 74J1700193 74D1701253 74J1700680 74D1701539 74J1701583 74D1702241 74J1702180 74E1700485 74J1702742 74E1701026 74K1700635 74E1701692 74K1701435 74E1702410 74K1702040 74F1700147 74K1702604 74F1701966 74L1700203 74F1702681 74L1700932 74F1703240 74L1702112 74G1700539 74M1700833 74G1701226 74M1701615

    Distribution

    Nationwide distribution.

    Quantity

    38