BEUDAMED
    FDA Enforcement Class II Terminated

    Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.

    Recall: Z-1633-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1633-2014
    Event ID
    67833
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    July 17, 2013
    Classification Date
    May 19, 2014
    Termination Date
    March 30, 2015
    Address
    2400 Bernville Road, N/A, Reading, PA, 19605, United States

    Description

    Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.

    Reason

    The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r

    Code Info

    MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733

    Distribution

    US Distribution only to MI.

    Quantity

    4285