BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.

    Recall: Z-1823-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1823-2012
    Event ID
    62125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    June 7, 2012
    Classification Date
    June 19, 2012
    Termination Date
    April 3, 2014
    Address
    2400 Bernville Road, N/A, Reading, PA, 19605, United States

    Description

    Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.

    Reason

    Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

    Code Info

    Lot number RF2033361

    Distribution

    USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.

    Quantity

    1,085