BEUDAMED
    FDA Enforcement Class II Terminated

    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A

    Recall: Z-1336-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1336-2018
    Event ID
    79512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 18, 2018
    Initiation Date
    December 22, 2017
    Classification Date
    April 10, 2018
    Termination Date
    May 27, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A

    Reason

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

    Code Info

    Lot Numbers: (1) 13F16M0268, 13F17C0395, 13F17E0158, 13F17E0536; (2) 13F17A0254; (3) 13F16M0233, 13F17D0190; (4) 13F17B0137, 13F17D0225

    Distribution

    Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.