BEUDAMED
    FDA Enforcement Class II Terminated

    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

    Recall: Z-0996-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0996-2018
    Event ID
    79339
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    November 27, 2017
    Classification Date
    March 13, 2018
    Termination Date
    September 22, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

    Reason

    Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

    Code Info

    ASK-45552-RWJ4 13F16J0286 13F16L0014 13F17A0217 13F17D0222 13F17E0849 13F17F0784 13F17G0413

    Distribution

    US in the states of OH, FL, SC, TX, KY, NJ, MI

    Quantity

    23,904 in total