BEUDAMED
    FDA Enforcement Class II Terminated

    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental 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 and injection of contrast media.

    Recall: Z-2136-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2136-2016
    Event ID
    74362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    June 2, 2016
    Classification Date
    July 6, 2016
    Termination Date
    August 25, 2017
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental 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 and injection of contrast media.

    Reason

    Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.

    Code Info

    Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084

    Distribution

    US Nationwide Distribution: in the states of MA, CA, IL, TN, IL

    Quantity

    1, 170 units