BEUDAMED
    FDA Recall 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 · Initiated June 2, 2016

    Recall

    Recall Number
    Z-2136-2016
    Event Number
    74362
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 2, 2016
    Posted
    July 6, 2016
    Terminated
    August 25, 2017
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    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.

    Action

    Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.

    Distribution

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

    Quantity

    1, 170 units