BEUDAMED
    FDA Recall Terminated

    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied

    Recall: Z-1879-2017 · Initiated March 17, 2017

    Recall

    Recall Number
    Z-1879-2017
    Event Number
    76935
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 17, 2017
    Posted
    April 10, 2017
    Terminated
    March 24, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied

    Reason

    Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.

    Action

    Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to [email protected] or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.

    Distribution

    US Distribution to NJ, IL, and PA

    Quantity

    310 units