BEUDAMED
    FDA Recall Terminated

    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter 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 ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.

    Recall: Z-0192-2020 · Initiated July 18, 2019

    Recall

    Recall Number
    Z-0192-2020
    Event Number
    83456
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 18, 2019
    Terminated
    November 10, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter 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 ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.

    Reason

    Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length

    Action

    Teleflex issued notification letter dated July 17, 2019 issued via FedEx 2-day mail identifies the problem, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. If you do have stock a customer service representative will contact you to arrange issuing correct labels to relabel the product. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

    Distribution

    US Nationwide distribution.

    Quantity

    745 eaches