BEUDAMED
    FDA Recall Terminated

    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

    Recall: Z-2617-2021 · Initiated October 17, 2017

    Recall

    Recall Number
    Z-2617-2021
    Event Number
    88596
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 17, 2017
    Terminated
    June 14, 2022
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

    Reason

    Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

    Action

    Angiodynamics issued Recall Notifications Packages via Federal Express to 1 International Medical Facility on 2017-10-17. Letter states reason for recall, health risk and action to take: IMMEDIATELY " Stop using the product subject to recall. " Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to AngioDynamics, Inc. " Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. " If affected product is located in your institution, please can AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. " Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. o Email Reply Verification Tracking Form (preferred): [email protected] o Fax Reply Verification Tracking Form: Ann: PICC Kit Product Description Recall Coordinator Fax number 1 800-782-1357.

    Distribution

    Canada

    Quantity

    4 boxes (5/each)= 20 eaches