BEUDAMED
    FDA Recall Terminated

    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

    Recall: Z-1073-2018 · Initiated December 4, 2017

    Recall

    Recall Number
    Z-1073-2018
    Event Number
    79429
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 4, 2017
    Posted
    March 15, 2018
    Terminated
    June 12, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

    Reason

    Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.

    Action

    Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed.

    Distribution

    Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.

    Quantity

    1,077 units total