BEUDAMED
    FDA Recall Terminated

    Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266

    Recall: Z-0743-03 · Initiated March 20, 2003

    Recall

    Recall Number
    Z-0743-03
    Event Number
    25817
    Firm
    Tyco Healthcare/Kendall
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2003
    Posted
    April 18, 2003
    Terminated
    May 12, 2021
    Address
    15 Hampshire Street, Mansfield, MA, 02048

    Description

    Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266

    Reason

    Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter

    Action

    The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.

    Distribution

    Nationwide International: Canada, Chile, Singapore. Belgium

    Quantity

    254