BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019

    Recall: Z-2358-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2358-2021
    Event ID
    88250
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    May 28, 2021
    Classification Date
    August 27, 2021
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019

    Reason

    This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

    Code Info

    Lot Numbers: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247

    Distribution

    Worldwide distribution.

    Quantity

    N/A