BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

    Recall: Z-2359-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2359-2021
    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 23 cm, Item Code 8888541023

    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: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121

    Distribution

    Worldwide distribution.

    Quantity

    N/A