BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P

    Recall: Z-2375-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2375-2021
    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 Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P

    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: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093

    Distribution

    Worldwide distribution.

    Quantity

    N/A