BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P

    Recall: Z-2372-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2372-2021
    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 28 cm, Item Code 8888541028P

    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: 2034400130 1812200184 1911500092 2000700096 2034400084 1816400076 1914800226 2004400083 1724900107 1818500196 1924000133 2014900152 1731200157 1819100094 1926100267 2019500164 1731900150 1826200149 1926100246 2027200171 1801000137 1903500128 1927300072 2028200206 1802400068 1908800158 1930900080 2034400084 1810400148 1907800094 1930900081 2034400130

    Distribution

    Worldwide distribution.

    Quantity

    N/A