BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

    Recall: Z-2632-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2632-2023
    Event ID
    92902
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    September 25, 2023
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

    Reason

    Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.

    Code Info

    UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom.

    Quantity

    3050 devices