BEUDAMED
    FDA Enforcement Class II Ongoing

    Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

    Recall: Z-1887-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1887-2025
    Event ID
    96809
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mozarc Medical US LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    April 23, 2025
    Classification Date
    May 30, 2025
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

    Reason

    Potential breach of sterile barrier packaging.

    Code Info

    Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

    Quantity

    95,938 units