BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1885-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1885-2025
    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 Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

    Reason

    Potential breach of sterile barrier packaging.

    Code Info

    Model No. 8888128450P, 8888123404P, 8888123410P, 8888128454P, 8888128460P, 8888133500P, 8888133504P, 8888133510P, 8888123400P, 8888119360P, 8888119370P, 8888119364P; UDI: A8845211578301, A8845211577701, A8845211578101, A8845211578401, A8845211578801, A8845211579001, A8845211579101, 20884521157955, A8845211577601, A8845211576901, A8845211577401, A8845211577001; UPN 20884521157832, 20884521157771, 20884521157818, 20884521157849, 20884521157887, 20884521157900, 20884521157917, 10884521157767, 20884521157764, 20884521157696, 20884521157740, 20884521157702; Lot/Serial No. 240450106, 240640172, 240640173, 240640180, 240640210, 240660013, 240780122, 240790012, 240850175, 240850176, 241170007, 241270012, 241340007, 241340289, 241410006, 241550024, 241620025, 241690028, 241800007, 241900044, 241970039, 242110216, 242110217, 242110218, 242180246, 242180247, 242180248, 242180253, 242180254, 2119700109, 2130800058, 2130800068, 2130800101, 2133500082, 2133600117, 2133700190, 2200400069, 2200400070, 2200400086, 2200400087, 2203800224, 2203800233, 2203900155, 2203900156, 2203900206, 2203900207, 2204000093, 2204000123, 2204000124, 2204000125, 2208100120, 2211200115, 2211200117, 2219600123, 2219600124, 2221700135, 2228000066, 2228000076, 2228000078, 2232700133, 2232700150, 2232700158, 2232700159, 2232700161, 2232700162, 2232700170, 2232700183, 2232700185, 2232700186, 2232700191, 2232700192, 2232700193, 2232700194, 2234800146, 2302500151, 2304400085, 2305300140, 2305300141, 2305300143, 2305300145, 2305300146, 2305300147, 2305300162, 2305300163, 2305300165, 2305300171, 2305300173, 2305300174, 2305300175, 2305300176, 2305800058, 2305800059, 2308000130, 2308000135, 2308000137, 2308000150, 2310300140, 2310300141, 2310300142, 2311000397, 2311000398, 2311000399, 2311000400, 2311000405, 2311000411, 2311000412, 2311000416, 2311000419, 2311000420, 2311000421, 2313000134, 2313000140, 2313000141, 2313000142, 2324100188, 2324100295, 2324100296, 2324100303, 2324100304, 2335200418, 2335200419, 2405800232, 2414300189, 2414300190, 2425500133, 2425500134, 2425500135, 2425500136, 2426700099, 2427700184, 2427700187, 2427700188, 2427700191, 2427700193, 2427700194, 2430500205, 2430500216, 2430500241.

    Distribution

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

    Quantity

    95,938 units