Mozarc Medical US LLC: Medical Device Recall in 2025 - (Recall #: Z-1885-2025)

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

Class II

Potential breach of sterile barrier packaging.

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.

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

Voluntary: Firm initiated