Z-1885-2025 Class II Ongoing
FDA device recall Z-1885-2025 was initiated by Mozarc Medical US LLC on April 23, 2025 and is designated Class II. Reason for recall: Potential breach of sterile barrier packaging. The recall status is ongoing. Affected quantity: 95,938 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- April 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95,938 units
Product Description
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason for Recall
Potential breach of sterile barrier packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Code Information
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.