Recall archive / FDA device enforcement
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. — FDA record Z-1885-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Reason
- Potential breach of sterile barrier packaging.
- Classification
- Class II
- Recalling firm
- Mozarc Medical US LLC
- Quantity
- 95,938 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1885-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 11, 2025
- Recall initiation date
- Apr 23, 2025
- Center classification date
- May 30, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.