Palindrome Precision Chronic Hemodialysis Catheter Sport Pack — Class II medical device recall Z-1885-2025
Ongoing recall by Mozarc Medical US LLC, reported 2025-06-11, distributed nationwide. Potential breach of sterile barrier packaging.
| Recall number | Z-1885-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mozarc Medical US LLC, Mansfield, MA, United States |
| Recall initiated | 2025-04-23 |
| Classified | 2025-05-30 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 95,938 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10884521157767, 20884521157696, 20884521157702, 20884521157740, 20884521157764, 20884521157771, 20884521157818, 20884521157832, 20884521157849, 20884521157887, 20884521157900, 20884521157917, 20884521157955 |
| Serial numbers | 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 and 113 more |
| Model numbers | 8888119360P, 8888119364P, 8888119370P, 8888123400P, 8888123404P, 8888123410P, 8888128450P, 8888128454P, 8888128460P, 8888133500P, 8888133504P, 8888133510P |
Product
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Reason for recall
Potential breach of sterile barrier packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1885-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.