Device product
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Z-1888-2025
Product summary
- Event
- Event 96809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95,938 units
- Official record key
device-enforcement:Z-1888-2025
Official wording
Reason: Potential breach of sterile barrier packaging.
Code information: Model No.8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, 8888133505P; UDI: 20884521157788, 20884521157825, 20884521157856, 20884521157894, 20884521157719, 10884521157750, 20884521157924; Lot/Serial No. 2204000102, 2228000068, 2228000070, 2234800148, 2234800159, 2234800160, 2302500128, 2305300136, 2315600104, 2315600113, 2315600119, 2315600122, 2318500135, 2318500136, 2318500140, 2320000255, 2332700275, 2335200414, 2412000238, 2412000239, 2414300228, 2414300233, 2418000150, 2426300169.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Derived failure modes
-
Sterility assurance
breach of sterile barrier