Device product
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Z-1886-2025
Product summary
- Event
- Event 96809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95,938 units
- Official record key
device-enforcement:Z-1886-2025
Official wording
Reason: Potential breach of sterile barrier packaging.
Code information: Model No.8888128459P, 8888119369P, 8888133509P, 8888123409P; UDI: 20884521157870, 20884521157733, 20884521157948, 20884521157801; Lot/Serial No. 2133600044, 2201700104, 2203300067, 2228000065, 2228000067, 2228000077, 2234800091, 2234800133, 2234800161, 2301100103, 2302500152, 2302500153, 2302500156, 2302500158, 2305300130, 2318500118, 2318500120, 2318500143, 2330300100, 2330300102, 2332700278, 2332700279, 2335200415, 2335200416, 2402400082, 2402400083, 2402400084, 2405800231, 2418000151, 2424200129, 2426300194, 2427700220.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Derived failure modes
-
Sterility assurance
breach of sterile barrier