Device product
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Z-1887-2025
Product summary
- Event
- Event 96809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95,938 units
- Official record key
device-enforcement:Z-1887-2025
Official wording
Reason: Potential breach of sterile barrier packaging.
Code information: Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Derived failure modes
-
Sterility assurance
breach of sterile barrier