Device product
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Z-1889-2025
Product summary
- Event
- Event 96809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 95,938 units
- Official record key
device-enforcement:Z-1889-2025
Official wording
Reason: Potential breach of sterile barrier packaging.
Code information: Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
Derived failure modes
-
Sterility assurance
breach of sterile barrier