Device product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Z-1684-2021
Product summary
- Event
- Event 87739
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,487 units
- Official record key
device-enforcement:Z-1684-2021
Official wording
Reason: There is a potential leak between the venous patient connector and patient's hemodialysis access.
Code information: Product Code: 101025; Lot 1000276191, UDI: 37332414007837
Distribution pattern: Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Derived failure modes
-
Unknown
There is a potential leak between the venous patient connector and patient's hemodialysis access.