Device product
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Z-1644-2014
Product summary
- Event
- Event 67996
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,461,824 units total
- Official record key
device-enforcement:Z-1644-2014
Official wording
Reason: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Code information: Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.
Distribution pattern: Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Derived failure modes
-
Unknown
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.