Device product
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Z-0370-2017
Product summary
- Event
- Event 75414
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,656 units
- Official record key
device-enforcement:Z-0370-2017
Official wording
Reason: Potential presence of particulate matter on the blood side of the dialyzer
Code information: C416201601
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter