Device product
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Z-1909-2019
Product summary
- Event
- Event 83015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65403 units
- Official record key
device-enforcement:Z-1909-2019
Official wording
Reason: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Code information: UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
Distribution pattern: US Nationwide Distribution and Internationally to: Canada and Bermuda.
Derived failure modes
-
Unknown
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.