Device product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Z-1409-2020
Product summary
- Event
- Event 84339
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101976 devices
- Official record key
device-enforcement:Z-1409-2020
Official wording
Reason: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Code information: UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.