Device product
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
Z-1869-2018
Product summary
- Event
- Event 79878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139
- Official record key
device-enforcement:Z-1869-2018
Official wording
Reason: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Code information: Lot 28562-0220171
Distribution pattern: US Distribution to the state of NY
Derived failure modes
-
Unknown
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.