Device product
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Z-2402-2020
Product summary
- Firm
- Diasol, Inc
- Event
- Event 85695
- Status
- Terminated
- Classification
- Class II
- Quantity
- 212 Cases of 4 gallons each
- Official record key
device-enforcement:Z-2402-2020
Official wording
Reason: Incorrect labeling of dialysate concentration for hemodialysis.
Code information: Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920
Distribution pattern: U.S.: CA O.U.S.:None
Derived failure modes
-
Labeling or packaging
Incorrect labeling