Z-2402-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- April 30, 2020
- Termination Date
- May 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212 Cases of 4 gallons each
Product Description
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Reason for Recall
Incorrect labeling of dialysate concentration for hemodialysis.
Distribution Pattern
U.S.: CA O.U.S.:None
Code Information
Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920