Z-2402-2020 Class II Terminated

Recalled by Diasol, Inc — Phoenix, AZ

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