FDA recall Z-2402-2020

Product

DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

Reason for recall

Incorrect labeling of dialysate concentration for hemodialysis.

Distribution

U.S.: CA O.U.S.:None

Key facts

Status

Terminated

Initiation date

2020-04-30

Report date

2020-06-24

Termination date

2024-05-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2020