RecallRadar

FDA Device recall Z-2402-2020

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

On 2020-06-24 the FDA classified a Class II recall of DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS by Diasol, citing incorrect labeling of dialysate concentration for hemodialysis.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2402-2020
ClassificationClass II
Statusterminated
Initiated2020-04-30
Published2020-06-24
Last updated2026-09-13 11:55 UTC
CompanyDiasol
DistributionCA

Product

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

Reason

Incorrect labeling of dialysate concentration for hemodialysis.

Identifiers

code_infoModel Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2402-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.