FDAClass IIJune 24, 2020

Diasol 1000225-10-dex100 Liquid Acid Concentrate for recall: Labeling Error

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

Why was Diasol 1000225-10-dex100 Liquid Acid Concentrate for recalled?

Incorrect labeling of dialysate concentration for hemodialysis.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Recalling firm
Diasol, Inc
Quantity
212 Cases of 4 gallons each
Distribution
U.S.: CA O.U.S.:None
Recall date
June 24, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls