Diasol Recalls Liquid Acid Concentrate for Hemodialysis Due to Labeling Error
Diasol, Inc. is recalling 212 cases of liquid acid concentrate for hemodialysis because of incorrect labeling of the dialysate concentration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Diasol, Inc. is recalling 212 cases of 4-gallon containers of DIASOL 1000225-10-DEX100 Liquid Acid Concentrate for Bicarbonate Dialysis. The recall was initiated due to incorrect labeling of the dialysate concentration for hemodialysis.
The affected product is identified by Model Number 100225-10-DEX100 and UDI codes B467100225101004 and B4671000225101004. The specific lot code is PHQ03041/030920. The product was distributed in California, United States.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should check their inventory for the specific lot and model numbers listed and stop using the product if it matches the description. They should contact Diasol, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
- Manufacturer
- Diasol, Inc
- Category
- Medical Device — Dialysis Fluid
- Hazard
Distribution
Distributed in 1 state:
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