Medical dialysis concentrates recalled for freezing temperature exposure
Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical medical device used in life-sustaining hemodialysis treatment. While no illnesses or injuries have been reported, the freezing exposure poses a documented risk to product integrity and the ability to prepare safe dialysate. The recall meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate. These products are used as one component in preparing dialysate for 3-stream proportioning hemodialysis machines according to a physician's prescription.
The products were exposed to freezing temperatures due to malfunctions in refrigerated delivery trucks. This exposure may affect the chemical stability and performance of the concentrates when used to prepare dialysate for hemodialysis treatment.
The affected lot numbers are 21BTAC004, 21AGAC026, and 21BTAC008, distributed exclusively to Texas. Patients receiving hemodialysis should contact their healthcare provider or dialysis facility if they have questions about which concentrates were used in their treatment.
The recalled product
- Product
- Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for…
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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