Fresenius Naturalyte Liquid Bicarbonate Concentrate Recalled for Temperature Violation
Fresenius Medical Care is recalling 72 cases of Naturalyte Liquid Bicarbonate Concentrate distributed in Texas because the product was held at temperatures above the recommended storage range.
What this means for you
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a storage temperature deviation, which fits the criteria for a moderate, precautionary recall without reported harm.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 72 cases of Fresenius Naturalyte Liquid Bicarbonate Concentrate, Product Number 08-4000-LB, Lot Number 14BMLB012. The product was distributed in Texas. This concentrate is formulated for use with three steam hemodialysis machines calibrated for acid and bicarbonate concentrates.
The recall was initiated because the product was held at a temperature above the labeled recommended storage temperature. This deviation from storage requirements may affect the product's stability or safety.
Patients and healthcare facilities in Texas who have this specific lot of the product should stop using it and contact their supplier or Fresenius Medical Care for further instructions.
The recalled product
- Product
- Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 14BMLB012
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · temperature violation
See all →- ModerateFixodent Denture Cream Recalled Due to Improper Storage Conditions
FDA (Devices) · 2023-11-15
- ModerateUNFI Recalls Apetina Marinated Olives and Feta Due to Temperature Violation
FDA (Food) · 2019-10-02
- ModerateMimoso Queijo Minas Frescal Cheese Recalled for Temperature Violation
FDA (Food) · 2019-02-13
- ModerateMitsuwa Recalls Baked Seasoned Fish Products Due to Temperature Violation
FDA (Food) · 2015-08-19
- ModerateMitsuwa Recalls Baked Seasoned Sardine and Goby Products for Temperature Violation
FDA (Food) · 2015-08-19