Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels
Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.
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. The hazard involves a deviation from manufacturing specifications (low sodium/calcium) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 27 drums of NaturaLyte Liquid Acid concentrate, Model Number 13-2201-5. The affected lots are 20LXAC030, 20LXAC084, 20NXAC002, 20LXAC014, and 20NXAC018. These products were distributed nationwide in the United States.
The recall was initiated because the sodium and/or calcium levels in the concentrate were below manufacturing specifications. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Healthcare facilities and users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 27
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 Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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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