Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.
What this means for you
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 a Class II recall for a medical device used in hemodialysis where the product failed to meet manufacturing specifications for critical electrolytes (sodium/calcium), posing a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 230 drums of NaturaLyte Liquid Acid concentrate, Model Number 13-3251-9. The product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. The affected lots were distributed nationwide in the United States.
The specific lot numbers affected are 20LXAC024, 20LXAC072, 20LXAC073, 20LXAC085, 20NXAC017, 20NXAC030, 20LXAC074, 20LXAC023, 20LXAC104, 20LXAC066, and 20LXAC089. Healthcare facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - 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
- 230
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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