Fresenius NaturaLyte Liquid Acid concentrate drums recalled 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: The recall involves a medical device with a defect that could affect patient safety (low sodium/calcium levels), but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 592 drums of NaturaLyte Liquid Acid concentrate, Model Number 13-2251-0. 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 include 20LXAC070, 20LXAC103, 20NXAC021, 20LXAC100, 20LXAC026, 20LXAC027, 20LXAC028, 20LXAC029, 20LXAC065, 20LXAC067, 20LXAC071, 20NXAC001, 20NXAC019, 20NXAC020, 20NXAC029, 20LXAC082, 20LXAC025, 20LXAC081, and 20LXAC083.
The product was distributed nationwide in the United States. Healthcare facilities and consumers should stop using the affected product and contact Fresenius Medical Care for further instructions.
The recalled product
- Product
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - 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
- 592
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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