Fresenius Citrasate Liquid Acid Concentrate Recall Due to Low Sodium Levels
Fresenius Medical Care is recalling 198 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used in hemodialysis where chemical levels were below specifications, posing a risk of serious injury.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 198 drums of Citrasate Liquid Acid concentrate, Model Number 13-2251-CA. The affected lots are 20LXAC031, 20NXAC004, 20LXAC033, 20NXAC003, and 20LXAC032. The product was distributed nationwide in the United States.
The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. This product is used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - 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.
- Category
- Medical Device — Dialysis Fluid
- Affected units
- 198
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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