Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels
Fresenius Medical Care is recalling 176 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 agency classified this as a Class II recall. Under the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 176 drums of Citrasate Liquid Acid concentrate, Model Number 13-3251-CA. The affected lot numbers are 20LXAC032 and 20NXAC003. 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.
Healthcare facilities and users should stop using the affected lots immediately and contact the manufacturer for further instructions.
The recalled product
- Product
- Citrasate Liquid Acid concentrate drums, Model Number 13-3251-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.
- Affected units
- 176
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: 20LXAC032 20NXAC003
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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