Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Alkalosis Risk
Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate due to a risk of alkalosis. The product is used for hemodialysis.
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 risk of harm (alkalosis) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Fresenius NaturaLyte Liquid Acid Concentrate. The recall is due to a risk of alkalosis associated with acetate-containing dialysis acid concentrates.
The affected product is used for the treatment of acute and chronic renal failure during hemodialysis procedures. The recall covers all lots of the product. Distribution was nationwide and included the country of Guam.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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