Fresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis
Fresenius Medical Care is recalling GranuFlo Acid Concentrate due to a risk of alkalosis in patients undergoing 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 risk of harm (alkalosis) in a medical device context where specific injury counts are not reported, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Fresenius GranuFlo (powder) Acid Concentrate. The product is used for the treatment of acute and chronic renal failure during hemodialysis procedures. The recall involves specific product codes, including OFD1201-3B, OFD1251-3B, and others, and applies to all lots.
The recall is being conducted due to a risk of alkalosis associated with acetate-containing dialysis acid concentrates. The product was distributed nationwide and in the country of Guam.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acu
- 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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