Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The source text only mentions discoloration without reporting injuries or illnesses.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 13,409 units of GranuFlo Naturalyte Dry Acid Concentrate for Bicarbonate Dialysis. The recall affects specific lots (12NXGF005, 12NXGF019, 12PXGF008) that were distributed nationwide in the United States.
The recall was initiated because the GranuFlo Dry Acid Concentrate may show discoloration. This product is indicated for the treatment of acute and chronic renal failure during hemodialysis.
Patients and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 13,409
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 (3)
- Lot Numbers:12NXGF005
- 12NXGF019
- 12PXGF008
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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