Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 is defined as unlikely to cause adverse health consequences, and the source text does not report any injuries or illnesses.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 101,108 units of GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis. The product is indicated for the treatment of acute and chronic renal failure during hemodialysis. The recall was initiated because the product may show discoloration.
The affected product is distributed nationwide in the United States. Specific lot numbers involved in the recall include 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, and 12PXGF016.
Healthcare providers and facilities using this product should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B 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
- 101,108
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 (17)
- Lot Numbers: 12NXGF001
- 12NXGF003
- 12NXGF006
- 12NXGF007
- 12NXGF013
- 12NXGF015
- 12NXGF016
- 12NXGF017
- 12PXGF001
- 12PXGF003
- 12PXGF005
- 12PXGF007
- 12PXGF009
- 12PXGF012
- 12PXGF013
- 12PXGF015
- 12PXGF016
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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