Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.
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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to potential discoloration, a cosmetic or quality defect without reported injury.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 14,240 units of GranuFlo Naturalyte 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 concentrate may show discoloration.
The affected product is identified by Catalog Number OFD3251-3B and includes Lot Numbers 12NXGF002, 12NXGF014, and 12PXGF006. The units were distributed nationwide in the United States.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B 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
- 14,240
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:12NXGF002
- 12NXGF014
- 12PXGF006
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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