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 2,711 units distributed nationwide.
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 FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 2,711 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 is being conducted because the concentrate may show discoloration.
The affected product is identified by Lot Number 12PXGF002 and Catalog Number OFD2325-3B. The units were distributed nationwide in the United States. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Patients and healthcare providers should stop using the affected product and contact their supplier or Fresenius Medical Care for further instructions.
The recalled product
- Product
- Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B 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
- 2,711
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)
- Lot Number:12PXGF002
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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