Agency classClass IIIOur severity:Low FDA (Devices)·Z-0682-2013·Announced 2013-01-23

Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.

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 indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for cosmetic or minor defects.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 2,493 units of GranuFlo Naturalyte Dry Acid Concentrate for Bicarbonate Dialysis. The product, identified by Lot Number 12NXGF012 and Catalog Number OFD2223-3B, was distributed nationwide in the United States. The recall was initiated because the concentrate may show discoloration.

GranuFlo is indicated for the treatment of acute and chronic renal failure during hemodialysis. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.

Patients and healthcare providers should stop using the affected lot of GranuFlo 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 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Supplies
Hazard: discoloration
Affected units: 2,493

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:12NXGF012

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.

See all 9 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · discoloration