CLASS III Device recall · Reported 23 Jan 2013 · FDA Enforcement Report

Fresenius GranuFlo Naturalyte Dry Acid Concentrate recalled

Fresenius Medical Care Holdings is recalling Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 0K 2,0 Ca 0Mg, distributed nationwide in the US. The recall was initiated on 26 Nov 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number:12PXGF017

Quantity recalled670 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0683-2013
FDA event ID: 63768
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class III
Status: Terminated
Recall initiated: 26 Nov 2012
FDA classified: 16 Jan 2013
Reported: 23 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

26 Nov 2012	Recall initiated by company
16 Jan 2013	Classified by FDA	+51 days
23 Jan 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 0K 2,0 Ca 0Mg recalled?

Yes. Fresenius Medical Care Holdings recalled Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 0K 2,0 Ca 0Mg on 26 Nov 2012. The recall is Class III and its status is Terminated. Recall number Z-0683-2013.

Why was it recalled?

GranuFlo Dry Acid Concentrate may show discoloration

Which lots are affected?

Lot Number:12PXGF017

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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