CLASS III Device recall · Reported 5 Dec 2018 · FDA Enforcement Report

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg, distributed nationwide in the US. The recall was initiated on 9 Oct 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011

Quantity recalled92225

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-0517-2019
FDA event ID: 81451
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class III
Status: Terminated
Recall initiated: 9 Oct 2018
FDA classified: 29 Nov 2018
Reported: 5 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Oct 2018	Recall initiated by company
29 Nov 2018	Classified by FDA	+51 days
5 Dec 2018	Published in enforcement report	+6 days

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

Reason for recall

Discolored powder has confirmed the presence of a foreign substance

Product as listed by the FDA

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Where it was distributed

Distribution US nationwide and Mexico

Nationwide

Questions about this recall

Why was it recalled?

Discolored powder has confirmed the presence of a foreign substance

Which lots are affected?

Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011

Where was it sold?

Distribution US nationwide and Mexico

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

Other products in this recall event

2 other products · FDA event 81451

This product is part of a recall event; the main page for the event is Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg recalled.

Reported	Class	Recall	Company	Reason	Where
5 Dec 2018	CLASS III	Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
5 Dec 2018	CLASS III	Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

More recalls from Fresenius Medical Care Renal Therapies Group

All 35

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	CombiSet Hemodialysis Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
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9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

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