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

Fresenius Granuflo Dry Acid Concentrate- 2K 0 Ca 1 Mg recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Granuflo Dry Acid Concentrate- 2K 0 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:18ETGF005
Quantity recalled4752

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-0516-2019
FDA event ID
81451
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

Timeline

9 Oct 2018Recall initiated by company
29 Nov 2018Classified by FDA+51 days
5 Dec 2018Published 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 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Where it was distributed

Distribution US nationwide and Mexico

Nationwide

Questions about this recall

Is Fresenius Granuflo Dry Acid Concentrate- 2K 0 Ca 1 Mg recalled?

Yes. Fresenius Medical Care Renal Therapies Group recalled Fresenius Granuflo Dry Acid Concentrate- 2K 0 Ca 1 Mg on 9 Oct 2018. The recall is Class III and its status is Terminated. Recall number Z-0516-2019.

Why was it recalled?

Discolored powder has confirmed the presence of a foreign substance

Which lots are affected?

Lot code:18ETGF005

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 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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