CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report

Fresenius Dry Acid Dissolution Unit recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Dry Acid Dissolution Unit, distributed nationwide in the US. The recall was initiated on 23 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Quantity recalled348 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-0295-2016
FDA event ID: 72484
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2015
FDA classified: 18 Nov 2015
Reported: 25 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

23 Oct 2015	Recall initiated by company
18 Nov 2015	Classified by FDA	+26 days
25 Nov 2015	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

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Fresenius Dry Acid Dissolution Unit recalled?

Yes. Fresenius Medical Care Renal Therapies Group recalled Fresenius Dry Acid Dissolution Unit on 23 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0295-2016.

Why was it recalled?

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Which lots are affected?

All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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