CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

Fresenius 2008K Series : Hemodialysis System recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius 2008K Series : Hemodialysis System, distributed nationwide in the US. The recall was initiated on 21 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled78481 (US) 2734 units (OUS)

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-1027-2017
FDA event ID: 76037
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2016
FDA classified: 13 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Dec 2016	Recall initiated by company
13 Jan 2017	Classified by FDA	+23 days
25 Jan 2017	Published in enforcement report	+12 days

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

Reason for recall

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Product as listed by the FDA

Fresenius 2008K Series : Hemodialysis System

Where it was distributed

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers

Where was it sold?

Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam

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 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

3 other products · FDA event 76037

This product is part of a recall event; the main page for the event is Fresenius 2008K@home Series : Hemodialysis System recalled.

Reported	Class	Recall	Company	Reason	Where
25 Jan 2017	CLASS II	Fresenius 2008K@home Series : Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
25 Jan 2017	CLASS II	Fresenius 2008K2 Series : Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
25 Jan 2017	CLASS II	Fresenius 2008T Series Hemodialysis System recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

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All 34

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