CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

2008 Series Hemodialysis Machines: 2008T with the following product recalled

Fresenius Medical Care Holdings is recalling 2008 Series Hemodialysis Machines: 2008T with the following, distributed nationwide in the US. The recall was initiated on 20 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016

Quantity recalled133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)

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-1550-2015
FDA event ID: 70574
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2015
FDA classified: 29 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Feb 2015	Recall initiated by company
29 Apr 2015	Classified by FDA	+68 days
6 May 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

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Product as listed by the FDA

2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

Where it was distributed

Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.

Nationwide

Questions about this recall

Why was it recalled?

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

Which lots are affected?

Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016

Where was it sold?

Worldwide Distribution: US (Nationwide) and countries of: Canada 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 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 70574

This product is part of a recall event; the main page for the event is 2008 Series Hemodialysis Machines: 2008K with the following product recalled.

Reported	Class	Recall	Company	Reason	Where
6 May 2015	CLASS II	2008 Series Hemodialysis Machines: 2008K with the following product recalled	Fresenius Medical Care Holdings	Other	Nationwide
6 May 2015	CLASS II	2008 Series Hemodialysis Machines: 2008K2 with the following product recalled	Fresenius Medical Care Holdings	Other	Nationwide
6 May 2015	CLASS II	2008 Series Hemodialysis Machines: 2008Kathome recalled	Fresenius Medical Care Holdings	Other	Nationwide

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