CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

Revision K Actuator Test Boards sold as replacement parts recalled

Fresenius Medical Care Holdings is recalling Revision K Actuator Test Boards sold as replacement parts for use with Fresenius, distributed nationwide in the US. The recall was initiated on 25 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRevision K Actuator Test Boards

Quantity recalled39 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-1619-2014
FDA event ID: 68042
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 25 Apr 2014
FDA classified: 13 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Apr 2014	Recall initiated by company
13 May 2014	Classified by FDA	+18 days
21 May 2014	Published in enforcement report	+8 days

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

Reason for recall

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

Where it was distributed

USA (nationwide) and the country of Canada.*

Nationwide

Questions about this recall

Why was it recalled?

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

Which lots are affected?

Revision K Actuator Test Boards

Where was it sold?

USA (nationwide) and the country of Canada.*

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

1 other product · FDA event 68042

Reported	Class	Recall	Company	Reason	Where
21 May 2014	CLASS II	Fresenius 2008T Hemodialysis Machine recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	Nationwide

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