Z-1619-2014Class II

Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis...

Name: Z-1619-2014 Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-04-25
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-04-25 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part... on 2014-04-25. FDA classified it as Class II and gives the reason as "2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1619-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Posted: 2014-05-13
Terminated: 2021-05-18
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572.
Quantity in commerce: 39 units
Distribution: USA (nationwide) and the country of Canada.*
Product codes and lots: Revision K Actuator Test Boards

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1619-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1618-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13
Z-1619-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)