Z-1027-2017Class II

Fresenius 2008K Series : Hemodialysis System

Name: Z-1027-2017 Fresenius 2008K Series : Hemodialysis System
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2016-12-21
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2016-12-21 / Terminated / root cause: design

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius 2008K Series : Hemodialysis System on 2016-12-21. FDA classified it as Class II and gives the reason as "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". 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-1027-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Posted: 2017-01-13
Terminated: 2023-03-17
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008K Series : Hemodialysis System
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
Quantity in commerce: 78481 (US) 2734 units (OUS)
Distribution: Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1027-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1026-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13
Z-1027-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13
Z-1028-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13
Z-1029-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13

Product code KDI

K150708Class II2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC / cleared 2015-12-10

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)