Z-3083-2011

Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute...

Name: Z-3083-2011 Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2011-05-04
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2011-05-04 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also... on 2011-05-04. The reason FDA records is "Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)". 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-3083-2011
Status: Terminated
Initiated: 2011-05-04
Posted: 2011-08-29
Terminated: 2014-08-14
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Product code: ONW Hemodialysis System For Home Use
Reason for recall: Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.
Quantity in commerce: 705 units
Distribution: Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
Product codes and lots: All serial numbers

Product code ONW

K070049Class IIFresenius 2008K @Home with Wireless Wetness DetectorFresenius Medical Care North America / cleared 2011-02-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)