Z-0629-2014Class II

Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H...

Name: Z-0629-2014 Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-11-12
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-11-12 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic... on 2013-11-12. FDA classified it as Class II and gives the reason as "2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0629-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Posted: 2014-01-06
Terminated: 2019-03-26
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. 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: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
FDA root cause: Under Investigation by firm
Action: Fresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who encounter a saline bag that is inappropriately filling, should discontinue the setup and remove the machine from service until the drain line and drain-associated hydraulic components can be checed by a qualified service technician. Customers were also instructed to ensure that the hemodialysis machine is installed and operated in compliance with the Machine Specification section of their operator's manual, including the specification located in the Water/Drain Section. Customers with questions were instructed to call 1-800-227-2572. For questions regarding this recall call 800-662-1237.
Quantity in commerce: 111,504 units US and 3,638 Canada and Mexico-
Distribution: Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0629-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0629-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-06

Product code KDI

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)