Z-1325-2016Class II

Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius...

Name: Z-1325-2016 Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2016-03-10
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2016-03-10 / Terminated / root cause: design

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System... on 2016-03-10. FDA classified it as Class II and gives the reason as "Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)". 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-1325-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2016-04-05
Terminated: 2017-03-09
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and chronic dialysis therapy
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008 Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.
Quantity in commerce: 8384 units (8369 US) (15 OUS)
Distribution: Nationwide Distribution
Product codes and lots: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1325-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1325-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

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)