Z-3269-2011

CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the...

Name: Z-3269-2011 CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2011-08-11
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2011-08-11 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the... on 2011-08-11. The reason FDA records is "Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions". 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-3269-2011
Status: Terminated
Initiated: 2011-08-11
Posted: 2011-09-20
Terminated: 2016-08-24
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient
Product code: ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
Reason for recall: Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.
Quantity in commerce: 118 cases
Distribution: Nationwide Distribution.
Product codes and lots: Product Code: 03-2962-3 Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804 Exp. Date 05-2014

Product code ODX

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)