Z-0184-2014Class II

2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended...

Name: Z-0184-2014 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2013-08-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2013-08-29 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during... on 2013-08-29. FDA classified it as Class II and gives the reason as "Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0184-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2013-11-08
Terminated: 2021-02-11
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Product code: ONW Hemodialysis System For Home Use
Reason for recall: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.
Quantity in commerce: 8,528 cases
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0184-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0184-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0185-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0186-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

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)