Z-0844-2011

Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7

Name: Z-0844-2011 Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2010-11-19
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2010-11-19 / Terminated / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7 on 2010-11-19. The reason FDA records is "Hemodialysis Blood tubing Sets may develop kinking of the arterial line". 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-0844-2011
Status: Terminated
Initiated: 2010-11-19
Posted: 2011-01-10
Terminated: 2012-11-03
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
Quantity in commerce: 10, 032 units (418 cases x 24 units)
Distribution: Distribution Nationwide and Canada
Product codes and lots: Lots 09JR01174, 09JR01229, 09NR01139, 10KR01801

Product code FJK

K962081Class IICombilines Hemodialysis Blood Tubing SetNational Medical Care, Medical Products Div., Inc. / cleared 1996-11-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)