Z-1367-2008

Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+)...

Name: Z-1367-2008 Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+)...
Creator: Gambro Renal Products, Inc.
Published: 2007-09-10
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2007-09-10 / Terminated / root cause: design

FDA source

Gambro Renal Products, Inc. began a recall of Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 on 2007-09-10. The reason FDA records is "Kinked tubing on hemodialysis device may cause hemolysis". 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-1367-2008
Status: Terminated
Initiated: 2007-09-10
Posted: 2008-03-25
Terminated: 2012-01-03
Recalling firm: Gambro Renal Products
Product: Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Kinked tubing on hemodialysis device may cause hemolysis.
Root cause tag: design
FDA root cause: Device Design
Action: On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.
Quantity in commerce: 41,000,000
Distribution: Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.
Product codes and lots: All catalog numbers involving the Gambro Cartridge Blood Sets: 003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500.

Product code KDI

K001156Class IIPhoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing SetGambro Renal Products / cleared 2000-07-07

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)