Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
FDA Recall Z-1367-2008 · Posted 2008-03-25
Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2007-09-10
Date Terminated2012-01-03
Product Quantity41,000,000
Reason for Recall
Kinked tubing on hemodialysis device may cause hemolysis.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.