Recall Z-1367-2008 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Inc.
Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
| Date | Mar 25, 2008 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | Kinked tubing on hemodialysis device may cause hemolysis. |
| 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 | 41,000,000 |
| Distribution | Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET Gambro Renal Products, Jul 7, 2000 |