Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, G
FDA device recall Z-1367-2008 · posted 2008-03-25 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Inc.
- Reason for recall
- Kinked tubing on hemodialysis device may cause hemolysis.
- Action taken
- 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
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 41,000,000
- Distribution
- Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.
- Date initiated
- 2007-09-10
- Date posted
- 2008-03-25
- Date terminated
- 2012-01-03
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET (K001156) | Gambro Renal Products | 2000-07-07 |