Recall Z-0395-05 ยท FKP System, Dialysate Delivery, Single Patient
Baxter Healthcare Renal Div
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
| Date | Dec 2, 2004 (initiated May 28, 2003) |
| Status | Terminated |
| Reason | The air detector may not detect air bubbles consistently at the selected limit. |
| Root cause | Other |
| Action | Important Product Information letters were sent to customers on 5/28/03, informing them of the potential for the air detector not detecting air bubbles consistently. The letters instructed the accounts to measure the air detector sensor voltage output on each of their instruments, using the enclosed instructions, to determine whether the installation of an air detector attenuator connector is needed. The instructions also included directions for installation of the attenuator connector. Since the instrument requires re-qualification after the testing and installation, the accounts were give |
| Quantity | 28,482 units |
| Distribution | The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, the Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc., Apr 9, 1991 |