Recall Z-0583-04 ยท FII System, Dialysate Delivery, Sealed
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 | Jul 20, 2004 (initiated Feb 20, 2004) |
| Status | Terminated |
| Reason | These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire. |
| Root cause | Other |
| Action | Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dial |
| 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, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Ita |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl, Jun 2, 1997 |