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
This recall has been terminated (originally issued December 2, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- May 28, 2003
- Posted
- December 2, 2004
- Terminated
- February 26, 2008
- Recall Number
- Z-0395-05
- Quantity
- 28,482 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The air detector may not detect air bubbles consistently at the selected limit.
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, Italy, Korea, Lebanon, Malaysia, Morocco, the Netherlands, Oman, Palestine, Panama, Peru, the Philippines, Poland, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
Lot / Code Info
All System 1000 units with serial numbers prior to 22224.
Root Cause
Other
Action Taken
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 given the choice to have the testing and installation done during the next service call or as part of the instrument''s next normally scheduled maintenance.