Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as Sy
FDA device recall Z-0395-05 · posted 2004-12-02 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- The air detector may not detect air bubbles consistently at the selected limit.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FKP
- Quantity affected
- 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,
- Date initiated
- 2003-05-28
- Date posted
- 2004-12-02
- Date terminated
- 2008-02-26
- Location
- Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST (K910215) | Cd Medical, Inc. | 1991-04-09 |