Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as Sy
FDA device recall Z-0833-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
- Action taken
- Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change
- Root cause
- Other
- Status
- Terminated
- Product code
- FKP
- Quantity affected
- 25,014 units
- Distribution
- The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong
- Date initiated
- 2003-03-20
- Date posted
- 2003-05-15
- Date terminated
- 2004-01-23
- Location
- Round Lake, IL
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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 |