Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser,
FDA device recall Z-0944-2009 · posted 2009-02-27 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.
- Action taken
- Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- combined 11,840 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada and Australia.
- Date initiated
- 2008-12-03
- Date posted
- 2009-02-27
- Date terminated
- 2012-04-03
- Location
- Morgan Hill, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |