Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.
FDA device recall Z-2381-2010 · posted 2010-09-08 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.
- Action taken
- Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 28485 units
- Distribution
- Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
- Date initiated
- 2010-03-26
- Date posted
- 2010-09-08
- Date terminated
- 2012-03-30
- 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 |