Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufact
FDA device recall Z-1895-2010 · posted 2010-07-02 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
- Action taken
- Hospira issued a "Urgent: Medical Device Recall Notification" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form. For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 28,485 total
- Distribution
- Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia,
- Date initiated
- 2010-04-09
- Date posted
- 2010-07-02
- Date terminated
- 2013-12-03
- 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 |