Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-0
FDA device recall Z-0128-2011 · posted 2010-10-22 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.
- Action taken
- Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers. Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available. Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Distribution
- Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
- Date initiated
- 2010-02-22
- Date posted
- 2010-10-22
- Date terminated
- 2013-12-03
- Location
- Morgan Hill, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |