Recall Z-0127-2011
Hospira Inc · initiated February 22, 2010
Product
Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 53/54, Distributed by: Hospira, Inc. Morgan Hill, CA
Codes / lots: All units of these List Numbers.
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0127-2011
- Initiated
- February 22, 2010
- Posted by FDA
- October 22, 2010
- Terminated
- December 3, 2013
- Product code
- FRN – Pump, Infusion
- Distribution
- Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
- Recalling firm
- Hospira Inc, Morgan Hill, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0128-2011 | Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser…Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to… | 02/22/2010Terminated |