—#93732

Product

Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54, Distributed by: Hospira, Inc. Morgan Hill, CA

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550
Affected lot / code info: All units of these List Numbers.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.

Timeline

Recall initiated: 2010-02-22
Posted by FDA: 2010-10-22
Terminated: 2013-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.