—#93736

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

The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.

Root cause (FDA determination)

Device Design

Action the firm took

Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira 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 (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.

Timeline

Recall initiated: 2010-02-22
Posted by FDA: 2010-09-09
Terminated: 2011-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.