Recall Z-2391-2010

Hospira Inc · initiated February 22, 2010

Terminated

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

Codes / lots: All units of these List Numbers.

Reason for recall

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.

FDA-determined cause: Device Design

Action taken

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.

Details

Recall number
Z-2391-2010
Initiated
February 22, 2010
Posted by FDA
September 9, 2010
Terminated
April 1, 2011
Product code
FRN – Pump, Infusion
Distribution
Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.
Recalling firm
Hospira Inc, Morgan Hill, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2390-2010 Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List…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… 02/22/2010Terminated