Recall Z-2391-2010 ยท FRN Pump, Infusion
Hospira Inc
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
| Date | Sep 9, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Distribution | Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041550 | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Abbott Laboratories, Jun 30, 2004 |