Atlas FDA

Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04

FDA device recall Z-2390-2010 · posted 2010-09-09 · Terminated

Recall details

Recalling firm
Hospira Inc
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.
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.
Root cause
Device Design
Status
Terminated
Product code
FRN
Distribution
Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.
Date initiated
2010-02-22
Date posted
2010-09-09
Date terminated
2011-04-01
Location
Morgan Hill, CA

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Related 510(k) clearances

RecordFirmDate
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550)Abbott Laboratories2004-06-30