Company:Hospira Inc.
Date of Enforcement Report 10/26/12
Class l:
PRODUCT
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
Recall Number Z-0070-2013
REASON
The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump’s confirmation screen prior to starting the infusion.
RECALLING FIRM/MANUFACTURER
Hsopira Inc., Lake Forest, IL on 8/26/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14,067 units
DISTRIBUTION
Nationwide and Canada
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