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FDAFDA · Food and drugs·Recall number Z-0069-2013

Symbiq One 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 16026-01 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

Published October 31, 2012 · Recall initiated: August 29, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hospira Inc.
Distributor
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
Lot
List Number 16026-01, all serial numbers
Risk classification
Class I
Area (FDA)
device
Country
United States

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