FDA Enforcement Class I Terminated

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: Z-0070-2013 · Reported October 31, 2012

Enforcement

Recall Number
Z-0070-2013
Event ID
63056
Classification
Class I
Status
Terminated
Product Type
Devices
Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
October 31, 2012
Initiation Date
August 29, 2012
Classification Date
October 19, 2012
Termination Date
March 15, 2017
Address
275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

Description

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

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.

Code Info

List Number 16027-01, all serial numbers

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada

Quantity

14,067 units