The Recall Desk
HighFDA (Devices)·Z-0070-2013·Announced 2012-10-31

Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions

Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (infusion pump) where injury has not yet been reported, fitting the High severity criteria for potential medication delivery errors without confirmed harm.

Plain-English summary

Hospira Inc. is recalling 14,067 units of the Symbiq Two Channel Infuser, a prescription medical device used to administer intravenous fluids and medications. The recall covers devices with List Number 16027-01 and all serial numbers. These units were distributed nationwide in the United States, in Puerto Rico, and internationally to Canada.

The recall is due to a defect where the pump's touchscreen may not respond to user selection, may experience a delayed response, or may register a different value than the one selected by the user. If the touchscreen fails to respond to user input, it could result in a delay in therapy or the 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.

Healthcare providers and facilities using these devices should stop using the affected Symbiq Two Channel Infusers and contact Hospira for instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

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, agent
Manufacturer
Hospira Inc.
Affected units
14,067

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • List Number 16027-01
  • all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →