The Recall Desk
HighFDA (Devices)·Z-0362-2017·Announced 2016-11-16

Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown

Hospira is recalling Symbiq Two Channel Infusers that may display a white screen, causing the device to stop infusion and sound an alarm, which can delay or interrupt therapy.

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 is classified as FDA Class II. The hazard involves the interruption of medical therapy, which poses a risk of harm to patients, but the source text does not report any specific injuries, hospitalizations, or deaths.

Plain-English summary

Hospira Inc. is recalling the Symbiq Two Channel Infuser, a prescription medical device used to administer intravenous fluids, solutions, drugs, and blood products. The recall involves 10,897 units that were distributed nationwide in the United States and in Canada. Hospira retired this specific pump model on June 30, 2015.

The recall is due to a problem with the SOM2 module that may cause the device to display a white screen. This white screen is part of the device's safety shutdown procedure. When this occurs, the infusion and processor stop, a three-minute audible alarm sounds from the backup buzzer, and the device deactivates the couch screen and the automated loading and unloading of cassettes.

The primary risk associated with this defect is the delay or interruption of therapy. Healthcare facilities and users should check their inventory for affected serial numbers and follow the recall instructions provided by Hospira to ensure patient safety and continuity of care.

The recalled product

Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritional
Manufacturer
Hospira Inc.
Affected units
10,897

Distribution

Distributed nationwide across the United States.

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 →