Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms
Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient 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 involves a medical device defect that can cause a delay or interruption in therapy, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Hospira Inc. is recalling 15,285 Symbiq Two Channel Infusion Pumps, a prescription medical device used to administer intravenous fluids, medications, and other solutions. The recall is due to frequent Proximal Occlusion Alarms (POAs) occurring on devices with list numbers 16026 and 16027.
These false alarms occur even when no occlusion is present, causing the pump to continue alarming. This issue can result in a delay or interruption in patient therapy and may require clinicians to reset the alarm multiple times or replace the pump. The affected devices were distributed worldwide, including nationwide in the United States.
Healthcare facilities and users should stop using the affected Symbiq devices and contact Hospira for instructions on replacement or repair.
The recalled product
- Product
- Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 15,285
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.
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