Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms
Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal 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 is classified as FDA Class II. The hazard involves a risk of harm (delay/interruption of therapy) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling Symbiq One Channel Infuser medical devices, which are prescription infusion pumps used to administer intravenous fluids, medications, and blood products. The recall affects 20,311 units distributed nationwide in the United States.
The recall is due to frequent proximal occlusion alarms (POAs) occurring on Symbiq 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 therapy and may require clinicians to reset the alarm multiple times or replace the pump.
Healthcare facilities should identify affected units by checking the list numbers and contact Hospira for further instructions on the recall.
The recalled product
- Product
- Symbiq One 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
- 20,311
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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