Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunction
Hospira is recalling 19,614 Symbiq One Channel Infusion Pumps because the touchscreen may fail to respond or register incorrect values, potentially leading to medication dosing 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 medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hospira, Inc. is recalling 19,614 units of the Symbiq One Channel Infuser, a prescription medical device used to administer intravenous fluids and medications. The recall is due to a defect where the pump's touchscreen may not respond to user selection, experience delayed responses, or register a different value than the one selected by the user.
The affected devices were distributed nationwide in the United States, in Puerto Rico, and internationally to Canada. The recall covers List Number 16026-01 with all serial numbers. The device is manufactured in Costa Rica.
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. This risk exists if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. Users should verify programmed values on the confirmation screen before initiating any infusion.
The recalled product
- Product
- Symbiq One 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 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 19,614
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 16026-01
- all serial numbers
Distribution
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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