Hospira Symbiq Infuser Recall for Potential White Screen Error
Hospira is recalling Symbiq One Channel Infusers because a white screen during KVO titration may allow premature programming, potentially causing therapy delays and significant injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 source text explicitly states the error could "potentially result in significant injury," which aligns with the rubric criterion for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Hospira Inc. is recalling 35,596 Symbiq One Channel Infusers, prescription medical devices used to administer intravenous fluids, medications, and blood products. The devices were distributed nationwide in the United States and in Canada.
The recall is due to a potential software error where the device may display a white screen during the titration of a Keep Vein Open (KVO) delivery. This error can allow a clinician to select the "NEXT" button before the programming is complete. If this occurs, it could result in a delay in therapy, which potentially leads to significant injury.
Healthcare facilities should check their inventory for affected devices using the provided lot codes and contact Hospira for further instructions on the recall process.
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…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 35,596
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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