CareFusion Recalls Alaris Syringe Modules Due to Software Anomaly
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units with software version 9.15 because a software anomaly may cause infusions to stop unexpectedly.
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 recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
CareFusion 303, Inc. is recalling 12,000 units of the Alaris Syringe Module Model 8110 equipped with software version 9.15. The Alaris Syringe Pump module is part of the Alaris System and is used to deliver fluids in a manner similar to other syringe pumps on the market. Up to four modules can be connected to the Alaris PC unit, which serves as the central programming, monitoring, and power supply component.
The recall is due to a software anomaly that may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another. This issue affects the specific software version 9.15.
The affected units were distributed worldwide, including nationwide in the United States and in Canada, Australia, and the United Arab Emirates. Healthcare facilities and users should identify affected units by checking for software version 9.15 and follow instructions from CareFusion 303, Inc. regarding the recall.
The recalled product
- Product
- Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the…
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 12,000
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 (1)
- Software version 9.15
Distribution
Distributed nationwide across the United States.
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