CareFusion Recalls Alaris PC Unit 8015 Due to Infusion Interruption Risk
CareFusion 303, Inc. is recalling Alaris PC Unit Model 8015 devices because a software error can interrupt infusions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can interrupt infusions, posing a significant risk of harm to patients.
Plain-English summary
CareFusion 303, Inc. is recalling Alaris PC Unit Model 8015 medical devices. The recall involves 568,283 units that were distributed nationwide in the United States and internationally to Europe, Australia, New Zealand, South Africa, Greater Asia, the Middle East, and Canada.
The recall was initiated after the firm identified five scenarios that can trigger Systems Error Code 255-16-275. This error can potentially result in interrupted infusions. The recall applies to customers using software versions greater than 9.12.
Healthcare facilities and customers should contact CareFusion 303, Inc. for instructions on how to address the software issue and ensure patient safety.
The recalled product
- Product
- Alaris PC Unit, Model 8015
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 568,283
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · CareFusion 303, Inc.
See all →- HighBD Pyxis MedBank Mini fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedStation ES fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Anesthesia Station fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedBank Tower fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Mini Main cabinets may overheat at fingerprint scanner
FDA (Devices) · 2026-06-10
Same hazard · infusion interruption
See all →- SevereLarge Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
FDA (Devices) · 2025-01-15
- SevereInfusomat Administration Sets recalled for tubing dimension defects
FDA (Devices) · 2023-12-13
- SevereInfusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication
FDA (Devices) · 2023-11-01
- SevereInfusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
FDA (Devices) · 2021-08-18
- SevereCareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects
FDA (Devices) · 2020-09-16
Similar recalls
- SevereCareFusion Alaris PC Unit Software Error Recall
FDA (Devices) · 2020-03-11
- HighCareFusion Alaris PC Unit Infusion Pump Software Recall
FDA (Devices) · 2015-06-24
- SevereCareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
FDA (Devices) · 2020-08-12
- SevereCareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect
FDA (Devices) · 2020-09-16
- SevereCareFusion Alaris PCA Module Recalled for Software Errors
FDA (Devices) · 2020-03-11
- ModerateCareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error
FDA (Devices) · 2016-03-30