CareFusion Recalls Alaris PC Infusion Pumps Due to Keypad Error Code
CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional error code during self-test with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling 56,015 units of the Alaris PC infusion pump, Model No. 8015. The recall was initiated due to a potential keypad issue that may cause an error code to appear upon power-on during the "Power-On Self Test."
The affected units were distributed worldwide, including in the United States, Canada, the European Union, Singapore, and Australia. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their units are affected. The source text does not provide specific consumer instructions for remediation, such as repair or replacement protocols.
The recalled product
- Product
- Alaris PC units, Model No. 8015. Infusion pump.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 56,015
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereCareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect
FDA (Devices) · 2020-09-16
- ModerateCareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error
FDA (Devices) · 2016-03-30
- SevereCareFusion Recalls Alaris PC Unit 8015 Due to Infusion Interruption Risk
FDA (Devices) · 2017-07-12
- SevereCareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects
FDA (Devices) · 2020-09-16
- 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