Alaris PCA Pump Module May Have Defective IUI Connector
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
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: FDA Class II medical device recall of an infusion pump with a manufacturing defect creating risk of device malfunction and treatment delay. No illnesses or injuries have been reported, and the hazard remains theoretical, placing this at High severity per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
The Alaris PCA Module Model 8120 is a modular infusion pump and monitoring system manufactured by CareFusion 303, Inc., used to deliver patient-controlled analgesia and related monitoring.
CareFusion is recalling approximately 10,460 units of the Alaris PCA Module Model 8120 due to a manufacturing defect. The affected devices may have bent female IUI connectors that could prevent the device from operating properly. This defect may cause delays in the initiation of infusion therapy or patient monitoring.
The affected devices were distributed worldwide, including throughout the United States in all states, territories, and internationally to Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates. Specific model numbers, UDI codes, and serial numbers of affected devices have been identified.
Consumers and healthcare providers with affected devices should not use them until the manufacturer provides resolution instructions. Contact CareFusion 303, Inc. for further information regarding this recall.
The recalled product
- Product
- Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- device-malfunction
- connector-defect
- treatment-delay
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 (5)
- Model Number: 8120 UDI-DI codes: 10885403516030
- 10885403515316
- 10885403812033
- 10885403812026
- 10885403494291
Distribution
Distributed nationwide across the United States.
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