Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector
CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.
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: This is an FDA Class II recall without reported hospitalizations, illnesses, or injuries. The hazard—a bent connector that may prevent device operation or delay infusion—is theoretical rather than documented. Under the rubric, Class II without reported harm is at most score 3.
Plain-English summary
The Alaris System PC Unit Model 8015, manufactured by CareFusion 303, Inc., is being recalled due to a mechanical defect affecting approximately 125,017 devices distributed worldwide. This is an FDA Class II recall.
The affected devices may have a bent female IUI connector that could prevent the device from operating properly or cause delays in starting infusion or monitoring functions.
The recalled devices have been distributed to all U.S. states, territories, and internationally to countries including Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates.
Healthcare providers and patients possessing an affected device should contact CareFusion 303, Inc. for guidance on device replacement or remediation.
The recalled product
- Product
- Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- connector-defect
- device-malfunction
- 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 (6)
- Model Number: 8015 UDI-DI codes: 10885403516023
- 10885403515231
- 10885403801549
- 10885403801532
- 10885403801518
- 10885403519284
Distribution
Distributed nationwide across the United States.
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