The FDA announced on Jan. 24, 2023, that CareFusion 303, Inc. is recalling Alaris PC Unit 8015 devices due to potential wireless network connection failures. The agency stated the recall was voluntarily initiated by the firm.
How to tell if you have it
- Brand: CareFusion
- Product: Alaris PC Unit 8015
- Network cards: 802.11 b/g or 802.11 a/b/g
- IP addresses: x.x.x.224 to x.x.x.255
- UDI-DI: 10885403801549, 10885403801532
- Software versions: 12.1.0, 12.1.2, 12.1.3
- Quantity: 83,185 units
The hazard
According to the FDA, the affected infusion pump PCs may experience network or wireless connection failures. This could cause an inability to receive new datasets and transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication records may be unable to send or receive data, potentially requiring manual programming of infusions.
Context
GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. On 2025-12-03, a recall addressed a software issue that may result in equipment not receiving timely updates of patient or medication information from enterprise systems. Other recent recalls of similar products include BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03) and Fresenius Kabi Ivenix Infusion System Software Recall (2025-11-14).