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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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