BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk
CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.
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 device recall involving a risk-of-harm hazard (fire and smoke from fluid ingress) with no reported illnesses or injuries to date. While the potential consequences are serious, the absence of reported incidents and the theoretical nature of the hazard (stated as 'may result') limits the severity to High rather than Severe.
Plain-English summary
The BD Pyxis Anesthesia Station 4000 (reference 338) is manufactured by CareFusion 303, Inc. and is being recalled by the FDA due to potential fluid ingress.
Potential fluid ingress of the anesthesia station may result in smoke, system downtime, and/or fire. The defect has been classified as FDA Class II.
The recall involves approximately 11,875 units with specific serial numbers. The affected units have been distributed worldwide, including throughout the United States and in multiple international markets.
Healthcare facilities that use this equipment should consult the provided list of affected serial numbers and contact the manufacturer or FDA for further information and guidance on remediation.
The recalled product
- Product
- BD Pyxis(TM) Anesthesia Station 4000, REF: 338
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- fire
- smoke
Distribution
Distributed nationwide across the United States.
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