BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk
CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.
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 FDA Class II recall addresses potential fire and smoke hazards from fluid ingress into the device. No injuries or illnesses are reported in the source text. Per the severity rubric, this qualifies as High: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the BD Pyxis Anesthesia Station ES, REF: 327, a medication dispensing system used in anesthesia settings. Approximately 71,569 units have been distributed worldwide.
The device may experience fluid ingress, which could result in smoke, system downtime, or fire. This potential hazard affects the safe operation and reliability of the device in clinical anesthesia environments.
The affected units have been distributed throughout the United States and internationally to numerous countries including Canada, Australia, Japan, the United Kingdom, South Korea, China, and others. Healthcare facilities with this device are potentially affected.
The FDA has assigned this recall the number Z-1931-2024. Affected devices can be identified using the UDI 10885403512636 and the specific serial numbers listed in the official recall notice.
The recalled product
- Product
- BD Pyxis" Anesthesia Station ES, REF: 327
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- fire
- smoke
- fluid-ingress
Distribution
Distributed nationwide across the United States.
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