BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk
The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 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: This FDA Class II recall involves potential fluid ingress that could cause fire or smoke in a medical device. Without reported incidents but with serious potential consequences, this meets the criteria for a high-severity risk-of-harm product.
Plain-English summary
The BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower (REF: 306), manufactured by CareFusion 303, Inc., is subject to an FDA Class II recall. The recall involves 35,029 units with specific serial numbers.
Fluid may enter the anesthesia station or medication station portions of the device. If fluid ingress occurs, it could result in smoke generation, system downtime, and/or fire.
The affected units were distributed worldwide, including throughout all US states and territories, Canada, Australia, Japan, the United Kingdom, Mexico, and other countries.
Healthcare facilities with affected units should consult the FDA recall notice and contact CareFusion 303, Inc. for instructions on addressing this potential hazard in their specific devices.
The recalled product
- Product
- BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- fire
- smoke
- fluid-ingress
- system-downtime
Distribution
Distributed nationwide across the United States.
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