FDA (Devices) recall action 94527
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.
CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.
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.
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.
BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.
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.