Medication dispensing stations recalled because antivirus software was not consistently installed
BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is an incomplete software installation step with no device defect or patient harm described.
Plain-English summary
BD Pyxis devices are being recalled, including the Pyxis MedStation 4000 Main (UDI-DI 10885403512629, catalog number 303), the Pyxis MedStation ES Tower (UDI-DI 10885403512674, catalog number 352) and the Pyxis Anesthesia Station ES (UDI-DI 10885403477836, catalog number 327), among other configurations listed in the recall notice. The recall covers 8,353 devices, of which 6,738 are in the United States and 1,615 outside it.
Antivirus software was not consistently installed on impacted devices during the implementation process. The FDA classified the action as Class II. The notice does not describe a defect in the devices themselves.
Hospital pharmacies operating these devices should follow the manufacturer's instructions for verifying and completing the antivirus installation.
The recalled product
- Product
- BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323…
- Manufacturer
- CareFusion 303, Inc.
Distribution
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