The Recall Desk
HighFDA (Devices)·Z-1207-2023·Announced 2023-03-29

BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall

CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.

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 is an FDA Class II recall with no reported illnesses or injuries. The firmware downgrade presents a theoretical risk of drawer failures that could delay medication delivery. Per the rubric, Class II recalls without reported hospitalizations and with theoretical hazards score at most 3 (High).

Plain-English summary

CareFusion 303, Inc. is recalling 7,914 units of BD Pyxis automated medication dispensing systems: the Anesthesia ES System (REF 327), MedStation ES (REF 323), and MedStation ES Tower (REF 352), each with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Distribution was nationwide throughout the United States and in Canada.

During new device installations or device replacement upgrades, the drawer firmware may have been inadvertently downgraded to an earlier version. This downgrade may lead to an increased frequency of drawer failures.

Drawer failures could increase the likelihood of patients experiencing delays in receiving medications. These automated medication dispensing systems are used in hospital and pharmaceutical settings for medication management and dispensing.

The recalled product

Product
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an a
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Medication Dispensing System
Hazard
Affected units
7,914

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • REF/UDI-DI: 327/10885403477836
  • 323/10885403512667
  • 352/10885403512674

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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