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.
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 3/5 (High).
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…
- Manufacturer
- CareFusion 303, Inc.
- 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
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