Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling
BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.
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 a risk-of-harm medical device where a software defect causes incorrect labeling that could lead to medication placement errors. No illnesses or injuries have been reported; the hazard is potential rather than manifested. This meets the rubric criterion for High (Score 3).
Plain-English summary
CareFusion 303, Inc. is recalling BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P automated medication dispensing cabinets containing software version 3.9.1.9 due to a software defect.
When a restock label is printed for a medication stored in the cabinet, the software may print an incorrect bin location on the label. This could cause pharmacy staff to place medications in the wrong bin during the restocking process, creating a potential for medication dispensing errors.
The affected units have been distributed nationwide throughout the United States.
Healthcare facilities using this device should contact CareFusion 303, Inc. for corrective instructions, such as a software update. For additional information, reference FDA recall number Z-2496-2024.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- mis-labeling
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 (1)
- UDI: 10885403512568/ Serial Number: 15639711
Distribution
Distributed nationwide across the United States.
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