BD PYXIS Medication Cabinet Software Defect Causes Incorrect Restock Labels
A software issue in BD PYXIS automated medication dispensing cabinets can cause restock labels to print with incorrect bin numbers. Four units are affected nationwide.
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 with a potential software defect that could result in medication errors. No illnesses or injuries have been reported, and the hazard is theoretical, placing this at High severity per the rubric's criteria for risk-of-harm products without reported injury.
Plain-English summary
CareFusion 303, Inc. is recalling BD PYXIS MEDBANK TWR MN automated medication dispensing cabinets (REF: 169-90) containing software version 3.9.1.9 due to a software defect. The issue affects the restock label printing function.
When a restock label is printed for a medication stored in the cabinet, the software may direct the label to print with the incorrect bin number. This creates the potential for medications to be placed in or retrieved from an incorrect storage location.
Four units with serial numbers 16042128, 16042129, 16044049, and 16044052 are affected by this recall. These units have been distributed nationwide across the United States.
Healthcare facilities using affected units should contact CareFusion 303, Inc. for further information and guidance on this matter.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- labeling-error
- medication-error
- software-defect
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 (4)
- UDI: 10885403512568/ Serial Number: 16042128
- 16042129
- 16044049
- 16044052
Distribution
Distributed nationwide across the United States.
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