Automated Medication Cabinet Software Bug May Print Wrong Bin Labels
CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.
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 of medical device software that presents a clear risk of harm through potential medication dispensing errors. While no illnesses or injuries have been reported, the incorrect bin labeling in automated medication dispensing cabinets could directly lead to medication selection errors during pharmacy restocking operations.
Plain-English summary
CareFusion 303, Inc. is recalling the BD PYXIS MEDBANK TWR MN CR-14HH-P automated medication dispensing cabinet (software version 3.9.1.9) due to a software issue that may cause incorrect bin location labels to be printed when restocking medications.
The software defect creates a potential for pharmacy staff to select medications from the wrong bin during restocking operations. This could result in medication dispensing errors if the incorrect bin location is used to retrieve drugs for patient distribution.
The recall affects 4 units distributed nationwide across all 50 states. Healthcare facilities currently using affected units should verify their cabinet's software version against the recalled version to determine if they are impacted.
Affected users should contact CareFusion 303, Inc. or the FDA for remediation instructions. Do not rely on the automated restock label system until the software defect is corrected.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- 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 (1)
- UDI: 10885403512568/ Serial Number: 16223707 16253385 16253384 16238929
Distribution
Distributed nationwide across the United States.
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