BD PYXIS MEDBANK Software Issue Causes Incorrect Medication Bin Labels
A software issue in BD PYXIS MEDBANK automated dispensing cabinets can cause incorrect medication bin labels to print during restocking. This could lead to medication dispensing errors in healthcare facilities.
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 Class II medical device in a high-risk medication dispensing system. The software defect creates a potential risk of incorrect medication placement and medication errors; however, no illnesses or injuries have been reported, and the hazard is theoretical. This meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P automated medication dispensing cabinet (software version 3.9.1.9, UDI: 10885403512568) due to a software defect.
A software issue can cause an incorrect bin location to be printed on medication restock labels. When medications are restocked into the automated cabinet, the label may indicate the wrong bin location where the medication should be stored or retrieved. This discrepancy between the label and actual medication location could result in incorrect medication dispensing.
The affected device was distributed nationwide across all U.S. states. Healthcare facilities currently using this specific model should contact the manufacturer for corrective action and guidance. Users should verify that medication bin locations match printed labels before relying on the cabinet for medication dispensing and should implement additional verification procedures until the issue is resolved.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 1
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: 15684798
Distribution
Part of a larger recall action
This product is one of 19 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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