BD PYXIS MEDBANK Cabinet Software Causes Incorrect Medication Labels
FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.
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: FDA Class II recall for a medical device with potential to cause medication labeling errors. While the device could impact medication dispensing accuracy, no illnesses or injuries are mentioned in the source, limiting the score to 3 per the rubric criteria for risk-of-harm products without reported adverse events.
Plain-English summary
CareFusion 303, Inc. is recalling 2 units of the BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P automated medication dispensing cabinet (Reference 169-85, Software Version 3.9.1.9) due to a software defect.
The software issue causes incorrect medication bin locations to be printed on restock labels for medications stored in the automated dispensing cabinet. These incorrect labels could lead to medication identification errors during inventory management operations in healthcare facilities.
The affected units have been distributed nationwide across the United States (Serial Numbers: 16049610 and 15958460). Healthcare facilities with these units should contact CareFusion 303, Inc. regarding remediation options.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 2
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: 16049610 and 15958460
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.
See all 19 products in this recall →Related recalls
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