BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels
A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.
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: This is a risk-of-harm medical device with a software defect that could lead to medication administration errors through incorrect bin labeling. As no illnesses or injuries have been reported and the hazard is potential rather than realized, this meets the criteria for High severity (Score 3) under the rubric.
Plain-English summary
The BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P automated medication dispensing cabinet, containing software version 3.9.1.9, is being recalled due to a software defect. The issue affects 6 units that were distributed nationwide across the United States.
The software issue causes incorrect medication bin numbers to be printed on restock labels. When pharmacy staff restock medications in the automated dispensing cabinet, they may receive labels directing them to place medications in the wrong bins, creating a risk of medication administration errors.
Healthcare facilities with the affected units should stop using the system for medication dispensing and contact CareFusion 303, Inc. immediately for remediation. Verify that medications are correctly placed in their intended locations before returning the system to normal operation.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 6
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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