Automated Dispensing Cabinet Software Error May Print Incorrect Medication Bin Labels
CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.
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 involving a software defect in a medication dispensing system that could lead to incorrect medication administration. The hazard is described as 'potential' with no reported illnesses or injuries, making this a theoretical risk-of-harm scenario rather than an acute crisis.
Plain-English summary
CareFusion 303, Inc. is recalling six units of the BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P automated medication dispensing cabinet (REF: 169-93) due to a software issue in version 3.9.1.9.
The defect occurs when restock labels are printed for medications stored in the cabinet. Due to the software error, the printed label may display the incorrect bin location for the medication. This could result in pharmacy staff or users selecting and dispensing the wrong medication to patients.
The affected units have been distributed nationwide across the United States. Healthcare facilities that have received these units should immediately verify medication bin locations match printed labels before dispensing medications, and contact the manufacturer or the FDA if they have questions or concerns.
No illnesses or injuries have been reported at this time.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 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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