Agency classClass IIOur severity:High FDA (Devices)·Z-2496-2024·Announced 2024-08-14

Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling

BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.

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 where a software defect causes incorrect labeling that could lead to medication placement errors. No illnesses or injuries have been reported; the hazard is potential rather than manifested. This meets the rubric criterion for High (Score 3).

Plain-English summary

CareFusion 303, Inc. is recalling BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P automated medication dispensing cabinets containing software version 3.9.1.9 due to a software defect.

When a restock label is printed for a medication stored in the cabinet, the software may print an incorrect bin location on the label. This could cause pharmacy staff to place medications in the wrong bin during the restocking process, creating a potential for medication dispensing errors.

The affected units have been distributed nationwide throughout the United States.

Healthcare facilities using this device should contact CareFusion 303, Inc. for corrective instructions, such as a software update. For additional information, reference FDA recall number Z-2496-2024.

The recalled product

Product: BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Automated Medication Dispensing System
Hazard: mis-labeling
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: 15639711

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

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 →

Same manufacturer · CareFusion 303, Inc.

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Same hazard · mis labeling