Agency classClass IIOur severity:High FDA (Devices)·Z-2493-2024·Announced 2024-08-14

Medication dispensing cabinet software issue causes incorrect medication bin labels

A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage 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: This is an FDA Class II medical device recall affecting automated medication dispensing cabinets. While no illnesses or injuries have been reported, the software issue creates a risk of medication storage errors in a critical healthcare device. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the BD PYXIS MEDBANK TWR MN CR-2HH-6FH automated medication dispensing cabinet containing software version 3.9.1.9 due to a software issue.

The software issue can cause an incorrect medication bin designation to be printed on restock labels. When medications are restocked in the automated dispensing cabinet, incorrect bin labels could result in medications being placed in wrong storage locations, creating a risk of medication errors in patient care.

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

Healthcare facilities using this equipment should contact CareFusion 303, Inc. regarding this recall for additional information and instructions.

The recalled product

Product: BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Automated Medication Dispensing Cabinet
Hazard: mis-labeling
medication-error-risk
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: 15910847

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