Agency classClass IIOur severity:High FDA (Devices)·Z-2501-2024·Announced 2024-08-14

Medication Dispensing Cabinet Software Error Can Print Incorrect Bin Labels

A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing 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 recall involving a medication dispensing device with potential to cause medication errors. No hospitalizations, injuries, or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High.

Plain-English summary

CareFusion 303, Inc. is recalling the BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P automated medication dispensing cabinet containing software version 3.9.1.9. Three units distributed nationwide have been identified as affected.

A software issue in this model can cause an incorrect medication bin number to be printed on restock labels when labels are generated for medications stored in the cabinet. The system prints the wrong bin designation for the medication on the label.

This recall affects hospitals and healthcare facilities throughout the United States using the affected units. The error creates potential for medication dispensing errors if staff rely on the mislabeled restock information.

Healthcare facilities with affected units should contact CareFusion 303, Inc. for technical support or replacement options. Staff should verify the correct medication locations in the cabinet directly rather than relying solely on printed restock labels until corrected.

The recalled product

Product: BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Pharmacy Automation
Hazard: medication-error
software-defect
mis-labeling
Affected units: 3

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: 16113307 16111232 15949570

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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