The Recall Desk
HighFDA (Devices)·Z-2491-2024·Announced 2024-08-14

BD PYXIS MEDBANK Cabinet Software Causes Incorrect Medication Labels

FDA recall of BD PYXIS MEDBANK automated medication dispensing cabinets due to a software defect that prints incorrect bin information on restock labels, potentially leading to medication identification errors.

What this means for you

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 for a medical device with potential to cause medication labeling errors. While the device could impact medication dispensing accuracy, no illnesses or injuries are mentioned in the source, limiting the score to 3 per the rubric criteria for risk-of-harm products without reported adverse events.

Plain-English summary

CareFusion 303, Inc. is recalling 2 units of the BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P automated medication dispensing cabinet (Reference 169-85, Software Version 3.9.1.9) due to a software defect.

The software issue causes incorrect medication bin locations to be printed on restock labels for medications stored in the automated dispensing cabinet. These incorrect labels could lead to medication identification errors during inventory management operations in healthcare facilities.

The affected units have been distributed nationwide across the United States (Serial Numbers: 16049610 and 15958460). Healthcare facilities with these units should contact CareFusion 303, Inc. regarding remediation options.

The recalled product

Product
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Medication Dispensing Cabinet
Hazard
Affected units
2

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: 16049610 and 15958460

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 →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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