The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2488-2024·Announced 2024-08-14

BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units

CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.

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 involving a software defect that could cause medications to be dispensed from incorrect storage locations. While no illnesses or injuries have been reported, the potential for serious patient harm from medication errors in an automated dispensing system meets the criteria for high severity.

Plain-English summary

CareFusion 303, Inc. has recalled 11 units of the BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P automated medication dispensing cabinet (reference 169-82) running software version 3.9.1.9. The units were distributed across the United States.

The recall stems from a software defect in version 3.9.1.9. When a restock label is printed for medication stored in the cabinet, the software may print the incorrect bin number on the label. This error could result in medications being stored in or removed from the wrong bin location.

The affected cabinets were distributed nationwide to healthcare facilities across multiple states. Each unit has a unique serial number that can be used to verify whether a facility's equipment is included in this recall.

The recalled product

Product
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Dispensing System
Hazard
Affected units
11

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 →

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