The Recall Desk
HighFDA (Devices)·Z-2485-2024·Announced 2024-08-14

Automated medication cabinet software prints incorrect bin labels

The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

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 medical device recall involving a software issue that creates risk of medication errors through incorrect bin labeling. No illnesses or injuries have been reported; the hazard remains theoretical rather than confirmed.

Plain-English summary

CareFusion 303, Inc. has recalled the BD PYXIS MEDBANK MINI CR-2HH-1FH-P automated medication dispensing cabinet system (software version 3.9.1.9) due to a software defect. The issue causes incorrect bin location information to be printed on restock labels for medications stored in the cabinet.

The recall affects 84 units that were distributed nationwide throughout the United States. The affected devices are identified by UDI 10885403512544 and specific serial numbers provided in the FDA notice.

When staff restock medications using incorrect bin location labels, medications may be placed in wrong locations within the cabinet. This could potentially result in medication dispensing errors if the incorrect placement is not detected and corrected. Facilities operating affected units should review the FDA notification for guidance on remediation.

The recalled product

Product
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Hazard
  • labeling-error
  • medication-error-risk

Distribution

Distributed nationwide across the United States.