The Recall Desk
HighFDA (Devices)·Z-0928-2023·Announced 2023-01-18

BD Pyxis MedBank System may dispense wrong medication due to software error

The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.

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: This is FDA Class II medication dispensing system with potential for serious harm (wrong medication or dose), but no hospitalizations or injuries have been reported. The hazard is potential rather than documented, meeting the criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The BD Pyxis MedBank System is an automated medication dispensing cabinet used in healthcare settings to manage and dispense medications. The system stores medications in individual drawer pockets, with labels indicating which medication is in each pocket.

The MedBank software has an issue where a different medication may be loaded in a drawer pocket than what is physically displayed on the pocket label. This discrepancy means the system software does not accurately reflect the actual medication contents.

Because of this software error, a healthcare provider dispensing medication from the affected system could receive and administer the wrong medication or wrong dose to a patient, potentially causing serious patient harm.

Healthcare facilities operating affected BD Pyxis MedBank systems should contact CareFusion 303, Inc. (the manufacturer) for guidance on remediation. Affected serial numbers and system variants are listed in the official FDA recall documentation.

The recalled product

Product
BD Pyxis MedBank System - Product Label/labeling pending
Manufacturer
CareFusion 303, Inc.
Hazard
  • wrong-medication
  • wrong-dose
  • software-error

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 (3)

  • 169-100
  • 169-132
  • 169-138

Distribution

Distributed nationwide across the United States.