The Recall Desk
HighFDA (Devices)·Z-2947-2024·Announced 2024-09-11

BD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling

A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.

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 FDA Class II recall involves a software defect in a medication dispensing system that could result in incorrect medication selection—a risk-of-harm scenario in healthcare. No injuries or illnesses have been reported, which places this below Severe level.

Plain-English summary

BD Pyxis QFill Replenishment Station medication cabinet systems (REF: 138904-01) are being recalled due to a software defect that affects label printing for medications stored in certain locations.

When restocking medications from non-CUBIE locations, the software may print an incorrect medication bin label. This label misdirection could cause pharmacy or hospital staff to retrieve medication from the wrong bin during replenishment, creating a risk of medication dispensing errors.

Three units are affected, with serial numbers 44210411, 43880801, and 44227426. The systems have been distributed in California, Florida, Kansas, Minnesota, New Jersey, New York, and Pennsylvania.

Affected facilities should contact CareFusion 303, Inc. for guidance on remediation.

The recalled product

Product
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Manufacturer
CareFusion 303, Inc.
Hazard
  • mislabeling
  • medication-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)

  • serial numbers: 44210411
  • 43880801
  • 44227426/ UDI: None

Distribution

Distributed nationwide across the United States.