The Recall Desk
HighFDA (Devices)·Z-2948-2024·Announced 2024-09-11

BD Pyxis QFill Medication Cabinet Software Bug Causes Incorrect Restock Labels

The BD Pyxis QFill Replenishment Station medication cabinet has a software issue that may print incorrect bin information on restock labels for medications stored in non-CUBIE 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: Class II medical device recall with no reported injuries or illnesses. The software defect poses a risk of medication dispensing errors in a critical healthcare setting, but the hazard remains theoretical with no confirmed patient harm.

Plain-English summary

CareFusion 303, Inc. is recalling the BKIT BD Pyxis QFill Replenishment Station (Ref: 155197-01), a medication management cabinet system used in healthcare facilities. The recall affects units with specific serial numbers distributed across California, Florida, Kansas, Minnesota, New Jersey, New York, and Pennsylvania.

A software issue in the device can cause incorrect bin location information to be printed on medication restock labels when medications are stored in non-CUBIE locations. This labeling error could lead to medications being placed in wrong locations or incorrect medications being dispensed, creating potential patient safety risks.

Healthcare facilities using affected units should verify the accuracy of restock labels before placing medications into the cabinet and contact the manufacturer or their device representative for guidance on addressing this issue.

The recalled product

Product
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Manufacturer
CareFusion 303, Inc.
Hazard
  • medication-error
  • labeling-error
  • software-defect

Distribution

Distributed nationwide across the United States.