The Recall Desk
HighFDA (Devices)·Z-2487-2024·Announced 2024-08-14

BD PYXIS medication cabinet software error causes incorrect bin labels

A software issue in the BD PYXIS MDBNK medication dispensing cabinet may cause restock labels to print with incorrect bin locations, potentially affecting medication storage accuracy.

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 a Class II recall involving a risk-of-harm scenario in medication dispensing equipment. While no illnesses or injuries have been reported, incorrect medication bin locations present a potential safety risk in healthcare settings, meeting the criteria for High severity.

Plain-English summary

CareFusion 303, Inc. is recalling the BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow automated medication dispensing cabinet (software version 3.9.1.9) due to a software issue. When a restock label is printed for medications stored in the cabinet, the label may display the incorrect bin location for the medication.

Approximately 61 units have been distributed nationwide throughout the United States. The error could lead to medications being restocked in incorrect bins if the printed label information is relied upon without additional verification.

Healthcare facilities and pharmacies operating affected units should be aware of this issue and take appropriate precautions when restocking medications. For additional information about this recall, contact CareFusion 303, Inc. or visit the FDA recall page.

The recalled product

Product
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Hazard
  • mis-labeling
  • medication-dispensing-error

Distribution

Distributed nationwide across the United States.