The Recall Desk
HighFDA (Devices)·Z-2490-2024·Announced 2024-08-14

BD PYXIS automated medication cabinet software defect causes incorrect bin labels

A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.

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 risk-of-harm product (automated medication dispensing equipment) where no illnesses or injuries have been reported. The defect creates potential for medication errors through incorrect bin labeling, but the hazard remains theoretical without documented incidents. Per the rubric, such cases score as High (3).

Plain-English summary

BD PYXIS MEDBANK TWR MN CR-12HH-1FH (software version 3.9.1.9) automated medication dispensing cabinets contain a software defect that may cause incorrect bin information to print on medication restock labels.

The defect occurs when restock labels are printed for medications stored in the cabinet. Due to the software issue, the label may indicate the wrong bin location for a medication. This could result in healthcare staff selecting incorrect medication bins during restocking, potentially leading to medication errors.

Seven units have been distributed nationwide across 40 U.S. states. Facilities with affected equipment should contact CareFusion 303, Inc. immediately for guidance on remediation or software updates to correct the defect.

The recalled product

Product
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Hazard
  • medication-error
  • mis-labeling
  • software-defect

Distribution

Distributed nationwide across the United States.