BD PYXIS Automated Dispensing Cabinet Software Issue Causes Incorrect Medication Bin Labels
A software issue in BD PYXIS automated dispensing cabinets may cause incorrect medication bin labels to print during restocking, potentially leading to medication dispensing errors. CareFusion is recalling 16 units.
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: FDA Class II medical device recall for a risk-of-harm product (incorrect medication dispensing) with no reported illnesses or injuries. The potential for serious patient harm from medication errors justifies High severity despite lack of reported adverse events.
Plain-English summary
CareFusion 303, Inc. is recalling 16 units of the BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P automated dispensing cabinet system (software version 3.9.1.9). The product contains a software issue that may cause an incorrect bin location to be printed on restock labels for medications stored in the cabinet, potentially resulting in medication dispensing errors.
The affected units were distributed nationwide to healthcare facilities across the United States.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- software-defect
- mis-labeling
- medication-error
Distribution
Distributed nationwide across the United States.
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