Automated dispensing cabinet software issue causes incorrect medication bin labels
CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing 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 Class II medical device recall involving a risk-of-harm product—medication dispensing errors in automated systems could lead to serious patient harm. However, no illnesses, injuries, or deaths have been reported, so per the rubric criteria for High severity, the score is 3 rather than Severe.
Plain-English summary
CareFusion 303, Inc. is recalling 232 units of the BD PYXIS MEDBANK MINI CR-4HH-P automated medication dispensing cabinet (REF: 169-115, software version 3.9.1.9) due to a software issue affecting label printing.
The software issue creates a potential where restock labels printed for medications stored in the cabinet may show an incorrect bin location. This could cause healthcare workers to select the wrong bin when stocking medications, potentially resulting in medication dispensing errors.
The recalled units were distributed nationwide to healthcare facilities across multiple states. Each affected device has a specific serial number documented by the FDA, with universal device identifier UDI: 10885403512544.
The recalled product
- Product
- BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 232
Distribution
Part of a larger recall action
This product is one of 19 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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