BD Pyxis MedBank CUBIE Replenishment Station software issue
A software issue in the BD Pyxis MedBank CUBIE Replenishment Station prevents medication restocking when users receive an error message, potentially delaying patient access to medications.
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 an FDA Class II recall of a medical device used in medication dispensing. The hazard—potential delays in patient access to medications—poses a direct risk of harm to patient care, even though no illnesses or injuries have been reported. The risk-of-harm nature of the defect in a critical care delivery device warrants a High severity rating.
Plain-English summary
CareFusion 303, Inc. is recalling BD Pyxis MedBank CUBIE Replenishment Stations due to a software issue. When users attempt to restock the automated dispensing cabinet, they may receive a banner message stating "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance." When this error message appears, the medication cannot be restocked.
This issue can potentially lead to delays in accessing medication for patients. The recall affects 404 systems distributed across the United States, including Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Customers who have received affected units should contact CareFusion 303, Inc. for further assistance and resolution of the software issue.
The recalled product
- Product
- BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXI
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- software-defect
- medication-access-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product / Material ID / GTIN OPT
- MEDBANK
- HD
- WIN10
- QFILL
Distribution
Distributed in 32 states:
- AL
- AZ
- CA
- CT
- FL
- GA
- IA
- IL
- IN
- KS
- KY
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- NE
- NJ
- NY
- OH
- PA
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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