Medical Device Software May Display Duplicate Medication Doses
BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.
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 recall involving a medication dispensing system with risk of duplicate dose administration. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where patient injury could occur but has not yet been documented.
Plain-English summary
BD Pyxis MedBank MedPass Software (REF: 139088-01) from CareFusion 303, Inc. is subject to recall due to a software defect in versions prior to 1.2.3.23. After dispensing a timed dose of medication to a patient, the automated dispensing cabinet software may continue to display the already-dispensed medication dose as still available for dispensing. This could result in duplicate medication administration to the patient.
This recall affects 37 units of the affected software currently in use at healthcare facilities in Florida, Michigan, and Kansas. The defect creates a patient safety risk through potential medication errors from duplicate dosing.
Affected facilities should immediately update their BD Pyxis MedBank MedPass Software to version 1.2.3.23 or later. Healthcare providers using affected software versions should verify their current version and apply the update as soon as possible. To date, no patient illnesses or injuries from this defect have been reported.
The recalled product
- Product
- BD Pyxis MedBank MedPass Software, REF: 139088-01
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- medication-error
- duplicate-dose
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 (2)
- UDI-DI: 10885403513817
- Software versions prior to but not including v1.2.3.23
Distribution
Distributed in 3 states:
- FL
- KS
- MI
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