BD Pyxis MedBank software bypass allows incorrect medication dispensing
CareFusion's BD Pyxis MedBank receiving cabinet software contains a flaw that can bypass pharmacist validation when 'Clear All' is selected, potentially allowing unintended medication removal. The recall affects 2,679 units distributed nationwide.
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 device recall involving a medication dispensing system vulnerability. Although no injuries or illnesses have been reported, the flaw can bypass critical pharmacist validation controls, creating a direct risk of incorrect medication dispensing—a serious potential harm to patients.
Plain-English summary
CareFusion 303, Inc. is recalling BD Pyxis MedBank automated dispensing cabinet software due to a vulnerability that can bypass required medication validation controls.
The issue occurs when the 'Clear All' function is selected on a patient profile. This selection can allow the cabinet to dispense medications without requiring entry of the RxVerify Validation Code or pharmacist validation, potentially resulting in unintended and incorrect medication removal.
The recalled units include multiple MedBank software versions (2.1.2.11, 2.2.1.8, 2.3.1.8, 2.3.2.1, and 2.4.2.26) distributed nationwide across 17 states: Kansas, Texas, California, Pennsylvania, New Jersey, Florida, Indiana, Arizona, Illinois, Massachusetts, New York, Kentucky, Utah, Maryland, Washington, Ohio, and Alabama. A total of 2,679 units are affected.
Healthcare facilities using affected BD Pyxis MedBank units should review their medication dispensing workflows and consider implementing additional controls to ensure pharmacist validation is not bypassed when dispensing medications.
The recalled product
- Product
- MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- medication-error
- validation-bypass
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 (20)
- BD Pyxis MedBank Receiving Cabinet Software Software versions: 2.1.2.11
- 2.2.1.8
- 2.31.8
- 2.3.2.1
- 2.4.2.26 REF/UDI-DI: 1119-00/10885403512704
- 1137-00
- 1139-00/10885403512704
- 1145-00/10885403517167
- 1147-00/10885403517181
- 139090-01
- 169-100/10885403512568
- 169-101/10885403512544
- 169-102/10885403512544
- 169-103/10885403512544
- 169-104/10885403512544
- 169-105/10885403512544
- 169-106/10885403512544
- 169-107/10885403512544
- 169-108/10885403512544
- 169-109/10885403512544
Distribution
Distributed nationwide across the United States.
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