BD Pyxis recallZ-2646-2023 · CareFusion 303, Inc. · initiated Aug 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.
FDA root cause category: Device Design
What the company is doing
On 8/18/23, correction notices were mailed to directors of Biomedical Engineering/Risk Management/Nursing/Pharmacy and distributors. They were asked to take the following actions: 1) Remind users that affected devices do not replace the electronic (or paper) patient record, specifically the medication order, which will remain accurate and serves as the source of truth for medication administration. Nursing best practice is to confirm the 5 rights of medication orders prior to administration. Some inpatient psychiatric units also utilize barcode medication administration (BCMA) which may detect duplicate administrations. If a duplicate medication is inadvertently administered, ensure the patient is appropriately monitored and follow organizational process for reporting of a medication error. 2. Please ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3. Complete and return the response form. Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service The recall issue will be resolved in software v1.2, which will be provided to all customers approximately October 2023 via remote upgrade. On 8/26/24, correction-update notices were sent informing customers the field correction (software update to BD Pyxis MedBank MedPass software v1.2.1.17) was not effective. As a result, devices required an additional update to BD Pyxis MedBank MedPass software version v1.2.3.23.
Recall details
- Recall number
- Z-2646-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2023
- Posted by the FDA
- Sep 28, 2023
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 37
- Product code
- BRY
- Distribution
- US: FL, MI, KS
Product description
BD Pyxis MedBank MedPass Software, REF: 139088-01
Code information (models, lots, serial numbers)
UDI-DI: 10885403513817, Software versions prior to but not including v1.2.3.23
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Pyxis SW-MP-V1Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA2 recalls1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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