Z-2646-2023Class II

BD Pyxis MedBank MedPass Software, REF: 139088-01

Name: Z-2646-2023 BD Pyxis MedBank MedPass Software, REF: 139088-01
Creator: CareFusion 303, Inc.
Published: 2023-08-18
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-08-18 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis MedBank MedPass Software, REF: 139088-01 on 2023-08-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2646-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-18
Posted: 2023-09-28
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis MedBank MedPass Software, REF: 139088-01
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 37
Distribution: US: FL, MI, KS
Product codes and lots: UDI-DI: 10885403513817, Software versions prior to but not including v1.2.3.23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2646-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2646-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-28

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)