Z-2948-2024Class II

BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system

Name: Z-2948-2024 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Creator: CareFusion 303, Inc.
Published: 2024-07-09
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2024-07-09 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system on 2024-07-09. FDA classified it as Class II and gives the reason as "Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2948-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-08-30
Recalling firm: CareFusion 303, Inc
Product: BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
Root cause tag: software
FDA root cause: Software design
Action: On July 11, 2024, CareFusion a subsidiary of Becton Dickinson (BD) issued a "Urgent Medical Device Correction" Notification to affected customers via Email. BD also notified customers through customer software release notes beginning June 24, 2024. BD asked consignees to take the following actions: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. 2. Users should verify the contents of the bin location being restocked. Actions to be Taken by the Customer: 3.Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 4.Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter. 5. BD will perform remote upgrades to impacted customer devices with the updated CR/QFill station software. BD will contact customers by the end of August to initiate this scheduling.
Distribution: US Nationwide distribution in the states of CA, FL, KS, MN, NJ, NY, PA.
Product codes and lots: serial numbers: 16056243 16068264 16082950 16142772 16192674 16208218 16208219 16284106 16346254 16388826 16388833 16623139 / UDI: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2948-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2947-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-08-30
Z-2948-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-08-30

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)