Z-0976-2025Class II

BD Pyxis Med 4000 Auxiliary (AUX), REF 314

Name: Z-0976-2025 BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Creator: CareFusion 303, Inc.
Published: 2023-02-14
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-02-14 / Open, Classified / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis Med 4000 Auxiliary (AUX), REF 314 on 2023-02-14. FDA classified it as Class II and gives the reason as "Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0976-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2025-01-17
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD issued an Urgent Medical Device Product Advisory to its consignees on 02/14/2023 via letter. The notice explained the problems with the device, health hazards, and requested the following actions be taken: "1. Customers may continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If you experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. 4. If you have specific questions about this letter, please contact 1-866-583-8783." The firm issued a second notice on 01/09/2024 with the same information.
Quantity in commerce: 5 units
Distribution: Worldwide
Product codes and lots: UDI/DI 10885403512650, Serial Numbers: 16140589, 16194078, 16194079, 16194081, 16079165.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0976-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0971-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0972-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0973-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0974-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0975-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0976-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)