Z-1124-2025Class II

BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a...

Name: Z-1124-2025 BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a...
Creator: CareFusion 303, Inc.
Published: 2024-02-23
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2024-02-23 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider on 2024-02-23. FDA classified it as Class II and gives the reason as "Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications". 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-1124-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-23
Posted: 2025-02-11
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Root cause tag: design
FDA root cause: Device Design
Action: On February 14, 2023 and January 9. 2024 Carefusion issued a Urgent medical Device Product Advisory" Recall Notification to affected consignees. Carefusion asked consignees take the following actions: 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. 5. Any adverse health consequences experienced with the use of this product should be reported to BD and may be reported to the FDA s MedWatch Adverse Event Reporting Actions to be taken by distributor 1. Please provide a copy of this notification to any customers who may have received products listed in the Affected Products table above. 2. 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.
Distribution: US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
Product codes and lots: UDI: 10885403512636/ Serial Numbers: 16187325, 16187326, 16187327, 16173446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1124-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11
Z-1123-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11
Z-1124-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11
Z-1125-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

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)