FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: BD Pyxis Med 4000 Auxiliary (AUX), REF 314
- Recall number
- Z-0976-2025
- Recalling firm
- CareFusion 303, Inc.
- Product
- BD Pyxis Med 4000 Auxiliary (AUX), REF 314
- Status
- Open, Classified
- Initiated
- 2023-02-14
- Posted
- 2025-01-17
- Terminated
- not on file
- Reason
- 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
- 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
- 5 units
- Distribution
- Worldwide
- Lot, serial or model codes
- UDI/DI 10885403512650, Serial Numbers: 16140589, 16194078, 16194079, 16194081, 16079165.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28