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BD Pyxis recallZ-0976-2025 · CareFusion 303, Inc. · initiated Feb 14, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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,

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0976-2025
Status
Open, Classified
Initiated by the company
Feb 14, 2023
Posted by the FDA
Jan 17, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
5 units
Product code
BRY
Distribution
Worldwide

Product description

BD Pyxis Med 4000 Auxiliary (AUX), REF 314

Code information (models, lots, serial numbers)

UDI/DI 10885403512650, Serial Numbers: 16140589, 16194078, 16194079, 16194081, 16079165.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96053).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page