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Pyxis recallZ-1125-2025 · CareFusion 303, Inc. · initiated Feb 23, 2024

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

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1125-2025
Status
Open, Classified
Initiated by the company
Feb 23, 2024
Posted by the FDA
Feb 11, 2025
Recalling firm
CareFusion 303, Inc.
Product code
BRY
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 description

BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Code information (models, lots, serial numbers)

UDI: 10885403512629/ Serial Numbers: 16153360 16161369 16161370 16161371 16187328 16187329 16187330 15495060 15930189 16161368 16173444 16283947

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 96041).

Sources and updates

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