Class 2 Device Recall BD Pyxis MedStation Auxiliary 4000

• Date Initiated by Firm: February 23, 2024
• Date Posted: February 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1124-2025
• Recall Event ID: 96041
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
• Code Information: UDI: 10885403512636/ Serial Numbers: 16187325, 16187326, 16187327, 16173446
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.