Class 2 Device Recall BD Pyxis

• Date Initiated by Firm: February 14, 2023
• Date Posted: January 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0976-2025
• Recall Event ID: 96053
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD Pyxis Med 4000 Auxiliary (AUX), REF 314
• Code Information: UDI/DI 10885403512650, Serial Numbers: 16140589, 16194078, 16194079, 16194081, 16079165.
• FEI Number: 2016493
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: 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 Determined 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 in Commerce: 5 units
• Distribution: Worldwide
• 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.