Class 2 Device Recall BD Pyxis"

• Date Initiated by Firm: January 10, 2025
• Date Posted: February 21, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1206-2025
• Recall Event ID: 96150
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
• Code Information: User Guides: i. BD Pyxis MedBank Cabinet User Guide v2.4 ii. BD Pyxis MedBank MedPass User Guide v1.0 iii. BD Pyxis MedBank CR Station User Guide v3.10 iv. BD Pyxis MedBank myQLink Cloud Software User Guide v1.5 v. BD Pyxis Supply Cabinet Safety Guide (for SupplyBank models) Quick Reference Guides: i. BD Pyxis MedBank CR Station QRG (part number 155018-03) ii. BD Pyxis MedBank Cabinet QRG (PN 155023-03) iii. BD Pyxis MedBank RxNow CR Station QRG (PN 155026-03) iv. BD Pyxis MedBank RxNow Solution QRG 2.0 (PN 155027-02) v. BD Pyxis MedBank MedPass QRG (PN 155022-03) vi. BD Pyxis MedBank QFill Station QRG (PN 155020-02) vii. BD Pyxis MedBank myQLink Cloud Software QRG 3.0 (PN 155021-02) REF/UDI-DI/Serial Numbers: 1119-00/10885403512704/13517006, 13523350, 13754724, 13767953, 13789575, 13801727, 13826187, 13879544, 13883357, 13884848, 13934472, 13939327, 13948724, 14032802, 14037891, 14158187, 14159916, 14168580, 14172832, 14175162, 14182716, 14202337, 14220872, 14222746, 14228149, 14228150, 14244101, 14254813, 14254816, 14254812, 14254815, 14275112, 14278095, 14317945, 14317946, 14324386, 14332058, 14347747, 14347748, 14349106, 14348708, 14348709, 14352459, 14365786, 14365785, 14374965, 14374963, 14374964, 14377079, 14378428, 14377908, 14407523, 14407524, 14420205, 14420213, 14420211, 14420207, 14420208, 14420206, 14420223, 14420222, 14420212, 14441382, 14442352, 14442359, 14442686, 14442685, 14442585, 14442586, 14445911, 14456782, 14456757, 14458260, 14458256, 14458259, 14472490, 14472338, 14472980, 14472990, 14472975, 14472981, 14472970, 14472977, 14472982, 14472971, 14472987, 14472973, 14472983, 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• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
• FDA Determined Cause: Labeling design
• Action: On 1/10/2025, correction notices were mailed or emailed to Directors of Nursing or Nurse Managers, Directors of Pharmacy or Pharmacist In Charge, and Facility Administrators informing them to take the following actions: Customers should do the following to prevent delays in access: a. Ensure staff are aware of updates to User Guides, including: automated dispensing devices should not be used as a crash cart or code box. Medication or items may not be immediately accessible for an emergent situation causing a delay in treatment which could lead to serious injury or death. b. Have device keys available on-site in a secure location known to designated staff c. Train staff on how to manually access the device d. Ensure downtime policies and procedures are implemented and staff are appropriately trained e. Enable Over-ride mode permissions For pharmacies providing automated dispensing device products to clinical users that are not physically located at the pharmacy site, please ensure clinical users are aware of the risk of delay in access and provide access to keys. Firm will be strengthening labeling regarding delays in dispensing medication. Report any issues associated with the above devices via phone at 866-930-9251. Post these notices with the device until labeling has been updated. Complete and return the response form via email to BDRC54@bd.com If you require further assistance, please contact the firm: 1) Technical Support: Website: bd.com/self-service, Phone: 1-866-930-9251, Hours: 24 hours, 7 days a week. 2) BD Recall Operations, BDRC54@bd.com, Fax: (312) 949-0081. 3) Customer Letter Support, Email: PyxisQuestions@BD.com
• Quantity in Commerce: 1521
• Distribution: US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.
• 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.