Class 2 Device Recall BD PYXIS MDBNK TWR MN

• Date Initiated by Firm: June 24, 2024
• Date Posted: August 02, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2487-2024
• Recall Event ID: 94947
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
• Code Information: UDI: 10885403512568/ Serial Number: 16139674 16124908 16063924 16084467 16221549 16139675 16220875 16237258 16284001 15940400 15940104 15941703 15941654 15943750 15943749 15500696 15654711 15654721 15631099 15631104 15775749 15383480 15383481 15383475 15383486 15383487 15366328 15606170 15575974 15575976 15490745 15422133 15853047 15902413 15598095 15550853 15437809 15437812 15518269 15518273 15518270 15872432 15872429 15662816 15504833 15504836 15503511 15430948 15430963 15639687 15639724 15639720 15639718 15328493 15442794 15442789 15761398 15761401 15937579 15786154 15684803
• FEI Number: 2016493
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: BD Customer Support; 866-930-9251
• Manufacturer Reason for Recall: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
• FDA Determined Cause: Under Investigation by firm
• Action: On July 11, 2024, CareFusion, subsidiary of Becton, Dickinson and Company (BD) issued a "Urgent Medical Device Correction" Notification, via mail. On June 24, 2024, BD issued Customer Release Notes via their firm's customer portal. BD ask consignees to take the following actions: Clinicians: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. Users should verify the contents of the bin location being restocked. 2. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter Distributor: 1. Please provide a copy of the attached customer letter to all facilities within your distribution network that have any product listed in Appendix 1. 2. Please promptly complete and return the enclosed Distributor Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.
• Quantity in Commerce: 61 units
• Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
• 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.