{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195003", "product_res_number": "Z-1785-2022", "event_date_initiated": "2022-05-24", "event_date_posted": "2022-09-23", "recall_status": "Open, Classified", "res_event_number": "90600", "product_code": "BRY", "product_description": "BD Pyxis MedBank Cabinet Software v2.1.2.9 \n\nLegacy MedBank Cabinets with Matrix Drawers include:\n.\tCUBEX MedFlex operating with Windows 7 \n.\tMedBank 200 Main operating with Windows 7\n. \tMedBank 500 Main operating with Windows 7. \n\nAn automated dispensing cabinet intended to securely store and dispense medications to health care providers in a clinical setting.", "code_info": "Software Version - v2.1.2.9\nUDI Code: N/A\n\nCabinet System Serial Numbers containing the affected 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"firm_fei_number": "2016493", "recalling_firm": "CareFusion 303, Inc.", "address_1": "10020 Pacific Mesa Blvd", "city": "San Diego", "state": "CA", "postal_code": "92121-4386", "additional_info_contact": "888-876-7128", "reason_for_recall": "The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop opening in the MedBank Application) leading to delay in access to medications or supplies needed in residential or procedural care facilities.", "root_cause_description": "Under Investigation by firm", "action": "On 05/24/2022, BD engineers remotely performed the roll-back of the incompatible .dll files on the affected device. The affected pharmacies were verbally notified prior to and after the fix being implemented.\n\nBeginning in September 2022, BD will send an \"Urgent Medical Device Product Correction\" letter to customers informing them that they are performing a product correction for legacy MedBank Cabinets with Matrix drawers, due to a known issue when installing BD Pyxis MedBank Cabinets software version 2.1.2.9. Impacted Legacy MedBank Cabinets with Matrix drawers include:\n\"\tCUBEX MedFlex operating with Windows 7 \n\"\tMedBank 200 Main operating with Windows 7\n\"\tMedBank 500 Main operating with Windows 7\nActions to be taken by Pharmacy:\n1.\tProvide a copy of this customer letter to all facilities within their distribution network, that have any product listed in the Affected Products section above, on BD s behalf. \n\nActions to be taken by the Customer:\n1.\tPost this Customer Notification on all affected devices until additional software updates have been released. \n2.\tPromptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that they understand the information provided in this letter.\n3.\tIf customers experience loss in drawer functionality, please reach out to BD Technical Support/Product Complaints. \nActions to be taken by BD:\n1.\tBD has reverted all .dll files to the previous version on affected cabinets.\n2.\tAdditional software updates to legacy MedBank Cabinets with Matrix drawers will be available in the future. BD will contact customer to schedule a convenient time to update the software on their affected units. BD will remotely perform all necessary software updates at no charge.\n\nQuestions - Technical Question - \nPhone: 1-866-930-9251\nhours: 24 hours, 7 days a week \nEmail: MedBanksupport@BD.com", "product_quantity": "686 cabinets", "distribution_pattern": "U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME,. MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.", "openfda": { "registration_number": [ "3037012186", "3010373530", "2531463", "3015426639", "3027332478", "3007218972", "3008881803", "3007123908", "3024706751", "3031700059", "3007836437", "2024242", "2030624", "3014383485", "3027847726", "3003879246", "2016493", "3021559257", "3009567010", "3011647251", "3026311463", "3003882387", "3015526491", "2031508", "3005202235", "3014908171", "3013685983", "9680168", "3030488262", "3043177791", "3010303097", "3015978022", "1218386", "3033433849", "3007913191", "3010097171", "3010373263", "3038623066", "3005581012", "3007880912", "8043685", "3013408788", "3007573469", "3030522263", "3004068465", "3014739961", "1924066", "3043178571", "9613910", "3004604967", "3001109397", "3009526986", "3013237609", "2023337", "1223662", "1836161", "3007744192", "3015277949", "3008559238" ], "fei_number": [ "3037012186", "3010373530", "3015426639", "3027332478", "3007218972", "3008881803", "3007123908", "3024706751", "3002750084", "3031700059", "3007836437", "2024242", "3014383485", "3027847726", "3003879246", "2016493", "3021559257", "3001600991", "3009567010", "3011647251", "3026311463", "3011343761", "3015526491", "3003882387", "3001708019", "3005202235", "3014908171", "3013685983", "1000115734", "3030488262", "3043177791", "3010303097", "3015978022", "1218386", "3033433849", "3007913191", "3010097171", "3010373263", "3038623066", "3005581012", "3007880912", "1000159368", "3013408788", "3030522263", "1000295034", "3014739961", "3004068465", "3043178571", "1924066", "3004604967", "3009526986", "3001109397", "3013237609", "2023337", "3000206435", "3007744192", "3004574120", "3015277949", "3008559238" ], "device_name": "Cabinet, Table And Tray, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.6100", "device_class": "1", "k_number": [ "K921710", "K912346", "K821307", "K901474", "K871564" ] } } ] }