{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196727", "product_res_number": "Z-0928-2023", "event_date_initiated": "2022-12-12", "event_date_posted": "2023-01-10", "recall_status": "Open, Classified", "res_event_number": "91099", "product_code": "BRY", "product_description": "BD Pyxis MedBank System - Product Label/labeling pending", "code_info": "BD Pyxis\" MedBank Tower Main\nUDI Code: 10885403512568\nCatalog Numbers:\n169-23 to 169-81,\n169-100, 169-132,\n169-138, 169-139\n\nBD Pyxis\" MedBank Mini Main\nUDI Code: 10885403512544\nCatalog Numbers:\n169-101 - 169-113,\n169-137\n\nBD Pyxis\" MEDFLEX\nBD Pyxis\" MEDFLEX 2.0\nUDI Codes:10885403512704\nCatalog Numbers:\n1119-00\n1139-00\n\nMedBank 200/500\nUDI Code: N/A\nCatalog Numbers: 1137-00\n\nBD Pyxis MEDPASS v1.0 or prior\nUDI Code: 10885403513817\nCatalog Number: Not Provided\n\nBD Pyxis\" MedBank Cabinet Software v2.2 or prior\nUDI Codes: 10885403513794\nCatalog Number: N/A\n\nAffected Serial 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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": "Mr. Puneet Sarin\n888-876-7128", "reason_for_recall": "Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.", "root_cause_description": "Software design", "action": "On 12/12/2022, the firm sent an \"Urgent: Medical Device Correction\" Letter via FedEx 2-Day mail to customers informing them of a software anomaly affecting BD Pyxis MedBank Cabinets with software version v.2.2 or prior. The firm was made aware that when using an atypical workflow the software would indicate that a different medication is loaded in a CUBIE pocket that what is physically loaded and listed on the CUBIE pocket label. This issue may occur when a new CUBIE is placed into an empty position that the software considers already occupied.\n\nCustomer are instructed to:\nTo mitigate and avoid this issue, only restock or destock CUBIE pockets when in the Restock / Destock workflow. If a CUBIE is removed atypically, and you do not have the privileges to activate the Restock/Destock workflow, call BD Support to assist with inserting the CUBIE correctly into the MedBank automated dispensing cabinet. Do not manually insert the CUBIE without support.\nActions to be taken by Pharmacy:\n1. Provide a copy of this customer letter to all facilities within their distribution network that have the affected products.\n2. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that they understand the information provided in this letter.\nActions to be taken by the Customer:\n1. Post this Customer Notification on all affected devices until additional software updates have been released.\n2. 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.\n3. If customers experience a memory overwrite issue, reach out to BD Technical Support/Product Complaints at 1-866-930-9251.\nActions to be taken by BD:\n1. A software update to version 2.3.1.8 is currently in progress and will be available to all affected customers by December 2022. BD will contact customers to schedule a convenient time to update the software. BD will re", "product_quantity": "6,796 systems", "distribution_pattern": "U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WA, WI, and WV.", "openfda": { "registration_number": [ "1924066", "1836161", "3001109397", "3010373530", "3008559238", "3024706751", "3033433849", "3043178571", "3038623066", "2031508", "3007218972", "3005581012", "3010097171", "3015526491", "3013408788", "3026311463", "3008881803", "3013685983", "3011647251", "3037012186", "3007836437", "3010303097", "3030488262", "3015426639", "1223662", "3043177791", "3007880912", "9680168", "2016493", "3030522263", "3021559257", "3007744192", "3031700059", "3003879246", "2024242", "2531463", "1218386", "3027332478", "3010373263", "2023337", "8043685", "3009526986", "3007573469", "3027847726", "3013237609", "3014383485", "3015277949", "3014739961", "3004068465", "3003882387", "3015978022", "9613910", "3004604967", "2030624", "3014908171", "3005202235", "3009567010", "3007123908", "3007913191" ], "fei_number": [ "1924066", "3001109397", "3010373530", "3008559238", "3024706751", "3033433849", "3043178571", "3038623066", "3005581012", "3007218972", "3010097171", "3015526491", "3013408788", "3026311463", "3008881803", "3013685983", "3011647251", "3037012186", "3007836437", "3000206435", "3010303097", "3030488262", "3015426639", "3043177791", "3007880912", "2016493", "3030522263", "3021559257", "3007744192", "3031700059", "3003879246", "2024242", "3004574120", "1218386", "3001708019", "3027332478", "3010373263", "2023337", "3001600991", "3009526986", "1000295034", "1000115734", "3027847726", "3013237609", "3002750084", "1000159368", "3014383485", "3015277949", "3014739961", "3004068465", "3003882387", "3015978022", "3004604967", "3014908171", "3005202235", "3009567010", "3011343761", "3007123908", "3007913191" ], "device_name": "Cabinet, Table And Tray, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.6100", "device_class": "1", "k_number": [ "K901474", "K871564", "K821307", "K921710", "K912346" ] } } ] }