{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211019", "product_res_number": "Z-0672-2025", "event_date_initiated": "2024-11-14", "event_date_posted": "2024-12-11", "recall_status": "Open, Classified", "res_event_number": "95643", "product_code": "BRY", "product_description": "BD Pyxis CII Safe ES, REF: 1116-00", "code_info": "All software versions. REF/UDI-DI: \n1116-00/10885403512605/\n15938609\n15938608\n15960426\n15977244\n15977243\n15997587\n15997584\n15997586\n16001276\n16004167\n16004170\n16004168\n16006959\n16016028\n16018286\n16018285\n16027068\n16034363\n16038606\n16038608\n16042040\n16043100\n16051041\n16052300\n16056892\n16081629\n16089006\n16107354\n16121844\n16124176\n16124177\n16124175\n16124174\n16124178\n16142019\n16142717\n16147368\n16150604\n16150317\n16154380\n16154381\n16179910\n16185906\n16186402\n16186403\n16188916\n16188917\n16189876\n16191858\n16191855\n16192478\n16192476\n16198735\n16205805\n16205708\n16210899\n16211121\n16211303\n16211474\n16216310\n16216322\n16216171\n16216317\n16216324\n16216170\n16217014\n16217009\n16217010\n16217006\n16222804\n16229923\n16234971\n16234972\n16234970\n16234973\n16234969\n16235009\n16236311\n16238237\n16238264\n16239968\n16247326\n16253283\n16262739\n16267647\n16273818\n16273822\n16277384\n16280705\n16282121\n16282137\n16282082\n16283296\n16287656\n16291326\n16292340\n16294019\n16295348\n16295346\n16297236\n16297224\n16299107\n16300479\n16309949\n16315507\n16317206\n16317204\n16317205\n16317207\n16319700\n16319670\n16322458\n16322446\n16323719\n16327551\n16335942\n16337405\n16338265\n16338264\n16344600\n16344608\n16349184\n16349205\n16354606\n16380050\n16381506\n16381558\n16411952\n16411951\n16412194\n16413752\n16413747\n16415153\n16415200\n16415590\n16416557\n16416531\n16418522\n16418188\n16418187\n16418507\n16423221\n16425773\n16426437\n16433986\n16444194\n16445004\n16444237\n16445017\n16460539\n16461440\n16460710\n16460551\n16468172\n16468090\n16468208\n16468173\n16468174\n16469932\n16474654\n16479163\n16484107\n16487985\n16490699\n16507895\n16507875\n16529195\n16538278\n16550545\n16554103\n16554102\n16554100\n16554079\n16582605\n16585680\n16585665\n16585669\n16585576\n16585655\n16595099\n16595093\n16601179\n16627555\n16626472\n16627561\n16626460\n16630815\n16641357\n16664753\n16672435\n16685055\n16685063\n16706784\n16706834\n16712895\n16719658\n16719611\n16719695\n16755235\n16755194\n16764093\n16767178\n16769446\n16773194\n16785716\n16785719\n16790736\n16808348\n16808370\n16808330\n16811697\n16826563\n16832646\n16832644\n16832647\n16843563\n16881356\n16907911", "firm_fei_number": "2016493", "recalling_firm": "CareFusion 303, Inc.", "address_1": "10020 Pacific Mesa Blvd", "city": "San Diego", "state": "CA", "postal_code": "92121-4386", "reason_for_recall": "Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.", "root_cause_description": "Software design", "action": "On 11/14/24, correction notices were mailed/emailed to customers:\nDevices can continue to be used in accordance with the following:\nBest practice is for providers (e.g., nurses) to verify the medication being removed is accurate against the hospital patient record (source of truth) prior to administration1.\no Labeling includes the following warning: Always utilize the BD Pyxis ES System\npatient/order information in conjunction with the medical record when making clinical\ndecisions. Making clinical decisions solely from System information may result in errors in care resulting in serious injury or death.\n\" To further aid that verification step, it has been estimated that BCMA (Barcode Medication Administration) can reduce medication administration errors. Similarly, \"Scan on Remove\" functionality can be enabled within the MedStation to help capture an erroneously dispensed medication.\n\" Safe storage and labeling for neuromuscular blocking (NMB) agents - Institute for Safe\nMedication Practices (ISMP) recommends to segregate, sequester, and differentiate NMBs from other medications. This can help identify a high-risk medication is being removed in error.\n\" If a different medication is dispensed, the error may be caught during the check process prior to leaving the pharmacy. If error is not caught, pharmacy technician will still refill/load the medication dispensed properly at the device.\n\" ES server includes notifications for those medication pockets that are empty within the System to trigger pharmacy to refill.\n\nComplete and return response form to BDRC1@bd.com\nFor further assistance, contact firm: Technical Support - 1-800-727-6102, 24 hours, 7 days a week; Regional Complaint Center, 1-844-823-5433, Mon-Fri 8:00am-5:00pm CT, productcomplaints@bd.com; Post Market Quality Operations, Fax: 1-410-316-4258, Email: BDRC1@bd.com\n\nOn 2/6/2025, updated correction notices were sent notifying customers that the firmware update was available.", "product_quantity": "218", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.", "openfda": { "registration_number": [ "3011647251", "2024242", "3031700059", "3007880912", "3015526491", "3003879246", "3009567010", "9613910", "3014383485", "3007573469", "3007123908", "9680168", "3010373263", "3027847726", "3043178571", "3008881803", "3038623066", "3013408788", "3004068465", "3014739961", "3024706751", "3010097171", "3001109397", "3030488262", "3014908171", "3021559257", "1836161", "1218386", "3007913191", "3015978022", "3043177791", "3003882387", "3007218972", "3008559238", "3007836437", "2031508", "2023337", "3004604967", "3026311463", "3013237609", "2030624", "2531463", "1223662", "3037012186", "8043685", "2016493", "3030522263", "3027332478", "3005581012", "3015426639", "3007744192", "3013685983", "1924066", "3010373530", "3005202235", "3010303097", "3009526986", "3033433849" ], "fei_number": [ "3011647251", "2024242", "1000115734", "3004574120", "3007880912", "3031700059", "3015526491", "3002750084", "1000295034", "1000159368", "3003879246", "3009567010", "3014383485", "3007123908", "3010373263", "3027847726", "3043178571", "3008881803", "3038623066", "3013408788", "3004068465", "3014739961", "3024706751", "3010097171", "3001109397", "3030488262", "3014908171", "3021559257", "1218386", "3007913191", "3015978022", "3043177791", "3003882387", "3007218972", "3008559238", "3007836437", "3001600991", "3001708019", "2023337", "3004604967", "3026311463", "3000206435", "3013237609", "3037012186", "2016493", "3030522263", "3027332478", "3005581012", "3015426639", "3007744192", "3011343761", "3013685983", "1924066", "3010373530", "3005202235", "3010303097", "3009526986", "3033433849" ], "device_name": "Cabinet, Table And Tray, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.6100", "device_class": "1", "k_number": [ "K821307", "K871564", "K901474", "K921710", "K912346" ] } } ] }