{ "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": "149465", "product_res_number": "Z-0394-2017", "event_date_initiated": "2016-08-02", "event_date_created": "2016-11-10", "recall_status": "Terminated", "event_date_terminated": "2019-04-22", "res_event_number": "75150", "product_code": "CAZ", "product_description": "catalog # 405612\nBD Spinal Anesthesia Tray\n22G x 3.5 in. BD\" Quincke Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog # 405622 \nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Quincke Spinal Needle\nBupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\n\ncatalog # 405623\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Quincke Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405624\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Quincke Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog # 405634\nBD Spinal Anesthesia Tray\n26G x 3.5 in. BD\" Quincke Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog # 405636\nBD Spinal Anesthesia Tray\n26G x 3.5 in. BD\" Quincke Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405641\nBD Spinal Anesthesia Tray\n24G x 3.5 in. Sprotte Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405648\nBD Spinal Anesthesia Tray\n22G x 3.5 in. BD\" Whitacre Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog# 405649\nBD Spinal Anesthesia Tray\n22G x 3.5 in. BD\" Whitacre Spinal Needle\n25G x 3.5 in. BD\" Quincke Spinal Needle\nBupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\n\ncatalog # 405682\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405684\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405685\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\n\ncatalog#405694\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Quincke Spinal Needle\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW\nBupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\n\ncatalog #405704\nBD Spinal Anesthesia Tray\n27G x 3.5 in. BD\" Whitacre Spinal Needle\nLidocaine HCL (5%) with Dextrose (7.5%), 2 mL\n\ncatalog #405737\nBD Spinal Anesthesia Tray\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW\nBupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine)\n\ncatalog# 405829\nBD Spinal Anesthesia Tray\n27G x 3.5 in. BD\" Quincke Spinal Needle\n25G x 3.5 in. BD\" Whitacre Spinal Needle, TW", "code_info": "25G x 3.5 in. BD\" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B03H034D 1-May-2015 B04J262D 1-Oct-2016   25G x 3.5 in. BD\" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H034D 1-May-2015 B01H238D 1-Jan-2016 B01H259D 1-Jan-2016 B02J229D 1-Oct-2016 B03J364D 1-Oct-2016 B03K006D 1-Oct-2016 B03K048D 1-Oct-2016 B04H136D 1-Sep-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD\" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H035D 1-May-2015 B01H036D 1-May-2015 B01H070D 1-Jun-2015 B01H091D 1-Jun-2015 B01H138D 1-Sep-2015 B02H031D 1-May-2015 B04H119D 1-Jun-2015  BD Spinal Anesthesia Tray 25G x 3.5 in. BD\" Quincke Spinal Needle 25G x 3.5 in. BD\" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B01H191D 1-Oct-2016 B02H135D 1-Oct-2016 B03H050D 1-Jul-2016 B03H114D 1-Oct-2016   27G x 3.5 in. BD\" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL B02H034D 1-May-2015   25G x 3.5 in. BD\" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) B03H153D 1-Sep-2015   27G x 3.5 in. BD\" Quincke Spinal Needle 25G x 3.5 in. BD\" Whitacre Spinal Needle, TW B02H077D 1-Jun-2015 B03H106D 1-Jun-2015", "firm_fei_number": "2243072", "recalling_firm": "Becton Dickinson & Company", "address_1": "1 Becton Dr", "city": "Franklin Lakes", "state": "NJ", "postal_code": "07417-1815", "additional_info_contact": "201-847-6800", "reason_for_recall": "A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD\" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.", "root_cause_description": "Nonconforming Material/Component", "action": "BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016.\n\nStericycle is handling returns.", "product_quantity": "39,130 trays", "distribution_pattern": "Nationwide.", "openfda": { "k_number": [ "K925014", "K770096", "K991719", "K934526", "K063018", "K770356", "K954835", "K953790", "K153652", "K801912", "K971233", "K983125", "K880970", "K060311", "K896799", "K953766", "K951870", "K874105", "K012584", "K802290", "K822691", "K895955", "K933711", "K760343", "K813186", "K944029", "K885278", "K041158", "K925902", "K945497", "K770571", "K030937", "K113662", "K092657", "K885277", "K941343", "K922162", "K962880", "K060563", "K760249", "K954953", "K871066", "K082164", "K893938", "K941153", "K053283", "K895192", "K931670", "K912322", "K941493", "K033952", "K880181", "K043130", "K890733", "K874674", "K943319", "K014246", "K051171", "K945484", "K122690", "K964783", "K851479", "K885238", "K093662", "K761162", "K965017", "K994059", "K780120", "K904101", "K781469", "K930161", "K902647", "K854518", "K090995", "K904440", "K113188", "K113059", "K022752", "K961075", "K851134", "K061737", "K884552", "K896392", "K052946", "K122027", "K111355", "K924707", "K883314", "K760352", "K840179", "K954706", "K920615", "K001587", "K945671", "K950929", "K073187", "K844982", "K001129", "K031128", "K962821", "K770461", "K895476", "K062900", "K902312", "K890730", "K121403", "K933721", "K912445", "K842095", "K881429", "K891281", "K801724", "K121525", "K932249", "K033018", "K892660", "K832778", "K960100", "K882394", "K873943", "K840287", "K032144", "K202699", "K903761", "K201356", "K161075", "K932614", "K062902", "K001940", "K033080", "K960619", "K021567", "K060186", "K890731", "K013041", "K903887", "K102007", "K935245", "K210983", "K953467", "K063282", "K890732", "K962696", "K052954", "K143581", "K190345", "K894725", "K782069", "K103658", "K082183", "K860833", "K080804", "K110053", "K222341", "K781052" ], "registration_number": [ "", "2029015", "3015443199", "3011237704", "1423507", "1417592", "3041276591", "1047429", "3006371704", "2025816", "1000563940", "3007207906", "9617604", "9610825", "3016678045", "2011171", "2134812", "3010055973", "1644312", "3011193444", "2433012", "3043226252", "3004111573", "3004365956", "8010674", "2523676", "9611612", "2521402", "1018470", "3010041511", "1061927", "3015209038", "3004122598", "3005941719", "9610847", "1224960", "3012494290", "3014656749", "3011270181", "9680425", "1043214", "3008132398", "1721676", "3006946348", "1219114", "9611594", "1061124", "3013557562", "3009039068", "2618282", "2243072", "3015859709", "3005670221", "1055236", "3004605321", "3004014152", "3007221462", "9612086", "1643817", "3009888344", "3016904853", "1030451", "1417485", "3013764800", "3013162291", "1928237", "3010966701", "1319639", "3035642068", "1043729", "1643059", "1316297", "2030624", "1054241", "3004784537", "9680794", "3011137372", "3006425876", "3030626857", "1000632857", "9613419", "9610993", "9680591" ], "fei_number": [ "", "1000138054", "3005747797", "3015443199", "3011237704", "1417592", "3041276591", "1047429", "3006371704", "2025816", "1000563940", "3002827704", "3005732259", "3007207906", "3016678045", "3000206435", "3002806469", "3002807847", "3002807111", "3002879021", "2011171", "3007596547", "3010055973", "3011193444", "2433012", "3043226252", "3004111573", "3004365956", "2523676", "2521402", "1018470", "3010041511", "3015209038", "3004122598", "2649711", "1000160458", "3008002452", "3012494290", "3014656749", "3011270181", "3000168341", "1043214", "1000112968", "1721676", "3006946348", "3002807091", "3003737899", "1000512168", "1219114", "3013557562", "3002806575", "3002808374", "3009039068", "3000204727", "2243072", "3000203000", "3015859709", "3005670221", "1000117748", "3004605321", "1000112877", "3002558692", "3004014152", "3007221462", "6064", "1643817", "3009888344", "3016904853", "1030451", "1417485", "3013764800", "3013162291", "1928237", "3010966701", "3035642068", "1043729", "1643059", "1316297", "3004784537", "3006425876", "3030626857", "1000632857", "3002806436" ], "device_name": "Anesthesia Conduction Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5140", "device_class": "2" } } ] }