{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122134", "product_res_number": "Z-0162-2014", "event_date_initiated": "2013-09-23", "event_date_posted": "2013-11-05", "recall_status": "Terminated", "event_date_terminated": "2016-08-22", "res_event_number": "66351", "product_code": "CAZ", "product_description": "Portex Saddleblock Tray with Drugs 26g Quincke, 4745-20\n\nThe Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.", "code_info": "Lot: 2445619", "firm_fei_number": "1217052", "recalling_firm": "Smiths Medical ASD, Inc.", "address_1": "10 Bowman Dr", "city": "Keene", "state": "NH", "postal_code": "03431-5043", "additional_info_contact": "800-258-5361", "reason_for_recall": "Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.", "root_cause_description": "Material/Component Contamination", "action": "Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to spinal@smiths-medical.com. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361.\nFor questions regarding this recall call 800-258-5361.", "product_quantity": "100", "distribution_pattern": "Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.", "openfda": { "k_number": [ "K062900", "K781469", "K903761", "K941153", "K960619", "K033952", "K122027", "K895955", "K080804", "K202699", "K012584", "K153652", "K013041", "K890733", "K880970", "K022752", "K904440", "K934526", "K874674", "K031128", "K210983", "K032144", "K061737", "K060311", "K874105", "K113662", "K782069", "K945671", "K953766", "K885238", "K802290", "K854518", "K001587", "K062902", "K896799", "K090995", "K890732", "K903887", "K060563", "K030937", "K880181", "K962696", "K922162", "K962821", "K052946", "K904101", "K932614", "K895476", "K893938", "K103658", "K092657", "K883314", "K944029", "K063282", "K884552", "K770096", "K161075", "K082183", "K041158", "K121403", "K935245", "K896392", "K951870", "K873943", "K851134", "K770461", "K053283", "K983125", "K954835", "K945497", "K813186", "K842095", "K801912", "K882394", "K760343", "K965017", "K052954", "K954953", "K991719", "K780120", "K902312", "K932249", "K001129", "K892660", "K930161", "K043130", "K060186", "K941493", "K885277", "K121525", "K051171", "K111355", "K093662", "K033080", "K960100", "K073187", "K001940", "K920615", "K822691", "K961075", "K844982", "K933711", "K113188", "K801724", "K941343", "K962880", "K770356", "K222341", "K021567", "K760352", "K902647", "K971233", "K770571", "K924707", "K881429", "K832778", "K110053", "K840179", "K933721", "K953467", "K943319", "K994059", "K890730", "K895192", "K113059", "K014246", "K760249", "K063018", "K840287", "K890731", "K143581", "K885278", "K761162", "K860833", "K950929", "K945484", "K082164", "K894725", "K912322", "K190345", "K201356", "K964783", "K953790", "K954706", "K871066", "K122690", "K033018", "K925014", "K891281", "K851479", "K925902", "K931670", "K781052", "K102007", "K912445" ], "registration_number": [ "9613419", "3013764800", "", "3041276591", "3012494290", "3015209038", "1417485", "1054241", "3004605321", "3009039068", "1030451", "2030624", "2029015", "3013557562", "3004014152", "1928237", "1219114", "1643059", "3015443199", "3004111573", "9611612", "9680425", "1721676", "3013162291", "2011171", "3011270181", "1061124", "9611594", "1644312", "9680591", "2025816", "3030626857", "1417592", "3011193444", "3035642068", "3016904853", "3006946348", "1423507", "3014656749", "2523676", "1000563940", "1043214", "1643817", "3010041511", "3011237704", "3004784537", "9610825", "9610993", "3007221462", "9610847", "3006371704", "1018470", "3008132398", "3010055973", "1043729", "3009888344", "1000632857", "3015859709", "3010966701", "3043226252", "1047429", "1316297", "1055236", "2243072", "2433012", "3011137372", "3005670221", "9617604", "3006425876", "3005941719", "1061927", "2521402", "8010674", "9612086", "2134812", "3004122598", "3007207906", "3016678045", "1319639", "9680794", "3004365956", "2618282", "1224960" ], "fei_number": [ "3013764800", "", "3041276591", "3012494290", "3015209038", "1000160458", "1417485", "3004605321", "3009039068", "1030451", "3013557562", "3002806575", "1000117748", "3005747797", "3004014152", "1928237", "1219114", "1643059", "3015443199", "3000204727", "3004111573", "3002807847", "1000138054", "1721676", "3013162291", "2011171", "3011270181", "6064", "3002827704", "3008002452", "3002808374", "3002806436", "3002806469", "3000203000", "2025816", "3005732259", "3030626857", "3002807091", "3011193444", "1417592", "1000112877", "3035642068", "3016904853", "3006946348", "3014656749", "3000168341", "2523676", "1000563940", "1043214", "1643817", "3010041511", "3011237704", "3004784537", "1000512168", "3007596547", "3007221462", "3006371704", "2649711", "1018470", "3010055973", "1043729", "3009888344", "1000632857", "3015859709", "3010966701", "3043226252", "1047429", "1316297", "2243072", "2433012", "1000112968", "3005670221", "3006425876", "3002879021", "2521402", "3004122598", "3007207906", "3002807111", "3016678045", "3003737899", "3004365956", "3002558692", "3000206435" ], "device_name": "Anesthesia Conduction Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5140", "device_class": "2" } } ] }