{ "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": "130107", "product_res_number": "Z-0114-2015", "event_date_initiated": "2014-09-15", "event_date_posted": "2014-10-22", "recall_status": "Terminated", "event_date_terminated": "2015-12-18", "res_event_number": "69256", "product_code": "CAZ", "k_numbers": [ "K001587" ], "product_description": "ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit", "code_info": "Catalog No. ASK-05501-AFH1  Lot Number 23F13K0969", "firm_fei_number": "3015859709", "recalling_firm": "Arrow International Inc", "address_1": "2400 Bernville Road", "city": "Reading", "state": "PA", "postal_code": "19605", "additional_info_contact": "Customer Support\n610-378-0131", "reason_for_recall": "Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.", "root_cause_description": "Labeling mix-ups", "action": "Arrow International sent a Medical Device Advisory Notification dated September 15, 2014, to affected customers notifying them that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component, and requesting they provide this Advisory Notice to all those who need to be aware of it within your organization.\n\n Questions were directed to local sales representative or Customer Service at 1-866-246-6990.", "product_quantity": "300", "distribution_pattern": "US Distribution in Utah only.", "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" } } ] }