{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105014", "product_res_number": "Z-0309-2012", "event_date_initiated": "2011-06-20", "event_date_posted": "2011-11-30", "recall_status": "Terminated", "event_date_terminated": "2012-10-01", "res_event_number": "60314", "product_code": "CAZ", "k_numbers": [ "K021567" ], "product_description": "Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039\n\nPermits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours", "code_info": "Lot number MF0127039", "firm_fei_number": "3015859709", "recalling_firm": "Arrow International Inc", "address_1": "2400 Bernville Road", "city": "Reading", "state": "PA", "postal_code": "19605", "additional_info_contact": "Tracy Larish\n610-378-0131", "reason_for_recall": "Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.", "root_cause_description": "Packaging", "action": "The firm, Arrow International, sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account.\n\nIf you have questions or concerns, please call this toll free number 800-233-3187.", "product_quantity": "17 kits", "distribution_pattern": "Nationwide distribution: CT", "openfda": { "k_number": [ "K895476", "K013041", "K902312", "K941153", "K890730", "K052946", "K954835", "K033080", "K111355", "K844982", "K082183", "K761162", "K871066", "K983125", "K892660", "K965017", "K012584", "K822691", "K001587", "K001129", "K903887", "K941343", "K770356", "K885277", "K780120", "K053283", "K813186", "K033018", "K760249", "K890733", "K190345", "K960619", "K840179", "K883314", "K801912", "K874674", "K802290", "K760343", "K060311", "K063018", "K842095", "K103658", "K851134", "K090995", "K964783", "K991719", "K890731", "K924707", "K934526", "K962696", "K851479", "K122690", "K041158", "K961075", "K954953", "K954706", "K920615", "K884552", "K880181", "K873943", "K031128", "K891281", "K925902", "K945671", "K953766", "K895955", "K032144", "K063282", "K931670", "K971233", "K832778", "K935245", "K121525", "K210983", "K201356", "K092657", "K945497", "K052954", "K895192", "K121403", "K222341", "K912322", "K030937", "K874105", "K781469", "K014246", "K854518", "K022752", "K994059", "K932249", "K950929", "K043130", "K143581", "K903761", "K033952", "K944029", "K093662", "K102007", "K894725", "K904101", "K801724", "K933721", "K930161", "K080804", "K896392", "K922162", "K902647", "K925014", "K161075", "K933711", "K073187", "K943319", "K770461", "K912445", "K896799", "K113059", "K113188", "K021567", "K860833", "K001940", "K885278", "K881429", "K941493", "K882394", "K760352", "K932614", "K051171", "K951870", "K962880", "K770096", "K082164", "K893938", "K060186", "K062902", "K840287", "K113662", "K953467", "K781052", "K880970", "K060563", "K904440", "K962821", "K945484", "K770571", "K885238", "K062900", "K202699", "K890732", "K953790", "K960100", "K061737", "K122027", "K153652", "K110053", "K782069" ], "registration_number": [ "", "1644312", "1319639", "1054241", "1043729", "3015859709", "3004784537", "1000563940", "3006425876", "9613419", "3011237704", "9610847", "3014656749", "3005941719", "1224960", "3035642068", "3030626857", "9680591", "1000632857", "1721676", "3008132398", "3006371704", "1055236", "2025816", "9611594", "1047429", "2243072", "3004111573", "1423507", "1643817", "1061927", "3013764800", "9610825", "3007221462", "1030451", "3004122598", "2134812", "3006946348", "3013557562", "1043214", "2523676", "3010041511", "9680425", "1219114", "3010966701", "2618282", "9680794", "2030624", "9612086", "3005670221", "3011193444", "3015209038", "3004365956", "2521402", "3010055973", "1417592", "3015443199", "1928237", "3011137372", "1061124", "2433012", "9617604", "1316297", "2029015", "2011171", "1417485", "3009039068", "3007207906", "8010674", "3011270181", "1643059", "3012494290", "3009888344", "3013162291", "1018470", "3016678045", "9611612", "3004605321", "3004014152", "3043226252", "3016904853", "9610993", "3041276591" ], "fei_number": [ "", "3002827704", "3000203000", "1043729", "3002807847", "3015859709", "3002558692", "3004784537", "1000117748", "1000563940", "3006425876", "3011237704", "1000160458", "1000138054", "3002807111", "3014656749", "2649711", "3000206435", "3035642068", "3030626857", "1000632857", "1721676", "3006371704", "3002806575", "2025816", "1047429", "2243072", "3004111573", "1643817", "3013764800", "3007221462", "1030451", "3004122598", "3006946348", "1000512168", "3008002452", "3013557562", "1043214", "1000112877", "2523676", "1000112968", "3010041511", "1219114", "3010966701", "3005732259", "3002807091", "3005670221", "3011193444", "3015209038", "3004365956", "2521402", "3010055973", "1417592", "3015443199", "1928237", "2433012", "3007596547", "1316297", "3002808374", "2011171", "1417485", "3009039068", "3007207906", "3011270181", "3003737899", "3002806436", "3000168341", "1643059", "3012494290", "3009888344", "3000204727", "3002806469", "3013162291", "3002879021", "1018470", "3016678045", "3004605321", "3004014152", "3043226252", "3016904853", "6064", "3041276591", "3005747797" ], "device_name": "Anesthesia Conduction Kit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5140", "device_class": "2" } } ] }