{ "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": "123965", "product_res_number": "Z-0533-2014", "event_date_initiated": "2013-10-28", "event_date_posted": "2013-12-17", "recall_status": "Terminated", "event_date_terminated": "2014-01-29", "res_event_number": "66885", "product_code": "CAZ", "k_numbers": [ "K945484" ], "product_description": "Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only\r\n\r\nProduct Usage:\r\nThe Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.", "code_info": "Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,", "firm_fei_number": "1000138491", "recalling_firm": "Integra LifeSciences Corp. d.b.a. Integra Pain Management", "address_1": "3498 West 2400 South #1050 3498 West 2400 South", "address_2": "#1050", "city": "Salt Lake City", "state": "UT", "postal_code": "84119", "additional_info_contact": "Mr. David E. Gronostajski\n609-936-6822", "reason_for_recall": "Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.", "root_cause_description": "Component design/selection", "action": "BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762.", "product_quantity": "359,250", "distribution_pattern": "USA Nationwide Distribution and one foreign consignee in Mursalat.", "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" } } ] }