{ "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": "85638", "product_res_number": "Z-0509-2010", "event_date_initiated": "2009-09-23", "event_date_posted": "2009-12-15", "recall_status": "Terminated", "event_date_terminated": "2012-05-23", "res_event_number": "53495", "product_code": "LIT", "k_numbers": [ "K931009", "K983373" ], "product_description": "IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only \n--- Common/Usual Name: PTA and Esophageal Catheter \n--- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 \n--- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 \n--- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. \n--- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.", "code_info": "All Impact catheters distributed between 10/01/2004 and 9/23/2009 are affected: Lot numbers IM-0843, IM-0893, IM-0894, IM-0895, IM-0896, IM-0897,  IM-0898, IM-0899, IM-0900, IM-0901, IM-0902, IM-0903, IM-0904, IM-0905,  IM-0906, IM-0907, IM-0908, IM-0909, IM-0910, IM-0914, IM-0775, IM-0788,  IM-0807, IM-0817, IM-0823, IM-0827, IM-0843, IM-0845, IM-0846, IM-0852,  IM-0857, IM-0868, IM-0869, IM-0890, IM-0891, IM-0912, IM-0915, IM-0916,  IM-0917, IM-0918, IM-0919, IM-0920, IM-0921, IM-0922, IM-0923, IM-0924, IM-0925, IM-0926, IM-0927, IM-0943, IM-0944, IM-0945, IM-0946, IM-0644, IM-0793, IM-0814, IM-0849, IM-0884, IM-0928, IM-0929, IM-0930, IM-0931, IM-0932, IM-0933, IM-0934, IM-0935, IM-0936, IM-0937, IM-0938, IM-0939, IM-0940, IM-0941, IM-0942, IM-0644, IM-0854, IM-0855, IM-0866, IM-0878, IM-0889, IM-0905, IM-0924, IM-0947, IM-0948, IM-0949, IM-0950, IM-0951, IM-0952, IM-0953, IM-0954, IM-0955, IM-0956, IM-0957, IM-0958, IM-0959, IM-0960, IM-0961, IM-0962, IM-0963, IM-0964, IM-0644, IM-0831, IM-0851,  IM-0864, IM-0876, IM-0887, IM-0902, IM-0933, IM-0935, IM-0937, IM-0965, IM-0966, IM-0967, IM-0968, IM-0969, IM-0970, IM-0971, IM-0829, IM-0895,  IM-0897, IM-0898, IM-0917, IM-0918, IM-0931, IM-0949, IM-0972, IM-0973, IM-0974, IM-0975, IM-0976, IM-0977, IM-0978, IM-0986, IM-0979, IM-0980, IM-0981, IM-0982, IM-0983, IM-0984, IM-0985, IM-0882, IM-0915, IM-0928, IM-0945, IM-0951, IM-0954, IM-0967, IM-1002, IM-1003, IM-0987, IM-0988, IM-0989, IM-0990, IM-0991, IM-0992, IM-0993, IM-0994, IM-0995, IM-0996,  IM-0997, IM-0998, IM-0999, IM-1000, IM-1001, IM-0913, IM-0941, IM-1004, IM-1005, IM-1006, IM-1007, IM-1008, IM-1009, IM-1010, IM-1011, IM-1012, IM-1013, IM-1014, IM-1015, IM-1016, IM-0926, IM-0972, IM-1017, IM-1018, IM-0963, IM-0965, IM-1019, IM-0861, IM-0896, IM-0987, IM-1004, IM-1020, IM-1021, IM-1022, IM-1023, IM-1024, IM-1025, IM-1026, IM-1029, IM-1027, IM-1028, IM-1030, IM-1031, IM-1032, IM-1033, IM-1034, IM-1035, IM-0850, IM-0877, IM-0883, IM-0896, IM-0929, IM-0952, IM-0959, IM-0969, IM-0976, IM-0980, IM-1037, IM-1038, IM-1039, IM-1040, IM-1041, IM-1042, IM-1043, IM-1044, IM-0777, IM-0790, IM-0892, IM-0909, IM-0942, IM-0988, IM-1019, IM-1021, IM-0885, IM-0907, IM-0940, IM-0957, IM-0971, IM-0977, IM-0993, IM-1028, IM-1033, IM-1054, IM-1055, IM-1056, IM-1057, IM-1058, IM-0772, IM-0826, IM-0832, IM-0865, IM-0867, IM-0871, IM-0894, IM-0911, IM-0923, IM-0939, IM-0948, IM-0970, IM-0975, IM-0991, IM-1024, IM-1059, IM-1060, IM-1061, IM-1062, IM-1063, IM-1064, IM-1065, IM-1066, IM-0899, IM-0943, IM-1045, IM-0824, IM-0955, IM-0989, IM-1026, IM-1048, IM-1050, IM-1052, IM-1049, IM-1046, IM-1047, IM-1051, IM-1053, IM-0862, IM-0875, IM-0908, IM-0914, IM-0927, IM-0944, IM-0946, IM-0973, IM-1000, IM-1013, IM-1017, IM-1020, IM-1023, IM-1031, IM-1037, IM-1045, IM-1064, IM-1065, IM-1067,  IM-1068, IM-1069, IM-1070, IM-1071, IM-1072, IM-1073, IM-1074, IM-1075, IM-0982, IM-1020, IM-1043, IM-1060, IM-1066, IM-1076, IM-1077, IM-1078,  IM-1079, IM-1080, IM-1081, IM-1082, IM-1083, IM-1084, IM-1085, IM-0919,  IM-0994, IM-1029, IM-1040, IM-1042, IM-1051, IM-1074, IM-1086, IM-1087, IM-1088, IM-1089, IM-1090, IM-1091, IM-1092, IM-1093, IM-1094, IM-1095,  IM-1096, IM-1097, IM-1032, IM-1038, IM-1039, IM-1048, IM-1056, IM-1098, IM-1099, IM-1100, IM-1101, IM-1102, IM-1103, IM-1104, IM-1105, IM-1106, IM-1107, IM-1108, IM-0784, IM-1049, IM-1062, IM-1071, IM-1081, IM-1109, IM-1110, IM-1111, IM-1113, IM-1114, IM-1115, IM-1116, IM-1117, IM-1112, IM-1050, IM-1069, IM-1079, IM-1094, IM-1118, IM-1119, IM-1120, IM-1121, IM-1122, IM-1123, IM-1124, IM-1125, IM-1126, IM-1002, IM-1006, IM-1022, IM-1054, IM-1067, IM-1082, IM-1087, IM-1089, IM-1099, IM-1100, IM-1109, IM-1137, IM-1127, IM-1128, IM-1129, IM-1131, IM-1132, IM-1133, IM-1134,  IM-1135, IM-1136, IM-0932, IM-1046, IM-1092, IM-1100, IM-1110, IM-1138, IM-1139, IM-1140, IM-1141, IM-1142, IM-1143, IM-1144, IM-1145, IM-1146, IM-0932, IM-1096, IM-1101, IM-1105, IM-1107, IM-1113, IM-1120, IM-1124, IM-1127, IM-1147, IM-1148, IM-1149, IM-1150, IM-1151, IM-1152, IM-1153,  IM-1154, IM-1155, IM-1156, IM-1157, IM-0886, IM-0903, IM-0936, IM-0985, IM-1044, IM-1112, IM-1116, IM-1126, IM-1159, IM-1158, IM-1160, IM-1161, IM-1162, IM-1163, IM-1164, IM-1068, IM-1090, IM-1025, IM-1149, IM-1161,  IM-1165, IM-1166, IM-1167, IM-1168, IM-1169, IM-1170, IM-1171, IM-1172, IM-0968, IM-1009, IM-1080, IM-1159, IM-1174, IM-0981, IM-1102, IM-1132, IM-1142, IM-1155, IM-1173, IM-1175, IM-1176, IM-1177, IM-1178, IM-1179, IM-1180, IM-1186, IM-0958, IM-0960, IM-0983, IM-0999, IM-1063, IM-1111, IM-1153, IM-1160, IM-1168, IM-1179, IM-1181, IM-1182, IM-1183, IM-1184, IM-1185, IM-1187, IM-1188, IM-1189, IM-1190, IM-1191, IM-1192, IM-1193, IM-1194, IM-1195, IM-1196, IM-1197, IM-1198, IM-1199, IM-1200, IM-1201, IM-1156, IM-1164, IM-1174, IM-1182, IM-1202, IM-1203, IM-1204, IM-1205, IM-1206, IM-1207, IM-1208, IM-1063, IM-1070, IM-1121, IM-1123, IM-1151, IM-1162, IM-1186, IM-1188, IM-1209, IM-1210, IM-1211, IM-1212, IM-1213, IM-1115, IM-1141, IM-1171, IM-1199, IM-1205, IM-1206, IM-1218, IM-1016, IM-1157, IM-1171, IM-1172, IM-1192, IM-1213, IM-1222, IM-1214, IM-1215, IM-1216, IM-1217, IM-1219, IM-1220, IM-1221, IM-1230, IM-1231, IM-1018, IM-1167, IM-1169, IM-1184, IM-1198, IM-1218, IM-1232, IM-1233, IM-1223, IM-1224, IM-1225, IM-1226, IM-1227, IM-1228, IM-1229, IM-1246, IM-1234, IM-1235, IM-1236, IM-1238, IM-1086, IM-1098, IM-1195, IM-1204, IM-1214,  IM-1217, IM-1219, IM-1248, IM-1237, IM-1239, IM-1240, IM-1241, IM-1242, IM-1243, IM-1244, IM-1245, IM-1247, IM-1057, IM-1178, IM-1196, IM-1216, IM-1223, IM-1233, IM-1249, IM-1250, IM-1251, IM-1252, IM-1253, IM-1254, IM-1255, IM-1256, IM-1114, IM-1143, IM-1200, IM-1208, IM-1228, IM-1229, IM-1244, IM-1254, IM-1255, IM-1257, IM-1258, IM-1259, IM-1260, IM-1261, IM-1262, IM-1263, IM-1264, IM-1264, IM-1266, IM-1267, IM-1268, IM-1269, IM-1270, IM-1271, IM-1272, IM-1190, IM-1252, IM-1273, IM-1279, IM-1061, IM-1122, IM-1211, IM-1227, IM-1236, IM-1238, IM-1242, IM-1297, IM-1298, IM-1299, IM-1289, IM-1274, IM-1275, IM-1276, IM-1277, IM-1278, IM-1280, IM-1281, IM-1282, IM-1283, IM-1284, IM-1285, IM-1286, IM-1287, IM-1288, IM-1290, IM-1291, IM-1292, IM-1293, IM-1294, IM-1295, IM-1296, IM-1206, IM-1226, IM-1272, IM-1299, IM-1300, IM-1301, IM-1302, IM-1303, IM-1304, IM-1305, IM-1306, IM-1307, IM-1308, IM-1309, IM-1310, IM-1311, IM-1318, IM-1312, IM-1313, IM-1314, IM-1315, IM-1316, IM-1317, IM-1332, IM-1333, IM-1334, IM-1335, IM-1117, IM-1133, IM-1136, IM-1146, IM-1163, IM-1170, IM-1201, IM-1202, IM-1217, IM-1219, IM-1222, IM-1225, IM-1232, IM-1241, IM-1253, IM-1260, IM-1262, IM-1271, IM-1276, IM-1279, IM-1286, IM-1289,  IM-1293, IM-1319, IM-1320, IM-1321, IM-1322, IM-1323, IM-1324, IM-1325, IM-1326, IM-1327, IM-1224, IM-1250, IM-1328, IM-1329, IM-1330, IM-1331, IM-1336, IM-1337, IM-1338, IM-1339, IM-1340, IM-1341, IM-1342, IM-1343, IM-1344, IM-1345, IM-1346, IM-1347, IM-1348, IM-1349, IM-1232, IM-1235, IM-1311, IM-1318, IM-1322, IM-1350, IM-1351, IM-1352, IM-1353, IM-1354, IM-1355, IM-1356, IM-1357, IM-1358, IM-1360, IM-1361, IM-1362, IM-1359, IM-1363, IM1364, IM-1158, IM-1165, IM-1215, IM-1240, IM-1277, IM-1283, IM-1365, IM-1366, IM-1367, IM-1281, IM-1299, IM-1307, IM-1323, IM-1328, IM-1331, IM-1335, IM-1340, IM-1346, IM-1349, IM-1354, IM-1358, IM-1368, IM-1369, IM-1370, IM-1371, IM-1372, IM-1191, IM-1239, IM-1246, IM-1275, IM-1278, IM-1280, IM-1291, IM-1310, IM-1324, IM-1373, IM-1374, IM-1375, IM-1376, IM-1298, IM-1312, IM-1363, IM-1377, IM-1378, IM-1379, IM-1380, IM-1381, IM-1382, IM-1383, IM-1285, IM-1304, IM-1341, IM-1355, IM-1364,  IM-1367, IM-1376, IM-1384, IM-1385, IM-1386, IM-1387, IM-1255, IM-1257, IM-1266, IM-1274, IM-1301, IM-1338, IM-1348, IM-1363, IM-1385, IM-1388, IM-1389, IM-1390, IM-1391, IM-1392, IM-1393, IM-1394, IM-1308, IM-1320, IM-1347, IM-1359, IM-1395, IM-1396, IM-1397, IM-1398, IM-1399, IM-1400, IM-1401, IM-1290, IM-1333, IM-1402, IM-1403, IM-1404, IM-1405, IM-1406, IM-1407, IM-1408, IM-1337, IM-1350, IM-1365, IM-1409, IM-1410, IM-1411, IM-1412, IM-1413, IM-1354, IM-1375, IM-1390, IM-1414, IM-1415, IM-1416, IM-1359, IM-1360, IM-1366, IM-1372, IM-1387, IM-1392, IM-1417, IM-1418, IM-1419, IM-1420, IM-1421, IM-1423, IM-1422, IM-1273, IM-1282, IM-1336, IM-1371, IM-1380, IM-1405, IM-1409, IM-1424, IM-1425, IM-1426, IM-1427, IM-1428, IM-1429, IM-1430, IM-1431, IM-1432, IM-1433, IM-1434, IM-1367, IM-1435, IM-1436, IM-1438, IM-1439, IM-1440, IM-1310, IM-1321, IM-1441, IM-1442, IM-1443, IM-1444, IM-1445, IM-1446, IM-1351, IM-1373, IM-1402,  IM-1415, IM-1447, IM-1448.", "firm_fei_number": "1318694", "recalling_firm": "Numed Inc", "address_1": "2880 Main Street /Rt 11b", "city": "Hopkinton", "state": "NY", "postal_code": "12965", "additional_info_contact": "Ms. Nichelle LaFlesh\n315-328-4491", "reason_for_recall": "The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like \"paint crackle.\" The risk is that for continued sterility to be assured, the packaging must remain intact.", "root_cause_description": "Labeling design", "action": "An informal e-mail was sent to B. Braun to give them notice not to distribute any Impact devices until further notice. This was followed up by a formal URGENT MEDICAL DEVICE RECALL letter (dated 9/24/09) to the sole consignee. The products are to be returned to the manufacturer, including any products further distributed. Customer questions should be directed to the recall contact (replace \" AT \" with @) nlaflesh ATnumedusa.com", "product_quantity": "7,367 units domestically", "distribution_pattern": "One distributor in Pennsylvania", "openfda": { "k_number": [ "K952063", "K180007", "K242419", "K953647", "K830733", "K803057", "K962945", "K843880", "K830608", "K902454", "K893411", "K052757", "K163231", "K093636", "K981906", "K862467", "K143036", "K972512", "K130911", "K260304", "K102645", "K813331", "K140351", "K960501", "K834220", "K833616", "K910995", "K971577", "K902091", "K142379", "K890405", "K152080", "K133861", "K152230", "K880158", "K843383", "K152887", "K112513", "K844972", "K003159", "K000570", "K221832", "K901767", "K924358", "K143041", "K953298", "K913391", "K192399", "K052038", "K190753", "K911196", "K003052", "K000101", "K874706", "K983830", "K851848", "K121265", "K934191", "K973013", "K181323", "K895179", "K871796", "K831403", "K942293", "K992320", "K250706", "K150303", "K151317", "K103751", "K221414", "K230191", "K834429", "K882826", "K001134", "K944016", "K953569", "K120722", "K142654", "K141150", "K961980", "K931009", "K130786", "K991811", "K952064", "K946052", "K911203", "K971010", "K894944", "K900677", "K983650", "K020854", "K972357", "K910996", "K103354", "K003114", "K921943", "K935501", "K160013", "K120677", "K965183", "K904984", "K942154", "K970725", "K050645", "K202800", "K901601", "K093286", "K113681", "K993913", "K122070", "K131329", "K214038", "K160941", "K092286", "K883346", "K120971", "K081417", "K090364", "K896403", "K923947", "K051916", "K201794", "K940063", "K101047", "K192318", "K960517", "K851854", "K120660", "K142459", "K120805", "K884327", "K141112", "K915347", "K910155", "K881197", "K181529", "K923611", "K921856", "K913112", "K171251", "K941706", "K060959", "K151141", "K092361", "K981407", "K843501", "K023504", "K201333", "K211044", "K903606", "K030742", "K113300", "K945943", "K914976", "K925945", "K842556", "K897106", "K983055", "K911639", "K880612", "K894899", "K123358", "K230263", "K905698", "K970466", "K221057", "K905250", "K101361", "K000798", "K932537", "K141118", "K911870", "K132810", "K160004", "K880194", "K162350", "K093720", "K904410", "K173621", "K970379", "K822245", "K913689", "K021996", "K173515", "K132020", "K881088", "K902317", "K121175", "K060960", "K142261", "K201377", "K150946", "K251915", "K243704", "K991540", "K213631", "K942094", "K964881", "K130161", "K080264", "K072798", "K102482", "K890325", "K252512", "K201170", "K163479", "K080982", "K915895", "K122379", "K143652", "K912317", "K150452", "K143093", "K103464", "K993305", "K181128", "K942635", "K071309", "K132430", "K850075", "K113468", "K241740", "K963000", "K160256", "K953608", "K875175", "K851080", "K121856", "K921254", "K913297", "K142954", "K231402", "K992825", "K841961", "K972744", "K102035", "K885247", "K162316", "K092455", "K212215", "K812168", "K922610", "K152934", "K241683", "K924276", "K093965", "K122984", "K072765", "K870215", "K875064", "K933975", "K072824", "K924047", "K944989", "K882052", "K201246", "K953602", "K120164", "K921577", "K041293", "K933483", "K072947", "K221339", "K151678", "K073472", "K073318", "K161427", "K833248", "K080925", "K110319", "K220410", "K971516", "K915168", "K093139", "K192907", "K241025", "K915349", "K971448", "K903417", "K101062", "K051519", "K100921", "K143561", "K952884", "K923638", "K111295", "K071042", "K190037", "K172033", "K832474", "K222065", "K152665", "K130293", "K942150", "K103322", "K950119", "K911215", "K894250", "K130397", "K063563", "K120738", "K100490", "K902367", "K062843", "K973563", "K191275", "K914500", "K040954", "K896520", "K991977", "K905773", "K121385", "K872542", "K121402", "K945693", "K831659", "K151153", "K170635", "K131199", "K241040", "K912984", "K003276", "K151744", "K133043", "K924320", "K172494", "K143193", "K132777", "K934793", "K926271", "K871011", "K934411", "K910965", "K003972", "K030062", "K933236", "K900094", "K121442", "K112697", "K200700", "K210626", "K214009", "K862550", "K920547", "K882925", "K934433", "K071189", "K173894", "K890800", "K001087", "K955886", "K911089", "K951248", "K930745", "K934378", "K971579", "K993639", "K844913", "K113769", "K933183", "K921706", "K853746", "K944815", "K910822", "K170193", "K931384", "K152873", "K940868", "K133843", "K942400", "K051042", "K963688", "K903582", "K911130", "K854319", "K954313", "K884481", "K970299", "K241711", "K880298", "K943298", "K970620", "K202231", "K901018", "K093970", "K223177", "K850760", "K130414", "K171290", "K111899", "K152240", "K141521", "K980390", "K897124", "K923826", "K925485", "K945465", "K221245", "K112797", "K142300", "K102705", "K123544", "K972800" ], "pma_number": [ "P950020" ], "registration_number": [ "", "3010432890", "3016927279", "3015453963", "3019677404", "3009018440", "2134626", "3002807315", "3004730544", "2124215", "3009965866", "1000563940", "1282497", "3012448339", "3014222368", "1220452", "3016678045", "3006550224", "3008700817", "3011088743", "3022627847", "3002807314", "8043892", "2183870", "3018805824", "3030574705", "2011171", "1000121056", "1225687", "1721686", "9618000", "3027343398", "1647149", "3008361782", "9616666", "3007738736", "3004091615", "3012050423", "3015002281", "3011142981", "2024024", "3010291427", "2134265", "3004415014", "3003775186", "1219930", "3014656749", "3005994106", "1313046", "1422634", "3014687026", "9617601", "1016427", "1043214", "3000247873", "3013391155", "1721676", "2024168", "1646831", "2020394", "1000393132", "1820334", "9614654", "1318694", "2030598", "3014390222", "1018233", "1055236", "3005718570", "3011471056", "3009564766", "1643817", "3015910259", "3005580113", "3010220595", "3006082230", "2183744", "1319639", "9681477", "1028232", "3002807090", "9617592", "2939561", "3027395815", "3008261722", "3010273872", "3002806603", "3016591327", "1054241", "9681260", "3013944123", "2528981", "3010391265", "3021140368" ], "fei_number": [ "", "3010432890", "3016927279", "3015453963", "1000138054", "3019677404", "3009018440", "3002807315", "3002808050", "3001451463", "3004730544", "2124215", "3009965866", "1000563940", "1282497", "1000514656", "3012448339", "3002808904", "3003007911", "3014222368", "1220452", "3016678045", "3006550224", "3008700817", "3011088743", "3022627847", "3002807314", "3008906816", "2183870", "3018805824", "3002468371", "3030574705", "2011171", "1000121056", "1721686", "3027343398", "3008361782", "3002806565", "3007738736", "3004091615", "3012050423", "3015002281", "1000160215", "3011142981", "2024024", "1000518731", "3004635528", "3010291427", "3004415014", "3003775186", "1219930", "3014656749", "3005994106", "1313046", "3014687026", "3003245778", "3002095335", "3002534070", "1016427", "1043214", "3000247873", "1000112968", "3013391155", "1721676", "2024168", "3006003617", "2020394", "1000393132", "1820334", "1318694", "3014390222", "1018233", "1000112877", "3005718570", "3011471056", "3009564766", "1643817", "3015910259", "3005580113", "3010220595", "3006082230", "3002807439", "2183744", "1000306139", "1028232", "3027395815", "3008261722", "3010273872", "3002806603", "3016591327", "3013944123", "2528981", "3010391265", "3021140368" ], "device_name": "Catheter, Angioplasty, Peripheral, Transluminal", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }