Retiro De Equipo (Recall) de IMPACT

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Numed Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Percutaneous catheter and Percutaneous catheter, cardiovascular - Product Code LIT
  • Causa
    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.
  • Acción
    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


  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    One distributor in Pennsylvania
  • Descripción del producto
    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only || --- Common/Usual Name: PTA and Esophageal Catheter || --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 || --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 || --- 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. || --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.
  • Manufacturer


  • Dirección del fabricante
    Numed Inc, 2880 Main Street /Rt 11b, Hopkinton NY 12965
  • Empresa matriz del fabricante (2017)
  • Source