Events

Recall of IMPACT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Numed Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53495
  • Event Risk Class
    Class 2
  • Event Number
    Z-0509-2010
  • Event Initiated Date
    2009-09-23
  • Event Date Posted
    2009-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85638
  • Notes / Alerts
    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.
  • Extra notes in the data
    Percutaneous catheter and Percutaneous catheter, cardiovascular - Product Code LIT
  • Reason
    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.
  • 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

Device

IMPACT
  • Model / 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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One distributor in Pennsylvania
  • Product Description
    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
    Numed Inc

Manufacturer

Numed Inc
  • Manufacturer Address
    Numed Inc, 2880 Main Street /Rt 11b, Hopkinton NY 12965
  • Manufacturer Parent Company (2017)
    Numed, Inc.
  • Source
    USFDA