IMPACT

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.

Cardiovascular Devices

2

No

One distributor in Pennsylvania

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.