Device Recall Vaxcel

  • Model / Serial
    Lots 1267697, 1290638, 1317254, 1342462, 1362918
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

36 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 1192327, 1194228, 1198103, 1199717, 1200699, 1203533, 1214352, 1214648, 1215656, 1219022, 1225627, 1228411, 1232462, 1235617, 1239039, 1240898, 1244262, 1246155, 1251020, 1252584, 1258101, 1259057, 1263710, 1266809, 1267689, 1271309, 1273698, 1276597, 1280329, 1285143, 1286832, 1290363, 1292668, 1294048, 1295863, 1297670, 1299166, 1300520, 1303564, 1307354, 1307625, 1308513, 1313095, 1316267, 1343197, 1346939, 1354063, 1360019, 1364758, 1365528, 1369511, 1373470, 1377611, 4001730, 4006506, 4014211
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • Model / Serial
    Lots 1193952, 1194229, 1194579, 1198421, 1199718, 1202167, 1203534, 1208682, 1209895, 1210594, 1214353, 1214354, 1214649, 1215000, 1216849, 1218388, 1219023, 1219914, 1220172, 1220871, 1225940, 1226999, 1228412, 1229800, 1230457, 1230716, 1232463, 1233532, 1235319, 1236547, 1239040, 1239320, 1240035, 1242309, 1244263, 1245541, 1247037, 1248431, 1253940, 1257022, 1258102, 1259516, 1263711, 1264323, 1265770, 1267690, 1268134, 1272662, 1274410, 1276420, 1278339, 1281570, 1282582, 1285144, 1287097, 1288648, 1292158, 1294049, 1295864, 1298107, 1300117, 1304146, 1307355, 1309261, 1310503, 1313467, 1316807, 1319163, 1323431, 1325747, 1330396, 1333308, 1336009, 1340118, 1343198, 1346938, 1347894, 1351419, 1354064, 1355339, 1359540, 1361868, 1364432, 1366291, 1368296, 1369512, 1371077, 1372172, 1372901, 1373965, 1374540, 1375756, 1377315, 4000285, 4001731, 4003056, 4006508, 4007735, 4014212, 4014213
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • Model / Serial
    Lots 1193953, 1195311, 1198104, 1200700, 1202457, 1204614, 1207340, 1207664, 1214355, 1214650, 1215657, 1216850, 1221191, 1227000, 1228413, 1231143, 1232464, 1235320, 1239041, 1239321, 1240899, 1244264, 1247038, 1248432, 1250527, 1252585, 1257023, 1258103, 1263712, 1265771, 1267691, 1273901, 1277633, 1281030, 1285145, 1288649, 1294480, 1295865, 1296141, 1296709, 1297923, 1300521, 1307356, 1307357, 1307358, 1311034, 1313096, 1313097, 1348374, 1353274, 1355601, 1356197, 1365529, 1367037, 1368843, 1370103, 1372521, 1374541, 1377316, 1377612, 1377844, 1378093, 1378345, 1380085, 1381887, 4000284, 4001732, 4007724, 4014661
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • Model / Serial
    Lots 1192332, 1198106, 1202172, 1204956, 1206895, 1208684, 1214359, 1214651, 1219666, 1227904, 1230056, 1231144, 1233993, 1239665, 1243253, 1245545, 1248436, 1251234, 1252586, 1257028, 1258107, 1262111, 1265536, 1267698, 1268135, 1275216, 1278343, 1286359, 1288651, 1292866, 1295866, 1305978, 1308308, 1314993, 1321214, 1329618, 1341521, 1349623, 1351954, 1357024, 1359288, 1362390, 1363949, 1365530, 1371855, 1373199, 1374542, 1377845, 1379701, 4001736, 4007727, 4010947, 1282267D
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • Model / Serial
    Lots 1193957, 1198107, 1198423, 1199454, 1200701, 1206362, 1214360, 1224333, 1228418, 1229803, 1239044, 1240037, 1243254, 1250135, 1252587, 1257029, 1258424, 1266810, 1267699, 1277308, 1278344, 1285147, 1285594, 1289476, 1296998, 1299862, 1307903, 1311285, 1316268, 1334583, 1351212, 1354065, 1355341, 1365531, 1367038, 1370574, 4007741
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
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