Devices

Device Recall Vaxcel

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
General Hospital and Personal Use Devices
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
Navilyst Medical, Inc
1 Event
- Recall of Device Recall Vaxcel

Manufacturer

Navilyst Medical, Inc

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

36 devices with a similar name

Learn more about the data here

Device Recall Vaxcel

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
General Hospital and Personal Use Devices
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
Navilyst Medical, Inc

Device Recall Vaxcel

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
General Hospital and Personal Use Devices
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
Navilyst Medical, Inc

Device Recall Vaxcel

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
General Hospital and Personal Use Devices
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
Navilyst Medical, Inc

Device Recall Vaxcel

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
General Hospital and Personal Use Devices
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
Navilyst Medical, Inc

Device Recall Vaxcel

Model / Serial
Lots 1193958, 1198108, 1204957, 1214361, 1216851, 1223413, 1225631, 1227631, 1228419, 1229804, 1231145, 1232870, 1233994, 1235321, 1239045, 1239666, 1243255, 1247040, 1250136, 1257030, 1260760, 1263716, 1267700, 1271896, 1278345, 1278799, 1281754, 1285148, 1290364, 1294050, 1297426, 1305979, 1307359, 1308767, 1311690, 1318214, 1327177, 1332149, 1336928, 1341264, 1344773, 1347895, 1353759, 1356587, 1359289, 1362391, 1363950, 1366735, 1372174, 1373686, 1376248, 1380992, 4001737, 4010940, 4014270
Product Classification
General Hospital and Personal Use Devices
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) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, 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
Navilyst Medical, Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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