Device Recall Vaxcel

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

General Hospital and Personal Use Devices

2

Yes

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.

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.

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

General Hospital and Personal Use Devices

2

Yes

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.

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.

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

General Hospital and Personal Use Devices

2

Yes

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.

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.

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

General Hospital and Personal Use Devices

2

Yes

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.

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.

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

General Hospital and Personal Use Devices

2

Yes

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.

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.