Device Recall Vaxcel

Lots 1103350 and 1113798

General Hospital and Personal Use Devices

2

Yes

NY, CA, MD, WA, TN.

Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, (617) 972-4000/(800) 225-3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.

Lots 1109717 and 1120230

General Hospital and Personal Use Devices

2

Yes

NY, CA, MD, WA, TN.

Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific MEDI-TECH (617) 972-4000/(800) 225--3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.

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.