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
  • 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
  • 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
    913404; 913661; 917962; 924521; 930616; 936038; 943745; 950540; 950969; 3010403046; 3010403102; 3010803014; 3010803015; 3010803016; 3010803178; 3011002259; 3011102034; 3011102035;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • Product Description
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY ''. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.
  • Manufacturer
  • Model / Serial
    933284
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • Product Description
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap.
  • Manufacturer
  • Model / Serial
    933285; 982726
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • Product Description
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: Catheter; caps; tape measure, 60 cm length;stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 1.5 inch introducer needle with echogenic tip; 30 cm floppy tip guidewire; 5cm peelable introducer sheath with locking dilator; 10 ml syringe; scalpel, CSR wrap.
  • Manufacturer
  • Model / Serial
    913405; 924522; 930838; 939045; 950541; 977138; 982727; 3010303254; 3010403103; 3010403104; 3011002260; 3011002261; 3011102036; 3011102037;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • Product Description
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart.
  • Manufacturer
  • Model / Serial
    898658; 898990; 901923; 921920; 931621; 933875; 938673; 939255; 942560; 960665; 961989; 970713; 975113; 982649;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • Product Description
    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.
  • Manufacturer
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