Device Recall Vaxcel

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 36 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    913404; 913661; 917962; 924521; 930616; 936038; 943745; 950540; 950969; 3010403046; 3010403102; 3010803014; 3010803015; 3010803016; 3010803178; 3011002259; 3011102034; 3011102035;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    933284
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    933285; 982726
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    913405; 924522; 930838; 939045; 950541; 977138; 982727; 3010303254; 3010403103; 3010403104; 3011002260; 3011002261; 3011102036; 3011102037;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    898658; 898990; 901923; 921920; 931621; 933875; 938673; 939255; 942560; 960665; 961989; 970713; 975113; 982649;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
  • 제품 설명
    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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