Devices

Device Recall Vaxcel Port with PASV Valve

  • 모델명 / 제조번호(시리얼번호)
    Cat. No. 45-233, including all lots as follows: 910022, 910022D, 923899, 973167, 974706
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
  • 제품 설명
    Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

제조사

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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Device Recall Vaxcel Port with PASV Valve
  • 모델명 / 제조번호(시리얼번호)
    Cat. No. 45-236, including all lots as follows: 791486, 906776, 916194, 917025
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
  • 제품 설명
    Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Vaxcel Port with PASV Valve
  • 모델명 / 제조번호(시리얼번호)
    Cat. No. 45-238 including all lots as follows: 791484, 791485, 906777, 916195, 916196, 916197, 917026, 918870, 919481, 920550, 921765, 924851D
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
  • 제품 설명
    Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
  • Manufacturer
    Boston Scientific Corporation