Device Recall Vaxcel Implantable Vascular Access System

  • 모델명 / 제조번호(시리얼번호)
    Lots 1103350 and 1113798
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    NY, CA, MD, WA, TN.
  • 제품 설명
    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.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lots 1109717 and 1120230
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    NY, CA, MD, WA, TN.
  • 제품 설명
    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.
  • Manufacturer