Devices

Device Recall Boston Scientific Endovive 20F (6.7 mm) Safety PEG Kit

  • 모델명 / 제조번호(시리얼번호)
    Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831   Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
  • 1 Event

제조사

Boston Scientific Corp
  • 제조사 주소
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA

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Device Recall Boston Scientific Endovive 20F (6.7 mm) Safety PEG Kit
  • 모델명 / 제조번호(시리얼번호)
    M00566470, Lot Numbers: 11898070, 11900304, 11098441, 11915503, 11916278, 11922657, 11930346, 11952977, 12018370, 12143998 and 12149325; and M00566471, Lot Numbers: 11906398, 11931539, 11942414, 11946168, 11957022, 11960383, 11963776, 11974413, 12000788, 12069495, 12300003, 12307021, 12318714 and 12392032.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • 제품 설명
    Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp