Device Recall SYSTEM 1E liquid chemical sterilant processing system

  • 모델명 / 제조번호(시리얼번호)
    All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.
  • 제품 설명
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System || The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • 제조사 모회사 (2017)
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model #6500 & 7500
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
  • 제품 설명
    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH || The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer