Device Recall SYSTEM 1E liquid chemical sterilant processing system

  • Model / Serial
    All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Model #6500 & 7500
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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