Manufacturers

Steris Corporation Hopkins Facility

3 devices in the database

Steris Quick Connects (QC) QFC1728 and QFC1729
  • Model / Serial
    C041782, C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749, 3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261, 3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160, 3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357, 3895661, 3900198
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain
  • Product Description
    Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.
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
    General Hospital and Personal Use Devices
  • 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.
Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm
  • Model / Serial
    MED. Serial Numbers: 400000 through 405499 are subject to correction.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
  • Product Description
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.