Device Recall STERRAD 200

  • Model / Serial
    Codes:  10217 10201-002 10201 10202-001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    STERRAD 200 Sterilization System, P/N 10201 || Product Usage: || The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product Code 10201
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer
  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.
  • Product Description
    STERRAD 200 System Carriage, P/N 10208. || Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
  • Manufacturer
  • Model / Serial
    10200050412 201080057 10200070902 10200080974 10200070758 10200070815 10200070925 201080046 10200070940 10200080949 201080052 10217040349 10200070827 10200040404 10200060693 201080075 10217000008 10217000013 10200070781 10200070824 217060639 200080955 10217050511 10200070782 10200080950 10200060679 10200060682 10200040436 10200070797 10200070844 10217050475 10200060660 10201050501 10200060683 200080996 201080055 10200080984 10200050506 201080040 217060618 10200050508 10200070894 10201060593 10200080976 10200070866 10217000014 10217050496 10200040359 10200050484 10200070791 10200070792 10200070890 10200040365 10200070891 10200050525 10200030329 10200060711 217010092 201080069 10200040379 10200070934 10200060709 10200070839 10200070859 10200060598 10200050519 10200070853 10200040334 217080023 10200070809 201080062 10200060661 10200060702 10200060750 10200070926 10201050524 201080039 201080076 10200070858 10200070892 10200060637 10217050510 10200050533 201080072 217100038 10200060688 200080995 10200080962 10200070897 10200060692 10200060738 201080035 10200070931 10200050536 10200060685 10200040401 10200070755 10217000003 217050373
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    STERRAD 200, Product Code 10118 || The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer
  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, The Philippines, Switzerland, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, The Czech Republic, Middle East, Portugal, S Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India & Slovenia
  • Product Description
    STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA
  • Manufacturer
  • Model / Serial
    all serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Peru, Canada, Czech Republic, Middle East, Portugal, S. Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
  • Product Description
    STERRAD 200 Sterilization System, Product Code 10201 || Used to sterilize heat and moisture sensitive reusable medical devices.
  • Manufacturer