Device Recall HLD SYSTEM 520

  • Model / Serial
    Serial numbers for Model 520 without Kits/Parts: 520901, 521001, 520703, 520902, 529701, 520702, 520801, 520701, 520502  The firm uses a serial number as broken down in the following format AABBCC: AA digits represent the Model Number;  BB digits represent the last two digit of the manufacturing year;  CC digits represent the unique number of the unit.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
  • Product Description
    HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". || Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cenorin, 6324 S 199th Pl Ste 107, Kent WA 98032
  • Source
    USFDA