Devices

Device Recall HLD SYSTEM 540

  • Model / Serial
    Serial numbers for Model 540 without Kits/Parts:  549204, 540702, 540716, 540717, 540718, 540719, 540720, 540721, 540722, 540728, 540811, 540812, 540813, 541001, 541005, and 541006.  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
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
  • Product Description
    HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. || Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***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 for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean 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
    Cenorin
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall HLD SYSTEM 540HT
  • Model / Serial
    Serial numbers for Model 540HT without Kits/Parts: 540911, 540910, 540909, 540908, 540907,  540906, 540905, 540904, 540903, 540902,  540901, 540709, 540707, 540708, 540715,  540714, 540713, 540712, 540711, 540723,  540727, 540726, 540725, 540724, 540805, 540804, 540803, 540802, 540801, 540810, 540809, 540808, 540807, 540806, 540912, 540914, 540913, 540917, 540916, 540915, 540607, 540701, 540706, 540918.   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
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
  • Product Description
    The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). The Model 540HT has an external heater (aka High Throughput Heater). This external heater is connected through hoses to the device and may be secured to a wall. || This external heater reduces the pasteurization cycle time by heating the water to higher temperatures. || Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540HT***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 for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean 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
    Cenorin