Cenorin, LLC
Kent, WA, US
CENORIN, LLC appears in FDA device records in Kent, WA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Cenorin, LLC in 2019.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004153171 | 3004153171 | CENORIN, LLC | 6324 S 199th Pl Ste 107, KENT, WA 98032 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2288-2018 | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization | There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. | Class II | Terminated | |
| Z-3034-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Class II | Terminated | |
| Z-3033-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Class II | Terminated | |
| Z-3032-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | Class II | Terminated | |
| Z-1729-2014 | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F 2 F for 30 minutes. | Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction. | Class II | Terminated | |
| Z-1995-2014 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water. | Class II | Terminated | |
| Z-0039-2011 | The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy. | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized | Terminated | ||
| Z-0038-2011 | 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. | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized | Terminated | ||
| Z-0037-2011 | 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. | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized | Terminated | ||
| Z-0036-2011 | 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. | The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized with enough wat | Terminated | ||
| Z-0713-2007 | ThermaSure Medical Device Drying Cabinet, series 1000 | Potential for user to receive an electrical shock. | Terminated | ||
| Z-0712-2007 | ThermaSure Medical Device Drying Cabinet, series 300 | Potential for user to receive an electrical shock. | Terminated | ||
| Z-0711-2007 | ThermaSure Medical Device Drying Cabinet, series 130 | Potential for user to receive an electrical shock. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain