Cenorin

6 recalls •

• Categories: Other Medical Devices

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

Class I - Dangerous

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

Apr 9, 2018 Other Medical Devices Nationwide View Details →

ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices

Class I - Dangerous

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Jun 7, 2017 Other Medical Devices Nationwide View Details →

ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices

Class I - Dangerous

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Jun 7, 2017 Other Medical Devices Nationwide View Details →

ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices

Class I - Dangerous

Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

Jun 7, 2017 Other Medical Devices Nationwide View Details →

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Class I - Dangerous

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.

Jan 24, 2013 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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.

Apr 24, 2014 Other Medical Devices Nationwide View Details →