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Cenorin, LLC recalls HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is appr
Recalled June 18, 2014 · FDA recall Z-1729-2014 · Cenorin
Hazard
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. · FDA Class II
Units
25 HLD systems
Sold at
Distribution USA Nationwide
Description
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.
Product
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.
Manufacturer(s)
Cenorin, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →