U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Device, pasteurization, hot water - Product Code LDS
원인
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.
조치
Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added.
Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at jwright@cenorin.com or call 800-426-1042, extension 224 for questions.
610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits ( 61 ) refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.
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.