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
tray for endoscope sterilizer - Product Code MED
원인
Failure to effectively sterilize: under certain conditions, the design/operation of the c1160 tray may compromise the ability of the system 1 processor to correctly assess the state of the high pressure pump during the sterile cycle. the l6 sensor fails to alarm when the high pressure pump is not working properly.
조치
Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.