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Advanced Sterilization Products recalls STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Recalled February 22, 2017 · FDA recall Z-1197-2017 · Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. · FDA Class II
Units
7,694 units total (5,935 units in US)
Sold at
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Description
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
Product
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Manufacturer(s)
Advanced Sterilization Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →