Advanced Sterilization Products recalls STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Recall date

January 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1197-2017

FDA classification

Class II

Brand / firm

Advanced Sterilization Products

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STERRAD NX Sterilization System, Product Code: 10033, 10033-002