BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1197-2017 · Initiated January 9, 2017

    Recall

    Recall Number
    Z-1197-2017
    Event Number
    76194
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 9, 2017
    Posted
    February 14, 2017
    Terminated
    November 2, 2017
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

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

    Reason

    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.

    Action

    Advanced Sterilization will send an Field Safety Notice dated January 9, 2017,to inform customers that 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. ASP is sending the letter to remind customers to follow the instructions in the STERRAD NX System Users Guide. Specifically, after cycle initiation, the user should only open the chamber door of the STERRAD NX System when prompted by the Graphical User Interface (GUI) per the Users Guide. Customers are instructed to complete and return the attached Business Reply Card (double-sided) for their acknowledgement within 3 business days of receipt of this notification letter via mail by using the pre-paid postage, by email at [email protected], or by fax to Stericycle: 8662297775. For questions regarding the business reply card, customers are instructed to contact Stericycle at (877) 497- 2425 and reference event # 5816. For further questions regarding this recall please call (949) 453-6400,

    Distribution

    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.

    Quantity

    7,694 units total (5,935 units in US)