Class 2 Device Recall STERRAD NX Sterilization System

• Date Initiated by Firm: January 09, 2017
• Date Posted: February 14, 2017
• Recall Status: Terminated on November 02, 2017
• Recall Number: Z-1197-2017
• Recall Event ID: 76194
• 510(K)Number: K151725 K142454 K042116
• Product Classification: Sterilizer, chemical - Product Code MLR
• Product: STERRAD NX Sterilization System, Product Code: 10033, 10033-002
• Code Information: Serial No 33100270 33110267 10033070599 33110166 33102348 10033070293 10033070296 10033070115 10033060166 33111764 33120476 10033050564 33130497 10033070381 10033070382 10033060659 33101036 33110266 33110308 33101084 33101087 33120355 33110445 33120379 1033160123 33101078 10033060377 33090564 33081028 33120585 33090532 10033060637 33130516 33110446 33110894 33111832 33111336 33111363 33111573 33111580 33110148 33101330 33120120 10033060898 33100023 33090562 33101545 33101573 33090528 10033070039 10033060706 33100367 10033050651 10033050652 10033050653 10033060178 10033070271 33110891 33120063 33111632 33081444 33081449 33111445 33101574 33120131 33130325 10033080299 33101333 33101352 1033142129 33130407 33111725 10033060230 33111710 33120162 33120165 33110448 33110454 10033080184 10033080185 10033080035 33101110 33101113 33101121 10033070022 10033070023 10033070026 10033070143 10033070144 10033070168 33110864 33110870 33101124 33101130 33090338 10033060582 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• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: 949-453-6400
• Manufacturer Reason for Recall: 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 Determined Cause: Software design
• 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 ASP5816@stericycle.com, 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,
• Quantity in Commerce: 7,694 units total (5,935 units in US)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS