Events

Recall of Device Recall STERRAD NX Sterilization System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76194
  • Event Risk Class
    Class 2
  • Event Number
    Z-1197-2017
  • Event Initiated Date
    2017-01-09
  • Event Date Posted
    2017-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152495
  • Notes / Alerts
    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.
  • Extra notes in the data
    Sterilizer, chemical - Product Code MLR
  • 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 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,

Device

Device Recall STERRAD NX Sterilization System
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    STERRAD NX Sterilization System, Product Code: 10033, 10033-002
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA