Events

Recall of STERRAD NX Cassettes

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
    63877
  • Event Risk Class
    Class 2
  • Event Number
    Z-0661-2013
  • Event Initiated Date
    2012-09-20
  • Event Date Posted
    2013-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114944
  • 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 is recalling three lots of sterrad nx system cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
  • Action
    Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questions are instructed to call Stericycle at (877) 650-7686 Mon-Fri from 8am to 5pm, ET. For questions regarding this recall call 949-453-6400.

Device

STERRAD NX Cassettes
  • Model / Serial
    Lot # 11J037, 11L038, 11J033
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.
  • Product Description
    STERRAD NX Cassettes, P/N 10133. || The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
  • 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