Events

Recall of Device Recall STERRAD 200

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
    69692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0844-2015
  • Event Initiated Date
    2014-11-04
  • Event Date Posted
    2014-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131360
  • 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 the sterrad system cassettes because the the leak indicator on the sterrad system cassettes packaging may not function properly after exposure to hydrogen peroxide.
  • Action
    A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken.

Device

Device Recall STERRAD 200
  • Model / Serial
    10200050412 201080057 10200070902 10200080974 10200070758 10200070815 10200070925 201080046 10200070940 10200080949 201080052 10217040349 10200070827 10200040404 10200060693 201080075 10217000008 10217000013 10200070781 10200070824 217060639 200080955 10217050511 10200070782 10200080950 10200060679 10200060682 10200040436 10200070797 10200070844 10217050475 10200060660 10201050501 10200060683 200080996 201080055 10200080984 10200050506 201080040 217060618 10200050508 10200070894 10201060593 10200080976 10200070866 10217000014 10217050496 10200040359 10200050484 10200070791 10200070792 10200070890 10200040365 10200070891 10200050525 10200030329 10200060711 217010092 201080069 10200040379 10200070934 10200060709 10200070839 10200070859 10200060598 10200050519 10200070853 10200040334 217080023 10200070809 201080062 10200060661 10200060702 10200060750 10200070926 10201050524 201080039 201080076 10200070858 10200070892 10200060637 10217050510 10200050533 201080072 217100038 10200060688 200080995 10200080962 10200070897 10200060692 10200060738 201080035 10200070931 10200050536 10200060685 10200040401 10200070755 10217000003 217050373
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    STERRAD 200, Product Code 10118 || The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • 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