Events

Recall of Device Recall STERRAD 50

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-0842-2015
  • 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=131358
  • 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, ethylene-oxide gas - Product Code FLF
  • 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 50
  • Model / Serial
    10050056174 10050021097 10050035006 10050035054 10050021012 10050035378 10050056170 10050035179 10050021050 10050035261 10050035388 10050021110 10050045549 10050035374 10050035338 10050045503 10050045613 10050035156 10050021060 10050000834 10050035172 10050035181 10050045569 10050035323 10050056188 10050056115 10050035141 10050000517 10050035284 10050045451 10050045404 10050021041 10050021111 10050000850 10050045478 10050010941 10050045603 10050056205 10050035392 10050000762 10050045429 10050000680 10050045491 10050056194 10050021049 10050000867 10050035173 10050056134 10050035387 10050056168 10050021149 10050035013 10050035159 10050035137 10050035100 10050035002 10050035121 10050056203 10050010945 10050010948 10050035287 10050045477 10050056165 10050045507 10050021032 10050035267 10050000712 10050045576 10050035061 10050045563 10050021145 10050045612 10050035143 10050035375 10050035174 10050045557 10050035188 10050021037 10050035330 10050056109 10050056116 10050021116 10050056166 10050000552 10050045494 10050056175 10050045614 10050021077 10050000554 10050021054 10050056145 10050000872 10050000532 10050000621 10050056138 10050056154 10050010952 10050035066 10050000858 10050035337
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    STERRAD 50, Product Code 10114. || 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