Events

Recall of Device Recall STERRAD 100S Sterilizer

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
    47355
  • Event Risk Class
    Class 2
  • Event Number
    Z-1628-2008
  • Event Initiated Date
    2008-02-25
  • Event Date Posted
    2008-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69272
  • 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
    Chemical Sterilizer - Product Code MLR
  • Reason
    Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke.".
  • Action
    The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.

Device

Device Recall STERRAD 100S Sterilizer
  • Model / Serial
    all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Peru, Canada, Czech Republic, Middle East, Portugal, S. Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
  • Product Description
    STERRAD 100S Sterilization System, Product Code 10101 || 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