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
    51413
  • Event Risk Class
    Class 2
  • Event Number
    Z-1419-2009
  • Event Initiated Date
    2009-03-09
  • Event Date Posted
    2009-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80227
  • 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
    Ethylene Oxide Gas Sterilizer - Product Code FLF
  • Reason
    Asp has identified a secondary, lower-occurring cause of oil mist within certain sterrad nx systems and sterrad 50 systems due to potentially defective oil fill plugs.
  • Action
    Firm mailed out Urgent Device Correction letters dated March 9, 2009, advising customers/users that on April 23, 2008, Advanced Sterilization Products (ASP) initiated a device correction notification related to certain models of STERRAD Sterilization Systems that have the potential to emit oil mist due to a premature mechanical failure in the oil mist filter and/or filter assemblies. All affected STERRAD Systems have been corrected since the notification was issued. Recently, a secondary, lower-occurring cause of oil mist has been identified within the STERRAD NX System and STERRAD 50 System oil fill plugs. STERRAD NX System and/or STERRAD 50 System may potentially have defective oil fill plugs. Less than 1% of the installed STERRAD NX Systems have been affected. ASP has received 18 complaints in 10 months related to this failure for the STERRAD NX System. No complaints related to this issue for the STERRAD 50 System have been received. As of December 22, 2008, ASP has been actively replacing the plugs in these systems with stainless steel plugs during service calls and will continue to replace the oil fill plugs until all affected units are corrected. The letter advises that there is a risk of symptoms, such as nausea, shortness of breath, dry throat, burning, watery and blurry eyes, and headache occurring if customers inhale oil mist. If you see mist, haze or smoke in the room or detect an oil odor, personnel should complete the following: - Cancel the cycle if the sterilizer is running and as always, do not use instruments from an incomplete cycle - Leave the room - Avoid working in the room until the mist has cleared - Discontinue use of the STERRAD System until the system is repaired. Any additional questions can be directed to the Clinical and Technical Support staff at 1-888-4613.

Device

Device Recall STERRAD 50
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
  • Product Description
    STERRAD 50 Sterilization System Product Code 10050 || The STERRAD Sterilization System 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 Drive, Irvine CA 92618
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA