Events

Recall of VERIFY Dual Species SelfContained Biological Indicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corporation.

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
    67036
  • Event Risk Class
    Class 2
  • Event Number
    Z-0605-2014
  • Event Initiated Date
    2013-09-10
  • Event Date Posted
    2013-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124585
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Steris has identified that the population of the g. stearothermophilus spores that monitor steam sterilization cycles does not meet specifications for lot # 131004 of the verify dual species self-contained biological indicators. as a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.
  • Action
    On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.

Device

VERIFY Dual Species SelfContained Biological Indicator
  • Model / Serial
    Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.
  • Product Description
    VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. || Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA