Events

Recall of Device Recall VERIFY SixCess 270FP Challenge Pack

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
    67308
  • Event Risk Class
    Class 2
  • Event Number
    Z-1166-2014
  • Event Initiated Date
    2013-12-19
  • Event Date Posted
    2014-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125270
  • 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, physical/chemical sterilization process - Product Code JOJ
  • Reason
    Steris has identified that the outer shipping package for one lot (lot #024552a) of verify¿ sixcess challenge packs incorrectly identifies the lot as lot #024522a.
  • Action
    The firm, Steris, sent an "URGENT VOLUNTARY RECALL NOTICE" dated December 20, 2013 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to verify if the outer packaging of your on-hand inventory contains lot number 024522A; destroy any remaining inventory of the affected product in your possession and contact STERIS Customer Service at 1-800-548-4873 to obtain no cost replacement product and if you do not have the affected product in your inventory, no further action is required. If you have any questions regarding this matter, please contact your STERIS Account Manager or STERIS Customer Service at 1-800-548-4873.

Device

Device Recall VERIFY SixCess 270FP Challenge Pack
  • Model / Serial
    Model LCC019, Lot #: 024552A
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada.
  • Product Description
    VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. || The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.
  • 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