Events

Recall of Device Recall Verify SixCess Indicator Strips

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
    59713
  • Event Risk Class
    Class 2
  • Event Number
    Z-3045-2011
  • Event Initiated Date
    2011-03-16
  • Event Date Posted
    2011-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103395
  • 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
    During an inspection the firm was notified that language contained in labeling and promotional literature directs customers that the products can be used to replace biological indicators and/or release loads containing implants.
  • Action
    STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3). For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.

Device

Device Recall Verify SixCess Indicator Strips
  • Model / Serial
    Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
  • Product Description
    Verify¿ SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¿F 30 minute Gravity Cycle).
  • Manufacturer
    Steris Corporation

Manufacturer

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