Events

Recall of Device Recall Cidex

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
    25725
  • Event Risk Class
    Class 3
  • Event Number
    Z-0694-03
  • Event Initiated Date
    2003-02-14
  • Event Date Posted
    2003-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26373
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code 6885
  • Reason
    Test strips which are used for qc of sterilant solution fail prematurely due to ingress of moisture.
  • Action
    Several emails and letters were sent between 2/14/03 and 2/27/03 to customers requesting return of product and also advising them that should return not be a viable option due to availability of replacements, a suggested temporary QC procedure could be used to separate good lots of strips from affected lots.

Device

Device Recall Cidex
  • Model / Serial
    Cidex Activated, Product Code 2920 lots: 7840 7739 8064 8503 8422 8661 8771 8923 9188 9313 9414  Cidex Plus, Product Code 2924, lots:  Cidex Activated, Product code 2927, lots: 7783 8160 8182 8604 8790 9317 9404
  • Product Classification
    General Hospital and Personal Use Devices
  • Distribution
    Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
  • Product Description
    Cidex Solution Test Strips || Browne GA Indicators for Cidex Solution Test Strips.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 926182346
  • Source
    USFDA