Events

Recall of Cidex Plus Test Strips

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
    28031
  • Event Risk Class
    Class 2
  • Event Number
    Z-0375-04
  • Event Initiated Date
    2003-12-17
  • Event Date Posted
    2004-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31070
  • 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
    May not accurately detect minimum effective concentration (mec).
  • Action
    Recall was made by various emails sent 12/12/2003 to 12/19/2003. Customers are requested to quarantine and return product.

Device

Cidex Plus Test Strips

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA