Events

Recall of Device Recall CIDEX OPA

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
    62919
  • Event Risk Class
    Class 2
  • Event Number
    Z-2276-2012
  • Event Initiated Date
    2012-06-01
  • Event Date Posted
    2012-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112036
  • 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
    Sterilant, medical devices - Product Code MED
  • Reason
    The recall was initiated because advanced sterilization products has discovered instances of missing labels on bottles of cidex opa solution, part # 20390 manufactured between may 2011 and april 2012.
  • Action
    An "Urgent Medical Device Recall" letter dated August 10, 2012 was sent to all customers who purchased the CIDEX OPA solution, part #20390 (manufactured between May 2011 and April 2012). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to notify their customers if they have distributed bottles of CIDEX OPA Solution to other locations. Customers were instructed to call Stericycle at (866) 629-6182 to arrange for return of the product.

Device

Device Recall CIDEX OPA
  • Model / Serial
    Product codes: 20390 (US).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) and Puerto Rico.
  • Product Description
    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

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