Events

Recall of Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Madison Polymeric Engineering.

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
    77164
  • Event Risk Class
    Class 2
  • Event Number
    Z-2211-2017
  • Event Initiated Date
    2017-04-17
  • Event Date Posted
    2017-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155123
  • 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
    Pad, alcohol, device disinfectant - Product Code LKB
  • Reason
    Product is contaminated with cladosporium cladosporioides/herbarum/phaenocomae.
  • Action
    Cygnus Medical sent a first class letter dated April 14, 2017, indicating to discontinue use of HY0305Z Draco Pads with information to return the unused product also included. Our records indicate that you have purchased this lot number. Please check your inventory. The lot number can be found on the individual product pouch and the label on the carton. We have found a mold contaminant and request that you remove the product from use and return to us. We are conducting an investigation. To obtain a return authorization please contact our Quality Department. You may also contact our customer service at (800) 990-7489. We regret any inconvenience this may cause. Please contact Cygnus Medical LLC should you have any questions.

Device

Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

Manufacturer

Madison Polymeric Engineering