Events

Recall of Device Recall Concept Lemon Scented Disinfectant Deodorant

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

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
    31174
  • Event Risk Class
    Class 2
  • Event Number
    Z-1407-05
  • Event Initiated Date
    2005-02-15
  • Event Date Posted
    2005-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37307
  • 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
  • Reason
    Failed epa required efficacy testing; may not perform as intended.
  • Action
    Telephone calls were initiated to the direct accounts on 2/15/05 and by letter initiated 2/21/05 requesting return of the product and subrecall by the direct account, unless the direct account preferred the recalling firm to conduct the subaccount recall. The recall was later expanded and recall letters dated 4/29/05 were issued requesting the same information as the initial letter.

Device

Device Recall Concept Lemon Scented Disinfectant Deodorant
  • Model / Serial
    Initially recalled lot number: Private label - A66241;  Expanded recalled lot numbers: Private label - A23141 and A28141
  • Distribution
    Distribution was nationwide to wholesalers and own-label distributors.
  • Product Description
    ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. || The product is also distributed under the following private labels: || (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; || (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.
  • Manufacturer
    ITW Dymon

Manufacturer

ITW Dymon
  • Manufacturer Address
    ITW Dymon, 805 E Highway 56, Olathe KS 66061-4914
  • Source
    USFDA