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U.S. Department of Health and Human Services

Class 2 Device Recall Concept Lemon Scented Disinfectant Deodorant

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 Class 2 Device Recall Concept Lemon Scented Disinfectant Deodorantsee related information
Date Initiated by FirmFebruary 15, 2005
Date PostedAugust 30, 2005
Recall Status1 Terminated 3 on March 12, 2008
Recall NumberZ-1407-05
Recall Event ID 31174
ProductITW 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.
Code Information Initially recalled lot number: Private label - A66241;  Expanded recalled lot numbers: Private label - A23141 and A28141
FEI Number 3001238779
Recalling Firm/
Manufacturer		 ITW Dymon
805 E Highway 56
Olathe KS 66061-4914
For Additional Information ContactJohn O. Bousum
913-397-8704 Ext. 258
Manufacturer Reason
for Recall		Failed EPA required efficacy testing; may not perform as intended.
FDA Determined
Cause 2		Other
ActionTelephone 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.
Quantity in Commerce260/12-can cases
DistributionDistribution was nationwide to wholesalers and own-label distributors.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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