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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 15, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on March 12, 2008
Recall Number Z-1408-05
Recall Event ID 31174
Product Classification Disinfectant, Medical Devices - Product Code LRJ
Product ITW Dymon Medaphene Plus Country Garden 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 #42620. The firm name on the label is ITW Dymon, Olathe, KS.

The product is also distributed under the following private labels:

(1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL;

(2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL;

(3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC;

(4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA;

(5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO;

(6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA;

(7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH;

(8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY;

(9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI;

(10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL;

(11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY;

(12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO;

(13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY;

(14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO;

(15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR;

(16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL;

(17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ;

(18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV;

(19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL.

One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.
Code Information Initially recalled lot numbers:  ITW Dymon brand - A66241 and A87241; private labels - A31141, A74241, A75241, A75242, A56241, A66241, and A88241  Expanded recall lot numbers:  ITW Dymon brand - A04141, A04142, A14141, A09141, A91241, A02241, A10341, A82341, A92341, A15341, A15342, and A25341; private label - A81141, B42141, A23141, A23142, A23143, A04141, A84141, A95141, A96141, A96142, A18141, A09141, A80241, A21241, A91241, A42241, A33241, A10341, A90341, C02341, A42341, A42342, A24341, A34341, A34342, A15341, A55341, A70051, A71051, and A12051.
Recalling Firm/
Manufacturer		 ITW Dymon
805 E Highway 56
Olathe KS 66061-4914
For Additional Information Contact John 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
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.
Quantity in Commerce 5,903/12-can cases
Distribution Distribution was nationwide to wholesalers and own-label distributors.
Total Product Life Cycle TPLC Device Report
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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