Class 2 Device Recall

• Date Initiated by Firm: February 15, 2005
• Date Posted: August 30, 2005
• Recall Status: Terminated on March 12, 2008
• Recall Number: Z-1406-05
• Recall Event ID: 31174
• Product Classification: Disinfectant, Medical Devices - Product Code LRJ
• Product: ITW Dymon Medaphene Plus Orange 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 52920. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) O.D.S. Orange Disinfectant Spray, Continental Research Corporation, St. Louis, MO; (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation, Vernon Hills, IL; (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies, Tulsa, OK, Newburgh, IN, and Hopkinsville, KY; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products, Cleveland, OH; (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply, Cape Girardeau, MO; (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries, Conway, AR; (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc., Norwood, MA; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc., Blue Springs, MO; (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc., Irving, TX; (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company, St. Louis, MO; (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc., Alpharetta, GA; (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc., Elmhurst, IL; (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Phoenix, AZ.
• Code Information: Initially recalled lot numbers: ITW Dymon brand - A66244 and A58241; private labels - A66241, A66243, A66244, A87241, and A58241. Expanded recalled lot numbers: ITW Dymon brand - A96141, A88241, A00341, A10341, A24342, A24343, A25341; private labels - A81141, A81142, A91141, A91142, A02141, A02142, A23141, A94141, A65141, A28141, A09141, A19141, A19142, A90241, A90242, A21241, A21242, A32241, A42241, A66242, A88241, A00341, A61341, A42341, A72341, A24341, A24342, A25341, A56341, A01051, A01052, A01053, A11051, A81051, A21051, A82051, A23051, and A23052.
• 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: 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: 3,015/12-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.