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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 15, 2005
Date PostedAugust 30, 2005
Recall Status1 Terminated 3 on March 12, 2008
Recall NumberZ-1405-05
Recall Event ID 31174
Product Classification Disinfectant, Medical Devices - Product Code LRJ
ProductITW Dymon Medaphene Plus 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 34720. The firm name on the label is ITW Dymon, Olathe, KS. The product is also sold under the following private labels: (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.
Code Information Initially recalled lot numbers:  ITW Dymon brand - A56241, A56242, and A87242; private labels - A17241, A27241, A30141, A31141, A31142, A75241, A85241, A85244, A57241, A57242, A87241, A95241, and A99041;   Expanded recall lot numbers:  ITW Dymon brand - A84141, A84142, A18143, A98141, A09141, A09142, A80342, A90341, A14342, A14343, A66341, and A66342; private labels - A91141, A91142, A23141, A74141, A84141, A65141, A65142, A65143, A18141, A18142, A18143, A98141, B89141, B89142, A60241, A80241, A80242, A21241, A91241, A91242, A85242, A85243, A49241, A59241, A59242, A70341, A80341, A80342, A61341, A71341, A71342, A82341, A83341, A14341, A14342, A55341, A55342, A56341, A56342, A66341, A70051, A01051, A81051, A13051, and A13052.
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 Commerce13,383/12-can cases
DistributionDistribution was nationwide to wholesalers and own-label distributors.
Total Product Life CycleTPLC 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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