Recall Z-1405-05 ยท LRJ Disinfectant, Medical Devices
ITW Dymon
ITW 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) R
| Date | Aug 30, 2005 (initiated Feb 15, 2005) |
| Status | Terminated |
| Reason | Failed EPA required efficacy testing; may not perform as intended. |
| Root 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 | 13,383/12-can cases |
| Distribution | Distribution was nationwide to wholesalers and own-label distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.