9/25/2020 - STOP SALE, USE, OR REMOVAL ORDER ISSUED.
ON OR AROUND JULY 9, 2020 TO ON OR AROUND JULY 14, 2020, UNIT INTERNATIONAL, INC. (HEREINAFTER UNIT INTERNATIONAL), THE LICENSED CUSTOMS BROKER FOR 3B, FILED AN ENTRY IN THE CBP ACE SYSTEM FOR THE IMPORTATION OF 2,200 UNITS OF THE PESTICIDE DEVICE LUMIN LM3000, WHICH ARRIVED AT THE PORT OF ATLANTA, GEORGIA ON OR AROUND JULY 6, 2020. NEITHER AN NOA, NOR AN ALTERNATIVE FILING THROUGH THE CBP ACE SYSTEM, WAS SUBMITTED WITH THE ENTRY. EPA CONTACTED UNIT INTERNATIONAL AND 3B TO REQUEST ADDITIONAL INFORMATIONAL AS THE PRODUCT SHIPMENT APPEARED TO BE A PESTICIDE DEVICE. 3B EMAILED A COPY OF THE PRODUCT LABEL FOR RETAIL BOX OF THE DEVICE LUMIN LM3000. EPA DETERMINED THE PRODUCT WAS MISBRANDED IN THAT THE LABEL INCLUDED FALSE AND MISLEADING CLAIMS AND DID NOT INCLUDE THE EPA ESTABLISHMENT NUMBER OF THE MANUFACTURER.
ON OR AROUND JULY 15, 2020 TO ON OR AROUND JULY 29, 2020, UNIT INTERNATIONAL CANCELLED THE ENTRY AND SUBMITTED THE ELECTRONIC ALTERNATIVE TO THE NOA IN THE CBP ACE SYSTEM. UPON INSPECTION OF THE SECOND SET OF LABELS SUBMITTED BY 3B, THE EPA DETERMINED THE PRODUCT WAS MISBRANDED IN THAT THE LABELING ON THE RETAIL BOXES OF THE PRODUCT DID NOT INCLUDE AN EPA ESTABLISHMENT NUMBER, THE SHIPPING BOX LABEL INCLUDED AN EPA ESTABLISHMENT NUMBER FOR A DOMESTIC FACILITY INSTEAD OF THE FOREIGN MANUFACTURING FACILITY, AND CONTAINED THE FALSE AND MISLEADING CLAIM ?NO OZONE?. ADDITIONALLY, 3B MEDICAL?S WEBSITE FOR THE PRODUCT WH