Shipment # E41-0094805-5. The quantity is as follows: Lumin LM3000- 1,100 cartons containing 4 units per carton (4,400 units total).
On July 31, 2020, 3B Medical, Inc., attempted to import the Lumin LM3000 into the United States. CBP provided photographs of the product and the instruction manual. The following claims were on the box of the Lumin LM3000: UV Multi-Purpose Sanitizer, Hospital Strength, Kills 99.99% Human Corona-virus 229E, and The Lumin LM3000 bioburden Reduction UV System is also effective with COVID-19 and inactivates the SARS-CoV-2 virus on N95 respirators. Consequently, the distribution of a misbranded device is an unlawful act under FIFRA Section 12(a)(1)(F), 7 U.S.C. Section 136j(a)(1)(F). Based on the above information, these products should be refused/denied pursuant to Section 17(c) of FIFRA 7 U.S.C. Section 136o(c). Finally, the Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) was not filed in accordance with 19 C.F.R. ? 12.112. Failure to file a report required by the Act is a violation of FIFRA Section 12(a)(2)(N), 7 U.S.C. Section 136j(a)(2)(N).