EPA v. 3B Medical - August 26, 2020 - Entry #E41-0094531-7 Lumin LM 3000 (COVID-19)

Case summary

The quantity is as follows: Lumin LM3000- 509 cartons containing 4 units per carton (2,036 units total). 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). Therefore, this entry must be denied pursuant to Section 17(c) of FIFRA 7 U.S.C. Section 136o(c). Finally, the Notice of Arrival of Pesticides and Devices was not filed on EPA Form 3540-1 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).

Defendants (1)

• 3B MedicalNamed in complaintNamed in settlement

Facilities (1)

• 3B MEDICAL INC

  203 AVENUE A NW, SUITE 300, WINTER HAVEN, FL, 33881

  Registry ID: 110070836544

Statutes cited

• FIFRA 12A2N — Failure to File Reports
• FIFRA 12A1F — Device Misbranded

Enforcement conclusions (1)

• 3B Medical - August 26, 2020 - Entry #E41-0094531-7 Lumin LM 3000 (COVID-19)entered 2020-08-26

  Primary law: FIFRA

Timeline (3 milestones)

• 2020-08-26Final Order Issued
• 2020-08-26Enforcement Action Closed
• 2020-09-24Enforcement Action Data Entered