Lexion Medical LLC

Warning LetterOpen

Patrick Spearman Owner Lexion Medical LLC 545 Atwater Circle Saint Paul , MN 55103 United States pspearman@lexionmedical.comFEI 3003631551Issued Jul 26, 2021Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003631551.

Violations1

Issue DateJul 26, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Lexion Medical LLC
Location: Patrick Spearman Owner Lexion Medical LLC 545 Atwater Circle Saint Paul , MN 55103 United States pspearman@lexionmedical.com
FEI Number: 3003631551
Country: United States
Issue Date: July 26, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

Lexion Medical LLC was warned for marketing three medical devices—the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE Gas Evacuation Cannula—without FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket approval (PMA) or investigational device exemption (IDE) authorization and did not submit a 510(k) notification to the FDA before introducing the devices into commercial distribution. The violations were particularly concerning because the devices were marketed for use in the mitigation, prevention, treatment, diagnosis, and cure of COVID-19, and the FDA discovered the unapproved marketing through the company's website and social media as recently as June 2021.

Lexion Medical LLC FDA Warning Letter, July 26, 2021