FDA WARNING_LETTER - Hemcon Medical Technologies, Inc. - December 18, 2013

On December 4-18, 2013, an FDA inspection of a Portland, Oregon firm manufacturing hemostasis bandage products (Bandage PRO, Patch PRO, Strip PRO, Strip FIRST AID, GuardaCare PRO 2 in x 2 in 8 ply, and ChitoGauze PRO 3 in x 4 yrds) revealed significant violations.

The products are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are also misbranded under section 502(o) of the Act for failing to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k) and 21 CFR 807.81(a)(3)(ii).

Specifically, the firm is marketing these devices with unapproved indications, including claims related to shortening bleeding times for patients on blood thinners, effectiveness on anticoagulated patients, reducing time to hemostasis for anticoagulated patients, preventing infection, and offering antibacterial properties. These claims are inconsistent with the devices' cleared 510(k) indications (K023298, K043050, K030946, K072486, K080818, K0