FDA WARNING_LETTER - Vital Signs, Inc.

On September 25, 2008, the FDA obtained information from Vital Signs, Inc.'s website regarding the enFlow® IV Fluid/Blood Warming System, identifying serious regulatory problems. This product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The enFlow® system's online operator's manual claims it "will reduce surgical infections," an intended use not cleared for the firm's previously cleared "eFlow® IV Fluid Warmer" (K060537), which is intended for warming blood/IV solutions to prevent hypothermia. Vital Signs, Inc. has not obtained marketing approval or clearance for the enFlow® system.

The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), due to the lack of an approved premarket approval (PMA) application (section 515(a)) or an investigational device exemption (IDE) (section 520(g)). It is also misbranded under section 502(o), 21 U.S.C. 352(o), because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution as required by section 510(k), 2