Promotional material for Baxter International Inc.'s (BAX) surgical sealant Tisseel overstates the product's effectiveness and is false and misleading, according to the U.S. Food and Drug Administration.

Presentations and brochures for Tisseel, a type of surgical tissue used to control bleeding, makes claims about the product that aren't supported by evidence, according to a letter posted Tuesday on the FDA's Web site. The letter was sent to Baxter on April 14.

Baxter spokesman Christopher Bona said the letter relates only to the promotional material and doesn't call into question Tisseel's effectiveness or safety. He said the company is withdrawing the promition material from the market as the FDA requested.

The FDA said the promotional material claims Tisseel is "97.5% effective in achieving hemostasis" for patients undergoing heart and lung bypass surgery. Hemostasis is the stoppage of bleeding. Tisseel's label notes the product has a demonstrated effectiveness of up to 88.2%.

The FDA said the material also implies Tisseel is effective for more treatments than those for which it has been approved. Tisseel is approved only for patients undergoing heart and lung bypasses, or injuries of the spleen.

The FDA wants the company to respond, detailing how it plans to put truthful, corrective messages out to make sure the audiences that saw the old material get the correct information.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@dowjones.com