C.R. Bard surgical patch recall is serious: FDA

Last Updated: 2007-02-01 14:00:17 -0400 (Reuters Health)

WASHINGTON (Reuters) - Certain C.R. Bard Inc. surgical patches, already under recall, could cause death or serious health problems, the U.S. Food and Drug Administration said on Thursday.

"Customers should stop using the recalled product and return unused units to the company," the FDA said of the company's Composix Kugel Mesh Large Patch.

The recall, announced last March and expanded earlier this month, now has "Class I" status because of its serious nature, the agency said.

Holly Glass, a spokeswoman for the company, said it was unclear what prompted the FDA announcement, but C.R. Bard had already noted the Class I status in a letter to customers earlier this month.

Coil rings in the Composix Kugel Mesh Patches, used to repair hernias, could break under stress during placement, causing abdominal pain or bowel perforation, the FDA and C.R. Bard previously said.

The company later expanded the recall to voluntarily withdraw any patches with the same design as those pulled off the market.

C.R. Bard shares were down 40 cents, or less than 1 percent, at $82.12 in morning New York Stock Exchange trade.

The FDA posted the updated notice on its Web site at http://www.fda.gov/medwatch/safety/2007/safety07.htm#Composix