|2/1/2007 - Hernia Mesh Patch Recall is Serious:FDA|
|Hernia Patch Recall for Bard Composix Kugel Mesh|
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