January 2007 Kugel Patch Product Recall List

January 24, 2007—The FDA expanded a recall of hernia patches manufactured by Davol, Inc., a subsidiary of C.R. Bard. The following Bard Composix Kugel Mesh Patch devices have been recalled due to risk of bowel perforations and other significant health problems:

Product Code

Description

Lot Numbers

0010206

Bard Composix Kugel Extra Large Oval, 8.7" x 10.7"

All lot numbers manufactured before January 2006

0010207

Bard Composix Kugel Extra Large Oval, 10.8" x 13.7"

All lot numbers manufactured before January 2006

0010208

Bard Composix Kugel Extra Large Oval, 7.7" x 9.7"

All lot numbers manufactured before January 2006

0010209

Bard Composix Kugel Oval, 6.3" x 12.3"

All lot numbers manufactured before March 2006

0010202

Bard Composix Kugel Large Oval, 5.4" x 7.0"

Lot numbers manufactured before October 2005

0010204

Bard Composix Kugel Large Circle, 4.5"

Lot numbers manufactured before October 2005