Friday, January 26, 2007

Kugel Mesh Patch Recall

An updated and expanded recall on the Kugel/Bard Mesh Patch.

Products included in the expanded recall are: Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal;Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”; andProduct Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5.”

Back in March the first recall was ordered. “The 'memory recoil ring' that opens the Composix Kugel Mesh Hernia Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).