Kugel Patch Recall

On March 31, 2006 the Food and Drug Administration updated a previous Class 1 Recall notice from December 22, 2005 regarding the Bard Composix Kugel Mesh Patch. These devices were used to repair ventral hernias caused by thinning or stretching of scar tissue that occurs around incisions after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

This ring 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).

The following are the batches of the Bard Composix Kugel Mesh Patch affected by the December 2005 recall and then Updated on March 31, 2006 to include additional product codes and lot numbers recalled by the manufacturer:

Product Code

Description

Lot Numbers Recalled

Date Recalled

0010206

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

All Lot Numbers

December 2005 and January 2006

0010207

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

All Lot Numbers

December 2005 and January 2006

0010208

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

All Lot Numbers

December 2005 and January 2006

0010209

Bard ® Composix ® Kugel Oval, 6.3" x 12.3"

All Lot Numbers

March, 24, 2006

0010202

Bard ® Composix ® Kugel Large Oval, 5.4" x 7"

41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****

March 24, 2006

0010204

Bard ® Composix ® Kugel Large Circle, 4.5"

41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****

March 24, 2006

If you or someone you love has been injured by the Kugal patch, please contact our service today. We can help put you in touch with experienced Kugal patch attorneys who specialize in this type of litigation and get you the compensation that you deserve.

 
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