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"
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