March 2006 Bard Composix Kugel Mesh Patch Recall
Link to Article: March 2006 Bard Composix Kugel Mesh Patch Recall
Posted in: Kugel Mesh Hernia Patch Recall
Source | FDA
Class 1 Recall: Bard® Composix® Kugel® Mesh Patch
*This recall notice was updated on March 31, 2006, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued (see previous announcement) . The expanded list below includes all recalled product codes and lot numbers.*
| 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 7.0” | 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 |
Use:
The Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms 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.
Reason for the Recall:
The “memory recoil ring” that opens the Composix® Kugel® Mesh 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).
Do I Have a Kugel Mesh Patch Lawsuit?
If you or a loved one has suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel Mesh Patch, you should contact us immediately. You may be entitled to compensation and we can help.
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