The FDA has expanded its recall of the hernia mesh patch designed by Dr. Robert D. Kugel and manufactured by Davol, Inc. (a subsidiary of C.R. Bard). The FDA sent a letter to health care professionals and distributors on January 10, 2007 notifying them of the most recent expansion of the recall which includes the specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. The FDA stated that “surgeons and hospitals should stop using the recalled product and return unused units to the company.
The recall was prompted by a problem with the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh patches. The recoil ring can break under the stress of placement of the large sized products in the intra-abdominal space. This breakage can lead to bowl perforations and/or chronic intestinal fistulae.
Davol notified US customers of the initial recall on December 27, 2005. On March 24, 2006, Bard issued letters to hospitals and health care professionals of the additional recalls.
The table below gives a complete list of all product codes and lot numbers, according to the FDA.
Product Code
Description
Lot Numbers Recalled
Date Recalled
0010206
Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7”
All Lot Numbers manufactured before January 2006
December 2005 and January 2006
0010207
Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7”
All Lot Numbers manufactured before January 2006
December 2005 and January 2006
0010208
Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”
All Lot Numbers manufactured before January 2006
December 2005 and January 2006
0010209
Bard® Composix® Kugel® Oval, 6.3” x 12.3”
All Lot Numbers manufactured before March 2006
March, 24, 2006
0010202
Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”
Lot Numbers manufactured before October 2005 (see below)
January 10, 2007
0010204
Bard® Composix® Kugel® Large Circle, 4.5”
Lot Numbers manufactured before October 2005 (see below)
January 10, 2007
If you or a loved one have been injured as a result of these medical devices, call us at 800-748-7115