Bard® Composix® Kugel® Mesh X-Large Patch
Class 1 Recall
*This recall notice was superseded with an updated notice on March 31, 2006, to include additional product codes and lot numbers recalled by the manufacturer.*
|Date Recall Initiated:|
December 22, 2005
Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:
(If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.)
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.
Davol, Inc., Sub. C.R. Bard, Inc.
|Reason for Recall:|
The "memory recoil ring" that opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the recall by letter on 12/27/05 via Federal Express. Customers should stop using the recalled product and return unused units to the company. For more information, customers can contact Bard Customer Service at 1-800-FOR-BARD or email@example.com. Physicians may contact bard Medical Services and Support at 800 227-3357 or firstname.lastname@example.org.
|See the Bard website.|