*This recall notice was superseded with an updated notice on March 31, 2006, to include additional product codes and lot numbers recalled by the manufacturer.* | |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 |
December 22, 2005 |
Product: |
Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:
|
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. |
Recalling Firm: |
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). |
Public Contact: |
Robin Drago |
FDA District: |
New England |
FDA Comments: |
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 bard.helpline@crbard.com . Physicians may contact bard Medical Services and Support at 800 227-3357 or medical.services@crbard.com. |
|
A copy of the company’s press release regarding this recall can be found on the Bard website. |
Updated March 2, 2006
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH