2/1/2007 Recall Upgraded to Class 1
Hernia Patch Recall for Bard Composix Kugel Mesh
2/1/2007 - FDA - Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal - Recall Upgraded to Class I due to risk of death and serious injury

 

Audience: Surgeons, surgical service personnel and hospital risk managers
[UPDATE 02/01/2007] Recall classified as Class I because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death. Customers should stop using the recalled product and return unused units to the company.