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U.S. Department of Health and Human Services

Safety

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Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal

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.

[Posted 01/12/2007] Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.

[January 31, 2007 – Recall Notice – FDA]
[January 10, 2007 – Letter – Davol/Bard]

Previous MedWatch Alert:
[March 31, 2006]