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U.S. Department of Health and Human Services

Safety

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Davol/Bard Composix Kugel Mesh Patch

Audience: Surgeons, surgical service personnel and hospital risk managers
[UPDATE 3/31/2006] Davol/Bard and FDA notified healthcare professionals of an expanded recall of this product to include Oval, Large Oval and Large Circle Kugel mesh patches.  Bard also issued letters to hospitals and health care professionals providing updated Instructions for Use, clarifying the proper insertion technique and offering supplemental patient management information.

[Posted 03/02/2006] Bard/Davol and FDA notified healthcare professionals of a class 1 recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. 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).

[March 31, 2006 – Recall Notice – FDA]
[March 24, 2006 – Dear Chief of Surgery letter –Davol/Bard]
[March 24, 2006 – Dear Hospital Administrator letter –Davol/Bard]
[March 24, 2006 – Dear Distributor letter –Davol/Bard]

[March 02, 2006 – Previous Recall Notice – FDA]