The Food and Drug Administration (FDA) released the following information:
Bard/Davol and the 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).
Product:
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE with the following lot numbers:
41XMXXXX – M = 2002
41XNXXXX – N = 2003
43XMXXXX – M = 2002
43XNXXXX – N = 2003
43XOXXXX – O = 2004
43XPXXXX – P = 2005
(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.)
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.
100 Sockanossett Crossroad
Cranston , RI 02920
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:
Roin Drago
VP Regulatory and Clinical Affairs
Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston , RI 02920
401-463-7000 x2389
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.
Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
