Contact Us

Composix Kugel Mesh X-Large Patch
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

Cell Phone 

Street Address 

Zip Code 

City 

State 

Date of surgery: 

Was a Davol Bard Composix Kugel Mesh Hernia Patch used in your hernia repair surgery? If so, please indicate which type.

Please describe any problems or injuries caused by the product:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.


Class 1 Recall: Bard® Composix® Kugel® Mesh X-Large Patch

Dec 22, 2005 | www.fda.gov
Facebook Twitter Stumble AddThis Social Bookmark Button Pin It Email to friend Print Page
Date Recall Initiated:
December 22, 2005

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).

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.
Tags:  
Related articles
Parker Waichman Accolades And Reviews Law Dragon Best Lawyers Find Us On Avvo Protected by Copyscape Web Copyright Protection Software php-5 VendorsBay Inc