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FDA Issues Class 1 Recall for Bard Composix Kugel Mesh X-Large Patch

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Although this Class 1 (highest) recall (http://www.fda.gov/cdrh/recalls/recall-122205.html) has been in effect for about two months, it appears to have not been widely reported until now. As a service to our readers, therefore, we have reproduced that recall notice from the FDA, as well as an excerpt from the manufacturer’s recall letter below: Kugel hernia mesh recall

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).
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.

Bard Announces Recall of Composix� Kugel� Mesh X-Large Patch
MURRAY HILL, NJ — (January 13, 2006) — C. R. Bard, Inc. (NYSE-BCR) today announced that it is voluntarily recalling its Bard Composix Kugel Mesh X-Large Patch intended for ventral hernia repair. This recall does not affect any of the company’s other hernia repair products.
The company is initiating this recall due to reports that the device’s plastic coil ring, designed to aid in its deployment, may not withstand the increased stress associated with certain surgical placement techniques. The company has received 24 reports of broken rings out of approximately 32,000 units sold since 2002, a rate of approximately 0.08%.
The products affected by this recall were distributed to customers worldwide. Bard has notified affected customers and the appropriate regulatory agencies, including the U.S. Food and Drug Administration.
The three product codes involved generated sales of approximately $11 million in 2005, before the effect of the recall.�
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