On December 22, 2005, the Food and Drug Administration issued its first Class 1 recall for the Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE. The FDA advised customers to stop using the product and return unused units to the company.
According to the FDA notice, the recall was issued because “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).”
The specific lot numbers for the recalled patches are:
41xMxxxx (made in 2002)
41xNxxxx (made in 2003)
43xMxxxx (made in 2002)
43xNxxxx (made in 2003)
43xOxxxx (made in 2004)
43xPxxxx (made in 2005)
If the lot number does not contain the letter M, N, O, or P as the fourth character, then it is not affected by the recall.
The FDA listed the following manufacturer and public contact information:
Davol, Inc., a subsidiary of C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston , RI 02920
Public Contact: Robin Drago, VP Regulatory and Clinical Affairs
Customer Contact: Bard Customer Service, 1-800-FOR-BARD, firstname.lastname@example.org
Physician Contact: Bard Medical Services and Support, 800 227-3357, email@example.com
On January 13, 2006, C.R. Bard issued a press release concerning the recall stating, “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 remainder of the press release discusses the company’s financial performance and the minor impact of the recall on the company’s future earnings projections.
Three months after this recall was published, however, the recall was expanded to include additional product codes and lot numbers. In January 2007, the recall was expanded yet again to include products manufactured in more recent years.