On January 24, 2007, the FDA issued a second update to its Class 1 recall of Bard® Composix® Kugel® Mesh Patches. The update expands the lot numbers of previously recalled products to include some that were manufactured in more recent years.
In a slightly more patient friendly version of previous statements concerning the reasons for the recall, the FDA notes “the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”
The latest notice still cautions that “patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.”
The January update applies specifically to product codes 0010202 and 0010204. According to the FDA: “It should be noted that product codes 0010202 and 0010204 were involved in both recall expansions. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March expansion, Davol received four confirmed complaints of recoil ring breakage from product code 0010202 manufactured between January 2004 and September 2005. There were no complaints for product code 0010204 . Davol is recalling the following lots for product codes 0010202 and 0010204:
- All lots with the letter “O” in the fourth position
- All lots with the letter “P” in the fourth position and the letters “A” through “I” in the third position.
For instance, an example of a recalled lot number is “43IPD###.”
To make matters even more confusing, the January update includes Davol’s voluntary recall of more recently manufactured lots. As the FDA explains, “Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm’s removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA. Davol is withdrawing the following lots:
- All lots with the letter “P” in the fourth position and the letters “J” through “L” in the third position
- All lots with the letter “Q” in the fourth position and the letters “A” through “I” in the third position
For instance, an example of a withdrawn lot number is “43IQD###.”
Encouragingly, the FDA noted that “an upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product can easily be identified on the case or unit package with the label stating ‘Redesigned for improved ring integrity.’ If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.”
Recapping some of Bard’s earlier communications with customers: “On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information. Copies of current product IFUs to be used for both Open Placement and Laparoscopic Placement for the Large Bard® Composix® Kugel® Mesh Patches are available from Davol Customer Service by calling 1-800-531-4124.”
This update also includes new manufacturer 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: Davol Customer Service, 1-800-531-4124
Physician Contact: Bard’s Medical Services and Support Department, 1-800-562-0027, or Bard Medical Director, 1-908-277-8306
The Davol website, rather than the Bard website, contains the company’s press release regarding the 2007 recall update.