On March 26, 2006, the FDA issued an update to its Class 1 recall of Bard® Composix® Kugel® Mesh Patches. The update adds three additional types of patches to the recall because of defects similar to those in the products recalled three months earlier. The notice advises that “surgeons and hospitals should stop using the recalled product and return unused units to the company.”
The updated notice reiterates the reason for the recall being that “the ‘memory recoil ring’ that opens the Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”
In its comments, the FDA also advises that “patients who have 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 recalled products specified in the notice include those previously announced in the December 22, 2005 recall notice.
Product Code: 0010206
Description: Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7”
Lot Numbers Recalled: All Lot Numbers
Date Recalled: December 2005 and January 2006
Product Code: 0010207
Description: Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7”
Lot Numbers Recalled: All Lot Numbers
Date Recalled: December 2005 and January 2006
Product Code: 0010208
Description: Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”
Lot Numbers Recalled: All Lot Numbers
Date Recalled: December 2005 and January 2006
Product Code: 0010209
Description: Bard® Composix® Kugel® Oval, 6.3” x 12.3”
Lot Numbers Recalled: All Lot Numbers
Date Recalled: March 24, 2006
Product Code: 0010202
Description: Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”
Lot Numbers Recalled: 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Date Recalled: March 24, 2006
Product Code: 0010204
Description: Bard® Composix® Kugel® Large Circle, 4.5”
Lot Numbers Recalled: 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Date Recalled: March 24, 2006
The FDA lists 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, bard.helpline@crbard.com
Physician Contact: Bard Medical Services and Support, 800 227-3357, medical.services@crbard.com
The FDA recall notice also includes a hyperlink to a press release on the C.R. Bard website, but the press release has evidently been removed or relocated as the link now results in a “file not found” error.
In Janaury 2007, the FDA expanded the recall again to include products manufactured in more recent years.
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