Bard Expanded Recall Action
January 12, 2007
BARD EXPANDED RECALL ACTION:
Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches. Products included in the expanded recall are:
- Bard ® Composix ® Kugel ® Large Sized Patch Class I Recall and Market Withdrawal
- Bard ® Composix ® Kugel ® Large Oval, 5.4" x 7.0", Product Code: 0010202
- Bard ® Composix ® Kugel ® Large Circle, 4.5", Product Code: 0010204
On March 31, 2006 the Food and Drug Administration updated a previous Class 1 Recall notice from December 22, 2005 regarding the Bard Composix Kugel Mesh Patch. These devices were used to repair ventral hernias caused by thinning or stretching of scar tissue that occurs around incisions after surgery. The working component of the patch is a "memory recoil ring" that causes the patch to spring open after surgeons fold it flat in order to insert it into the body.
Unfortunately, this "memory recoil ring" that is so critical to the Bard Composix Kugel Mesh Patch is prone to breakage during the stress of placing it inside the body. Should this device break, it can cause a number of serious and potentially life-threatening complications, such as bowel perforation and/or chronic intestinal fistulae, or abnormal connections of passageways between intestines and other gastrointestinal organs.
The following are the batches of the Bard Composix Kugel Mesh Patch affected by the December 2005 recall:
- Bard ® Composix ® Kugel ® Extra Large Oval, 8.7" x 10.7", all lot numbers
- Bard ® Composix ® Kugel ® Extra Large Oval, 10.8" x 13.7", all lot numbers
- Bard ® Composix ® Kugel ® Extra Large Oval, 7.7" x 9.7", all lot numbers
These are the batches affected by the March 24, 2006 recall:
- Bard ® Composix ® Kugel ® Oval, 6.3" x 12.3", all lot numbers
- Bard ® Composix ® Kugel ® Large Oval, 5.4" x 7", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
- Bard ® Composix ® Kugel ® Large Circle, 4.5", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
A Class 1 Recall is the highest health alert the FDA can enact. It means that there is a "reasonable probability that the use of or exposure to a product will cause serious injury or death." There have been at least 24 reports of broken rings since the recall, and patients with the device are advised to seek medical attention immediately if they suffer from unexplained and persistent abdominal pain, fever, tenderness at the implant site or unusual symptoms.
If you or someone you love was injured by the Bard Composix Kugel Mesh Patch, you must act quickly. You may have the right to see monetary compensation for your pain and suffering, but if you hesitate the statute of limitation laws in your state could end your case before it has a chance to begin. Let our dedicated, experienced, and aggressive defective medical device attorneys help you get the justice you deserve.
Contact Our Bard Composix Kugel Mesh Patch Recall Attorney Today
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