The FDA issues a Class I recall for C.R. Bard's Davol XenMatrix surgical graft over fears the fabric-like device could contain toxins.
The FDA issued a Class I recall of a surgical graft manufactured by C.R. Bard Inc. (NYSE:BCR) subsidiary Davol Inc. on fears it might contain a toxin.
The federal watchdog agency is recalling several lots of Davol's XenMatrix product because of concerns that it might contain elevated levels of endotoxins. The toxins, which are found in certain bacteria, can cause fatal illness at higher levels, according to the FDA.
The cloth-like XenMatrix product is indicated for hernia and abdominal wall repair, according to Davol.
The FDA classified the recall as Class I because it believes the tainted products could cause serious injury or death.
Although Warwick, R.I.-based Davol sent a recall letter to customers Jan. 6, the FDA posted a recall notice on its website today.
The recall refers specifically to Davol's XenMatrix surgical graft manufactured beginning June 1, 2010, and distributed until Oct. 31, 2010. The affected lot numbers begin with HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH and HUUJ.
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