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Covidien Tracheostomy Tube Recall Listed As Class I

Law360 (March 11, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has listed Covidien Ltd.'s nationwide recall of some its pediatric tracheostomy tubes as a Class I — the most serious type of recall in which there is “a reasonable probability that use of these products will cause serious injury or death.”

Covidien initiated the recall in mid-January after receiving complaints about problems inserting the tubes into patients. The FDA made the listing on Monday.

The recall targets 21 lots of the company’s Shiley 3.0 PED Cuffless Pediatric Tracheostomy Tube, which...
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