The Food and Drug Administration said Monday that Covidien Ltd. (COV) was recalling 21 lots of a pediatric tracheostomy tube after receiving complaints about difficulties inserting the product into patients.

The agency said the recall, which started in January, is considered a Class I recall, which means there's "a reasonable chance that the product will cause serious health problems or death." A notice of the recall was posted Monday on the FDA's Web site.

The FDA said the recall involves the Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube, which was manufactured from July 7, 2008, through Dec. 9, 2008, and distributed from July 24, 2008, through Dec. 23, 2008. Such tubes are used in surgical procedures to create an opening through the neck into the a person's windpipe, or trachea, to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

The FDA said Covidien recalled the product because of complaints about difficulty inserting the device used to place the tracheostomy tube into the windpipe and difficulty inserting a suction tube into the tracheostomy tube. The FDA said the problem could have required the tracheostomy tube to be removed and replaced.

Sherri Hughes-Smith, a Covidien spokeswoman, said the recall involved about 5,000 tubes. She said there have been 10 reported incidents requiring the tracheostomy tube be replaced. In one case, a patient required additional medical intervention and respiratory support, prior to being returned to a ventilator.

Hughes-Smith said the problem has been resolved and Covidien resumed shipping of the tubes last month.

The FDA said Covidien sent an alert letter to customers on Jan. 14, 2009, telling them about the problem, and then sent a second letter on March 6 asking them to remove remaining products from their inventory and return them for replacement products or a credit.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com