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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.

The FDA said the tube is used in a surgical procedure to create an opening through the neck into the windpipe or the trachea. A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

The agency 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.

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.

Covidien didn't immediately return a request for comment.

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