Sept 18 (Reuters) - The U.S. Food and Drug

Administration, on Wednesday, classified the recall of certain

tubes made by a unit of ICU Medical ( ICUI ) as the most serious

type, which could cause severe injury or death.

Specific lots of the tubes sold under the Bivona brand by

ICU's unit Smiths Medical for neonatal or pediatric and adult

patients are being recalled due to a manufacturing defect that

may cause the device's securement flange to tear.

ICU Medical ( ICUI ) did not immediately respond to a Reuters request

for comment.

A tracheostomy is performed on a patient with an illness or

injury that blocks their airway. The procedure helps oxygen

reach the lungs by creating an opening into the windpipe from

outside the neck.

The regulator said use of affected products may cause

serious health consequences, including lack of proper

ventilation, loss of a protected airway and death.

There have been 35 reported injuries, and two reports of

death, the FDA said.