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.O), opens new tab 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, opens new tab that may cause the device's securement flange to tear.
ICU Medical 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.
Source: Reuters
Source: Reuters
