The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and ...

ICU Medical subsidiary Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. There have been 35 reported injuries. There have been two reports of death.

The company said not to use the Bivona tracheostomy tubes from the affected lot numbers. They should be thrown away. Price Action: At last check Thursday, ICUI stock was up 2.25% at $180.19.

On Wednesday, ICU Medical Inc’s (NASDAQ:ICUI) subsidiary, Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. The FDA classified the recall as the ...

Sept 18 (Reuters) - The U.S. Food and Drug Administration, on Wednesday, classified the recall of certain tubes made by a ... a Reuters request for comment. A tracheostomy is performed on a ...

Smiths Medical has recalled and removed Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect that can cause the securement flange of the device to tear, which can ...

The latest recall involves tracheostomy tubes, which are used to support breathing when a patient’s airway is blocked. The pilot balloon used to inflate the tracheostomy cuff may become detached from ...