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 most serious type, which could cause severe injury or death.
Smiths Medical is recalling specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that may cause the securement flange of the device to tear.
Affected products include:
- Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tubes.
- Bivona Aire-Cuf, TTS, Cuffless FlexTend, TTS FlexTend Adult Tracheostomy Tubes.
The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death.
There have been 35 reported injuries. There have been two reports of death.
Bivona neonatal/pediatric and adult tracheostomy tubes provide direct airway access for up to 29 days for a patient with a tracheostomy, a surgical procedure that creates an opening in the neck and into the windpipe (trachea) to help a person breathe.
Some tubes can be reprocessed and reused several times for a single patient.
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.
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