The Teleflex ISIS HVT is designed to meet the needs of patients requiring both short- and long-term ventilation, without the need to change tubes.
It includes a separate line for subglottic secretion suctioning, which can help prevent ventilator-associated pneumonia among patients who are using a ventilator long-term.
The recall comes after complaints the company that the tracheal tube can kink during patient use, creating a life-threatening situation. Customers were notified of the recall on 6 January 2014, when Teleflex sent them a letter instructing them to immediately discontinue use of the recalled devices and return unused product.
The US Food and Drug Administration (FDA) has classified this action as a Class I recall.
According to the FDA the class I recalls refers to a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
