US-based Teleflex has issued a worldwide voluntary recall of its ISIS HVT tracheal tube cuffed with subglottic secretion suction port (with and without preloaded stylet).
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.