Medical technologies provider Teleflex is voluntarily recalling Hudson RCI Sheridian Sher-I-Bronch Endobronchial Tube.
The company is recalling the device, as the double swivel connector may crack or separate on the endobronchial tube that may result in leak, causing a risk of respiratory distress or hypoxia.
According to the firm, the recall involves the retrieval of unused product in the field and there were 78 complaints of this issue at the time of the recall.
Around 233 lots across 12 product codes are affected by the recall for a total of 188,195 units distributed to the field.
The firm informed about the recall to both domestic and foreign hospitals and distributors through an urgent medical device recall letter.
The US Food and Drug Administration (FDA) has classified the voluntary medical device recall of the Endobronchial Tube as a Class 1 recall.
FDA defines Class I recalls as, "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."
Teleflex provides solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.