US-based Teleflex Incorporated is voluntarily recalling Hudson RCI Pediatric Anesthesia Breathing Circuits.
The US Food and Drug Administration (FDA) classified the voluntary medical device recall as a Class 1 recall.
The company is recalling the product as a result of complaints that the ends of the pediatric breathing circuits can crack prior to and during use.
When circuits crack during use, there will be a chance of respiratory distress to the patient, said Teleflex.
Teleflex notified the recall to domestic and foreign hospitals, as well as distributors through an Urgent Medical Device recall letter dated 10 September 2014.
The company said that six product codes over thirty (30) lots have been affected by the recall for a total of 27,176 units distributed to the field.
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."