09.08.15
Teleflex Inc. has initiated a voluntary, worldwide recall of its Hudson RCI Sheridan Sher-I-Bronch endobronchial tube, which the U.S. Food and Drug Administration (FDA) has classified as a Class I recall.
The 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 is recalling the products following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. Should this occur, the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient. There have been no reports of patient injury as a result of this issue.
Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated June 1. This recall involves the retrieval of unused product in the field.
At the time of the recall, there were 78 complaints of this issue. Two-hundred thirty-three lots across 12 product codes are affected by this recall for a total of 188,195 units distributed to the field.
Teleflex, which is based in Wayne, Pa., makes device for critical care and surgical applications.
The 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 is recalling the products following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. Should this occur, the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient. There have been no reports of patient injury as a result of this issue.
Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated June 1. This recall involves the retrieval of unused product in the field.
At the time of the recall, there were 78 complaints of this issue. Two-hundred thirty-three lots across 12 product codes are affected by this recall for a total of 188,195 units distributed to the field.
Teleflex, which is based in Wayne, Pa., makes device for critical care and surgical applications.