Sam Brusco, Associate Editor06.22.23
Teleflex announced a global recall of affected batches of its Rüsch endotracheal (ET) tube products. The device provides oral or nasal intubation for airway management via insertion into the tracheal via nose or mouth.
Teleflex began this voluntary Field Safety Corrective Action on May 23 because of reports of disconnection of the 15 mm connector from the ET tube in the affected products. This can cause oxygen desaturation—in that event, immediate or long-term health consequences depend on the degree and duration of desaturation.
A full list of affected lots/batches can be found here.
As of June 15, Teleflex has received 189 complaints about the connector issues. Of these, 11 reported injury, including nine reports of desaturation. There were four reports of patient death; three complaints reported the patient deaths were not related to the device’s disconnection and one reported it was impossible to determine whether the device contributed to the death.
Initial investigation identified the disconnection is caused by intermittent cross-contamination of the 15 mm connector with trace amounts of silicone oil. This increases the connection’s lubricity but does not present further clinical risks.
Teleflex advised clinical staff to ensure the 15 mm is seated firmly in the ET tube to prevent disconnecting during use. Should disconnection happen, the company advised to reconnect the two components promptly and securely described in the product’s instructions for use.
Teleflex began this voluntary Field Safety Corrective Action on May 23 because of reports of disconnection of the 15 mm connector from the ET tube in the affected products. This can cause oxygen desaturation—in that event, immediate or long-term health consequences depend on the degree and duration of desaturation.
A full list of affected lots/batches can be found here.
As of June 15, Teleflex has received 189 complaints about the connector issues. Of these, 11 reported injury, including nine reports of desaturation. There were four reports of patient death; three complaints reported the patient deaths were not related to the device’s disconnection and one reported it was impossible to determine whether the device contributed to the death.
Initial investigation identified the disconnection is caused by intermittent cross-contamination of the 15 mm connector with trace amounts of silicone oil. This increases the connection’s lubricity but does not present further clinical risks.
Teleflex advised clinical staff to ensure the 15 mm is seated firmly in the ET tube to prevent disconnecting during use. Should disconnection happen, the company advised to reconnect the two components promptly and securely described in the product’s instructions for use.