UPDATE Aug. 5, 2019: Teleflex is recalling multiple models of Hudson RCI Sheridan and Sheridan endotracheal tubes distributed in the U.S. due to a risk the endotracheal tube connector could dislodge from the endotracheal tube, causing disconnection of the patient from the breathing circuit. This could result in insufficient oxygenation, decrease in vital signs, or death.
The recall included 80 airway kits containing Sheridan endotracheal tubes and 70 components not in kits. The devices have now been linked to four patient deaths and 18 injuries, FDA said in an Aug. 2 notice.
- Teleflex Medical is recalling more than six million endotracheal tubes distributed in the United States due to a risk that the devices may become disconnected from the breathing circuit. Disconnection may cause insufficient oxygenation and death.
- Two deaths and one injury were reported among 179 complaints with 192 incidents involving a device disconnection, FDA said.
- The recall includes multiple models of the Hudson RCI Sheridan and Sheridan endotracheal tubes.
In the three cases resulting in death or injury, a decision was made to extubate and reintubate the patient. Patients died during subsequent reintubation attempts, Teleflex said in a field safety notice.
Each tracheal tube includes a 15-millimeter connector that can be removed but should not disconnect from the endotracheal tube without significant force, FDA said.
In most of the reported cases of device disconnection, clinical personnel identified that the connector became detached, or an eventual decrease in ventilator circuit pressure triggered alarms, Teleflex said.
Endotracheal tubes are often used when a patient cannot breathe on their own during surgical procedures that require inhaled anesthetic gases. The tubes are used to open a patient’s airway, provide ventilation and administer anesthesia.
The recalled Teleflex devices were distributed from October 2016 to May 2019. A total of 6,067,502 Select Sheridan EIF-000361 endotracheal tubes and connectors in sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 millimeters are included in the U.S. recall.
In a May 24 urgent recall notification, Teleflex instructed customers to inspect their inventories, discontinue use of affected products and quarantine them. Customers should also notify the company and return the recalled devices. Distributors were directed to notify their customers and request the recalled products be returned to them for consolidation and subsequent return to Teleflex.
The specific lots included in the recall are:
- Hudson RCI Sheridan LTS.
- Hudson RCI Sheridan (CF, Preformed, HZT) 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm.
- Hudson RCI Sheridan/EZ-ENDO 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm.
- Hudson RCI Sheridan Uncuffed 6.0, 6.5, 7.0 mm.
- Sheridan/CF Novaplus 7.0.
- Sheridan/HVT Novaplus 7.0, 7.5, 8.0, 8.5 mm.