Teleflex Incorporated TFX announces a global recall of Rüsch Endotracheal Tube products due to reports of disconnection of the 15mm connector from the endotracheal tube.
The affected products are used for oral or nasal intubation for airway management via insertion into a patient’s tracheal via nose or mouth.
The disconnection may lead to oxygen desaturation, with potential health consequences depending on the degree and duration of desaturation.
Stylets are used to aid the insertion of the endotracheal tubes into the trachea.
All batches of Rüsch Endotracheal Tubes manufactured between January 2018 - April 24, 2023, are subject to recall.
Also Read: Teleflex’s Growth Drivers In Question: Analyst Predicts Potential Business Realignment.
Teleflex received 189 complaints regarding connector issues, including reports of injuries and deaths.
Initial investigation shows that the disconnection is due to cross-contamination of the connector with silicone oil. The lubricity increase from the contamination does not pose additional clinical risks.
Clinical staff should ensure the 15mm connector is securely seated in the ET tube during use.
In case of disconnection, promptly and securely reconnect the components as per the product instructions for use.
Clinical staff may consider replacing the device on a case-by-case basis, evaluating the risks associated with extubation and reintubation.
Price Action: TFX shares are up 0.18% at $245.34 on the last check Thursday.
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