June 22, 2023
Teleflex recently announced a global recall affecting batches of its Rüsch endotracheal tube products after the company received 189 complaints, as of June 15, 2023, documenting reports of connector issues with the products. Of the 189 complaints, 11 reported injuries — nine reports of patient desaturation and four of patient death. Regarding the deaths, Teleflex wrote in the recall notice that three were unrelated and the fourth complaint reported it was impossible to determine whether the device contributed to death of the patient.
The Rüsch tubes are indicated for oral or nasal intubation for airway management through a patients nose or mouth. Stylets are used to aid in the insertion of the tubes into the trachea. Teleflex initially sent out a voluntary Field Safety Corrective Action on May 23, 2023, after reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. If disconnection occurs, there is a possibility of oxygen desaturation and, depending on the degree and duration or desaturation, immediate or long-term health consequences may occur.
After initial investigation, the company found that the disconnection is a result of intermittent cross contamination of the 15mm connector with trace amounts of silicone oil.
Within the recall notice, Teleflex urged clinical staff to ensure the 15mm connector is seated firmly in the ET tube to prevent disconnection during use, and should disconnection occur, reconnect the components quickly and securely as described in the product instructions for use.
Of note, for patients undergoing mechanical ventilation in either an operating room or critical care setting, a ventilation device the affected tubes are connected to are designed to alarm immediately upon a disconnection in the breathing circuit. This will alert clinical care staff to reattach the connector. Additionally, pulse oximetry also alerts clinicians of desaturation within seconds of the occurrence, allowing for prompt reattachment.
Affected Rüsch endotracheal tubes were manufactured between January 2018 and April 24, 2023. Products included in the recall include:
TOP Endotracheal tube with Cuff
RUSCHELIT Preformed Nasal Tracheal Tube, Two Eyes without Cuff
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal
Safety Clear Tracheal tube (without Cuff)
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
RUSCHELIT Preformed Oral Tracheal Tube, Cuffed, Oral, Murphy Eye
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal
AGT Orotracheal tube
Preformed AGT Oral Endotracheal Tube uncuffed/plain – Murphy
RUSCHELIT Preformed Nasal Tracheal Tube, Cuffed, Nasal, Murphy Eye
Preformed AGT Nasal Endotracheal Tube uncuffed/plain - Murphy AGT Nasotracheal tube
Endotracheal Tube oral/nasal uncuffed/plain - Murphy
RUSCHELIT Safety Clear Plus Tracheal Tube, oral/nasal, Cuffed
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff
RUSCHELIT Super Safety Clear Microlaryngeal Tube, oral/nasal
Preformed AGT Nasal Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff
RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Cuffed
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff
Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill
Super Safety Clear Tracheal tube
RUSCHELIT Preformed Oral Tracheal Tube, Two Eyes without Cuff
ENDOSOFT Tracheal tube
Endotracheal Tube oral/nasal uncuffed/plain – Magill
RUSCHELIT Edgar Tube (no cuff)
RUSCHELIT Edgar Tube (cuffed)
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