Teleflex Incorporated Announces Global Recall of Rüsch Endotracheal Tubes

WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has announced a global recall of affected batches of the below-mentioned Rüsch Endotracheal Tube products. The Rüsch Endotracheal Tube devices are indicated for oral or nasal intubation for airway management via insertion into a patient’s tracheal via nose or mouth. Stylets are used to aid insertion of endotracheal tubes into the trachea.

The products involved in the recall are as follows. Additional detail about how to identify the affected products is available in the recall letter.

Teleflex commenced this voluntary Field Safety Corrective Action on May 23, 2023 due to reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. There is the possibility of oxygen desaturation and in that event any immediate or long-term health consequences are dependent on the degree and duration of desaturation. All batches of Rüsch Endotracheal Tubes as listed in table above, manufactured between JAN2018 to 24APR2023 are subject to this recall. Reference Appendix 2 of the recall letter for a full list of affected lots / batches.

Where patients are undergoing mechanical ventilation in either the operating room or critical care settings, the ventilation devices to which the affected products are connected are designed to alarm immediately upon a disconnection in the breathing circuit, alerting the clinician to reattach the connector. Additional standards of care such as pulse oximetry also alert clinicians to desaturation within seconds of its occurrence, again permitting prompt reattachment of the connector.

As of 15-June-2023, Teleflex received 189 complaints reporting connector issues for products in scope of this field correction. Of these 189 complaints, 11 reported injury, including nine reports of patient desaturation, and four reports of patient death. Three complaints reported that the patient deaths were unrelated to the disconnection of the device and one complaint reported that it was impossible to determine whether the device contributed to the patient death.

The initial investigation has identified that the disconnection results from intermittent cross-contamination of the 15mm connector with trace amounts of silicone oil. Although this does increase the lubricity of the connection, this does not present additional clinical risks.

For product in situ, Teleflex advises clinical staff to ensure the 15 mm connector is seated firmly in the ET tube to prevent disconnection during use per the product instructions for use. Should disconnection occur, reconnect the two components promptly and securely in the manner described in the product instructions for use. Clinical staff may wish to consider replacing the device, making sure to evaluate on a case by case basis the risks associated with extubation and reintubation.

The recall notice, with a list of affected product codes and lot numbers, can be found through the following link: https://teleflex.widen.net/s/dc5gwfhkzh/eif-000537-fsn-online

Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email recalls@teleflex.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm, or via Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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