Rusch (endotracheal tubes)

2023: Recall of defective products

At the end of June 2023, the American company Teleflex announced a global recall of the corresponding batches of Rusch endotracheal tubes after reports of disconnecting the 15-mm connector from the products. Due to marriage, there is a possibility of oxygen desaturation, in which case any immediate or long-term health effects depend on the extent and duration of desaturation for patients.

An initial investigation by Teleflex and the FDA found that disconnection occurs as a result of periodic cross-contamination of the 15mm connector with trace amounts of silicone oil. Although this increases the lubricity of the compound, according to the developers of Teleflex, it does not pose additional clinical risks.

Teleflex Rusch

If patients undergo mechanical ventilation in the operating room or resuscitation, the ventilation devices to which the recalled devices are connected are designed so that when the respiratory circuit is disconnected, an alarm is immediately sent, warning the doctor to connect the connector. Rusch devices that fall under recall were produced between January 2018 and April 24, 2023.

As of June 23, 2023, Teleflex received 189 complaints about problems with connectors on these devices. 11 reported injuries, including nine reports of desaturation and four reports of patient deaths. Three complaints reported that the patient's death was not related to the detachment of the device, and one reported that it was not possible to determine whether the device contributed to the patient's death.

Teleflex recommends that clinical personnel ensure that the 15 mm connector is securely secured in the ET tube to prevent disconnection during use in accordance with the product instructions for use. If disconnection occurs, quickly and securely connect the two components as described in the instructions for use.^[1]

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