Smiths Medical's Intubation Oral/Nasal Endotracheal Tubes Recalled

(RTTNews) - Smiths Medical, affiliated to infusion therapy company ICU Medical, Inc., has called back various sizes of Intubation ORAL/NASAL Endotracheal Tube products for an urgent medical device correction, according to the U.S. Food and Drug Administration.

The 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products are being smaller than expected, which could result in serious injury.

The impacted products were manufactured from October 01, 2019 to October 03, 2024 and distributed from October 30, 2019 to December 16, 2024.

The device's diameter, if smaller than expected, may potentially result in inadequate ventilation to the patient, post-insertion of the endotracheal tube. In such situations, the patient may experience hypoxia, underdose, and/or cardiopulmonary collapse that could lead to death.

Smiths Medical so far has received eight reports of serious injury that are potentially related to the issue.

The company has notified all impacted customers and distributors through a letter outlining the risk, as well as specific steps to determine whether their devices are affected or not, and the steps to follow if they have affected product in service.

Customers are urged to report any adverse reactions or quality problems experienced with the use of the recalled product to the FDA's MedWatch Adverse Event Reporting program.

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