Intubation Oral/Nasal Endotracheal Tubes

  • Diameter of Device Smaller than Expected
  • Company: Smiths Medical
  • Medical Devices
  • FDA
  • March 7, 2025

Product details

  • Intubation Oral/Nasal Endotracheal Tubes

Company announcement

Smiths Medical issued an urgent medical device correction regarding Intubation ORAL/NASAL Endotracheal Tubes.

The 2.0, 2.5, 3.0 and 3.5 mm sizes of the tubes may be smaller than expected.

Eight reports of serious injuries potentially related to this issue have been received.

Products were manufactured from October 1, 2019, to October 3, 2024, and distributed from October 30, 2019, to December 16, 2024.

Risk:

If the diameter of the device is smaller than expected, it 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 which may lead to death.

Impacted states: Nationwide

Contact

For more information, call 1-(800)-259-5361 or email Customerservice@icumed.com.

View the original FDA notice

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