Certain Smiths Medical intubation ORAL/NASAL endotracheal tubes may be smaller than expected and could result in inadequate ventilation to the patient, according to an FDA alert.
RT’s Three Key Takeaways
- ICU Medical has issued an Urgent Medical Device Correction for certain Smiths Medical endotracheal tubes that may be smaller than expected, potentially leading to inadequate ventilation.
- The FDA warns that this issue could cause serious health risks, including hypoxia, underdosing, or cardiopulmonary collapse, with eight reported injuries linked to the defect.
- Customers have been notified with instructions to identify affected products, and further details, including a list of impacted devices, are available on ICU Medical’s website.
ICU Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Smiths Medical Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected, according to an FDA alert.
The FDA reports that, 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, the FDA says.
To date, the company has received eight (8) reports of serious injury that are potentially related to this issue, according to the FDA.
All products were manufactured from October 1, 2019 to October 3, 2024 and distributed from October 30, 2019 to December 16, 2024, according to the FDA alert.
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service.
A copy of that letter as well as a list of affected products can be accessed on ICU Medical’s website here.
For further inquiries, please contact Smiths Medical using the information provided below.
| Smiths Medical Contact | Contact Information | Areas of Support |
|---|---|---|
| Global Complaint Management | [email protected] 1-(866)-216-8806 | To report adverse events or product complaints |
| Customer Service | [email protected] 1-(800)-259-5361 | Questions about your product and/or replacement |
| Field Action Processing | [email protected] 1-(877)-877-0317 | Questions about this communication |
