System Correction Issued for Smiths Medical Endotracheal Tubes

Sure Smiths Medical intubation ORAL/NASAL endotracheal tubes could also be smaller than anticipated and will end in insufficient air flow to the affected person, in keeping with an FDA alert.

RT’s Three Key Takeaways

1. ICU Medical has issued an Pressing Medical System Correction for sure Smiths Medical endotracheal tubes which may be smaller than anticipated, doubtlessly resulting in insufficient air flow.
2. The FDA warns that this situation might trigger critical well being dangers, together with hypoxia, underdosing, or cardiopulmonary collapse, with eight reported accidents linked to the defect.
3. Clients have been notified with directions to establish affected merchandise, and additional particulars, together with a listing of impacted gadgets, can be found on ICU Medical’s web site.

ICU Medical has issued an Pressing Medical System Correction to inform affected world clients of a possible situation with the two.0, 2.5, 3.0 and three.5 mm sizes of Smiths Medical Intubation ORAL/NASAL Endotracheal Tube merchandise being smaller than anticipated, in keeping with an FDA alert.

The FDA reviews that, if the diameter of the system is smaller than anticipated, it could doubtlessly end in insufficient air flow to the affected person, post-insertion of the endotracheal tube.

In such conditions, the affected person might expertise hypoxia, underdose, and/or cardiopulmonary collapse which can result in demise, the FDA says.

So far, the corporate has acquired eight (8) reviews of great harm which might be doubtlessly associated to this situation, in keeping with the FDA.

All merchandise have been manufactured from October 1, 2019 to October 3, 2024 and distributed from October 30, 2019 to December 16, 2024, in keeping with the FDA alert.

All impacted clients and distributors have been despatched a letter outlining the chance and offering particular steps to find out whether or not their gadgets are affected or not and what steps to comply with if they’ve affected product in service.

A duplicate of that letter in addition to a listing of affected merchandise may be accessed on ICU Medical’s web site right here.

For additional inquiries, please contact Smiths Medical utilizing the data supplied under.