#United States #Minneapolis #Patient Safety #Smiths Medical #Intubation Tubes

Urgent Alert: Intubation Tubes from Smiths Medical

On March 7, 2025, Smiths Medical, a recognized leader in medical technology, announced an urgent medical device correction regarding certain sizes of their Intubation Oral/Nasal Endotracheal Tubes. The sizes in question include the 2.0, 2.5, 3.0, and 3.5 mm tubes, which have been found to be smaller than expected. This discrepancy raises significant safety concerns, as it could lead to inadequate ventilation for patients.

The primary risk associated with these undersized tubes is the potential for hypoxia, medication underdose, and in severe cases, cardiopulmonary collapse, which could ultimately result in fatal outcomes. Alarmingly, Smiths Medical has already received eight reports of serious injuries that appear to be linked to this issue. These events illustrate the critical need for immediate attention from healthcare professionals using these devices.

In response to these findings, Smiths Medical has proactively reached out to all impacted customers and distributors with detailed letters outlining the nature of the risk. The communication includes specific steps to help determine whether the endotracheal tubes in their possession are affected and guidance on what actions to take if they have any of the impacted products still in use.

The affected tubes are noted to have been manufactured between October 1, 2019, and October 3, 2024, and were distributed from October 30, 2019, to December 16, 2024. For those who believe they might possess these products, a comprehensive list is made available on the ICU Medical website, allowing for easy cross-referencing.

The World Health Organization (WHO) and various safety regulatory agencies stress the importance of monitoring medical device performance as part of ongoing patient safety efforts. Therefore, healthcare professionals are strongly advised to take this alert seriously and check their supply for the mentioned tube sizes. Ensuring the well-being of patients during intubation procedures must remain a top priority, and undersized devices threaten that safety.

Healthcare professionals and customers are encouraged to reach out to Smiths Medical for inquiries related to this issue. Smiths Medical has established a dedicated support framework to field any questions about product replacements, adverse events, or general concerns regarding the alerts issued.

The U.S. Food and Drug Administration (FDA) has been notified of this situation and urges any adverse reactions or quality problems associated with these devices to be reported through their MedWatch program. Reports can be filed online or through regular mail or fax using the FDA's provided resources.

As part of their continued commitment to customer safety and product integrity, Smiths Medical emphasizes the importance of vigilance in product monitoring and responsible reporting in case of adverse effects. For further assistance, the contact details for their Global Complaint Management and Customer Service departments are available, ensuring that their clients can resolve any issues swiftly.

In conclusion, all healthcare providers using Smiths Medical Intubation Tubes should heed this urgent alert and take immediate action to review their supplies, ensuring the safety and well-being of their patients remain uncompromised.