Product Recall ICU Medical Intubation ORAL/NASAL Endotracheal Tubes (ICN 2842)

• The affected products remain impacted by the supply issue outlined in ICN 2759.
• See our Useful Links section to view ICN 2759.
• Further alternatives have been sourced for the affected products and the product listing has been updated, however, some of these products may also become subject to intermittent supply with the increase in demand.
• Please continue to review ICN 2759 for current information regarding product availability.
• The supply issue is anticipated to be resolved by 30 April 2025.
• Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.

Alert:

• ICU Medical International Limited (formerly Smiths Medical) has issued a Field Safety Notice regarding specific lots of their Intubation ORAL/NASAL Endotracheal Tubes.
• The supplier became aware that certain sizes of Intubation ORAL/NASAL Endotracheal Tube products may have a smaller diameter than expected.
• 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.

 Products Affected:

• There are 10 NHS Supply Chain products affected. Please see the product listing for more information.
• Only the lot numbers noted in the Field Safety Notice, page 3 and 4, are affected.
• Three products are delisted from our online catalogue and are no longer available to order:
  • FDF1262, FDF1261 and FDF048.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.
• Please review ICN 2759 for current information regarding product availability.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. However, some of these products may also become subject to intermittent supply with the increase in demand.
• Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.
• See our Downloads ▼ section to access the product listing for further information on the affected products and potential alternatives.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.