Field Safety Notice Teleflex Medical Endotracheal Tubes (ICN 2149)

• In addition to the previous notification of the Field Safety Notice, a further six product codes have been identified and are affected:
  • FDF944 – Oral Endotracheal Tube cuffed with murphy eye PVC low pressure cuff AGT preformed south facing size 8.5mm
  • FDF851 – Standard Endotracheal Tube cuffed with murphy eye PVC low pressure cuff size 7.5mm short term use NON RETURNABLE
  • FDF879 – Standard Endotracheal Tube cuffed with murphy eye PVC high volume low pressure cuff long term size 7.0mm NON RETURNABLE
  • FDF885 – Standard Endotracheal Tube cuffed with murphy eye PVC high volume low pressure cuff long term size 8.5mm NON RETURNABLE
  • FDF886 – Standard Endotracheal Tube cuffed with murphy eye PVC high volume low pressure cuff long term size 9.0mm NON RETURNABLE
  • FSM2776 – Standard endotracheal tube cuffed without murphy eye single use PVC high-volume low pressure latex-free sterile size 8.5 NON RETURNABLE.
• Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc in the circulation of this notice.
• Immediately check your inventory for products within the scope of this Field Safety Corrective Action Notice.
• Users should cease the use and distribution of the affected product and immediately quarantine the affected product.
• If you have any of the affected products, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and contact Teleflex Customer Service by calling the phone number provided.
• If you do not have any of the affected products, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex at the contact details provided.
• Please maintain awareness of this notice until all required actions have been completed in your organisation.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.
• Where affected product and Lot numbers are identified, please also contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).  Please confirm if the quantity of product to be returned is single or pack (unit of issue).
• All products are to be returned no later than 30 June 2023.

Alert:

• Teleflex has issued a precautionary Field Safety Notice following reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products listed in Appendix 2.
• There is the possibility of oxygen desaturation and in that event, any immediate and long-term health consequences are dependent on the degree and duration of desaturation, which may include serious injury or death.
• Teleflex initial investigation has identified that the disconnection results from intermittent cross-contamination of the 15mm connector with trace amounts of silicone oil. Although this does increase the lubricity of the connection, this does not present additional expected risks.

Products Affected:

• There are 114 NHS Supply Chain products suspended until the company can resume supply of unaffected lot numbers.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Please note only the batch numbers listed in Appendix 2 of the Field Safety Notice are affected by the recall.
• For details regarding the availability of alternatives please refer to ICN 2156 on our website which will be updated as more information becomes available.

Next Steps:                      

• Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc in the circulation of this notice.
• Immediately check your inventory for products within the scope of this Field Safety Corrective Action Notice.
• Users should cease the use and distribution of the affected product and immediately quarantine the affected product.
• If you have any of the affected products, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and contact Teleflex Customer Service by calling the phone number provided.
• If you do not have any of the affected products, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex at the contact details provided.
• Where affected product and Lot numbers are identified, please also contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall). Please confirm if the quantity of product to be returned is single or pack (unit of issue).
• All products are to be returned no later than 30 June 2023.
• Please maintain awareness of this notice until all required actions have been completed in your organisation.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible persons and distributors 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.