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Teleflex RUSCHELIT® Super Safety Clear Tracheal Tube (ICN 1267)

Important Customer Notice Update

Ref: 2021/1267 ICN Number: 1267
  • Teleflex have advised that recovery to full supply of all the affected products is currently expected by Q2 of 2022.
  • Endotracheal Tube supply has been impacted globally by a quality hold (a standard procedure for manufacturers where products are held for quality inspection) resulting in the Field Safety Notice and recall being issued.  While production has restarted supply will be limited up to Q2 2022 due to component availability, manufacturing capacity and the volume of backlog for these particular codes.
  • These products are now on allocation globally, but as Teleflex is not in a position to guarantee continued supply to NHS Supply Chain the request was made that they be suspended.
  • Teleflex has issued a further Field Safety Notice EIF-000464 – EIF000478 expanding the products affected. See appendix 2 on page 5 onwards of the Field Safety Notice.
  • There are 54 products included in the latest Field Safety Notice.
  • Please see our Downloads ▼ section to view the expanded product listing.
  • The risk and next steps remain as explained in the original Field Safety Notice.
  • Teleflex advise there may be an impact on the supply of these products.  See the product listing for suggested potential alternatives. NHS Supply Chain will work with Teleflex and other Suppliers and provide updates as appropriate.

MHRA: 2021/005/004/487/001

NHSSC: 13

Alert:

  • Teleflex has initiated a voluntary Field Safety Notice for RUSCHELIT® Super Safety Clear Tracheal Tube due to reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
  • In the event of the pilot balloon remaining flat there is the potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff.

Products Affected:

  • There are 22 NHS Supply Chain product codes affected available.
  • Please see our Downloads ▼ section to refer to the Field Safety Notice and Product Listing for details of affected products.
  • Please note only product with manufactured and expiry dates specified in Appendix 2, page 4 of the notice, are affected.

Next Steps:       

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
    Complete the Acknowledgment Form, page 3 of the notice, and return to Recalls.Intl@teleflex.com.
  • Teleflex will arrange collection of affected products up receipt of the completed Acknowledgment Form.
  • Where affected product is identified, please also contact your NHS Supply Chain Customer Service Advisor with full details of product returned to the supplier to enable us to manage your  credit as appropriate.

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

Downloads ▼

  • 1267 Teleflex Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1267.
  • 1267 Teleflex Product Listing with Alternatives

    An Excel file detailing the affected product codes for ICN 1267.
    Login to view the downloads