Field Safety Notice TRACOE Tracheostomy Tubes (ICN 1866)

MHRA 2022/010/027/611/006
NHS Supply Chain Reference: 60

Alert:

• TRACOE medical GmbH has issued a Field Safety Notice to emphasise the importance of following the details in the instructions for use for the following devices:
• TRACOE vario P-Tracheostomy Tube, TRACOE experc Set vario, TRACOE twist plus P-Tracheostomy Tube, TRACOE experc Set twist plus.
• The application bears a very low risk of tearing off the silicone sleeve when removing the insertion system. The incidence rate is 0.016 % and may be further minimized if the application is performed as described in the IFU.
• Despite general measures in production and in-process control to improve the strength of adhesion of the silicone sleeve to the guiding catheter, a small residual risk remains during use, as in all areas of medicine.

Products Affected:

• There are 32 products affected by this notice supplied by NHS Supply Chain.
• Please see our Downloads section for further information on the affected product codes.
• Please note that FDF1388, FDF1389 and FDH248 are delisted and are no longer available to order.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• To reduce the risks even further, users should follow closely the instructions in the user manual with specific attention to the steps described, with diagrams, in the Field Safety Notice.

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