Field Safety Notice – Smiths Medical Tracheostomy Connector

17th September 2024

Dear Customer,

Smiths Medical has issued an updated Field Safety Notice (FSN) in relation to a potential issue related to the neck plate/flange of Portex Blue Line Siliconised PVC Tracheotomy Tube.

Specifically, this failure mode can manifest itself during use as a complete or partial detachment of the neck plate from the tracheostomy tube on Portex Blue Line Classic Tracheotomy tubes.

The following information details the additionally affected batches of stock purchased through NVS and the required steps for you to perform. See attached letter dated 9th September 2024.

 

NVS Code

Description Item No. Affected Batch Number

91169

Tracheostomy 5.0mm Uncuffed 15mm Connector + 10/Ca

100/506/050

3792295
3955115
4153262
3835671

 

NVS Code

Description Item No. Affected Batch Number

91157

Tracheostomy 4.0mm Uncuffed 15mm Connector + 10/Ca

100/506/040

3792289
3901278
3955752
3965902
3990451
4056476
4150717
4187261

 

What do I need to do next? –  If you have the affected products:

  • Quarantine the product.
  • If you have any of the affected stock, then please contact our Customer Services Team on 01782 771111 (Option 3) to arrange the return of the products.
  • This affected product will only be accepted until 25th October 2024, after this date we will not accept this product.