Teleflex Endotracheal Tube

Important Customer Notice Field Safety Notice

Ref: 2020/1079 ICN Number: 1079

MHRA : 2020/006/018/487/011
NHSSC : 23

Alert:

  • Teleflex Medical has issued a Field Safety Notice for Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery.
  • Due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
  • If the defect is present and is not recognised prior to use, adverse health consequences may result from the use of the device during laser therapy in the trachea and larynx including potential for mucosal cell trauma/bleeding, scarring, infection and pain. No patient injuries have been reported.

Products Affected:

  • There are five NHS Supply Chain product codes affected:
    NPC Product Description Supplier Code/MPC Supply Route
    FDF982 Standard Endotracheal Tube cuffed with murphy eye White rubber (contains latex) with murphy eye laser resistant size 4.0mm 102004-000040 Blue Diamond
    FDF983 Standard Endotracheal Tube cuffed with murphy eye White rubber (contains latex) with murphy eye laser resistant size 5.0mm 102004-000050 eDirect
    FDF984 Standard Endotracheal Tube cuffed with murphy eye White rubber (contains latex) with murphy eye laser resistant size 6.0mm 102004-000060 Blue Diamond
    FDF985 Standard Endotracheal Tube cuffed with murphy eye White rubber (contains latex) with murphy eye laser resistant size 7.0mm 102004-000070 eDirect
    FDF986 Standard Endotracheal Tube cuffed with murphy eye White rubber (contains latex) with murphy eye laser resistant size 8.0mm 102004-000080 Blue Diamond
  • Please refer to the Field Safety Notice and product listing for further information on the affected product codes and specific lot numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Complete and return the acknowledgement form on page 3 of the Field Safety Notice to orders.uk@teleflex.com.
  • Where affected product has been identified remove and quarantine.
  • If you have any of the affected Blue Diamond products please contact your NHS Customer Service Advisor who will arrange for the products to be returned. All products to be returned no later than 17 July 2020.
  • If you have any of the affected eDirect products please contact your NHS Customer Service advisor with full details to enable us to monitor return direct to the supplier and manage your credit.

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

Downloads ▼

  • 1079 Teleflex Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1079.