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Field Safety Notice Intersurgical Clear-Therm 3 HMEF with Luer Port and Retainable Cap (ICN 2083)

Important Customer Notice Field Safety Notice

Ref: 2023/2083 ICN Number: 2083


  • The supplier Intersurgical has issued a Field Safety Notice following reports of foam dust particles on the machine side housing of the HMEF and in the packaging, where it may come into contact with the patient side connection.
  • Whilst aesthetically undesirable the observed dust within the HMEF housing and packaging is unlikely to be released during use or compromise the patient’s airway.
  • However, there remains a possibility that it could come into contact with the patient.

Products Affected:

  • The products affected have been supplied by NHS Supply Chain:
NPC Product Description Supplier Code / MPC Status

Electrostatic filter with luer lock port and superset catheter mount with detachable elbow   22f 15m

1541974 Suspended   unavailable to order*

Electrostatic filter with luer lock port and retainable cap – adult 22f 15m




Suspended   unavailable to order*

Clear-Therm 3 HMEF with luer port Superset catheter mount double swivel elbow and 22f 15m


1541019 Suspended   unavailable to order*


*See our Downloads section to access the product listing for further information on the affected product codes and potential alternatives.

  • Please note only the Lot numbers quoted in the Field Safety Notice Customer Response Form are affected.
  • Intersurgical advises the manufacturing process for the HME material has been investigated and resolved; although unable to give a firm ETA they are currently producing code 1541974 / FTC212, production of the other codes will follow.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
  • Cease use and quarantine any affected batches.
  • Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including NPC, Lot numbers and quantity stating whether boxes or eaches.
  • Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, email quoting the CMS reference, of disposal in accordance with your local regulations will raise the appropriate credit.

Where potential alternatives are identified, Customers are advised to consult your 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.

Downloads ▼

  • 2083 Intersurgical Field Safety Notice 27 March 2023

    A PDF showing the Field Safety Notice for ICN 2083.
  • 2083 Intersurgical Response Form 27 March 2023

    A PDF showing the response form for ICN 2083.
  • 2083 Intersurgical Product Listing with Alternatives 27 March 2023

    An Excel file showing the product listing with alternatives for ICN 2083.