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

Alert:

• 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:

*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.