Field Safety Notice Pennamed Endoscope Seal Bags XL FAL15595 (ICN 3448)

NHSSC: 52

Alert:

• Pennamed has issued a Field Safety Notice regarding a specific batch of FAL15595 (large endoseal bags- 27902).
• The affected batch is marked as a latex free product.
• Following an internal investigation, a rubber elastic band which contains latex has been included in the packaging meaning the affected batch is no longer a latex free product.

Products Affected:

• One product is affected.
• The affected product is available to order through NHS Supply Chain’s eDirect service:

• Please note only the Lot number quoted above and on page 1 of the Field Safety Notice is affected.
• The affected batch was distributed on and after 23 July 2026.
• The product is currently suspended and unavailable to order.
• Customers may wish to consider other suitable products depending on the size of the tray being used:
  • FAL18676 – Eze Use Endoseal Bags
  • FYY85490 – Sterile liner set.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.
• The supplier is yet to advise when unaffected stock of FAL15595 is likely to be available to order.
• NHS Supply Chain and Pennamed are reviewing any further indirect alternatives that may be considered.
• This ICN will be updated as soon as more information is available. 

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use immediately and quarantine all product of the affected batch number.
• Complete Annex A: Reply Form, page 3 of the Field Safety Notice and return to productsupport@pennamed.co.uk.
• Where customers have affected product for return, customers can either request an alternative liner from Pennamed or credit.
• For customers wishing to receive credit, please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products returned to Pennamed, including National Product Code (NPC), Lot number and quantity.
• Your Customer Services Advisor will give you a unique CMS log number and organise your credit as appropriate.

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

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.