Field Safety Notice Intersurgical Guedel Airways (ICN 3381)

NHSSC: 28 Update

• See our Downloads ▼ section to access the product matrix showing the Guedel ISO information and the alternatives associated with each colour and size.
• The supplier is yet to advise an expected resolution date.
• We will update this Field Safety Notice as soon as we have further information.

NHSSC: 28 Update

• Intersurgical has advised that the product recall of affected Guedel Airway products has created a disruption in supply.
• The four affected products are now suspended and unavailable to order:
  • FDB443 – Airway oropharyngeal guedel disposable Size 00 ISO 5 blue
  • FDB442 – Airway oropharyngeal guedel disposable Size 000 ISO 3.5 light green
  • FDB312 – Airway oropharyngeal One piece size 00 ISO 5.0 blue
  • FDB311 – Airway oropharyngeal One piece size 000 ISO 3.5 light green.
• We are expecting deliveries of FDB311 and FDB312 in our depots next week.
• Once stock has been received, FDB311 and FDB312 will be subject to Protect Demand Management to support continuity for all customers.
• These products will be available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure fair supply of available stock across the NHS.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for more information on the affected products and potential alternatives.
• The supplier is yet to advise a likely date the supply disruption will be resolved.
• We will update this ICN as soon as we have further information.

NHSSC: 28

Alert:

• Intersurgical has issued a Field Safety Notice for all lots with an expiry date in the range 2026-06 to 2031-02 of Guedel airway products.
• The supplier advises that during manufacture, some devices have been identified with occluded or partially occluded tips of the Guedel airway.
• The hazard arising from this manufacturing fault depends on the level of occlusion.
• Potential issues include, but are not limited to, respiratory distress, laryngospasm, stridor, stenosis, oedema, neurological impairment, hypoxia, hypoxemia and cyanosis and their consequences.
• Should an occluded or partially occluded Guedel airway be used on a patient, the severity of the risk has been evaluated as critical and the probability as probable. We therefore believe it is essential to address the issue promptly to reduce the risk of any potential patient harm.

Products Affected:

• Six products are affected.
• Four of the affected products are available from NHS Supply Chain:

• All lot numbers with an expiry date in the range 2026-06 to 2031-02 are affected.
• All NHS Supply Chain stock has been checked, and future orders will be fulfilled with unaffected stock.
• The supplier has advised this recall does not impact future supply of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Complete the Customer Reply Form, found page 8 of the notice, and return to priority@intersurgical.co.uk
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

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.