Field Safety Notice GBUK Safety Hypodermic Needle 25G FTR3356 (ICN 3299)

Update:

• GBUK has issued a Field Safety Notice regarding specific lots of Safety Hypodermic Needle 25G x 5/8″ (0.5 x 16mm) Orange.
• After receiving complaints regarding blockage of the safety needle, the supplier’s analysis revealed that the blockage was caused by the solidification of the silicone oil inside the needle cannula.
• GBUK advise that the occurrence of the blockage will render the product unusable and will not cause personal injury.

Products Affected:

• There is one product affected.
• The product affected is available via NHS Supply Chain:

• Please note an additional lot number has been identified.
• NHS Supply Chain has quarantined all affected stock held.
• The affected product is suspended and unavailable to order.
• Supply is expected to resume mid-April 2026.
• Potential indirect alternative products are available to order through our online catalogue:
  • FTR3009 – Safety Hypodermic Needle 25G x 16 mm (0.625 inch) Orange Sterile Safety Mechanism to be activated via hard surface
  • FTR1978 – Safety Hypodermic Needle 25G Orange x 16mm (0.625inch) Sterile
  • FTR2438 – Safety Hypodermic Needle 25G Orange x 16mm (0.625 inch) Sterile
• 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.
• See our Downloads ▼ section to access the product listing for further information on the affected product and potential alternatives.

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 lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, reason code seven – Supplier recall. All products must be returned no later than Friday 17 April 2026.
• GBUK have implemented corrective action with an observation port being installing on the production line’s air pressure valve to prevent similar incidents from occurring.

NHSSC: 123

Alert:

• GBUK has advised NHS Supply Chain of a potential manufacturing error regarding one lot of its Safety Hypodermic Needle 25G × 5/8″ (0.5 × 16mm) Orange.
• The error potentially leads to blockage of the needle and thus renders it unusable.
• The supplier is working with the manufacturer to release a Field Safety Notice.
• As a precautionary measure, and until the Field Safety Notice has been received, GBUK requests that all customers immediately quarantine the affected lot.

Products Affected:

• There is one product affected.
• The product affected is available via NHS Supply Chain:

• NHS Supply Chain has quarantined any affected stock held.
• The affected product is suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue:
  • FTR3009 – Safety Hypodermic Needle 25G x 16 mm (0.625 inch) Orange Sterile Safety Mechanism to be activated via hard surface.
  • FTR1978 – Safety Hypodermic Needle 25G Orange x 16mm (0.625inch) Sterile.
  • FTR2438 – Safety Hypodermic Needle 25G Orange x 16mm (0.625 inch) Sterile.
• 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.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.

Next Steps:

• Identify and quarantine any of the affected lot found.
• We will update this ICN with further actions once advised by the supplier.

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.