Field Safety Notice GBUK Enteral Feeding Syringe 5ml Transposed Lot Numbers FWD304 (ICN 2888)

NHSSC: 97

Alert:

• GBUK has issued an Advisory Field Safety Notice following discovery that two lot numbers, 241109 and 241119, have been transposed.
• The lot number on the outer shipper label does not match the lot number on the inner shelf box.
• The outer shippers labelled LOT 241109 have inner shelf boxes labelled 241119, and outer shippers labelled LOT 241119 have inner shelf boxes labelled LOT 241109.
• GBUK advise the issue does not pose any risk or potential hazard to the patient. The devices themselves remain unaffected and are safe for use.
• The primary concern is with traceability.

Products Affected:

• The affected product is available from NHS Supply Chain:

•  GBUK advise they are currently correct this packaging error.
• NHS Supply Chain issued the affected lot numbers during February and March 2025, our current stock is of a different lot number (250103).

Next Steps:

• Read and follow the full instructions in the Advisory Field Safety Notice and share with all users of the affected products.
• GBUK advise the issue does not affect the use of the device, and request to maintain traceability, the items be entered into your traceability system at the shelf box level.
• GBUK confirm the product is safe for use and does not pose any risk to patient safety or the proper use of the device.

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