Field Safety Notice Micsafe GBUK Safety Hypodermic Needles Printing Error on Packaging (ICN 2617)

MHRA TBC

NHS Supply Chain Reference: 32

Alert:

• Micsafe Medical has issued a Field Safety Notice following discovery that the blister level of the packaging for two sizes of their safety hypodermic needles, has the expiry and manufacture dates transposed.
• The blister packaging reads date of manufacture 2027-12-29,and the expiry date as 2022-12-30. This should read date of manufacture 2022-12-30, and the expiry 2027-12-29.
• All the other layers of packaging are printed correctly.

Products Affected:

•  The products affected are stocked and available from NHS Supply Chain:

• Please note this lot number will continue be supplied until stocks are run down / replenished.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Micsafe confirms this error poses no risk to the safety of the patient, the operator, or affects the performance of the device, therefore will not be subject to a product recall and the devices can continue to be used within the scope of this notice.
• Customers with any concerns and requiring exchange with replacement product may contact Jenny Fang by email: fang@micsafe.com
• In this event please also contact your local NHS Suppy Chain Customer Service Advisor with full details to enable us to log the information and offer support as appropriate.

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.