Field Safety Notice Medicina IV Syringe Luer Slip for Insulin Use FSW773 (ICN 2516)

Alert:

• Medicina has issued a Field Safety Notice to inform users that although the primary packaging of the affected batches of the 1ml luer slip IV insulin syringe listed below, and in the Field Safety Notice, is orange, the printing on the barrel is black.
• This is not in line with Medicina’s specification for the product.
• Medicina advise there is no risk of harm when used as intended, the primary packaging features the appropriate colour coding. The graduation markings display accurate measurements suitable for insulin use.

Products Affected:

•  The affected product has been supplied on the Blue Diamond route by NHS Supply Chain:

• Please note this product is currently unavailable to order.
• Medicina intend to include a copy of this Field Safety Notice with each box prior to despatch. As soon as this can be implemented supplies will resume.
• A potential Indirect alternative is available to order from our online catalogue:
  • FSW1425 – Insulin Syringe 1ml Luer Slip Concentric Clear Plunger Sterile.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternative.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Highlight to users that extra care should be taken to ensure that syringe graduation markings with ‘units’ not ‘ml’ should be used to administer insulin, and that this should always be checked prior to administration.
• Please note this is not a product recall if you have any questions or queries in relation to this notice please contact Maria Ziden, QMS Manager. Email: administrator@medicina,co,uk  Telephone: 01204 695050 Fax: 01204 697755.

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.

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.