Field Safety Notice Medicina ENFit Reusable and Medicina Oral Syringes Product Recall of Specific Batch Numbers (ICN 1732)

MHRA TBA
NHSSC: 30

Alert:

• Medicina is voluntarily recalling the batches of product listed in their Field Safety Corrective Action Notice because the plunger component has been manufactured with an unapproved material.
• Medicina would like to reassure users that material that was used is safe for the intended use, however it does not meet their raw material specification, and this is the reason for the recall.

Products Affected:

• 10 products available from NHS Supply Chain are affected, please see our Downloads section to refer to the product listing for full details.
• The Field Safety Corrective Action Notice details all the affected batch numbers.
• Please note no other Medicina products or batch numbers are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Corrective Action Notice and share with all users of the affected products.
• Where affected product/lot numbers are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).
• Please confirm if the quantity of product to be returned is single pack in unit of issue or part pack in which case please advise number of single products.
• All products to be returned no later than Friday 5 August 2022.
• Medicina advise it will be several weeks before supplies return to normal. Alternatives are being sourced where possible and we will issue updates as more information becomes available.
• 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 Customer Relationship Manager.