Field Safety Notice Rocialle RSET5003 Pack Minor Op (Bronze) (ICN 3050)

NHSSC: 58

Alert:

• Rocialle has issued a Field Safety Notice withdrawing specific lot numbers of their RSET5003 Pack Minor Op (Bronze) due to a labelling error.
• Some individual packs of Rocialle RSET5003 Pack Minor Op (Bronze), lot no. W556093 are labelled as RMT9683 lot no. W556187.
• The case label for the products is correct but some of the packs within each case are incorrect
• Rocialle advise this is a labelling issue only and that there is no impact on the contents of the pack.

Products Affected:

• The product affected is available from NHS Supply Chain:

• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Rocialle are requesting customers in possession of the affected lot numbers log this information on the Rocialle Customer Complaint Portal: https://www.rocialleacutecare.com/report-a-problem/ after which Rocialle Customer Services team will contact you to organise collection and replacement.
• If you have any queries regarding this Field Safety Notice, please contact: regulatory@rociallehealthcare.com.

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.