Field Safety Notice Mediplus Silicone 2 Way Foley (Open Tip) Catheter Kit 18FR FUS85043 (ICN 3072)

NHSSC: 64

Alert:

• Mediplus has issued a Field Safety Notice regarding specific Lot numbers of their 5775 Silicone 2 Way Foley (open tip) Catheter Kit, 18Fr. 10cc, Standard, 42cm – FUS85043 due to a labelling error.
• Unit Box Label of Mediplus 18FR, Lot no. D01110 and D01341 are labelled as 14fr rather than the 18fr.
• The correct size catheter is in the box. The pouch label, and the shipper have the correct description listed.
• Mediplus 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 via our eDirect Route:

• Please note only the Lot numbers quoted in the Field Safety Notice are affected by this labelling defect.
• 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.
• Continue to use the products as indicated, considering the updated information provided.
• Mediplus have informed us that they are also in contact with affected customers.

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.