Field Safety Notice Promedics Orthopaedics Ltd Wrist and Thumb Brace (ICN 2258)

Alert:

• The Supplier Promedics Orthopaedics Ltd has issued an urgent Field Safety Notice due to wrist and thumb brace products missing the correct latex labelling within the packaging.
• Promedics Orthopaedics Ltd has advised that a small number of products within the batches listed on the Field Safety Notice have been mislabelled without the latex warning displayed on or within the product packaging.

Products Affected:

• Please note – only the Lot numbers listed in the Field Safety Notice are affected:
  • 075213, 077370, 077903, 077990, 078102 and 078448.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• Current warehouse stock has been checked to ensure future supplies will be of unaffected batch numbers.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected batches.
• 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).
• All products should be returned no later than 22 September 2023.
• Where potential alternatives are identified, customers are advised to consult their 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.

Please be aware that in the event of a Field Safety Notice or 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.