Field Safety Notice Healthcare 21 Niti-S Tracheobronchial Uncovered Stent (ICN 2479)

Alert:

• HealthCare 21 has circulated a Field Safety Notice issued by Taewoong recalling all unexpired Lot numbers of a range of Niti-S Tracheobronchial Uncovered Stents, (BRxxxxW).
• The recall is due to a design defect, leading to a possibility that some of the Niti-S Tracheobronchial Uncovered Stents (BRxxxxW) within the expiration date may not perform as intended due to the underperformance of expansion and compression.
• Taewoong Medical advise they have not been notified of any patient injuries related to this issue.

Products Affected:

• There are seven affected products available from NHS Supply Chain eDirect route:
  • FRM4412, FAL17515, FAL17270, FRM4372, FAL17484, FAL17278 and FAL17280.
• See our Downloads ▼ section to access the product listing below for further information on the affected product codes, Recall Notice
• The supplier has confirmed that they can fulfil future orders with unaffected products.

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 devices.
• Complete the HC21 Verification Form and return by emailing compliance@hc21.group
• Upon receipt of the completed form HC21 will contact you to arrange collection of the affected devices.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of affected products returned to HC21, including NPC, Lot numbers and quantities, to enable us to assist and raise your credit where necessary.
• 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 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.