Field Safety Notice Teleflex Arrow Haemodialysis Catheters Multiple Products (ICN 3314)

NHSSC: 02

Alert:

• Arrow International, a subsidiary of Teleflex Incorporated, has received a Field Safety Notice from Merit Medical Systems, advising of a recall for the Merit 16F Dual-Valved Splitable Sheath Introducer.
• As a result, Teleflex Arrow has issued a precautionery Field Safety Notice EIF-000605, recalling a number of Arrow Haemodialysis Kits and Sets which contain the affected Merit 16F Dual-Valved Splitable Sheath.
• According to the Merit FSN, in some cases the sheath introducer may not split as intended due to a design related issue.
• Use of a sheath introducer that does not split as intended during removal may result in immediate procedural complications, such as resistance during withdrawal, prolonged procedure time, localised pain, minor bleeding, hematoma, or superficial tissue injury. Application of excessive force during removal may lead to vessel wall injury or significant bleeding requiring medical or surgical intervention.
• Teleflex Arrow advises long-term health consequences are not anticipated, as the malfunction occurs during removal of the sheath introducer and would be promptly recognised and managed by trained healthcare professionals.

Products Affected:

• There are 72 affected products listed on the Field Safety Notice
• 24 affected products are available via NHS Supply Chain’s eDirect route.
• 5 products with affected batch numbers have been supplied by Teleflex via NHS Supply Chain’s eDirect Service, these trusts have been contacted individually by NHS Supply Chain.
• Please refer to the product listing and Field Safety Notice Appendix 2, pages 5 to 16, for details of the products and batch numbers affected.
• Please note only the batch numbers quoted in the Field Safety Notice are affected.

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.
• Complete the acknowledgment form, page 4 of Teleflex Field Safety Notice and return to UK@teleflex.com.
• On receipt of the completed form, Teleflex will contact you to arrange collection of the affected products
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and arrange credit where appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute 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.