Field Safety Notice Johnson & Johnson Gynecare TVT Exact® EIR075 (ICN 3430)

NHSSC: 38

• The affected product remains suspended and unavailable to order:
  • EIR075 – Stress Incontinence Mesh Continence System.
• Potential indirect alternative products are available to order through our online catalogue:
  • EIR016 – Stress Incontinence Mesh Sling Retropubic System
  • EIR061 – Stress Incontinence Mesh Continence System
  • FXS85801 – Synthetic womens health mesh CESA F1.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for their organisation’s use of these products.
• We are working with the supplier to establish when the affected product will be available to order and will update this ICN once known.

NHSSC: 38

Alert:

• Johnson & Johnson has issued a Field Safety Notice FSCA# FA-0000152 in support of Ethicon Sarl’s Medical Device Recall of eight Lot numbers of Gynecare TVT Exact® mesh following complaints of white particles present in the sterile barrier.
• Johnson & Johnson advise further investigation determined that the white particulates originated from the adhesive layer applied to the Tyvek lid of the product packaging, and that the particulates come from packaging materials which are not cytotoxic not genotoxic.
• They are not expected to sensitize or irritate, or be systemically toxic, and are unlikely to affect device functionality.
• The root cause was identified as a manufacturing issue associated with this recall and corrective actions and controls have been implemented to prevent recurrence.

Products Affected:

• One product code is affected.
• The product code affected was available via NHS Supply Chain’s eDirect service.
• Cease the use, implant or distribution of the following product Lots, effective immediately:

• Please note that only the Lot numbers quoted above and on page 1 of the Field Safety Notice are affected.
• The product is currently suspended and unavailable to order through our online catalogue.
• This ICN will be updated as soon as more information is available.

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 the affected Lot numbers immediately.
• Complete the Business Reply Form (BRF) Attachment 2, page 5 of the Field Safety Notice and email it to MDFieldActionsUKIrl@its.jnj.com. Please return the BRF even if you do not have any affected products.
• If you have affected products for return, please ensure you enclose a copy of the BRF when you return the affected products.
• Johnson & Johnson advises products subject to this recall must be returned no later than 31 August 2026 to MDFieldActionsUKIrl@its.jnj.com. Any non-affected product and any product returned after the date specified will not receive credit reimbursement.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products returned to Johnson & Johnson, including product codes, Lot numbers, and quantity. Your Customer Services Advisor will give you a unique CMS log number and organise your credit as 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.