Product Recall TSC Life Fluido® Trauma Sets VCB522 (ICN 2554)

Alert:

• The Surgical Company International BV (TSC Life) has issued a Field Safety Notice recalling specific batches of Fluido® Trauma Sets following a temporary change to a manufacturing technique resulted in the production of a number of individual Fluido® Trauma Sets with an unstable connection junction.
• This could result in leakage from the set connection leading to unreliable infusion during use.
• The Surgical Company International BV has decided to recall all batches manufactured between April 2022 and September 2022 which have been produced with the same manufacturing technique.
• The affected batch numbers are listed in Appendix 1, page 3 of the Field Safety Notice.

Products Affected:

•  The product affected is available from NHS Supply Chain:

• Please note only the batch numbers quoted in appendix 1, page 3, of 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 batch numbers.
• Complete the Product Response Form and email to: quality@tsc-life.com.
• On receipt of the completed form the supplier will contact you to arrange collection and exchange.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products for exchange to enable us to assist you if 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/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.