Field Safety Notice Vygon UK Ltd Peelable Cannula FSU562, FSQ2107 and FSU263 (ICN 1609)

Alert: 

• The legal manufacturer, Vygon GmbH, has identified a possible malfunction of the peelable introducer cannula included with the product codes and batch numbers listed below.
• After catheter placement and withdrawal of the peelable cannula, in a few cases the cannula may not peel completely, causing one half of the cannula to break off. As a result, a section of the cannula will remain on the catheter.

Products Affected:

• There are three NHS Supply Chain products affected across four batch numbers:

• Vygon has confirmed that affected stock held in their premises has been quarantined and is not being shipped to fulfil customer orders.
• Potential indirect alternative products are available to order through our online catalogue.
• Please see our Downloads ▼ section to refer to the product listing for further information on the affected product codes and potential indirect alternatives.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Vygon has confirmed any customers who have purchased the affected batches of these products through NHS Supply Chain and want to return them will be credited upon receipt of the items.
• Please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).
• All products to be returned no later than Friday 29 April 2022.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.