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

Important Customer Notice Field Safety Notice

Ref: 2022/1609 ICN Number: 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:
NPC Product Description Supplier Code/ MPC Affected Batch
FSU562 MICROSITE 2FR MST KIT 114702 060122GG
FSU562 MICROSITE 2FR MST KIT 114702 091221GG
FSQ2107 NUTRILINE STYLETTED 24G 30CM 1252030 240122GP
FSU263 PREMICATH+STYLET+MICROFLSH INTRO B10 1261208 050122GS
  • 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.

Downloads ▼

  • 1609 Vygon UK Ltd Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1609.
  • 1609 Vygon UK Ltd Product Listing with Alternatives

    An Excel file detailing the affected product codes for ICN 1609.
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