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Supply Issues Getinge Adult Oxygenators FXA405, FXA182 and FXA538 (ICN 1969)

Important Customer Notice Resolved

Ref: 2022/1969 ICN Number: 1969
  • The supplier Getinge has informed us that this temporary supply issue is now resolved.
  • All product codes are now available to order through our online catalogue.
    • FXA405 – Adult Oxygenators PMP Set for Cardiohelp
    • FXA182 – Adult Oxygenators Tubing set PMP set for Rotaflow
    • FXA538 – Adult Oxygenators PMP set for Rotaflow.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Change:

  • The supplier Getinge has informed us of a supply issue with its Adult Oxygenators.
  • The three product codes affected are:
    • FXA405 – Adult Oxygenators PMP Set for Cardiohelp
    • FXA182 – Adult Oxygenators Tubing set PMP set for Rotaflow
    • FXA538 – Adult Oxygenators PMP set for Rotaflow.
  • The supply issue is due to concerns highlighted by German authorities with the quality of the testing of the packaging resulting in a global suspension of the products.

Impact:          

  • The affected codes are in the process of being suspended and will not be available to order.
  • There are currently no identified alternative products available to order through our online catalogue.
  • Customers should prepare to use an alternative ECMO machine, if available, in the event of their stock of the suspended items depleting.
  • Trusts will need to order the consumables for the alternative ECMO machine from the supplier and ensure staff are trained and confident in using it.
  • See our Downloads ▼ section to access the product listing for further information on the affected product codes.
  • The supply issue is anticipated to be ongoing for a period of more than six months.

Next Steps:               

  • Customers are advised to log into our website to view the affected products.
  • NHS Supply Chain are working closely with the supplier and the Department for Health and Social Care to minimise the disruption to NHS trusts and exploring all avenues to attempt to release some additional stock to NHS trusts in great need.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Downloads ▼

  • 1969 Getinge Product Listing 29 December 2022

    An Excel file showing the product listing for ICN 1969.
    Login to view the downloads