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Field Safety Notice Baxter Y-Type Blood Solution Infusion sets (ICN 1921)

Important Customer Notice Field Safety Notice

Ref: 2022/1921 ICN Number: 1921

Alert:

  • The supplier Baxter Healthcare has issued a Field Safety Notice following discovery that specific Lot numbers of the Y-type Blood Solution Sets have an incorrectly positioned (non centered) drop former in the blood chamber.
  • If the drop former is not in the centre of the chamber, the set may not function as intended. A shorter lower section of the blood chamber may impact the ability to prime the set and impact the flow performance.
  • A non-centered drop former in the blood chamber may lead to a delay in therapy, interruption of therapy, and/or the administration of damaged blood or blood products. Baxter advises there have been no reports of serious injury related to this issue.

Products Affected:

  •  The affected product was available from stock via NHS Supply Chain:
NPC Product Description Supplier Code / MPC   Affected lot numbers
FSB998 Administration Set Pump / Gravity Colleague Pump EMC9612 21l14T924                                22E20T151
  • Please note this administration set is currently suspended due to supply issues. Please refer to ICN 1868 for more information.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Locate and quarantine all unused affected products.
  • Contact your NHS Supply Chain Customer Service Advisor who will give you a unique CMS log number and advise the next steps.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1921 Baxter Field Safety Notice 21 December 2022

    A PDF showing the Field Safety Notice for ICN 1921.