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.