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Field Safety Notice B Braun Original Perfusor® Line (ICN 2423)

Important Customer Notice Field Safety Notice

Ref: 2024/2423 ICN Number: 2423

Alert:

  • B Braun has issued a Field Safety Notice regarding specific batches of their Original Perfusor® Line.
  • It has been identified that the male Luer connectors of the affected batches show dimensional deviations. This could have the effect, that a tight and safe connection to other products is not possible.
  • The deviation might harbour the risk for the patient of microbial contamination, under supply, open patient access or air infusion.
  • A potential consequence for the healthcare worker is given by contact with hazardous drugs.

Products Affected:

  •  There are 3 affected products available from NHS Supply Chain:
NPC Product Description MPC Affected Batches
FSB495 PERFUSOR LINE, PVC, LL, 150 CM 8722960 23F12E8SB4 23E31E8SB5
FSB1577 PERFUSOR LINE, PVC, LL, 50 CM 8255172 23F20E8SB4
FSB612 PERFUSOR LINE, PVC, LL, 200 CM 8722862 23E25E8SB5 23F11E8SB5
  • Please note only the Lot numbers specified are affected.
  • NHS Supply Chain has quarantined any affected stock and all future orders will be fulfilled with unaffected products.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Cease use and quarantine any affected stock.
  • Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, reason code 7 Supplier recall, by 8 March 2024.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or your Hospital Care Team.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.

Downloads ▼

  • 2423 Field Safety Notice B Braun 15 February 2024

    A PDF showing the Field Safety Notice for ICN 2423.