Field Safety Corrective Action Notice B Braun Perfusor Line PE FSB611 Specific Batch Numbers (ICN 1753)

Important Customer Notice Field Safety Notice

Ref: 2022/1753 ICN Number: 1753

MHRA TBC
NHSSC Ref: 36

Alert:

  • B Braun has issued a Field Safety Corrective Action Notice following the discovery during routine post-market surveillance activity of the potential for the luer connector to detach from the perfusor line in one batch number.
  • This could lead to the risk of patient microbial contamination, under supply or air infusion.
  • Refer to the Field Safety Corrective Action notice for full details.

Products Affected:

  • This product is available via NHS Supply Chain’s stocked route:
NCP Product Description Supplier Code / MPC Batch Number
FSB611 Extension set perfusor tubing PE Luer Lock 200cm 8723060 22C25E8SC6
  • Please note this issue only affects the one batch number.
  • NHS Supply Chain’s current stock has been checked and future deliveries will be of different, unaffected batch numbers.
  • B Braun have confirmed there will be no impact on future supplies.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected product.
  • Where the affected product/ lot number is found, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall).
  • Please confirm if the quantity of product to be returned is single, or pack of 100.
  • All products to be returned no later than Friday 26 August 2022.

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

Downloads ▼

  • 1753 B Braun Field Safety Corrective Action Notice 1 August 2022

    A PDF file showing the Field Safety Corrective Action Notice for ICN 1753.