Field Safety Notice B Braun Melsungen AG Infusomat® Space Line (Transfusion) (ICN 1551)

Important Customer Notice Field Safety Notice

Ref: 2022/1551 ICN Number: 1551

Alert:             

  • B Braun Melsungen AG has issued a Field Safety Notice to proactively recall four batches  of Infusomat® Space Line (Transfusion).
  • Post market surveillance activities identified that the gluing connection between the tube and the patient connector might be inadequate. Due to temporary deviations in the production, the glue was supplied insufficiently, resulting in leakage of the device between the patient connector and the tube.
  • This might harbour the theoretical risk for microbial contamination, under supply, open patient access or air infusion.

Products Affected:

  • The product affected is available from NHS Supply Chain as:
NPC Product Description Supplier Code/ MPC Batch Numbers
FSB2495 Administration sets for Infusomat Space Volumatic Pump, type transfusion 8270066SP-01 21F23E8ST5, 21F25E8ST5, 21G16E8ST5, 21G17E8ST5.
  • Please note no other batch numbers are affected. NHS Supply Chain stocks have been checked and future orders will be of different batch numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Cease use immediately and quarantine the affected batch numbers.
  • Where affected product/ lot numbers are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall)
  • All products to be returned no later than Friday 18 March 2022.
  • Please note this withdrawal will have no impact on the availability of the product.

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

Downloads ▼

  • 1551 B Braun Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1551.