B Braun Histoacryl Blue and Histoacryl Transparent (ICN 1265)

Important Customer Notice Recall

Ref: 2021/1265 ICN Number: 1265

NHSSC: 12

Alert:     

  • B Braun is voluntarily recalling some batch numbers of their Histoacryl sterile liquid tissue adhesive. Following some complaints, the company detected that the adhesive could not polymerise completely after application.
  • The product provided lower adhesive forces than expected.
  • Histoacryl can be used for wound closure, mesh fixation in gastric varices according to the approved indications.
  • Topical use only of Histoacryl products are not included as the risk is accepted for this indication in this FSCA.
  • Mesh fixation:
    Risk of herniation, foreign body reaction. Risk of infection, pain, irritation, inflammation.
    Need for medical treatment or reoperation.
    Operating time extension
  • Sclerotherapy:
    Non-stoppable haemorrhage, delayed embolization.
    Need for medical treatment or reoperation.
    Operating time extension.
    The potential harm could lead to a life-threatening injury or even death.
  • Please note B Braun issued two Field Safety Notices in March 2021, which did not include any lot numbers supplied to NHS Supply Chain. The Field Safety Notice issued 27 April 2021 covers additional batches some of which have been issued to NHS Supply Chain, this latest FSN is attached which includes all previously published details.

Products Affected:

  • The affected products are available from NHS Supply Chain as:
NPC Product Description Supplier Code/MPC Route
FKV081 Tissue Adhesives Histoacryl skin adhesive 10 ampoules of 0.5ml monometric n-butyl-cyanoacrylate – translucent pack 10 1050071 eDirect
FVN055 Tissue adhesive Histoacryl skin adhesive 5 ampoules of 0.5ml monomeric n-butyl-2-cyanoacrylate blue pack 10 1050052 Stock
FVN069 Tissue adhesive Histoacryl skin adhesive 5 ampoules of 0.5ml monomeric lucent n-butyl-2-cyanoacrylate pack 10 1050060 Stock
FVN176 Tissue adhesive Histoacryl skin adhesive 10 ampoules of 0.5ml monomeric n-butyl-2-cyanoacrylate blue pack 10 1050044 eDirect
  • Please note FVN055 and FVN069 as currently suspended, please refer to our online catalogue for available alternatives.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Where affected product/ lot numbers are identified, quarantine and contact your NHS Supply Chain Customer Service Advisor by Friday 21 May 2021, latest, with full details including all part packs still in your possession.
  • Your Customer Service Advisor will confirm details regarding disposal and will manage your credit as appropriate.

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

Downloads ▼

  • 1265 B Braun Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1265.