Field Safety Notice B Braun Original Perfusor Line (ICN 1992)

Alert:

• B Braun Melsungen AG has decided to proactively recall the article/batch combinations of Original Perfusor® Line listed within Appendix 1 of this Field Corrective Action Notice.
• In the course of post market surveillance, the potential for holes or leakage was identified.
• This 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 to hazardous drugs.

Products Affected:

• Three of the affected products are available from NHS Supply Chain as:

• Please note only the batch numbers listed in Appendix 1, page 3 of the notice, are affected.
• Current warehouse stock has been checked and future supplies will be of unaffected batch numbers, this withdrawal should have 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 products.
• Where affected product/ lot numbers are identified, cease use and quarantine.
• Contact your NHS Supply Chain Customer Service Advisor with full details to arrange a return for credit (reason code 7 Supplier Recall).
• Please confirm if the quantity of product to be returned are singles (eaches) or pack 100.
• All products to be returned no later than Friday 10 February 2023.

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