Field Safety Notice B Braun Original Perfusor Line (ICN 1992)
Important Customer Notice Field Safety Notice
- 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.
- Three of the affected products are available from NHS Supply Chain as:
|NPC||Product Description||Supplier Code / MPC|
|FSB557||Extension set bore micro male/female luer lock PE 1mm id x 2mm od x 150cm pressure resistant up to 4 bar||8722935|
|FFF879||Extension set Light sensitive micro bore male/female luer lock PE 1mm id x 2mm od x 150cm pressure resistant up to 2 bar||8723017|
|FSB611||Extension set bore micro male/female luer lock PE 1mm id x 2mm od x 200cm Perfusor tubing resistant to 4 bar||8723060|
- 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.
- 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.