Field Safety Notice Sol-Millennium (Sol-M) Blunt Fill Needle FTR3440 (ICN 1646)

Important Customer Notice Field Safety Notice

Ref: 2022/1646 ICN Number: 1646

Alert: 

  • Sol-Millennium, Poland has issued a Field Safety Notice initiating a voluntary recall for a range of lot numbers of the SOL-M Blunt Fill Needle having determined an increase in coring of the vial rubber stoppers of medication when reconstituting dilutant and accessing vials. Visible pieces of rubber were found floating in the barrel of the syringe and the IV bag used to administer the medication.
  • The Sol-M Blunt Fill Needle is used to pierce the medicine vial septum or ampule and aspirate medication into a syringe. Once medication is aspirated into a syringe, the contents of the syringe may be injected into an I.V. System or pre-slit septum covering injection sites. The SOL-M Blunt Fill Needle may be removed and replaced with a needle and the contents of the syringe can be injected into individuals.
  • The SOL-M Blunt Fill Needle is not intended for human injections.

Products Affected:

  • One of the affected products is available from NHS Supply Chain:
NPC Product Description Supplier Code/ MPC Affected Lot numbers
FTR3440 Safety Needle Blunt Fill 18g 38mm (1.5”) BN1815 210305
210308
210308
210310
  • Please note no other lot numbers are affected and all stock held for issue in NHS Supply Chain warehouses is of different lot numbers.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products(see our Downloads ▼ section).
  • Cease use of the affected lot number, quarantine and contact your NHS Supply Chain Customer Service Advisor with full details including, confirmation of the lot number and full quantity in boxes x 100 or eaches if opened boxes.
  • Your Customer Service Advisor will confirm the details and on written confirmation of safe disposal arrange full credit on your behalf.

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

Downloads ▼

  • 1646 Sol Millennium Field Safety Notice 13 May 2022

    A PDF of the Field Safety Notice for ICN 1646.