Field Safety Notice Convatec Avelle Pump Kit ELZ853 (ICN 1458)

Important Customer Notice Field Safety Notice

Ref: 2021/1458 ICN Number: 1458

NHSSC Ref: 58

Alert:      

  • Convatec has issued a Field Safety Notice following discovery that the Avelle pump kit contains an unapproved luer lock connector located on the male end of the Avelle tube.
  • Identified potential hazards include tissue damage, non-penetrating wounds, (maceration), infection requiring prescriptive treatment.

Products Affected:

  • Of the products affected one is available from NHS Supply Chain:
NPC Product Description Supplier Code/ MPC Affected Lot Number
ELZ853 Negative Pressure Wound Therapy Disposable Pump (30 days) 421551 (1724310) WO027648
  • Please note although other products and lot numbers are listed in the Field Safety Notice, Convatec advise only one delivery of 60 units to NHS Supply Chain was affected, as detailed above.
  • There should be no impact on future supplies of this product.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Where pumps with lot number WO027648 are identified, immediately quarantine, and contact your NHS Supply Chain Customer Service Advisor with full details. Following verification, you will be asked to destroy the pump and complete and return the Certificate of Destruction ( COP). see our Downloads ▼ section.
  • On receipt of the completed Certificate of Destruction NHS Supply Chain will raise full credit on your behalf.

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

Downloads ▼

  • 1458 Convatec Certificate of Destruction

    A PDF of the Certificate of Destruction for ICN 1458.
  • 1458 Convatec Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1458.