Aquacel Gelling Fibre Antimicrobial dressing 20cm x 30cm Silver Impregnated Dressing (ICN 1354)

Important Customer Notice Field Safety Notice

Ref: 2021/1354 ICN Number: 1354

MHRA TBA
Recall Ref: NHSSC 39

Alert:

  • The supplier Convatec issued a Field Safety Notice in May for Aquacel Extra and an extension in August to include Aquacel for a voluntary withdrawal of a total of three lot numbers following receipt of a complaint of an open seam on the primary packaging, with the dressing partially stuck within the seal.
  • This has therefore breached the sterile barrier and made the product unable to be used.
  • Using a non-sterile device on a patient may potentially expose the patient to infectious agents.

Products Affected:

  • Please note the only product with affected lot numbers supplied to NHS Supply Chain is as listed in the table below.
  • Aquacel Extra which is in the FSN is in our offer as NPC ELY517, MPC 413569. Convatec confirms the affected lot number (OA01855) of this NPC was never supplied to us.
NPC Product Description Supplier Code/MPC Affected Lots
ELY112 Aquacel Gelling Fibre Antimicrobial dressing 20cm x 30cm Silver Impregnated Dressing 403711 0A03126 9L04131
  • Please note no other batch numbers are affected.
  • Current stock in our warehouses have been checked and do not contain these lot numbers.

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, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall). Please confirm if the quantity of product to be returned is in singles or pack of five.
  • All products to be returned no later than Friday 24 September 2021.

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

Downloads ▼

  • 1354 Convatec Field Safety Notice

    A PDF file detailing Field Safety Notice information and instructions for ICN 1354.