Aquacel Extra Hydrocolloid Gelling Fibre Dressing FSCA 2020-002 (ICN 1208)

Important Customer Notice Field Safety Notice

Ref: 2021/1208 ICN Number: 1208

MHRA: 2021/002/017/487/012

NHSSC:  77

Alert:        

  • ConvaTec has issued an urgent Field Safety Notice affecting one lot number of the Aquacel Extra Hydrocolloid Sterile Dressing 15cmx 15cm because in some  instances where the dressing has been found to be attached to the seam of the primary packaging, therefore breaching the sterile barrier making the product unable to be used.
  • Using a non-sterile device on a patient may potentially expose the patient to infectious agents.

Products Affected:  

  • This dressing is available from NHS Supply Chain as detailed below.
NPC Description Supplier Code/ MPC AffectedLot Number
ELY379 Aquacel Extra gelling fibre dressing 15cm x 15cm 420673 0C01702
  • Stock held in the NHS Supply Chain warehouses has been checked and future supplies will be of unaffected lot numbers.
  • The manufacturer has confirmed withdrawal of this single lot number will have no impact on future supplies of this dressing.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products. See our Downloads ▼ section.
  • Identify, cease use and quarantine all the affected lot number.
  • Perform a count of the affected product currently in your inventory.
  • Complete and return the Corrective Action Response Form and return to uk.customerservice@convatec.com. Return this form even if you have no affected product in your possession.
  • Contact your NHS Supply Chain Customer Service Advisor with full details, including any part packs of the quantity of lot number OCO1702 in your possession, for the actions required to obtain your credit.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor

Downloads ▼

  • 1208 ConvaTec Attachments 1 and 2

    A PDF of Attachments 1 and 2 for ICN 1208.
  • 1208 Customer Response Form

    A PDF of the Customer Response Form for ICN 1208.
  • 1208 ConvaTec Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1208.