Smith & Nephew IODOFLEX Dressing 3 X 10g (ICN 1127)

Important Customer Notice Recall

Ref: 2020/1127 ICN Number: 1127

NHSSC : 46
MHRA : 2020/009/025/487/003

Alert:

  • Smith & Nephew have issued a Field Safety Notice for 1 lot of their IODOFLEX Dressing 3 X 10g due to a manufacturing error.
  • The welding of the dressing seals could potentially result in a sterile barrier breach.
  • In the most likely scenario, the breached package does not lead to product contamination and the use of the product has no impact on the procedure or patient. In the worst case the package breach resulted in a non-sterile product, the product use could potentially result in a biological response such as local infection and/or systemic infection.

Products Affected:

  • The affected product is available through NHS Supply Chain as:
NPC Product Description Supplier Code/MPC Affected Lot
EKB008 IODOFLEX Dressing 3 X 10g 66001302 CDB201
  • Please See our Downloads ▼ section to refer to the Field Safety Notice for further information on the product code and lot number.

Next Steps:

  • Locate and quarantine affected unused devices immediately.
  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Complete the return slip, found on page 2 of the Field Safety Notice, and email to AWM.CS.UKI@smith-nephew.com.
  • Where affected product/ lot number are identified, please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 7 Supplier Recall). All products to be returned no later than Friday 30 October 2020.

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

Downloads ▼

  • 1127 Smith & Nephew Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1127.