Advanced Medical Solutions ACTIVHEAL® Hydrogel 8g (ICN 1126)

Important Customer Notice Recall

Ref: 2020/1126 ICN Number: 1126

MHRA 2020/008/011/601/008
NHSSC: 45

Alert:

  • Advanced Medical Solutions have issued a Field Safety Notice for 2 lots of ACTIVHEAL® Hydrogel 8g (REF 10011131).
  • The supplier has identified that due to a tube quality issue determined during the manufacturing process, the sterility of a small number of the Affected Tubes may have been compromised.
  • The quality issue can affect the sterility of the Hydrogel product, potentially compromising patient safety (potential risk of infection) however based on internal investigation the likelihood is considered low.

Products Affected:

  • The affected product is available through NHS Supply Chain as:
NPC Product Description Supplier Code/MPC Affected Lot
ELA639 ACTIVHEAL® Hydrogel 8g 10011131 43783 ,45556
  • The quality issue only affects these two lot numbers of ELA639. The affected tubes are not present in other batches of the ACTIVHEAL® Hydrogel product.
  • See our Downloads ▼ section to refer to the Field Safety Notice for further information on the product code and lot numbers.

Next Steps:

  • Users are instructed to dispose of any affected tubes in accordance with their trusts’ disposal procedures.
  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Contact your local NHS Supply Chain Customer Service Advisors with full details of all products disposed confirming if quantities relate to individual tubes or our unit of issue, pack of 10, to enable us to manage the credit on your behalf.

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

Downloads ▼

  • 1126 Advance Medical Solutions Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1126.