Field Safety Notice Medline Sterile Surgical Drapes and Gowns (ICN 3221)

NHSSC: 99

Alert:

• Medline has issued a Field Safety Notice for specific lots of sterile surgical drapes and sterile surgical gowns.
• Medline determined that one of its suppliers did not adequately document calibrations for sealing equipment and sterilisation-related sensors.
• As a result, although products underwent a validated sterilisation cycle, the accuracy of the sterilisation data cannot be verified, and the minimum sterility assurance level and the integrity of the sterile barrier over the intended shelf life cannot be assured.
• The sterility of the product is at risk in case of inadequate sealing and/or sterilisation methods, which may cause an increased risk of infection during procedures.

Products Affected:

• There are 66 affected products available from NHS Supply Chain.
• Please refer to the Field Safety Notice and product listing below for further information on the affected products and affected lots.
• Impacted lot numbers can be identified:
  • The two first digits of the lot number are the production year (25xxCxxx)
  • The fifth letter of the lot number must be C
  • Every lot produced before 2026 (lot numbers starting with 25 – 24 – 23 – 22 and 21) and having a C in the fifth position is concerned by this recall. For example, lot number 23AAC001 is concerned.
• All NHS Supply Chain stock is being checked and affected products quarantined. Future orders will be fulfilled with unaffected stock.
• Affected products will be subject to Protect Demand Management. Products given ‘Protect‘ status for Demand Management remain available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity, also known as ‘threshold’, to ensure fair supply of available stock across the whole of the NHS.
• NHS Supply Chain is working with suppliers to review product availability and alternatives. We will update this ICN when information is available.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected lots.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

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

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.