Field Safety Notice Integra Sciences MediHoney® Wound and Burn Products (ICN 3049)

NHSSC: 57

Alert:

• Integra Sciences has issued a Field Safety Notice having identified packaging failures related to the MediHoney® Wound and Burn product range, which could lead to a breach in the sterile barrier.
• The potential issues include:
  • Inadequate sealing of sterile barrier packaging
  • The shipping boxes not adequately protecting devices during transportation
  • The tube twist-off cap failing.
• The potential harm is infection if a non-sterile product is used on a patient. Additionally, the inability to use the device due to packaging failures may cause inconvenience to the user and prolong/delay the procedure.
• Integra Sciences advise there are no long-range health consequences expected due to these potential issues.

Products Affected:

• 11 of the affected products have previously been available from NHS Supply Chain.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.

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 products.
• Complete the Customer reply Form, page 4 of the notice, whether you have products or not, and return to emea-fsca@integralife.com.
• Where you have affected units available for return, Integra Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product(s). If the products can be discarded, Integra will provide a certificate of destruction for completion.
• Expired products should be destroyed following your normal protocol.
• Where unexpired product has been notified, please also contact your local NHS Supply Chain Customer Service 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.
• On confirmation of collection by Integra, or proof of destruction, quoting your 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 Hospital Care 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.