Product Recall  from Integra LifeSciences

This voluntary recall has been initiated by Integra LifeSciences for the following reasons:

• During an Investigation, packaging failures were identified related to the MediHoney®
  Wound & Burn products, which could lead to a breach in the sterile barrier.
  
• Across all affected MediHoney products, 17 complaints have been received worldwide
  from 01-Jan-2020 to 25-Sep-2025. Out of the 17 complaints, eleven (11) complaints
  were reported as serious injuries including infections and skin reactions.

Note: This recall should be carried out to the retail and user level.
*All MediHoney® Wound &Burn Products are now to be recalled at the date of this communication

MediHoney Products

This voluntary recall has been initiated due packaging failures and 17 worldwide complaints, 11 of which were reported as serious injuries, including infections and skin reactions.

Status : Open

Please review the instructions below and submit your response(s) to Performance Health.

Return Instructions

1. Immediately discontinue use of the product affected by this recall and return any unused
   product.
2. If you have used the product and have signs of wound infection, follow-up with your medical
   provider.
3. If you experience an injury or adverse event, please report it to the manufacturer and the
   FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax.
   Online: www.fda.gov/medwatch/report.htm
4. Complete the Patient/End User Acknowledgement Form provided.
   
   1. If you have united of the impacted product (Table 1), remove them immediately from
      service and quarantine them.
   2. If you have affected product, check the box “I do have affected product.” Record the lot
      number and total quantity of the affected product that you have.
   3. If you DO NOT have affected product, check the box, “I do not have affected product.”
5. Forward this notice to those who utilize the product so they are aware of this recall and can
   identify any affected product that may remain in clinical areas.
6. Complete the included response form and submit to Quality@PerformanceHealth.com or complete the form below and submit.
   
   1. Keep a copy of the response form if not using the below form for your records.

Where to find your Lot #