Class 2 Device Recall MediHoney Gel

• Date Initiated by Firm: January 10, 2025
• Date Posted: February 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1168-2025
• Recall Event ID: 96109
• 510(K)Number: K101793
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No
• Code Information: Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Mary O'Neill; 1-640-8679411
• Manufacturer Reason for Recall: Potential that the induction seal is not completely sealed to the device tube packaging.
• FDA Determined Cause: Process control
• Action: On January 10, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers (Medical Facility): 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have units of the affected product (Table 1), remove them immediately from service and quarantine them. 3. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 4. 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. 5. Complete and return the Medical Facility Acknowledgement Form to FCA3@integralife.com or FAX to 1-609- 750-4220. 6. Keep a copy of the form for your records. 7. When the form from you is received, and it is noted that you have affected product, Customer Service will contact you and provide an RMA number and directions to return the product. You can request a credit for the quantities returned. Actions to be Taken by Distributors: 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have the affected product (Table 1), remove the product from further distribution. 3. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. 4. Please check your customer traceability records for shipments of above catalog and lot numbers. 5. Forward this notice to any of your customers that have purchased the affected product (Table 1). 6. Complete and return the Distributor Acknowledgement Form to FCA3@integralife.com or FAX to 1-609-750- 4220. 7. Keep a copy of the form for your records. 8. When the form from you and/or your customer is received, and it is noted that you and/or your customer has affected product, Customer Service will contact you and/or your customer and provide an RMA n
• Quantity in Commerce: 12,166 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRO