—#212018

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

FDA product code: FRO — Dressing, Wound, Drug
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K101793
Affected lot / code info: Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;

Why it was recalled

Potential that the induction seal is not completely sealed to the device tube packaging.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-01-10
Posted by FDA: 2025-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.