Recall Z-1168-2025 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp.
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 percent
| Date | Feb 12, 2025 (initiated Jan 10, 2025) |
| Status | Open, Classified |
| Reason | Potential that the induction seal is not completely sealed to the device tube packaging. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY Derma Sciences, Inc., Feb 22, 2011 |