Recall Z-0054-2025 ยท FRO Dressing, Wound, Drug
Integra LifeSciences Corp.
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
| Date | Oct 10, 2024 (initiated Sep 13, 2024) |
| Status | Open, Classified |
| Reason | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION letter dated 9/13/24 was sent to customers. Actions to be Taken by Customers (Medical Facility): 1. Complete the Medical Facility Acknowledgement Form below. 2. If you do have units of the impacted product (Table 1) remove the applicator immediately from service and discard it. 3. 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. 4. Return the Medical Facility Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a |
| Quantity | 120124 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY Derma Sciences, Inc., Apr 23, 2008 |