Device product
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)
Z-0054-2025
Product summary
- Event
- Event 95397
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120124 units
- Official record key
device-enforcement:Z-0054-2025
Official wording
Reason: There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Code information: Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.