Device product
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Z-1363-2026
Product summary
- Event
- Event 98175
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,367 units
- Official record key
device-enforcement:Z-1363-2026
Official wording
Reason: Potential packaging failures, which could lead to a breach in the sterile barrier.
Code information: 1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.
Distribution pattern: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).
Derived failure modes
-
Sterility assurance
breach in the sterile barrier