Device product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.
Z-2508-2025
Product summary
- Event
- Event 97404
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 994 units
- Official record key
device-enforcement:Z-2508-2025
Official wording
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Code information: Model/Catalog Numbers: (1) 31720, (2) 31740; UDIs: (1) 10381780471417, (2) 10381780471424; lot #s: (1) 14422, 33324, 11524, 10224, (2) 23124, 42423;
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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.
Derived failure modes
-
Sterility assurance
breach in the sterile barrier