Device product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, 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-2510-2025
Product summary
- Event
- Event 97404
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1147 units
- Official record key
device-enforcement:Z-2510-2025
Official wording
Reason: Packaging failures were identified which could lead to a breach in the sterile barrier.
Code information: Model/Catalog Numbers: (1) 31722, (2) 31744; UDIs - (1) 10381780471387, (2) 10381780471394; Lot #s: (1) 44422, 14223, (2) 50423, 12523;
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