Z-1168-2025 Class II Ongoing
FDA device recall Z-1168-2025 was initiated by Integra LifeSciences Corp. on January 10, 2025 and is designated Class II. Reason for recall: Potential that the induction seal is not completely sealed to the device tube packaging. The recall status is ongoing. Affected quantity: 12,166 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- January 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,166 units
Product Description
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No
Reason for Recall
Potential that the induction seal is not completely sealed to the device tube packaging.
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, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.
Code Information
Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;