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Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)
Recalled October 16, 2024 · FDA recall Z-0054-2025 · Integra LifeSciences
Hazard
There is a potential for pinholes in the applicator pouch film which creates a sterility concern. · FDA Class II
Units
120124 units
Sold at
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.
Description
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
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)
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →