FDA-Device2024-10-16Class II
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)
Integra LifeSciences Corp.
Hazard
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Sold states
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.
Affected count
120124 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0054-2025Don't want to check this manually?
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