Integra LifeSciences Corp.: 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)

Hazard

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

Details from the source

Reason for recall: There is a potential for pinholes in the applicator pouch film which creates a sterility concern. Distribution: 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. Quantity: 120124 units Lot/code info: Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.

UPC codes

10381780486824, 10381780486831

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.