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)
Reported: October 16, 2024 Initiated: September 13, 2024 #Z-0054-2025
Product Description
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)
Reason for Recall
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 120124 units
- 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.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Integra LifeSciences Corp.. Units affected: 120124 units.
Why was this product recalled? ▼
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0054-2025.
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