MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)
Summary
The FDA issued a Class II for MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPL by Integra LifeSciences Corp.. Reason: There is a potential for pinholes in the applicator pouch film which creates a sterility concern..
Details
Source
Device Recall
External ID
Z-0054-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
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)
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.
Quantity Affected: 120124 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-13
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0054-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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