Medihoney Wound and Burn Products Recalled Due to Potential Sterility Breach

What Happened

Health Canada has announced a recall of Medihoney® wound and burn products manufactured by Derma Sciences, Inc. During an investigation, packaging failures were identified in sterile products that could lead to a breach in the sterile barrier. Additionally, for non-sterile products, Integra Lifesciences identified inadequately controlled manufacturing processes that could result in inadequate packaging.

Which Products Are Affected

The recall involves multiple Medihoney® products. While there are more than 10 lot numbers affected for each item, the specific model/catalogue numbers are listed below:

• Medihoney® Derma Cream: Model 597
• MediHoney® Leptospermum Honey Tube: Model 405
• Medihoney® With Active Leptospermum Honey: Model 795
• Medihoney® With Active Leptospermum Honey: Model 794
• Medihoney® With Active Leptospermum Honey: Model 796
• Medihoney® With Active Leptospermum Honey: Model 793
• Medihoney® Barrier Cream: Model 800
• Medihoney® Barrier Cream: Model 582

What You Should Do

Consumers and healthcare providers should identify if they possess any of the affected model numbers. Because there are numerous lot numbers involved, consumers are advised to contact the manufacturer, Derma Sciences, Inc., at their Toronto office for specific details regarding affected lots and instructions for returns or replacements.

Contact Information: Derma Sciences, Inc. 104 Shorting Road, Toronto, Ontario, Canada, M1S 3S4

Why This Matters

A breach in the sterile barrier of wound care products can introduce contaminants to a wound site, potentially leading to infections or other serious health complications. Proper packaging is essential to ensure the safety and efficacy of medical-grade honey products used in burn and wound management.

Source

Health Canada Recall Alert