Devices

Alert on Compromised Wound/Burn Dressings

FDA has issued an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra LifeSciences, citing packaging failures that could compromise product sterility and lead to patient infections. The alert covers all MediHoney Wound and Burn products and select lots of CVS Wound Gel. According to FDA, Integra LifeSciences has instructed affected customers to immediately remove the products from use or sale and quarantine remaining inventory.

Integra identified production and process control issues affecting the CVS Wound Gel, the alert says. Users may be unable to safely use the products if packaging integrity has been compromised.

The alert says the issue involves failures in product packaging that could result in a breach of the sterile barrier. Use of products with compromised sterility could increase the risk of infection, while the inability to use the devices due to packaging problems could delay patient care, it says.

The products are commonly used to treat burns and wounds by maintaining a moist wound environment and protecting skin from breakdown or irritation.

As of last month, Integra has reported 11 serious injuries associated with the wound products.

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