The Food and Drug Administration (FDA) has issued a recall of several wound and burn care products, including MediHoney and CVS brands, due to packaging failures that may compromise sterility.
In a notice published March 6, the FDA said the defects could compromise the sterility barrier and increase infection risk for patients.
The total number of impacted units remains unclear. The recall affects MediHoney Calcium Alginate Dress Rope, MediHoney Calcium Alginate Dressing in two different sizes, and two versions of MediHoney Gel in tubes.
CVS Wound Gel in 1 oz. tubes from lots 2446 and 2428 are also affected by the recall.
MediHoney Wound and Burn products and CVS Wound Gel are used for the treatment of burns and wounds. They help maintain a moist wound environment, protect skin from breakdown and irritation, or protect the skin from damage.
The FDA said use of the recalled products could cause temporary or reversible health problems, and in rare cases may lead to serious medical issues. Packaging failures identified by Integra LifeSciences in the MediHoney line could lead to infections or render the product unusable, potentially delaying patient care.
Similar production and process control issues were identified in CVS Wound Gel.
As of Dec. 19, Integra LifeSciences has reported 11 serious injuries related to MediHoney Wound and Burn products, three serious injuries related to CVS Wound Gel products. There are no deaths associated with the issue.
Integra LifeSciences sent a letter to customers on Jan. 16 recommending that users immediately remove affected products from service and quarantine them. Healthcare facilities were also advised to cease use and discard expired products in alignment with their facility’s standards.
Distributors were instructed to stop distribution, notify customers, and collect affected inventory.
