FDA: CVS and MediHoney wound gels recalled after 14 serious injuries
Multiple wound and burn gel products are being removed from where they are used or sold, after it was discovered that a packaging failure was leading to the sterile barrier being breached. Unfortunately, this has led to at least 14 serious injuries.
The manufacturer of the gels, Integra LifeSciences, issued a letter to distributors of the products, branded as MediHoney and CVS Wound Gel. The products are sold in retail settings, but also may be found in patient care settings.
In a statement, the U.S. Food and Drug Administration (FDA) said it’s aware of the issue and provided the known details. The agency said it has determined that using wound gels with the defective packaging may “cause temporary or reversible health problems, or—though unlikely—serious health problems.”
Despite the risk of severe infection and the recorded injuries, there are no known deaths associated with the recalled wound gels.
These products are used to treat wounds and burns, protecting the skin and promoting healing by keeping the affected area moist. They also provide a barrier that helps to mitigate further damage to skin.
It’s imperative that the gels remain sterile. Given the dangers of contamination due to the inadequate safety materials on the packaging, the gels are subjected to an emergency recall.
What is being recalled?
The FDA provided the following chart to identify the Integra LifeSciences wound gels that have been deemed dangerous. All of the below products are subject to a recall.
| Product Name | SKU Number | UDI-DI | Lots |
|---|---|---|---|
| MEDIHONEY CALCIUM ALGINATE DRESS ROPE, ¾” X 12” | 31012 | 10381780486909 | All |
| MEDIHONEY CALCIUM ALGINATE DRESSING, 2” X 2” | 31022 | 10381780486916 | All |
| MEDIHONEY CALCIUM ALGINATE DRESSING, 4” X 5” | 31045 | 10381780486923 | All |
| MEDIHONEY GEL IN TUBE, .5 FL OZ TWISTOFF – STERILE | 31805 | 10381780486978 | All |
| MEDIHONEY GEL IN TUBE, 1.5 FL OZ FLIPCAP – STERILE | 31815 | 10381780486886 | All |
| CVS WOUND GEL 1 OZ. TUBE (28.4 g) 24 CARTONS/CASE | CVS405406 | 00050428452547 | 2446 2428 |
Next steps
Once identified using the above information, the wound gels must be isolated to ensure they are not used or distributed.
In a letter sent on Jan. 16, Integra LifeSciences said healthcare facilities and provider offices should discard the wound gels in accordance with internal policies for the disposal of medical products.
The company said distributors should check their records and notify their customers of the recall. Acknowledgement forms were provided for distributor returns, and these forms can be modified for customers as well, per instruction provided in Integra LifeSciences.
Those with questions are advised to contact the company at 1-800-654-2873 or by emailing [email protected].
The FDA is asking that the recall notice be shared to increase visibility. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.