CVS, MediHoney Wound and Burn Gel Recall Issued Due to Infection Risks: FDA

Packaging errors could compromise sterility and contaminate certain wound and burn care products made by Integra LifeSciences.

Federal officials are advising customers to immediately stop using certain lots of CVS wound gel and MediHoney wound and burn products manufactured by Integra LifeSciences, following more than a dozen infections that may have resulted from contaminated packages.

The U.S. Food and Drug Administration (FDA) announced the CVS and MediHoney recall on January 22, noting manufacturing defects that may cause packaging failures to compromise sterility, potentially allowing bacterial contamination.

The affected products are used to treat burns and wounds by maintaining a moist wound environment and protecting the skin from breakdown, irritation and damage. However, if the product is not sterile and becomes contaminated with bacteria, its use could increase the risk of infection.

Wound Care Contamination Lawsuits

The concerns surrounding Integra LifeSciences’ wound and burn gels follow a similar pattern seen in a prior Nurse Assist recall involving sterile water and saline products commonly used to clean wounds, which were pulled from the market after packaging failures raised questions about sterility.

Following that recall, multiple Nurse Assist infection lawsuits have brought by patients who reported serious, and sometimes life-threatening, complications after using allegedly contaminated wound care products marketed for clinical and home use. Attorneys nationwide are now investigating similar infection claims tied to recalled or allegedly contaminated wound care products.

Wound and Burn Gel Recall

The manufacturer of the recalled CVS and MediHoney wound care products is Integra LifeSciences, who has received reports of of at least 11 serious injuries linked to affected MediHoney products and three serious injuries linked to CVS wound gel products.

Due to the potentially high-risk issue, the following products are included in the recall:

• CVS Wound Gel 1-oz (28.4 g) tubes packaged 24 cartons per case
• MediHoney Calcium Alginate Dressings in 4×5‑inch and 2×2‑inch sizes
• MediHoney Gel in 0.5‑fl‑oz twist‑off sterile tubes
• MediHoney Gel in 1.5‑fl‑oz flip‑cap sterile tubes
• MediHoney Calcium Alginate Dress Ropes in ¾×12‑inch size

Affected customers were notified by letter on January 16, instructing them that the products should not be used and that all impacted items should be removed immediately from service and quarantined. Expired products should also be discarded in accordance with facility policies and procedures.

Distributors are being instructed to remove affected products from further distribution, review customer traceability records, and notify any customers who may have received affected products. 

In addition, distributors should modify the manufacturer’s acknowledgement form and send that to their customers. Then, they should collect completed response forms and any returned products, indicating total quantities and lot numbers on the distributor reply form. 

The notice should be forwarded to those who use the product so they are aware of the alert and can identify any potentially compromised products that may remain in clinical areas.

For more information, customers can contact Integra LifeSciences at 1-800-654-2873 or custsvcnj@integralife.com.

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