Moderate riskFDA DeviceClass II

Private Label CVS wound care product recalled for packaging failure risk

CVS Private Label wound care gel (model CVS405406) may have packaging defects that could compromise the sterile barrier protecting the product. This affects specific lot numbers and could allow contamination of the gel used for minor burns, cuts, and abrasions.

From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls

What to do

  1. Check if you have model CVS405406 with lot numbers 2428, 2446, 2509, or 2514
  2. Do not use the product if you have an affected lot
  3. Contact CVS or Integra LifeSciences for instructions on return or disposal
  4. Use an alternative wound care product for minor cuts and burns

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
2,906 units
Illnesses reported
None reported
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Classification
Class II
Recall number
Z-1365-2026

In the FDA's words

Description
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions. Potential packaging failures, which could lead to a breach in the sterile barrier. Model Number: CVS405406; UDI-DI: 00050428452547; Lot Numbers: 2428, 2446, 2509, 2514. Distribution: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.). Affected quantity: 2,906 units
Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.

3 products in this recall

MediHoney and CVS wound dressings recalled for packaging failure

Integra LifeSciences is recalling three wound dressing products, including MediHoney Gel, MediHoney Calcium Alginate, and a CVS private label dressing. The packaging may fail, which could break the sterile barrier and let the dressing become contaminated. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

SterilityMedical devicesSold nationwideMore from FDA Device