Integra CVS Wound Dressing Recall Over Sterile Barrier Breach Risk
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. While no injuries or illnesses are reported in the source text, the potential sterile barrier breach in a wound care product poses a risk of infection, which aligns with the rubric criterion for FDA Class II recalls involving risk-of-harm products.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling 2,906 units of the Private Label CVS wound dressing, Model Number CVS405406. The product is intended to help maintain a moist wound environment and is used for minor scalds, burns, cuts, lacerations, and abrasions.
The recall is being issued due to potential packaging failures that could lead to a breach in the sterile barrier. A compromised sterile barrier may affect the product's sterility, posing a risk of infection to patients.
The affected units were distributed worldwide, including nationwide in the U.S. states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY, and in numerous countries including Australia, Canada, Germany, the United Kingdom, and others. The affected lot numbers are 2428, 2446, 2509, and 2514, with UDI-DI 00050428452547.
Healthcare facilities and consumers in possession of the recalled product should stop using it immediately and contact Integra LifeSciences for instructions on return or replacement. Questions may be directed to the recalling firm using the agency recall number Z-1365-2026.
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.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- sterile-barrier-breach
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model Number: CVS405406
- UDI-DI: 00050428452547
- Lot Numbers: 2428
- 2446
- 2509
- 2514.
Distribution
Distributed nationwide across the United States.
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