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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

MEDLINE INDUSTRIES, LP - Northfield: Waterproof Wound Tracking Dressings Recalled for Sterility Failure

Agency Publication Date: March 14, 2024
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Summary

Medline Industries is recalling 37,368 boxes of CVS Health Waterproof Wound Tracking Dressings because the product failed sterility testing. These 4-inch by 4-inch dressings, which are intended to provide a sterile environment for wounds, may be contaminated and pose a risk of infection. The affected boxes contain four dressings each and were sold in various states including California, Florida, New York, and Texas. Consumers should immediately stop using these dressings and contact their healthcare provider or the manufacturer.

Risk

The dressings failed testing designed to ensure they are free from bacteria and other microorganisms. Using a non-sterile dressing on an open wound can introduce contaminants directly into the body, significantly increasing the risk of serious skin or systemic infections.

What You Should Do

  1. Identify your product by checking the packaging for 'CVS Health Waterproof Wound Tracking Dressing' (REF CVS690330) in the 4 in. x 4 in. size.
  2. Check the box for the following specific lot numbers: 10322040003, 10322050003, 10322070006, or 10322100002.
  3. Verify the barcode number (UDI-DI) 0500428645208 located on the packaging.
  4. Immediately stop using any dressings from these affected lots to prevent the risk of infection.
  5. Contact your healthcare provider if you have used these dressings on a wound and notice signs of infection, such as increased redness, swelling, or heat.
  6. Contact Medline Industries at 1-800-633-5463 for further instructions and information regarding a potential refund.
  7. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer and Healthcare consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CVS Health Waterproof Wound Tracking Dressing (4 in. x 4 in., 4 dressings per box)
Model / REF:
REF CVS690330
UDI-DI 0500428645208
Lot Numbers:
10322040003
10322050003
10322070006
10322100002

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94036
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: CVS Health
Manufactured In: United States
Units Affected: 37,368 boxes
Distributed To: Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.