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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

Andover Healthcare Inc.: Sterile CoFlex NL Bandages Recalled Due to Potential Loss of Sterility

Agency Publication Date: May 15, 2024
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Summary

Andover Healthcare Inc. is recalling 108 cases (approximately 1,944 individual packages) of Sterile CoFlex NL Latex Free Flexible Cohesive Bandages. The recall was initiated because a gap in the packaging seal was discovered, which could compromise the sterility of the bandage. These tan-colored bandages, measuring 4 inches by 5 yards, were distributed to twelve states including California, Texas, and Pennsylvania.

Risk

A gap in the packaging seal allows the sterile product to be exposed to environmental contaminants. Using a non-sterile bandage on an open wound or surgical site significantly increases the risk of infection and subsequent medical complications.

What You Should Do

  1. Identify your product by checking the packaging for 'Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)'.
  2. Check the specific identification codes on the package: look for Batch 0031151359, Lot 10009897233, and UDI/DI 10724004641072.
  3. If your bandage matches the affected lot number, stop using it immediately and do not apply it to any wounds.
  4. Contact your healthcare provider or Andover Healthcare Inc. for further instructions regarding the disposal or return of the affected products and to discuss potential refunds.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer or healthcare provider

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

Affected Products

Product: Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Model / REF:
5400S
10724004641072
Lot Numbers:
0031151359
10009897233

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94394
Status: Active
Manufacturer: Andover Healthcare Inc.
Sold By: Distributors
Manufactured In: United States
Units Affected: 108 cases (1,944 individual product packages)
Distributed To: California, Colorado, Georgia, Iowa, Indiana, Ohio, Minnesota, North Carolina, Pennsylvania, Texas, Virginia, Washington

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.