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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

ConvaTec, Inc: ConvaTec CarboFlex Odor Control Dressings Recalled for Sterility Issues

Agency Publication Date: April 8, 2024
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Summary

ConvaTec, Inc. is recalling 63 market units of ConvaTec CarboFlex Odor Control Dressings because the product does not meet required sterility assurance levels. These 15cm x 20cm (6 in. x 8 in.) sterile dressings are used for wound care, and failure to meet sterility standards means the product could potentially be contaminated. Consumers should check for the specific lot numbers listed below to see if their dressings are part of this recall. You should contact your healthcare provider or the manufacturer immediately for instructions on how to handle affected products.

Risk

Using a medical dressing that is not properly sterile can introduce bacteria or other pathogens directly into a wound, significantly increasing the risk of developing a serious infection.

What You Should Do

  1. Check your ConvaTec CarboFlex Odor Control Dressing (15cm x 20cm / 6 in. x 8 in.) packaging for Order Number 403204.
  2. Verify the lot numbers on your individual dressing packages or market unit boxes. Affected lot numbers include 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
  3. Immediately stop using any dressings from the affected lots to avoid the risk of infection.
  4. 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.
  5. Contact the manufacturer, ConvaTec, Inc., to receive further instructions on how to return or dispose of the affected product and to inquire about a replacement or refund.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

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

Affected Products

Product: ConvaTec CarboFlex Odor Control Dressing, Sterile (15cm x 20cm, 6 in. x 8 in.)
Model / REF:
Order No. 403204
Recall #: Z-1495-2024
Lot Numbers:
3J00675
3J02320
3J02332
3L04811
4A00343

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94148
Status: Active
Manufacturer: ConvaTec, Inc
Manufactured In: United States
Units Affected: 63 market units
Distributed To: California, Missouri, New Mexico, Pennsylvania, Texas, 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.