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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/Surgical Equipment

Cook Approach CTO Micro Wire Guides Recalled for Incorrect Expiration Dates

Agency Publication Date: November 21, 2024
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Summary

Cook Incorporated has recalled 10 units of the Approach CTO Micro Wire Guide (Model RPN CMW-14-190-25G). These devices were labeled with incorrect expiration dates, which may lead to the use of the product beyond its validated shelf life. No incidents or injuries have been reported to date. Consumers should stop using the affected wire guides immediately and contact the manufacturer to coordinate a return or replacement.

Risk

Incorrect expiration dates can lead to the use of a device that is no longer sterile or mechanically sound. This poses a moderate risk of infection or procedural complications if the device fails during use.

What You Should Do

  1. This recall affects Approach CTO Micro Wire Guides (Model RPN CMW-14-190-25G, GPN G50789) with UDI-DI 00827002507890.
  2. Identify affected products by checking for lot numbers NS15635381, NS15618280, NS15466311, NS15212224, or NS14992020 on the device packaging.
  3. Stop using the recalled device. Contact Cook Incorporated or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Approach CTO Micro Wire Guide
Model / REF:
RPN CMW-14-190-25G
GPN G50789
Lot Numbers:
NS15635381
NS15618280
NS15466311
NS15212224
NS14992020
UDI:
00827002507890

Quantity: 10 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95582
Status: Active
Manufacturer: Cook Incorporated
Sold By: Specialized medical distributors
Manufactured In: United States
Units Affected: 10 units

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.