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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

Windstone Medical Packaging, Inc.: AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.; AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Agency Publication Date: December 4, 2015
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Affected Products

Product: AMS 4674 Custom Pack. For use in a general clinical procedure.

Lot 84370, expiration date: 2/28/2017

Lot Numbers:
84370
Product: AMS 4675 Angio Pack. For use in a general clinical procedure.

Lot 84371, expiration date: 2/28/2017

Lot Numbers:
84371

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72604
Status: Resolved
Manufacturer: Windstone Medical Packaging, Inc.
Manufactured In: United States
Units Affected: 2 products (40 kits)

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.

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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 · 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.