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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

Atrium Medical Corporation: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

Agency Publication Date: February 16, 2017
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Affected Products

Product: Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

All Lot Numbers With Expiration Date Prior To December 2019

Lot Numbers:
Numbers
Product: Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

All Lot Numbers With Expiration Date Prior To December 2019

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76138
Status: Resolved
Manufacturer: Atrium Medical Corporation
Manufactured In: United States
Units Affected: 2 products (660 cases (10/case); 1394 cases (10/case))

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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.