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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

Terumo Cardiovascular Systems Corporation: Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.

Agency Publication Date: March 14, 2017
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Affected Products

Product: Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.

Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.

Lot Numbers:
Numers
Product: Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.

Level Sensor II Gel Pads, Catalog No. 217390, UDI No: 00886799000519, Lot Numers Ranging from 782300 through 817488, Manufactured from 19-Nov-2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016.

Lot Numbers:
Numers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76458
Status: Resolved
Manufacturer: Terumo Cardiovascular Systems Corporation
Manufactured In: United States
Units Affected: 2 products (208,560; 3,794)

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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.