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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: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Agency Publication Date: July 30, 2019
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Affected Products

Product: Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

Lot Number: WP17

Lot Numbers:
Number
Product: Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

Lot Numbers: XAl 1, XA28, XC07

Lot Numbers:
Numbers
Product: Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

Lot Numbers: XA28, XC12, XC25, XD05, XD27

Lot Numbers:
Numbers
Product: Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83240
Status: Resolved
Manufacturer: Terumo Cardiovascular Systems Corporation
Manufactured In: United States
Units Affected: 4 products (16 units; 52units; 78 units; 123 units)

Were You Affected by This Recall?

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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.