The Recall Desk

FDA (Devices) recall action 83240

Terumo Cardiovascular Systems Corporation recalled 4 products on 2019-08-07

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-08-07
Critical
0
Units
269

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling 78 Capiox NX19 Oxygenators exported to Japan and Belgium because they may contain a non-functioning arterial thermistor component.

    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
    Category
    Distribution
    1 state