Reported Aug 7, 2019 · Terminated
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315
Is this the product you have?
- Terumo Capiox
- NX19 Oxygenator (West Orientation P/NCXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
- Lot codes and dates
- Lot Numbers
XA21XA29XC04XC18XD05XD27
- Lot Numbers
- Amount recalled
- 123 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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