Terumo recalls specific Japanese-exported Capiox NX19 Oxygenators due to potential non-functioning arterial thermistor. Affected units sold only in Japan with lot numbers XA28, XC12, XC25, XD05, XD27.
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Terumo is recalling certain Japanese-exported Capiox NX19 Oxygenators because they may have a non-functioning arterial thermistor. This could affect medical safety during use. Affected units have specific lot numbers and were sold only in Japan.
The oxygenator may have a thermistor that doesn't work properly, which could lead to incorrect temperature readings during medical procedures. This might cause unsafe conditions for patients.
Medical professionals using the recalled oxygenators in Japan are most at risk. The recall applies only to units sold within the Japanese market with specific lot numbers.
Check for the model name 'Capiox NX19 Oxygenator (East Orientation)' with part number CXOT280. Affected units were exported only to Japan and have lot numbers XA28, XC12, XC25, XD05, or XD27.
Verify the part number CXOT280 and lot numbers XA28, XC12, XC25, XD05, or XD27 for affected units.
The recall is due to potential non-functioning arterial thermistor components that could affect medical safety during use.
No, these units were exported only to Japan for use in convenience kits sold within the Japanese market.
The official recall record does not specify a remedy, so check with Terumo directly for guidance.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2103-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2103-2019 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
