Terumo recalls CAPIOX NX19 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak at arterial thermistor connection. Affected units may need repair or replacement.
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Terumo is recalling CAPIOX NX19 Hollow Fiber Oxygenators that may have a leak at the arterial thermistor connection. This could lead to oxygenator failure during medical use, posing a risk to patients.
The oxygenator may leak due to an improperly bonded arterial thermistor component. This leak could cause the oxygenator to fail during medical use, potentially harming patients.
Patients using this oxygenator for medical treatment are most at risk. Healthcare facilities that use the affected model numbers should check their inventory.
Check for the catalog number 3CX*NX19RE on the oxygenator. The UDI-DI code (01)00699753450868 and lot number AM03 are also associated with this recall.
Inspect the oxygenator for signs of leakage at the arterial thermistor connection.
Reach out to Terumo Cardiovascular Systems Corporation for guidance on next steps.
The recalled model is CAPIOX NX19 Hollow Fiber Oxygenator with catalog number 3CX*NX19RE.
Check for the catalog number 3CX*NX19RE, UDI-DI code (01)00699753450868, or lot number AM03.
The recall does not require immediate stop use; however, checking for leaks and contacting Terumo is recommended.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2023 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1346-2023 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.
