Terumo recalls CAPIOX RX15 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 RX15 Hollow Fiber Oxygenators that may have a leak at the arterial thermistor connection. This could cause bleeding or infection if the oxygenator is used in medical procedures.
The oxygenator may have an improperly bonded arterial thermistor component that leaks fluid at the connection point. This leak could lead to bleeding or infection during medical procedures.
Patients using the CAPIOX RX15 Oxygenator for medical procedures are most at risk. Healthcare providers who use this device should check if their unit is affected.
Check for the catalog number 3CX*RX15RE30 on the oxygenator. The unit was manufactured with Lot Number 2M10 and sold with UDI-DI (01)00699753450134.
Inspect the oxygenator for fluid leakage at the arterial thermistor connection point.
Reach out to Terumo Cardiovascular Systems Corporation for guidance on whether your unit is affected.
Check the catalog number on your oxygenator. If it's 3CX*RX15RE30 with Lot Number 2M10, it may be affected.
Inspect for leaks at the arterial thermistor connection. Contact Terumo for further instructions.
Look for the catalog number 3CX*RX15RE30 and Lot Number 2M10 on the device.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2023 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1345-2023 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.
