Terumo recalls CAPIOX FX25 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak risk from improperly bonded arterial thermistor components.
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 FX25 Hollow Fiber Oxygenators with catalog numbers 3CX*FX25REC and 3CX*FX25RWC. The recall is due to a possible leak at the arterial thermistor connection point, which could cause complications during medical use.
The oxygenator may have an arterial thermistor component that is improperly bonded to the oxygenator port. This improper bonding can lead to a leak at that specific connection point, potentially causing complications during medical use.
Patients using these oxygenators for medical treatment are affected. Healthcare providers who use the product are at risk of potential leaks during medical procedures.
Check for catalog numbers 3CX*FX25REC or 3CX*FX25RWC on the oxygenator. The product was sold with UDI-DI: (01)00699753450868 and lot number AM03.
Verify the catalog number on your CAPIOX FX25 Hollow Fiber Oxygenator to confirm if it is affected.
The recalled models are CAPIOX FX25 Hollow Fiber Oxygenators with catalog numbers 3CX*FX25REC and 3CX*FX25RWC.
The recall record does not mention a remedy or fix for this issue.
Check for catalog numbers 3CX*FX25REC or 3CX*FX25RWC on the oxygenator. The product was sold with UDI-DI: (01)00699753450868 and lot number AM03.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1347-2023 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1347-2023 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.
