Terumo recalls Capiox FX25 Advance Oxygenators with incorrect East/West configuration for heart surgery. This may cause improper gas exchange during cardiopulmonary bypass. Affected units have specific catalog numbers and lot numbers.
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
Terumo is recalling Capiox FX25 Advance Oxygenators that may have the wrong East or West configuration. This could lead to improper gas exchange during heart surgery, which is critical for patient safety.
The oxygenator may be configured incorrectly for East or West use. This could cause improper gas exchange between blood and the gaseous environment during cardiopulmonary bypass surgery, potentially affecting patient safety.
Heart surgery patients and medical teams using the Capiox FX25 Advance Oxygenators. Those with the specific catalog numbers (3CX*FX25RWC or 3CX*FX25REC) and lot numbers (YD16 or YD23) are most at risk.
Check for catalog numbers: 3CX*FX25RWC (West) or 3CX*FX25REC (East). Also look for lot numbers YD16 or YD23. These units are intended for heart surgery procedures.
Verify the catalog number and lot number to confirm if your unit is affected. The affected units have specific catalog numbers and lot numbers.
The Capiox FX25 Advance Oxygenators may have the incorrect East or West configuration, which could lead to improper gas exchange during heart surgery.
Incorrect configuration may cause improper gas exchange during cardiopulmonary bypass surgery, potentially affecting patient safety.
Check for catalog numbers: 3CX*FX25RWC (West) or 3CX*FX25REC (East), and lot numbers YD16 or YD23.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-0565-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-0565-2021 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.
