Maquet recalls Quadrox-iD oxygenators due to packaging defects that could expose non-sterile materials, risking infection during heart surgery. All units are affected.
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling oxygenators used in heart surgery because packaging flaws might let non-sterile materials touch the device, causing infections. This affects all units sold.
Packaging defects like holes, cracks, or dents could break the sterile seal. This might let non-sterile materials touch the oxygenator, increasing infection risk during surgery.
Healthcare professionals using the oxygenator during heart surgery are most at risk. All units sold are affected.
The oxygenator model is BEQ-HMOD701067859. All units sold are affected, including those with UDI-DI: 04058863019024.
Look for holes, cracks, dents, or crushed areas in the packaging.
Yes, all units sold are affected.
Holes, cracks, dents, or crushed areas might break the sterile seal, risking infection.
No, but check packaging for damage before use.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1635-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1635-2023 from Maquet. 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.
