Maquet recalls QUADROX-iD Adult Oxygenators with potential packaging pinholes that could allow contamination, risking infection during surgery. Affected units have specific model numbers and were sold in the U.S. between 2019-2020.
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling QUADROX-iD Adult Oxygenators used in heart surgery because their packaging might have tiny pinholes that could let non-sterile materials get inside. This could lead to infections or serious complications during surgery if the device is used without proper sterility.
The oxygenator packaging might have small pinholes invisible to the naked eye. If these pinholes allow non-sterile materials to enter the packaging, it could cause infections, inflammation, sepsis, or tissue damage during surgery.
Surgical teams using the QUADROX-iD Oxygenators for heart surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures with these specific models could be affected.
Check for model numbers HMOD 70000-USA with item numbers 701067840 or 701067859 on the packaging. These units were sold in the U.S. between 2019 and 2020.
Inspect the packaging for small pinholes that may not be visible without magnification. If found, stop using the device immediately.
The packaging may have small pinholes that could compromise sterility, risking infection during surgery.
Model numbers HMOD 70000-USA with item numbers 701067840 or 701067859.
Check for model numbers HMOD 70000-USA with item numbers 701067840 or 701067859 on the packaging. These units were sold in the U.S. between 2019 and 2020.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1656-2023 from Maquet Medical Systems. 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.
