Maquet recalls QUADROX-i Small Adult Oxygenators with potential packaging pinholes that could allow non-sterile exposure, risking infection. Affected units include specific model numbers and lots.
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-i Small Adult Oxygenators used during heart surgery because their packaging might have tiny pinholes that aren't visible to the naked eye. This could let non-sterile materials get inside, causing infections or other serious health issues.
The oxygenator packaging may have small pinholes that aren't visible without help. If these pinholes let non-sterile materials get inside, it could cause infections, inflammation, sepsis, or tissue damage.
Healthcare professionals using the QUADROX-i oxygenators during cardiopulmonary bypass procedures are most at risk. Patients undergoing heart surgery with this device could be affected if the packaging is compromised.
Check for model numbers BEQ-HMO 50000-USA (lot 701067905), BEQ-HMO 50000-USA (lot 701067891), or BEQ-HMO 51000-USA (lot 701067895) on the packaging. All lots of these models are affected.
Inspect the packaging for small pinholes that may not be visible to the unaided eye.
Yes, exposure to non-sterile materials could lead to infection, inflammation, sepsis, or tissue damage.
Check for model numbers BEQ-HMO 50000-USA (lot 701067905), BEQ-HMO 50000-USA (lot 701067891), or BEQ-HMO 51000-USA (lot 701067895) on the packaging.
The recall record does not specify a remedy for this issue, so contact Maquet Medical Systems USA for guidance.
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-1657-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1657-2023 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.
