Maquet recalls QUADROX-iD Pediatric Oxygenators due to packaging pinholes that could allow non-sterile exposure, risking infection and sepsis. 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 pediatric 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 serious health issues.
The packaging has small pinholes that aren't easily seen. If non-sterile materials enter the sterile packaging, it could lead to infections, sepsis, or tissue damage in patients during surgery.
Patients undergoing heart surgery using this specific oxygenator model are most at risk. Healthcare providers using the device in hospitals may also be affected.
Check for model numbers BEQ-HMOD30000-USA with item numbers 701070397 or 701050330. All lots of this oxygenator are affected.
Inspect the packaging for small pinholes that may not be visible to the naked eye.
The recall does not state that the device is safe to use; it has a packaging issue that could lead to infection risks.
Check for model numbers BEQ-HMOD30000-USA with item numbers 701070397 or 701050330. All lots of this oxygenator are affected.
The recall does not specify a remedy, so contact Maquet Medical Systems 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-1658-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1658-2023 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.
