Maquet recalls QUADROX -i neonatal oxygenators with packaging pinholes that could allow contamination. Affected units may cause infection or sepsis if sterile barrier is compromised.
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 neonatal oxygenators used during heart and lung surgery because packaging may have tiny pinholes invisible to the naked eye. These pinholes could let non-sterile materials enter the packaging, risking infection or sepsis for babies.
The packaging for the oxygenator may have small pinholes that aren't visible without help. If these pinholes let non-sterile materials get inside, they could cause infection, sepsis, or tissue damage in newborns.
Parents or caregivers of newborns using this oxygenator during heart or lung surgery are most at risk. The affected units are those with specific model numbers and serial codes listed in the recall.
Check for model numbers HMO 10000-USA (701070412) or HMO 11000-USA (701070416) on the packaging. These units were sold with specific serial codes and are part of the recall.
Look for small pinholes in the packaging that might not be visible to the naked eye.
The packaging may have small pinholes that aren't visible to the naked eye, which could compromise the sterile barrier and lead to infection or sepsis in newborns.
The recall does not specify a remedy, so contact Maquet Medical Systems USA directly for guidance.
Check for model numbers HMO 10000-USA (701070412) or HMO 11000-USA (701070416) on the packaging. These units were sold with specific serial codes and are part of the recall.
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-1660-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1660-2023 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.
