Maquet recalls QUADROX-i Pediatric Oxygenators with packaging pinholes that may allow non-sterile exposure, risking infection. Affected units include specific model numbers and lots sold globally.
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 may have tiny pinholes that aren't visible to the naked eye. This could let non-sterile materials enter the device, causing infections or serious health issues.
The packaging may have small pinholes that aren't visible without help. If these pinholes allow non-sterile materials to enter the device, it could cause infections, inflammation, or serious complications like sepsis.
Parents and healthcare providers using the QUADROX-i Pediatric Oxygenator during cardiopulmonary bypass surgery are most at risk. The recall affects specific model numbers and lots sold globally.
Check for model numbers HMO 30000-USA (701070384) or HMO 31000-USA (701070388) on the packaging. All lots of these models are affected.
Look for small pinholes in the packaging that may not be visible to the naked eye.
The packaging may have small pinholes that aren't visible to the naked eye, which could allow non-sterile materials to enter the device, risking infection.
Check the packaging for small pinholes that may not be visible to the naked eye. If found, contact Maquet for guidance.
Yes, model numbers HMO 30000-USA (701070384) and HMO 31000-USA (701070388) are affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1655-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1655-2023 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.
